Sidopin

Sidopin may be available in the countries listed below.

Ingredient matches for Sidopin

Amlodipine

Amlodipine is reported as an ingredient of Sidopin in the following countries:

• Bangladesh

International Drug Name Search

Paracetamol Rimafar

Paracetamol Rimafar may be available in the countries listed below.

Ingredient matches for Paracetamol Rimafar

Paracetamol

Paracetamol is reported as an ingredient of Paracetamol Rimafar in the following countries:

• Spain

International Drug Name Search

Bedix

Bedix may be available in the countries listed below.

Ingredient matches for Bedix

Loratadine

Loratadine is reported as an ingredient of Bedix in the following countries:

• Argentina

International Drug Name Search

Visiclear

Visiclear may be available in the countries listed below.

Ingredient matches for Visiclear

Tetryzoline

Tetryzoline hydrochloride (a derivative of Tetryzoline) is reported as an ingredient of Visiclear in the following countries:

• Slovenia

International Drug Name Search

Pergolide Sandoz

Pergolide Sandoz may be available in the countries listed below.

Ingredient matches for Pergolide Sandoz

Pergolide

Pergolide mesilate (a derivative of Pergolide) is reported as an ingredient of Pergolide Sandoz in the following countries:

• Netherlands

International Drug Name Search

UFA 902 DUO

UFA 902 DUO may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for UFA 902 DUO

Sulfadimidine

Sulfadimidine is reported as an ingredient of UFA 902 DUO in the following countries:

• Switzerland

Sulfathiazole

Sulfathiazole is reported as an ingredient of UFA 902 DUO in the following countries:

• Switzerland

Trimethoprim

Trimethoprim is reported as an ingredient of UFA 902 DUO in the following countries:

• Switzerland

International Drug Name Search

Lopresor Divitabs

Lopresor Divitabs may be available in the countries listed below.

Ingredient matches for Lopresor Divitabs

Metoprolol

Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Lopresor Divitabs in the following countries:

• Israel

International Drug Name Search

GenRX Isosorbide Mononitrate

GenRX Isosorbide Mononitrate may be available in the countries listed below.

Ingredient matches for GenRX Isosorbide Mononitrate

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of GenRX Isosorbide Mononitrate in the following countries:

• Australia

International Drug Name Search

Kalium Chlorid Fresenius

Kalium Chlorid Fresenius may be available in the countries listed below.

Ingredient matches for Kalium Chlorid Fresenius

Potassium Chloride

Potassium Chloride is reported as an ingredient of Kalium Chlorid Fresenius in the following countries:

• Luxembourg


• Serbia

International Drug Name Search

Depen

Generic Name: penicillamine (Oral route)

pen-i-SIL-a-meen

Oral route(Capsule;Tablet)

Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special dosage considerations, and therapeutic benefits. Patients should be warned to report promptly any symptoms suggesting toxicity .

Commonly used brand name(s)

In the U.S.

• Cuprimine


• Depen

Available Dosage Forms:

• Capsule


• Tablet

Therapeutic Class: Antirheumatic

Uses For Depen

Penicillamine is used in the treatment of medical problems such as Wilson's disease (too much copper in the body) and rheumatoid arthritis. Also, it is used to prevent kidney stones. Penicillamine may also be used for other conditions as determined by your doctor.

In addition to the helpful effects of this medicine, it has side effects that can be very serious. Before you take penicillamine, be sure that you have discussed the use of it with your doctor.

This medicine is available only with your doctor's prescription.

Once a product has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, penicillamine is used in certain patients with the following conditions:

• Felty's syndrome


• Heavy metal toxicity


• Rheumatoid vasculitis

Before Using Depen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information about the use of penicillamine in children, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older. In clinical trials, elderly people may have an increased chance for getting a skin rash.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aurothioglucose

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin


• Gold Sodium Thiomalate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iron

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disease caused by penicillamine treatment, history of or


• Kidney disease or history of (only for patients with rheumatoid arthritis)—The chance of side effects may be increased

Proper Use of penicillamine

This section provides information on the proper use of a number of products that contain penicillamine. It may not be specific to Depen. Please read with care.

Since penicillamine is taken in different ways for different medical problems, it is very important that you understand exactly why you are taking this medicine and how to take it. See below for information on specific medical problems. If you have any questions about this, check with your doctor.

For patients taking this medicine to prevent kidney stones:

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals) and at least 1 hour before or after any other food, milk, or medicine.


• You should drink 2 full glasses (8 ounces each) of water at bedtime and another 2 full glasses (8 ounces each) during the night.


• It is very important that you follow any special instructions from your doctor, such as following a low-methionine diet. If you have any questions about this, check with your doctor.

For patients taking this medicine for rheumatoid arthritis :

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals) and at least 1 hour before or after any other food, milk, or medicine.


