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Salsalate

Why is this medication prescribed?
Salsalate is used to relieve pain, tenderness, swelling, and stiffness caused by rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by a breakdown of the lining of the joints), and other conditions that cause swelling. Salsalate is in a class of nonsteroidal anti-inflammatory medications (NSAIDs) called salicylates. It works by stopping the body's production of a substance that causes pain, fever, and swelling.
How should this medication be used?
Salsalate comes as a tablet to take by mouth. It is usually taken two to three times a day. Salsalate may be taken with food or milk to prevent stomach upset. Take salsalate at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take salsalate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
It may take three to four days until you feel the full benefit of the medication. If your symptoms do not improve or get worse, call your doctor.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.



What special precautions should I follow?
Before taking salsalate,
tell your doctor and pharmacist if you are allergic to salsalate, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the ingredients in salsalate tablets. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: acetazolamide (Diamox); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); antacids; diuretics (''water pills'') such as furosemide (Lasix); lithium (Eskalith, Lithobid);medications for gout such as probenecid (Probalan) and sulfinpyrazone (Anturane); methazolamide; certain oral medications for diabetes such as chlorpropamide (Diabinese), glimepiride (Amaryl, in Avandaryl), glipizide (Glucotrol, in Metaglip),glyburide (Diabeta, Glynase, Micronase), tolazamide (Tolinase), and tolbutamide;certain medications for seizures such as phenytoin (Dilantin, Phenytek) and valproic acid (Depakene, Depakote); methotrexate (Trexall); penicillin (Veetids); salicylates such as bismuth subsalicylate (Kaopectate, Pepto-Bismol), choline magnesium trisalicylatecholine salicylate (Arthropan), diflunisal (Dolobid), and magnesium salicylate (Doan's, others); and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had any of the conditions in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); gout; kidney or liver disease; or swelling of the hands, feet, ankles or lower legs.
you should know that salsalate should not be taken by children and teenagers who have chicken pox, flu, flu symptoms, or who have received the varicella virus (chicken pox) vaccine in the past six weeks because of the risk of Reye's Syndrome (a serious condition in which fat builds up on the brain, liver, and other body organs).
tell your doctor if you are pregnant, especially if you are in the last few months of pregnancy; plan to become pregnant; or are breast-feeding. If you become pregnant while taking salsalate, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking salsalate.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.



What side effects can this medication cause?
Salsalate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
diarrhea
dizziness
Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:
ringing in the ears
loss of hearing
difficulty breathing or swallowing
shortness of breath
hoarseness
fast heartbeat
unexplained weight gain
swelling of the eyes, face, tongue, lips, throat, arms, hands, feet, ankles, or lower legs
rash
hives
blisters
itching
unusual bleeding or bruising
pale or cold skin
fever
nausea
headache
extreme tiredness
weakness
lack of energy
loss of appetite
pain in the upper right part of the stomach
yellowing of the skin or eyes
flu-like symptoms
cloudy, discolored, or bloody urine
back pain
difficult or painful urination
Salsalate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do if I forget to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
ringing in the ears
dizziness
headache
confusion
extreme tiredness
sweating
rapid breathing
extreme thirst
muscle cramps
fainting
flushing
loss of consciousness
What storage conditions are needed for this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking salsalate.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.



Important warning
People who take nonsteroidal anti-inflammatory medications (NSAIDs) (other than aspirin) such as salsalate may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, heart failure, a heart attack, or a stroke; if you smoke; and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.
If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take salsalate right before or right after the surgery.
NSAIDs such as salsalate may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, smoke, or drink large amounts of alcohol while taking salsalate. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; other NSAIDS such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking salsalate and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.
Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to salsalate. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with salsalate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Salmeterol Oral Inhalation

Why is this medication prescribed?
Salmeterol is used to treat wheezing, shortness of breath, and breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). It also is used to prevent bronchospasm (breathing difficulties) during exercise. Salmeterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
How should this medication be used?
Salmeterol comes as a dry powder to inhale by mouth using a specially designed inhaler. When salmeterol is used to treat asthma or COPD, it is usually used twice a day, in the morning and evening, about 12 hours apart. Use salmeterol at around the same times every day. When salmeterol is used to prevent breathing difficulties during exercise, it is usually used at least 30 minutes before exercise, but not more often than once every 12 hours. If you are using salmeterol twice a day on a regular basis, do not use another dose before exercising. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use salmeterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Talk to your doctor about how you should take your other oral or inhaled medications for asthma during your treatment with salmeterol. If you were taking a corticosteroid (a type of medication used to prevent airway swelling in patients with asthma), you doctor will probably tell you to continue taking it just as you did before you began using salmeterol. If you were using a short acting beta agonist inhaler such as albuterol (Proventil, Ventolin) on a regular basis, your doctor will probably tell you to stop using it regularly, but to continue to use it to treat sudden attacks of asthma symptoms. Follow these directions carefully. Do not change the way you use any of your medications without talking to your doctor.
Do not use salmeterol during an attack of asthma or COPD. Your doctor will prescribe a short-acting inhaler to use during attacks.
Salmeterol controls the symptoms of asthma and other lung diseases but does not cure these conditions. Do not stop using salmeterol without talking to your doctor. If you suddenly stop using salmeterol, your symptoms may worsen.
Before you use the salmeterol inhaler the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler while he or she watches.
To use the inhaler, follow these steps:
If you will be using a new inhaler for the first time, remove it from the box and the foil wrapper. Fill in the blanks on the inhaler label with the date that you opened the pouch and the date 6 weeks later when you must replace the inhaler.
Hold the inhaler in one hand, and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go until the mouthpiece appears and snaps into position.
Hold the inhaler in a level, horizontal position with the mouthpiece toward you. Slide the lever away from you as far as it will go until it clicks.
Every time the lever is pushed back, a dose is ready to inhale. You will see the number in the dose counter go down. Do not waste doses by closing or tilting the inhaler, playing with the lever, or advancing the lever more than once.
Hold the inhaler level and away from your mouth, and breathe out as far as you comfortably can.
Keep the inhaler in a level, flat position. Put the mouthpiece to your lips. Breathe in quickly and deeply though the inhaler, not through your nose.
Remove the inhaler from your mouth, and hold your breath for 10 seconds or as long as you comfortably can. Breathe out slowly.
You will probably taste or feel the salmeterol powder released by the inhaler. Even if you do not, do not inhale another dose. If you are not sure you are getting your dose of salmeterol, call your doctor or pharmacist.
Put your thumb on the thumbgrip and slide it back toward you as far as it will go. The device will click shut.
Never exhale into the inhaler, take the inhaler apart, or wash the mouthpiece or any part of the inhaler. Keep the inhaler dry. Do not use the inhaler with a spacer.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Other names
Serevent®