• After you begin taking this medicine, 2 to 3 months may pass before you feel its effects. It is very important that you keep taking the medicine, even if you do not feel better, in order to give it time to work.

For patients taking this medicine for Wilson's disease :

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals).


• It is very important that you follow any special instructions from your doctor, such as following a low-copper diet. If you have any questions about this, check with your doctor.


• After you begin taking this medicine, 1 to 3 months may pass before you notice any improvement in your condition.

For patients taking this medicine for lead poisoning :

• Take this medicine on an empty stomach (2 hours before meals or at least 3 hours after meals).

For all patients:

• Take this medicine regularly as directed. Do not stop taking it without first checking with your doctor, since stopping the medicine and then restarting it may increase the possibility of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or tablets):
  
  • For Wilson's disease (too much copper in the body):
    
    • Adults and teenagers—At first, 250 milligrams (mg) four times a day. After a while your doctor may need to increase the dose, depending on the amount of copper in your urine. Most people do not need more than 2000 mg a day (two 250-mg capsules or tablets four times a day).
    
    
    • Children (older than 6 months of age)—At first, 250 mg a day. After a while your doctor may need to increase the dose, depending on the amount of copper in your urine. Older children may need the same dose as adults.
    
    
  
  
  • For rheumatoid arthritis:
    
    • Adults—At first, 125 or 250 mg once a day. Your doctor may increase the dose after a few months, depending on how well the medicine is working and whether it causes any side effects. The largest dose is not more than 1500 mg a day (two 250-mg capsules or tablets three times a day).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For preventing kidney stones:
    
    • Adults—At first, 500 mg (two 250-mg capsules or tablets) four times a day. After a while your doctor may need to change the dose, depending on the results of your urine tests. Some people may need as much as 4000 mg a day (four 250-mg capsules or tablets four times a day).
    
    
    • Children—The dose is based on body weight and must be determined by your doctor. At first, 7.5 mg per kilogram (kg) (about 3.5 mg per pound) of body weight four times a day. After a while your doctor may need to change the dose, depending on the results of your urine tests.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Depen

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

Before having any kind of surgery (including dental surgery), tell the medical doctor or dentist in charge that you are taking this medicine.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Do not take iron preparations or vitamin preparations containing iron without checking with your healthcare provider. If your doctor tells you to take iron preparations, or vitamin preparations containing iron, do not take them within 2 hours of the time you take this medicine. Taking the two medicines too close together may keep the penicillamine from working properly.

Tell your doctor right away if you get a fever, sore throat, chills, bruising, or bleeding. These may be symptoms of a serious blood problem.

Tell your doctor right away if you have trouble breathing, noisy breathing, or an unexplained cough. These may be symptoms of a serious lung problem.

Depen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Fever


• joint pain


• lesions on the face, neck, scalp, and/or trunk


• skin rash, hives, or itching


• swollen and/or painful glands


• ulcers, sores, or white spots on lips or in mouth

Less common

• Bloody or cloudy urine


• shortness of breath, troubled breathing, tightness in chest, or wheezing


• sore throat and fever with or without chills


• swelling of face, feet, or lower legs


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight gain

Rare

• Abdominal or stomach pain (severe)


• blisters on skin


• bloody or black, tarry stools


• chest pain


• coughing or hoarseness


• dark urine


• difficulty in breathing, chewing, talking, or swallowing


• eye pain, blurred or double vision, or any change in vision


• general feeling of discomfort or illness or weakness


• lower back or side pain


• muscle weakness


• painful or difficult urination


• pale stools


• pinpoint red spots on skin


• redness, tenderness, itching, burning, or peeling of skin


• red or irritated eyes


• red, thick, or scaly skin


• ringing or buzzing in the ears


• spitting blood


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• lessening or loss of sense of taste


• loss of appetite


• nausea or vomiting


• stomach pain (mild)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Depen side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Depen resources

• Depen Side Effects (in more detail)
• Depen Use in Pregnancy & Breastfeeding
• Drug Images
• Depen Drug Interactions
• Depen Support Group
• 0 Reviews for Depen - Add your own review/rating

• Depen Prescribing Information (FDA)


• Depen MedFacts Consumer Leaflet (Wolters Kluwer)


• Depen Concise Consumer Information (Cerner Multum)


• Penicillamine Professional Patient Advice (Wolters Kluwer)


• Penicillamine Monograph (AHFS DI)


• Cuprimine Prescribing Information (FDA)

Compare Depen with other medications

• Cystinuria
• Rheumatoid Arthritis
• Wilson's Disease

Tramadol axcount

Tramadol axcount may be available in the countries listed below.