What special precautions should I follow?
Before using salmeterol,
tell your doctor and pharmacist if you are allergic to salmeterol, any other medications, milk protein, or any foods.
tell your doctor if you use another LABA such as fluticasone and salmeterol combination (Advair) or formoterol (Foradil). These medications should not be used with salmeterol. Your doctor will tell you which medication you should use and which medication you should stop using.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); clarithromycin (Biaxin); diuretics ('water pills'); HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); other medications for asthma or COPD; nefazodone; and telithromycin (Ketek). Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past 2 weeks: antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had irregular heartbeat, high blood pressure, hyperthyroidism (overactive thyroid), diabetes, seizures, or liver or heart disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using salmeterol, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.



What side effects can this medication cause?
Salmeterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
shaking of a part of your body that you cannot control
headache
nervousness
dizziness
cough
stuffed nose
runny nose
ear pain
pale skin
muscle pain, stiffness, or cramps
sore throat
throat irritation
flu-like symptoms
nausea
heartburn
tooth pain
dry mouth
sores or white patches in the mouth
red or irritated eyes
difficulty falling asleep or staying asleep
burning or tingling of the hands or feet
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
coughing, wheezing, or chest tightness that begins soon after you inhale salmeterol
fast or pounding heartbeat
chest pain
rash
hives
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
choking or difficulty swallowing
loud, high-pitched breathing
Salmeterol may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do if I forget to take a dose?
Skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
seizures
chest pain
dizziness
fainting
blurred vision
fast, pounding, or irregular heartbeat
nervousness
headache
shaking of a part of your body that you cannot control
muscle cramps or weakness
dry mouth
nausea
dizziness
excessive tiredness
lack of energy
difficulty falling asleep or staying asleep
What storage conditions are needed for this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away the inhaler 6 weeks after you remove it from the foil overwrap or after every blister has been used (when the dose indicator reads 0), whichever comes first. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.




Important warning
In a large clinical study, more patients with asthma who used salmeterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients with asthma who did not use salmeterol. If you have asthma, use of salmeterol may increase the chance that you will experience serious or fatal asthma problems.
Your doctor will only prescribe salmeterol if your asthma is so severe that two medications are needed to control it. You should never use salmeterol alone; you must always use it along with another asthma controller medication. Children and teenagers who need to be treated with salmeterol will probably be treated with a product that combines salmeterol and another medication in a single inhaler to make it easier for them to use both medications as prescribed.
Because of the risks of using salmeterol, you should only use salmeterol as long as it is needed to bring your asthma symptoms under control. Once your asthma is controlled, your doctor will probably tell you to stop using salmeterol but continue using the other asthma medication.
Do not use salmeterol if you have asthma that is quickly getting worse. Tell your doctor if you have had many severe asthma attacks or if you have ever been hospitalized because of asthma symptoms. If you have any of the following signs of worsening asthma, call your doctor immediately:
your short-acting inhaler (inhaled medication such as albuterol [Proventil, Ventolin] that is used to treat sudden attacks of asthma symptoms) does not work as well as it did in the past
you need to use more puffs than usual of your short-acting inhaler or use it more often
you need to use four or more puffs per day of your short-acting inhaler for two or more days in a row
you use more than one canister (200 inhalations) of your short-acting inhaler during an 8-week period
your peak-flow meter (home device used to test breathing) results show your breathing problems are worsening
you need to go to the emergency room for asthma treatment.
your symptoms do not improve after you use salmeterol regularly for one week or your symptoms get worse at any time during your treatment
Talk to your doctor about the risks of using this medication.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with salmeterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Salicylic Acid Topical

Why is this medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.
How should this medication be used?
Topical salicylic acid comes as a cloth (a pad or wipe used to cleanse the skin), cream, lotion, liquid, gel, ointment, shampoo, wipe, pad, and patch to apply to the skin or scalp. Topical salicylic acid comes in several strengths, including certain products that are only available with a prescription. Topical salicylic acid may be used as often as several times a day or as infrequently as several times a week, depending on the condition being treated and the product being used. Follow the directions on the package label or your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use salicylic acid exactly as directed. Do not use more or less of it or use it more often than directed on the package or prescribed by your doctor.
If you are using topical salicylic acid to treat acne, your skin may become dry or irritated at the beginning of your treatment. To prevent this, you may apply the product less often at first, and then gradually begin to apply the product more often after your skin has adjusted to the medication. If your skin becomes dry or irritated at any time during your treatment, you may apply the product less often. Talk to your doctor or check the package label for more information.
Do not swallow topical salicylic acid. Be careful not to get topical salicylic acid in your eyes, nose, or mouth. If you accidentally get topical salicylic acid in your eyes, nose, or mouth, flush the area with water for 15 minutes.
Do not apply topical salicylic acid to skin that is broken, red, swollen, irritated, or infected.
Only apply topical salicylic acid to the areas of skin that are affected by your skin condition. Do not apply topical salicylic acid to large areas of your body unless your doctor tells you that you should. Do not cover the skin where you applied topical salicylic acid with a bandage or dressing unless your doctor tells you that you should.
If you are using topical salicylic acid to treat acne or certain other skin condition, it may take several weeks or longer for you to feel the full benefit of the medication. Your condition may worsen during the first few days of treatment as your skin adjusts to the medication.
Read the package label of the topical salicylic acid product you are using very carefully. The label will tell you how to prepare your skin before you apply the medication, and exactly how you should apply the medication. Follow these directions carefully.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Other names
Akurza® Cream
Akurza® Lotion
Clearasil® Ultra Daily Face Wash
Compound W® products
DHS Sal® Shampoo
Dr. Scholl's® products
DuoPlant® Gel
Hydrisalic® Gel
Ionil® products
Mediplast® pads
MG217® products
Neutrogena® products
Noxzema® products
Oxy® Clinical Advanced Face Wash
Oxy® Maximum Cleansing Pads
P&S® Shampoo
Propa pH® Peel-Off Acne Mask
Salex® Cream
Salex® Lotion
Stri-Dex® products
Trans-Ver-Sal®