Ingredient matches for Tramadol axcount

Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramadol axcount in the following countries:

• Germany

International Drug Name Search

Actos

Actos is a brand name of pioglitazone, approved by the FDA in the following formulation(s):

ACTOS (pioglitazone hydrochloride - tablet; oral)

• 
  Manufacturer: TAKEDA PHARMS NA
  
  Approval date: July 15, 1999
  
  Strength(s): EQ 15MG BASE, EQ 30MG BASE, EQ 45MG BASE ^[RLD]

Has a generic version of Actos been approved?

No. There is currently no therapeutically equivalent version of Actos available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Actos. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

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See also...

• Actos Consumer Information (Drugs.com)
• Actos Consumer Information (Wolters Kluwer)
• Actos Consumer Information (Cerner Multum)
• Actos Advanced Consumer Information (Micromedex)
• Actos AHFS DI Monographs (ASHP)
• Pioglitazone Consumer Information (Wolters Kluwer)
• Pioglitazone Consumer Information (Cerner Multum)
• Pioglitazone Advanced Consumer Information (Micromedex)
• Pioglitazone Hydrochloride AHFS DI Monographs (ASHP)

Rumasin

Rumasin may be available in the countries listed below.

Ingredient matches for Rumasin

Methyl Salicylate

Methyl Salicylate is reported as an ingredient of Rumasin in the following countries:

• Turkey

International Drug Name Search

Xuric

Xuric may be available in the countries listed below.

Ingredient matches for Xuric

Colchicine

Colchicine is reported as an ingredient of Xuric in the following countries:

• Argentina

International Drug Name Search

Solubron

Solubron may be available in the countries listed below.

Ingredient matches for Solubron

Bromhexine

Bromhexine is reported as an ingredient of Solubron in the following countries:

• Peru

International Drug Name Search

Pargine

Pargine may be available in the countries listed below.

Ingredient matches for Pargine

Arginine

Arginine aspartate (a derivative of Arginine) is reported as an ingredient of Pargine in the following countries:

• Luxembourg

International Drug Name Search

Metronidazol DAK

Metronidazol DAK may be available in the countries listed below.

Ingredient matches for Metronidazol DAK

Metronidazole

Metronidazole is reported as an ingredient of Metronidazol DAK in the following countries:

• Denmark

International Drug Name Search

Gemfibrozilo Medifarma

Gemfibrozilo Medifarma may be available in the countries listed below.

Ingredient matches for Gemfibrozilo Medifarma

Gemfibrozil

Gemfibrozil is reported as an ingredient of Gemfibrozilo Medifarma in the following countries:

• Peru

International Drug Name Search

Riachol

Riachol may be available in the countries listed below.

Ingredient matches for Riachol

Chloramphenicol

Chloramphenicol is reported as an ingredient of Riachol in the following countries:

• Oman

International Drug Name Search

Ibuprofeno Pensa

Ibuprofeno Pensa may be available in the countries listed below.

Ingredient matches for Ibuprofeno Pensa

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofeno Pensa in the following countries:

• Spain

International Drug Name Search

Glipizide-Merck

Glipizide-Merck may be available in the countries listed below.

Ingredient matches for Glipizide-Merck

Glipizide

Glipizide is reported as an ingredient of Glipizide-Merck in the following countries:

• Luxembourg

International Drug Name Search

Lexmox-DC

Lexmox-DC may be available in the countries listed below.

Ingredient matches for Lexmox-DC

Amoxicillin

Amoxicillin is reported as an ingredient of Lexmox-DC in the following countries:

• India

Dicloxacillin

Dicloxacillin is reported as an ingredient of Lexmox-DC in the following countries:

• India

International Drug Name Search

Gadral

Gadral may be available in the countries listed below.

Ingredient matches for Gadral

Magaldrate

Magaldrate is reported as an ingredient of Gadral in the following countries:

• Italy

International Drug Name Search

Gen-Lisinopril

Gen-Lisinopril may be available in the countries listed below.

Ingredient matches for Gen-Lisinopril

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Gen-Lisinopril in the following countries:

• Canada

International Drug Name Search

Rilutek

Generic Name: riluzole (RIL yoo zol)

Brand Names: Rilutek

What is Rilutek (riluzole)?

Riluzole works by decreasing your body's levels of glutamate, an amino acid that affects nerves that send messages from your brain to your muscles. People with amyotrophic lateral sclerosis may have very high levels of glutamate, which can damage these nerve cells.

Riluzole is used to treat amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig's disease.

Riluzole is not a cure for ALS, but it may delay progression of the disease and prolong your life.

Riluzole may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Rilutek (riluzole)?

You should not use this medication if you are allergic to riluzole.

Before you take riluzole, tell your doctor if you have liver or kidney disease.

Riluzole may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Take riluzole on an empty stomach.

To be sure this medication is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

Avoid drinking alcohol. It may increase your risk of liver damage. Avoid products that contain caffeine. Caffeine may cause too much riluzole to build up in your body. Smoking cigarettes may make riluzole less effective.