What special precautions should I follow?
Before using topical salicylic acid,
tell your doctor and pharmacist if you are allergic to salicylic acid or any other medications.
do not apply any of the following products to the skin that you are treating with topical salicylic acid unless your doctor tells you that you should: abrasive soaps or cleansers; skin care products that contain alcohol; other medications that are applied to the skin such as benzoyl peroxide (BenzaClin, BenzaMycin, others), resorcinol (RA Lotion), sulfur (Cuticura, Finac, others), and tretinoin (Retin-A, Renova, others); or medicated cosmetics. Your skin may become very irritated if you apply any of these products to the skin that you are treating with topical salicylic acid.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin, diuretics ('water pills'), and methyl salicylate (in some muscle rubs such as BenGay). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had diabetesor blood vessel, kidney, or liver disease.
you should know that children and teenagers who have chicken pox or the flu should not use topical salicylic acid unless they have been told to do so by a doctor because there is a risk that they may develop Reye's syndrome (a serious condition in which fat builds up on the brain, liver, and other body organs).
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using topical salicylic acid, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.



What side effects can this medication cause?
Topical salicylic acid may cause side effects. Tell your doctor if either of these symptoms are severe or do not go away:
skin irritation
stinging in the area where you applied topical salicylic acid
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
confusion
dizziness
extreme tiredness or weakness
headache
fast breathing
ringing or buzzing in the ears
hearing loss
nausea
vomiting
diarrhea
Topical salicylic acid may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do if I forget to take a dose?
Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra topical salicylic acid to make up for a missed dose.
What should I do in case of overdose?
If someone swallows salicylic acid or applies too much salicylic acid, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
confusion
dizziness
extreme tiredness or weakness
headache
fast breathing
ringing or buzzing in the ears
hearing loss
nausea
vomiting
diarrhea
What storage conditions are needed for this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know?
Keep all appointments with your doctor.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using topical salicylic acid.
If you are using prescription strength topical salicylic acid, do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
Ask your pharmacist any questions you have about topical salicylic acid.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Pilocarpine

Why is this medication prescribed?
Pilocarpine is used to treat dry mouth caused by radiotherapy in people with head and neck cancer and to treat dry mouth in people with Sjogren's syndrome (a condition that affects the immune system and causes dryness of certain parts of the body such as the eyes and mouth). Pilocarpine is in a class of medications called cholinergic agonists.It works by increasing the amount of saliva in the mouth.
How should this medication be used?
Pilocarpine comes as a tablet to take by mouth. When pilocarpine is used to treat dry mouth caused by radiotherapy in people who have head and neck cancer, it is usually taken three times a day. When pilocarpine is used to treat dry mouth in people who have Sjogren's syndrome, it is usually taken four times a day. Take pilocarpine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pilocarpine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on an average dose of pilocarpine and adjust your dose depending on how well your symptoms are controlled and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with pilocarpine.
Pilocarpine will control your symptoms but will not cure your condition. Continue to take pilocarpine even if you feel well. Do not stop taking pilocarpine without talking to your doctor.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Other names
Salagen®



What special precautions should I follow?
Before taking pilocarpine,
tell your doctor and pharmacist if you are allergic to pilocarpine (Pilopine HS, Salagen)or any other medications.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: ambenonium (Mytelase); antihistamines; atropine (Motofen, in Lomotil, in Lonox); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); bethanechol (Urecholine); cevimeline (Evoxac); donepezil (Aricept); galantamine (Razadyne); ipratropium (Atrovent, in Combivent, in Duoneb); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; neostigmine (Prostigmin); physostigmine (Mestinon); rivastigmine (Exelon) and tacrine (Cognex). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have asthma, acute iritis (uveitis; swelling and irritation inside the eye), or glaucoma (an eye disease).Your doctor may tell you not to take pilocarpine.
tell your doctor if you have or have ever had chronic bronchitis or another type of chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); kidney stones; gallstones; mental illness; any condition that affects your ability to think; or gallbladder, heart, or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pilocarpine, call your doctor.
you should know that pilocarpine may cause decreased fertility in men and women. Talk to your doctor before you take pilocarpine if you or your partner would like to become pregnant.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pilocarpine.
you should know that pilocarpine may cause changes in vision, especially at night, or when there is not enough light. Be careful when driving at night, or when performing dangerous activities in low lighting.
you should know that pilocarpine may cause you to sweat a great deal, which can cause dehydration.Be sure to drink plenty of water and call your doctor right away if you are having difficulty drinking enough fluid or if you think you may be dehydrated.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.



What side effects can this medication cause?
Pilocarpine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
sweating
nausea
runny nose
diarrhea
chills
flushing
frequent urination
dizziness
weakness
headache
vomiting
heartburn
stomach pain
swelling of the arms, hands, feet, ankles, or lower legs
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
changes in vision
fast or slow heartbeat
Pilocarpine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do if I forget to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
headache
tearing of eyes
difficulty breathing
GI spasm
confusion
uncontrollable shaking of a part of the body
What storage conditions are needed for this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Vigabatrin

Why is this medication prescribed?
Vigabatrin tablets are used in combination with other medications to control certain types of seizures in adults whose seizures were not controlled by several other medications. Vigabatrin powder is used to control infantile spasms (a type of seizure that babies and children can have) in babies 1 month to 2 years of age. Vigabatrin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
How should this medication be used?
Vigabatrin comes as a powder to be mixed with water and as a tablet to take by mouth. It is usually taken twice a day with or without food. Take vigabatrin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vigabatrin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of vigabatrin and gradually increase your dose, not more often than once every 3 days for babies receiving the powder mixed with water and once a week for adults taking tablets.
Vigabatrin may help control your condition but will not cure it. Continue to take vigabatrin even if you feel well. Do not stop taking vigabatrin without talking to your doctor. If you suddenly stop taking vigabatrin, your seizures may happen more often. Your doctor will probably decrease your dose gradually, not more often than once every 3-4 days for babies receiving the powder mixed with water and once a week for adults taking tablets. Tell your doctor immediately if your seizures happen more often while you are stopping vigabatrin.
If you are taking the powder, you must mix it with cold or room temperature water immediately before taking it. Do not mix the powder with any other liquid or food. The doctor will tell you how many packets of vigabatrin powder to use and how much water to mix it with. The doctor will also tell you how much of the mixture to take for each dose. Do not use a household spoon to measure your dose. Use the oral syringe that came with the medication. Carefully read the manufacturer's instructions that describe how to mix and take a dose of vigabatrin. Be sure to ask your pharmacist or doctor if you have any questions about how to mix or take this medication.
Talk to the doctor about what to do if your baby vomits, spits up, or only takes part of the dose of vigabatrin.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Other names
Sabril®



What special precautions should I follow?
Before taking vigabatrin,
tell your doctor and pharmacist if you are allergic to vigabatrin, any other medications, or any of the ingredients in vigabatrin tablets or powder. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention either of the following: clonazepam (Klonopin) or phenytoin (Dilantin, Phenytek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with vigabatrin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear here.
tell your doctor if you have or have ever had kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking vigabatrin, call your doctor.
you should know that vigabatrin may make you drowsy or tired. Do not drive a car or operate machinery until you know how this medication affects you. If your vision is damaged by vigabatrin, talk with your doctor about whether or not you can drive safely.
you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking vigabatrin. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants like vigabatrin to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as 1 week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as vigabatrin, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling asleep or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); thinking about or trying to hurt yourself or end your life; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
you should know that in some babies that have taken vigabatrin there were changes in pictures of the brain taken by magnetic resonance imaging (MRI). These changes were not seen in older children or adults. Usually these changes went away when treatment was stopped. It is not known if these changes are harmful.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.



What side effects can this medication cause?
Vigabatrin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
sleepiness
dizziness
uncontrollable shaking of a part of the body
weakness
joint or muscle pain
problems walking or feeling uncoordinated
memory problems and not thinking clearly
weight gain
swelling of the hands, feet, ankles, or lower legs
pain, burning, or tingling in the hands or feet
fever
irritability
diarrhea
nausea
vomiting
constipation
stomach pain
heartburn
severely painful cramps during menstrual period
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:
confusion
tiredness
pale skin
fast heartbeat
difficulty breathing
hives
itching
Vigabatrin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do if I forget to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include the following:
drowsiness
loss of consciousness
What storage conditions are needed for this medication?
Keep vigabatrin tablets and vigabatrin powder in the container they came in, tightly closed, and out of reach of children. Store them at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know?
Keep all appointments with your doctor and eye doctor.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking vigabatrin.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.



Important warning
Vigabatrin can cause permanent vision damage, including loss of peripheral vision and having blurry vision. Although vision loss is possible with any amount of vigabatrin, your risk may be greater with the more vigabatrin that you take daily and the longer you take it. Vision loss can happen at any time during treatment with vigabatrin. Tell your doctor if you have or have ever had any vision problems. If you experience any of the following symptoms, call your doctor immediately: think you are not seeing as well as before taking vigabatrin; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; blurry vision; double vision; eye movements you can't control; eye pain; and headache. Vision loss is not likely to be noticed in infants before it is severe. Be sure to call your doctor immediately if you think your baby is not seeing as well as before taking vigabatrin or is acting differently than normal.
Vigabatrin is only available through a special program called SHARE. You and your doctor will need to be enrolled in this program before you can receive vigabatrin. You will need to get vigabatrin from a specialty pharmacy that is enrolled in the program. Your doctor will give you more information about the program, will have you sign an enrollment form, and will answer any questions you have about the program and your treatment with vigabatrin.
As part of the SHARE program, an eye doctor will test your vision within 4 weeks of starting vigabatrin, at least every 3 months during treatment, and 3-6 months after stopping treatment. Vision testing is difficult in infants and may not find vision loss before it is severe. Vision tests cannot prevent vision damage but they are important to decrease further damage from occurring by stopping vigabatrin if vision changes are found. Once detected, vision loss is not reversible. It is possible that further damage can occur after stopping vigabatrin.
Also as part of the SHARE program, your doctor will assess your response to and continued need for vigabatrin. This is done within 2-4 weeks of starting treatment in infants and children, within 3 months of starting treatment in adults, and then on a regular basis as needed for all patients. If your doctor determines that vigabatrin is not working for you, then your treatment should be stopped.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vigabatrin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking vigabatrin.

Tramadol

Why is this medication prescribed?
Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets are only used by people who are expected to need medication to relieve pain around-the-clock for a long time. Tramadol is in a class of medications called opiate agonists. It works by changing the way the body senses pain.
How should this medication be used?
Tramadol comes as a tablet and an extended-release (long-acting) tablet to take by mouth. The regular tablet is usually taken with or without food every 4-6 hours as needed. The extended-release tablet should be taken once a day. Take the extended-release tablet at about the same time of day every day, and either always take it with food or always take it without food. Take tramadol exactly as directed. Do not take more medication as a single dose or take more doses per day than prescribed by your doctor. Taking more tramadol than prescribed by your doctor may cause serious side effects or death.
Your doctor may start you on a low dose of tramadol and gradually increase the amount of medication you take, not more often than every 3 days if you are taking the regular tablets or every 5 days if you are taking the extended-release tablets.
Swallow the extended-release tablets whole; do not split, chew, or crush them. Do not snort (inhale powder from crushed tablet) or inject the dissolved extended-release tablets. Taking this medication in a way that is not recommended may cause serious side effects or death.
Tramadol can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. Call your doctor if you find that you want to take extra medication or if you notice any other unusual changes in your behavior or mood.
Do not stop taking tramadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tramadol you may experience withdrawal symptoms such as nervousness; panic; sweating; difficulty falling asleep or staying asleep; runny nose, sneezing, or cough; numbness, pain, burning, or tingling in your hands or feet; hair standing on end; chills; nausea; uncontrollable shaking of a part of your body; diarrhea; or rarely, hallucinations (seeing things or hearing voices that do not exist).
Are there other uses for this medicine?
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Other names
Ryzolt®
Ultracet® (as a combination product containing Acetaminophen, Tramadol)
Ultram® ER



What special precautions should I follow?
Before taking tramadol,
tell your doctor and pharmacist if you are allergic to tramadol or other opiate pain or cough medications such as meperidine (Demerol), morphine (Avinza, Kadian, MS Contin), codeine (in some pain medications and cough syrups), hydrocodone (in Vicodin), hydromorphone (Dilaudid), oxycodone (OxyContin, in Percocet), propoxyphene (Darvon, Darvon N, in Darvocet), any other medications, or any of the ingredients in tramadol tablets or extended-release tablets. Ask your pharmacist for a list of ingredients in tramadol tablets or extended release tablets.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: antifungal medications such as ketoconazole (Nizoral); digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); medications for anxiety, mental illness, nausea, and pain; medications for seizures, such as carbamazepine (Tegretol); muscle relaxants such as cyclobenzaprine (Flexeril); promethazine (Phenergan); quinidine; rifampin (Rifadin, Rifamate, Rimactane, others); sedatives; sleeping pills; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); tranquilizers; tricyclic antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil);and warfarin (Coumadin). Many other medications may also interact with tramadol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor what herbal products you are taking, especially St. John's wort.
tell your doctor if you have or have ever had seizures; an infection in your brain or spine; a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; depression or thoughts about harming or killing yourself or planning or trying to do so; diabetes; breathing problems or lung disease; or kidney or liver disease. Also tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tramadol, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tramadol.
you should know that this medication may make you drowsy and may affect your coordination. Do not drive a car or operate machinery until you know how this medication affects you.
talk to your doctor about the safe use of alcohol while you are taking this medication. Alcohol can make the side effects from tramadol worse.
you should know that tramadol may cause dizziness, lightheadedness, and fainting when you get up from a lying position. To avoid this, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
What special dietary instructions should I follow?
Talk to your doctor about drinking grapefruit juice while you are taking this medication.



What side effects can this medication cause?
Tramadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
dizziness
weakness
sleepiness
difficulty falling asleep or staying asleep
headache
nervousness
agitation
uncontrollable shaking of a part of the body
muscle tightness
changes in mood
drowsiness
heartburn or indigestion
nausea
vomiting
diarrhea
constipation
itching
sweating
chills
dry mouth
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section , call your doctor immediately:
seizures
sores on the inside of your mouth, nose, eyes, or throat
flu-like symptoms
hives
rash
difficulty swallowing or breathing
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
hallucinations (seeing things or hearing voices that do not exist)
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Tramadol may cause other side effects. Tell your doctor if you have any unusual problems while you are taking this medication.
What should I do if I forget to take a dose?
If your doctor has told you to take tramadol regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
decreased size of the pupil (the black circle in the center of the eye)
difficulty breathing
extreme drowsiness
unconsciousness
coma
seizure
heart attack
What storage conditions are needed for this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.



Notification
[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.
BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.
RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.
Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Rufinamide

Why is this medication prescribed?
Rufinamide is used with other medication(s) to control seizures in people who have Lennox-Gastaut syndrome (a severe form of epilepsy that begins during childhood and causes several types of seizures, behavioral disturbances, and developmental delays). Rufinamide is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
How should this medication be used?
Rufinamide comes as a tablet to take by mouth. It is usually taken with food twice a day. Take rufinamide at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rufinamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Rufinamide tablets may be swallowed whole, broken in half on the score mark, or crushed. Talk to your doctor or pharmacist about the best way for you to take rufinamide.
Your doctor will probably start you on a low dose of rufinamide and gradually increase your dose, not more than once every other day.
Rufinamide may help to control your condition but will not cure it. Continue to take rufinamide even if you feel well. Do not stop taking rufinamide without talking to your doctor. If you suddenly stop taking rufinamide, your seizures may worsen. Your doctor will probably decrease your dose gradually.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with rufinamide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Other names
Banzel®



What special precautions should I follow?
Before taking rufinamide,
tell your doctor and pharmacist if you are allergic to rufinamide or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital, phenytoin, primidone (Mysoline), triazolam (Halcion), and valproic acid (Depakene, Depakote, Stavzor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had familial short QT syndrome (an inherited condition that causes irregular heartbeat, dizziness, fainting, or sudden death). Your doctor will probably tell you not to take rufinamide.
tell your doctor if you are being treated with dialysis (treatment to remove waste from the blood when the kidneys are not working well) and if you have or have ever had liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking rufinamide, call your doctor.
you should know that rufinamide may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, and injections). Talk to your doctor about methods of birth control that will work for you while you are taking rufinamide.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rufinamide.
you should know that rufinamide may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
ask your doctor about the safe use of alcoholic beverages while you are taking rufinamide. Alcohol can make the side effects from rufinamide worse.
you should know that your mental health may change in unexpected ways, and you may become suicidal (think about harming or killing yourself or plan or try to do so) while you are taking rufinamide. A small number of adults and children 5 years of age and older who took anticonvulsants such as rufinamide during clinical studies were found to be twice as likely to become suicidal than people who did not take the medication. This increased risk of suicidal behavior was seen as early as one week after starting the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: difficulty falling asleep or staying asleep, impulsive and dangerous behavior, panic attacks, anxiety, agitation, hostility, mania (frenzied, abnormally excited mood), talking or thinking about wanting to hurt yourself or end your life, withdrawing from friends and family, new or worsening depression, preoccupation with death and dying, or giving away prized possessions. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.



What side effects can this medication cause?
Rufinamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
sleepiness
headache
loss of coordination
difficulty walking
excessive movement or activity
uncontrollable shaking of a part of the body
uncontrollable movements of the eyes
difficulty paying attention
dizziness
loss of appetite
nausea
vomiting
back pain
stomach pain
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
fever
rash
hives
itching
swelling of the face
decreased ability to respond to others
seizures
blurred or double vision
yellowing of the skin or eyes
dark-colored urine
light-colored stool
Rufinamide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do if I forget to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What storage conditions are needed for this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Doxorubicin

About your treatment
Your doctor has ordered the drug doxorubicin to help treat your illness. The drug is given by injection into a vein.
This medication is used to treat:
breast cancer
ovarian cancer
transitional cell bladder cancer
bronchogenic lung cancer
thyroid cancer
gastric cancer
soft tissue and osteogenic sarcomas
neuroblastoma
Wilms' tumor
malignant lymphoma (Hodgkin's and non-Hodgkin's)
acute myeloblastic leukemia
acute lymphoblastic leukemia
Kaposi's sarcoma related to acquired immunodeficiency syndrome (AIDS)
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Doxorubicin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body. The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have.
Are there other uses for this medicine?
Doxorubicin is also used to treat Ewing's tumor; squamous cell carcinomas of the head, neck, cervix, and vagina; carcinomas of the testes, prostate, and uterus; and refractory multiple myeloma. Talk to your doctor about the possible risks of using this drug for your condition.
Other names
Adriamycin®
Adriamycin PFS®
Adriamycin RDF®
Doxil®
Rubex®



What special precautions should I follow?
Before taking doxorubicin,
tell your doctor and pharmacist if you are allergic to doxorubicin or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially those listed in the IMPORTANT WARNING section, actinomycin D (Cosmegen), aspirin, cyclosporine (Neoral, Sandimmune), paclitaxel (Taxol), phenobarbitol (Barbital), phenytoin (Dilantin), progesterone injection, verapamil (Calan, Covera, Verelan), streptozocin (Zanosar), and vitamins.
in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had kidney disease.
you should know that doxorubicin may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men. However, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. Women who are pregnant or breast-feeding should tell their doctors before they begin taking this drug. You should not plan to have children while receiving chemotherapy or for a while after treatments. (Talk to your doctor for further details.) Use a reliable method of birth control to prevent pregnancy. Doxorubicin may harm the fetus.
do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.



What side effects can this medication cause?
Side effects from doxorubicin are common and include:
nausea and vomiting which may last up to 24-48 hours after treatment
loss of appetite
diarrhea
difficulty swallowing
thinned or brittle hair
skin irritation (sunburn-like) or rash on areas previously exposed to radiation treatments
darkening of fingernails or toenails
swelling, pain, redness, or peeling of skin on the palms and soles of the feet
Tell your doctor if either of these symptoms is severe or lasts for several hours:
fatigue
mouth blistering
If you experience any of the following symptoms or those listed in the IMPORTANT WARNINGS section, call your doctor immediately:
unusual bruising or bleeding
red urine or sweat
pain at the injection site
persistent diarrhea or any change in normal bowel habits for more than 2 days
fever
chills
sore throat
breathing discomfort
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.



Important warning
Doxorubicin can cause a decrease in the number of blood cells in your bone marrow. Prolonged use of doxorubicin can also cause severe heart damage, even years after you have stopped taking doxorubicin. The risk of heart damage after stopping doxorubicin is higher in children.
Tell your doctor if you have ever had chemotherapy with daunorubicin (Cerubidine, DaunoXome), doxorubicin, idarubicin (Idamycin), or radiation therapy to the chest and if you have or have had heart or liver disease. Tell your doctor if you are taking cyclophosphamide (Cytoxan, Neosar) or mitoxantrone (Novantrone).
If you experience any of the following symptoms, call your doctor immediately: back pain, flushing, or chest tightness. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to doxorubicin.
When doxorubicin is administered into a vein, it may leak into surrounding tissue. Your doctor or health care provider will monitor your administration site for this reaction.
Talk to your doctor about the risks of taking doxorubicin.

Oxycodone

Why is this medication prescribed?
Oxycodone is used to relieve moderate to severe pain. Oxycodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Oxycodone is also available in combination with acetaminophen (Endocet, Percocet, Roxicet, Tylox, others); aspirin (Endodan, Percodan, Roxiprin, others); and ibuprofen (Combunox). This monograph only includes information about the use of oxycodone alone. If you are taking an oxycodone combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
How should this medication be used?
Oxycodone comes as a solution (liquid), concentrate solution, tablet, capsule, and extended-release (long-acting) tablet to take by mouth. The solution, concentrated solution, tablet, and capsule are usually taken with or without food every 4 to 6 hours, either as needed for pain or as regularly scheduled medications. The extended-release tablet are usually taken every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxycodone exactly as directed.
If you are taking the oxycodone concentrate solution, be sure to carefully measure and double check the dose before taking the medication. Use the measuring dropper that comes with the medication to measure your dose. Mix the medication with at least 1 ounce (30 milliliters) of juice or other liquid, or with a semi-solid food such as applesauce or pudding. If you are taking oxycodone concentrate solution from an ampoule (small pre-packaged tube containing oxycodone liquid), be sure to follow your doctor's instructions for taking a dose. Ask your pharmacist or doctor if you have any questions about measuring your dose or taking your medication.
Your doctor will likely start you on a low dose of oxycodone and may increase this dose over time if your pain is not controlled. After you take oxycodone for a period of time, your body may become used to the medication. If this happens, your doctor may need to increase your dose to control your pain. Talk to your doctor about how you are feeling during your treatment with oxycodone.
Oxycodone can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. If you have been taking oxycodone for more than a few days, do not stop taking oxycodone suddenly. If you stop taking this medication suddenly, you may experience withdrawal symptoms such as restlessness, watery eyes, runny nose, sneezing, yawning, sweating, chills, muscle or joint aches or pains, weakness, irritability, anxiety, depression, difficulty falling asleep or staying asleep, cramps, nausea, vomiting, diarrhea, loss of appetite, fast heartbeat, and fast breathing. Your doctor will probably decrease your dose gradually. Call your doctor if you have any withdrawal symptoms when your dose is decreased or when you stop taking oxycodone.
Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Other names
Combunox® (as a combination product containing Ibuprofen, Oxycodone)
Dazidox®
Endocet® (as a combination product containing Acetaminophen, Oxycodone)
Endocodone®
Endodan® (as a combination product containing Aspirin, Oxycodone)
ETH-Oxydose®
Lynox® (as a combination product containing Acetaminophen, Oxycodone)
Magnacet® (as a combination product containing Acetaminophen, Oxycodone)
Narvox® (as a combination product containing Acetaminophen, Oxycodone)
Oxycontin®
Oxyfast®
OxyIR®
Percocet® (as a combination product containing Acetaminophen, Oxycodone)
Percodan® (as a combination product containing Aspirin, Oxycodone)
Percolone®
Perloxx® (as a combination product containing Acetaminophen, Oxycodone)
Primlev® (as a combination product containing Acetaminophen, Oxycodone)
Roxicet® (as a combination product containing Acetaminophen, Oxycodone)
Roxicodone®
Roxiprin® (as a combination product containing Aspirin, Oxycodone)
Taxadone® (as a combination product containing Acetaminophen, Oxycodone)
Tylox® (as a combination product containing Acetaminophen, Oxycodone)
Xolox® (as a combination product containing Acetaminophen, Oxycodone)



What special precautions should I follow?
Before taking oxycodone,
tell your doctor and pharmacist if you are allergic to oxycodone, codeine (in many pain relievers and cough medications), hydrocodone (in Hycodan, in Lortab, in Vicoprofen, others),dihydrocodeine (in Synalgos-DC, others), any other medications, or any of the ingredients in oxycodone liquid, tablets, or capsules. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); medications for mental illness, nausea, or seizures; other medications for pain, especially narcotics; muscle relaxants; nalbuphine (Nubain); naloxone (Narcan); nalmefene (Revex); pentazocine (Talwin); sedatives;sleeping pills, or tranquilizers; Also tell your doctor or pharmacist if you are taking the following medications or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had asthma, lung disease, slowed breathing, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take oxycodone.
tell your doctor if you drink or have ever drunk large amounts of alcohol and if you use or have ever used street drugs, or if you have overused prescription medications. Also tell your doctor if you have or have ever had a head injury,a tumor in your brain or nervous system, any condition causing increased pressure in your brain; hypothyroidism (condition in which the thyroid gland produces less hormone than normal), hallucinations (seeing things or hearing voices that do not exist); delirium tremens (severe withdrawal symptoms that may occur in people who drank large amounts of alcohol over time and have stopped drinking); kyphoscoliosis (curving of the spine that may cause breathing problems) low blood pressure;Addison's disease (condition in which the adrenal gland does not produce enough hormone), seizures; urethral stricture (blockage of the tube that allows urine to leave the body), enlarged prostate (a male reproductive gland), or heart, kidney,liver, or pancreas, or biliary tract disease.
tell your doctor if you are pregnant or plan to become pregnant, or are breast-feeding. If you become pregnant while taking oxycodone, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking oxycodone.
you should know that this medication may make you drowsy. Do not drive a car, operate heavy machinery, or participate in any other possibly dangerous activities until you know how this medication affects you.
ask your doctor about the safe use of alcoholic beverages while you are taking oxycodone. When alcohol is taken with this medication, dangerous side effects can occur.
you should know that oxycodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.



What side effects can this medication cause?
Oxycodone may cause side effects. Tell your doctor if any of these symptoms, are severe or do not go away:
nausea
vomiting
loss of appetite
constipation
dry mouth
lightheadedness
drowsiness
flushing
sweating
itching
weakness
headache
mood changes
decrease in pupil (dark circle in eye) size
red eyes
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
fast or slow heartbeat
difficulty breathing
slowed breathing
hives
rash
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
difficulty swallowing
hallucinating (seeing things or hearing voices that do not exist)
seizures
confusion
fainting
dizziness
loss of consciousness
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Oxycodone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
What should I do if I forget to take a dose?
If you are taking oxycodone on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
difficulty breathing or slowed or stopped breathing
excessive sleepiness
dizziness
fainting
limp or weak muscles
increase or decrease in pupil (dark circle in the eye) size
cold, clammy skin
slow or stopped heartbeat
blue color of skin, fingernails, lips, or area around the mouth
loss of consciousness or coma
What storage conditions are needed for this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Throw away oxycodone concentrate solution 90 days after you open the product. Talk to your pharmacist about the proper disposal of your medication.
Keep oxycodone in a safe place so that no one else can take it accidentally or on purpose. Keep track of how much liquid or how many tablets or capsules are left so you will know if any medication is missing.
What other information should I know?
If you are taking the extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.
Keep all appointments with your doctor.
Do not let anyone else take your medication. Selling or giving away this medication may cause severe harm or death to others and is illegal.
This prescription is not refillable. If you continue to experience pain after you finish the oxycodone, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.



Important warning
Oxycodone extended-release (long-acting) tablets should be used only to treat people who need regularly scheduled doses of pain medication to treat continuous pain for an extended period of time. Extended-release oxycodone tablets should not be taken as-needed or to treat occasional episodes of pain.
Oxycodone 60-mg tablets and oxycodone 160-mg tablets (not available in the United States) should only be used to treat people who are tolerant (used to the effects of a medication) to narcotic pain medication. These tablet strengths may cause serious breathing problems or death in people who are not tolerant to narcotics.
Swallow oxycodone extended-release tablets whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, or crushed extended-release tablets, you will receive the entire dose of oxycodone at once, instead of slowly over 12 hours. This may cause serious problems, including overdose and death.
Talk to your doctor about the risks of taking oxycodone.
Notification
[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.
BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.
RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.
Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Rotigotine Transdermal

Why is this medication prescribed?
Rotigotine transdermal patches are used to treat the signs and symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Rotigotine is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance produced in the brain that is needed to control movement.
How should this medication be used?
Transdermal rotigotine comes as a patch to apply to the skin. It is usually applied once a day. Apply the rotigotine patch at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use rotigotine exactly as directed.
Your doctor will probably start you on a low dose of rotigotine and gradually increase your dose, not more often than once a week.
Rotigotine controls the symptoms of Parkinson's disease but does not cure it. It may take several weeks before you feel the full benefit of rotigotine. Continue to use rotigotine patches even if you feel well. Do not stop using rotigotine transdermal patches without talking to your doctor. If you suddenly stop using rotigotine patches, you may experience fever, muscle stiffness, change in consciousness, or other symptoms. Your doctor will probably decrease your dose gradually.
Apply the patch to an area on the stomach, thigh, hip, flank (side of the body between the ribs and pelvis), shoulder, or upper arm. The area of skin should be clean, dry and healthy. Do not apply the patch to skin that is red, irritated, or injured. Do not use creams, lotions, ointments, oils, or powders on the area of skin where the patch will be placed. Do not apply the patch to skin folds and areas of skin that could be under a waistband or rubbed by tight clothing. If the patch is to be applied to a hairy area, shave the area at least 3 days before applying the patch. Select a different area of skin each day such as changing from the right side to the left side or by moving from the upper body to the lower body. Do not apply the rotigotine patch to the same area of skin more often than once every 14 days.
While you are wearing the patch, keep the area away from other sources of heat such as heating pads, electric blankets and heated waterbeds; or direct sunlight. Do not take a hot bath or use a sauna.
Be careful to not dislodge the patch during bathing or physical activity. If the edges of the patch lift, use a bandage tape to re-secure it to the skin. If the patch falls off, apply a new patch to a different place on your skin for the rest of the day. The following day, remove that patch and apply a new patch at the usual time.
If the area of skin that was covered by the patch becomes irritated or develops a rash, do not expose this area to direct sunlight until the skin heals. Exposure of this area to sun could cause changes in your skin color.
Do not cut or damage a rotigotine patch.
To apply the patch, follow these steps:
Hold the two sides of the pouch and pull apart.
Remove patch from the pouch. Apply the patch right away after removing it from the protective pouch.
Hold the patch with both hands, with the protective liner on top.
Bend the edges of the patch away from you so that the S-shaped cut in the liner opens.
Peel off one half of the protective liner. Do not touch the sticky surface because the medicine could come off on your fingers.
Apply the sticky half of the patch to a clean area of skin and remove the remaining liner.
Press the patch firmly with the palm of your hand for 20-30 seconds. Go around the edges with your fingers to press them onto the skin. Make sure that the patch is flat against the skin (there should be no bumps or fold in the patch).
After applying the new patch, be sure to remove the patch from the previous day. Use your fingers to peel it off slowly. Fold the patch in half with and press firmly to seal it shut. Throw it away in a closed trash can that is out of the reach of children and pets.
If there is any adhesive left on the skin, gently wash the area with warm water and mild soap or gently rub the area with baby or mineral oil to remove it.
Wash your hands with soap and water. Do not touch your eyes or any objects until you have washed your hands.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Other names
Neupro®



What special precautions should I follow?
Before using the rotigotine patch,
tell your doctor and pharmacist if you are allergic to rotigotine, sulfites, or any other medications, or any of the ingredients in rotigotine transdermal patches. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants, medications for anxiety, medications for mental illness, medications for seizures, metoclopramide, sedatives, sleeping pills, and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have asthma, high or low blood pressure, heart problems, or if you have had times that you fell asleep suddenly and without warning during the daytime.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking rotigotine, call your doctor.
you should know that rotigotine may make you drowsy or may cause you to suddenly fall asleep during your regular daily activities. You might not feel drowsy before you suddenly fall asleep. Do not drive a car or operate machinery at the beginning of your treatment until you know how the medication affects you. If you suddenly fall asleep while you are doing something such as watching television or riding in a car, or if you become very drowsy, call your doctor. Do not drive or operate machinery until you talk to your doctor.
remember that alcohol can add to the drowsiness caused by this medication. Tell your doctor if you regularly drink alcoholic beverages.
you should know that rotigotine may cause dizziness, lightheadedness, fainting, or sweating when you get up too quickly from a lying position. This is more common when you first start taking rotigotine or as the dose is being increased. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
you should know that transdermal rotigotine can cause burns on your skin if you are having magnetic resonance imaging (MRI; a radiology technique designed to show the images of body structures) or cardioversion (a procedure to normalize the heart rhythm). Tell your doctor that you are using transdermal rotigotine if you are to have either of these procedures.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.



What side effects can this medication cause?
Rotigotine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
rash, redness, swelling or itching of the skin that was covered by the patch
nausea
vomiting
constipation
loss of appetite
drowsiness
difficulty falling asleep or staying asleep
abnormal dreams
seeing things or hearing voices that do not exist (hallucinating)
dizziness or feeling that you or the room is moving
headache
fainting
weight gain
swelling of the hands, feet, ankles, or lower legs
increased sweating
dry mouth
loss of energy
back or joint pain
abnormal vision
frequent urination
difficult or painful urination
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
difficulty breathing or swallowing
hives
rash
itching
Some people who took medications such as rotigotine to treat Parkinson's disease developed gambling problems, increased sexual urges, or other intense urges. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have an urge to gamble, sexual urges or other urges that are difficult to control. Tell your family members about these risks so that they can call the doctor even if you do not realize that these urges have become a problem.
People who have Parkinson's disease may have a greater risk of developing melanoma (a type of skin cancer) than people who do not have Parkinson's disease. There is not enough information to tell whether medications used to treat Parkinson's disease such as rotigotine increase the risk of developing skin cancer. You should have regular skin examinations to check for melanoma while you are taking rotigotine even if you do not have Parkinson's disease. Talk to your doctor about the risk of taking rotigotine.
Rotigotine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do if I forget to take a dose?
Apply the missed dose (patch) as soon as you remember it, then apply a new patch at the usual time the next day. Do not apply an extra patch to make up for a missed dose.
What should I do in case of overdose?
If someone applies extra rotigotine patches, remove the patches. Then call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
nausea
vomiting
fainting
dizziness
lightheadedness
blurred vision
movements that are difficult to control
seeing things or hearing voices that do not exist (hallucinating)
confusion
seizures
What storage conditions are needed for this medication?
Keep this medication in the original pouch it came in, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication by opening each pouch and folding each patch in half with the sticky sides together. Be sure to throw away the rotigotine patch in a place that children and pets cannot reach.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.



Important warning
Rotigotine transdermal patches will no longer be available in the U.S. after April 2008. If you are currently using rotigotine transdermal patches, you should call your doctor to discuss switching to another treatment. Do not stop using rotigotine transdermal patches without talking to your doctor. If you suddenly stop using rotigotine patches, you may experience fever, muscle stiffness, change in consciousness, or other symptoms. Your doctor will probably decrease your dose gradually.