What should I discuss with my healthcare provider before taking Rilutek (riluzole)?

You should not use this medication if you are allergic to it.

If you have liver or kidney disease, you may need a dose adjustment or special tests to safely use this medication:

FDA pregnancy category C. It is not known whether riluzole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether riluzole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Rilutek (riluzole)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water. Take riluzole on an empty stomach, at least 1 hour before or 2 hours after a meal.

Riluzole is usually taken twice a day, every 12 hours. Follow your doctor's instructions. It is important to take your medicine at the same times each day.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with blood tests every month during the first 3 months of treatment, and less often as treatment continues. Visit your doctor regularly.

Store at room temperature away from moisture, heat, and bright light.

See also: Rilutek dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Rilutek (riluzole)?

Riluzole may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage. Avoid coffee, tea, cola, or other products that contain caffeine. Caffeine may cause too much riluzole to build up in your body. Avoid smoking. Smoking cigarettes may make riluzole less effective.

Rilutek (riluzole) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using riluzole and call your doctor at once if you have a serious side effect such as:

• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  chest discomfort, dry cough, trouble breathing;

  
  


• 
  

  cough with yellow or green mucus; or

  
  


• 
  

  stabbing chest pain, feeling short of breath.

  
  

Less serious side effects may include:

• 
  

  dizziness, spinning sensation;

  
  


• 
  

  muscle stiffness;

  
  


• 
  

  weakness, drowsiness;

  
  


• 
  

  numbness or tingly feeling in or around your mouth;

  
  


• 
  

  mild nausea, diarrhea, stomach pain, constipation;

  
  


• 
  

  headache; or

  
  


• 
  

  runny nose.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rilutek (riluzole)?

Many drugs can interact with riluzole. Below is just a partial list. Tell your doctor if you are using:

• 
  

  acetaminophen (Tylenol);

  
  


• 
  

  allopurinol (Zyloprim);

  
  


• 
  

  amitriptyline (Elavil, Vanatrip);

  
  


• 
  

  auranofin (Ridaura);

  
  


• 
  

  cancer medications

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  omeprazole (Prilosec);

  
  


• 
  

  sulfasalazine (Azulfidine);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl, and others);

  
  


• 
  

  tuberculosis medications;

  
  


• 
  

  birth control pills or other hormones;

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;

  
  


• 
  

  an antibiotic such as ciprofloxacin (Cipro), dapsone, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin), or rifampin (Rifater, Rifadin, Rifamate);

  
  


• 
  

  antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

  
  


• 
  

  cholesterol medications such as niacin (Advicor, Niaspan, Niacor, Slo-Niacin, and others), atorvastatin (Lipitor), simvastatin (Zocor, Simcor, Vytorin), lovastatin (Mevacor), pravastatin (Pravachol), and others;

  
  


• 
  

  HIV/AIDS medications such as abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Combivir, Epivir), nevirapine (Viramune), tenofovir (Viread), or zidovudine (Retrovir);

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others; or

  
  


• 
  

  seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene).

  
  

This list is not complete and there are many other drugs that can interact with riluzole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Rilutek resources

• Rilutek Side Effects (in more detail)
• Rilutek Dosage
• Rilutek Use in Pregnancy & Breastfeeding
• Drug Images
• Rilutek Drug Interactions
• Rilutek Support Group
• 0 Reviews for Rilutek - Add your own review/rating

• Rilutek Prescribing Information (FDA)


• Rilutek MedFacts Consumer Leaflet (Wolters Kluwer)


• Rilutek Monograph (AHFS DI)


• Rilutek Advanced Consumer (Micromedex) - Includes Dosage Information


• Riluzole Professional Patient Advice (Wolters Kluwer)

Compare Rilutek with other medications

• Amyotrophic Lateral Sclerosis

Where can I get more information?

• Your pharmacist can provide more information about riluzole.

See also: Rilutek side effects (in more detail)

Mukolina

Mukolina may be available in the countries listed below.

Ingredient matches for Mukolina

Carbocisteine

Carbocisteine is reported as an ingredient of Mukolina in the following countries:

• Poland

International Drug Name Search

Gadoversetamide

In the US, Gadoversetamide is a member of the drug class magnetic resonance imaging contrast media and is used to treat Magnetic Resonance Angiography.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

V08CA06

CAS registry number (Chemical Abstracts Service)

0131069-91-5

Chemical Formula

C20-H34-Gd-N5-O10

Molecular Weight

661

Therapeutic Category

Diagnostic agent

Chemical Names

[N,N-Bis[2-[[(carboxymethyl)[(2-methoxyethyl)carbamoyl]methyl]amino]ethyl]glycinato(3-)]gadolinium (WHO)

Gadolinium, [8,11-bis(carboxymethyl)-14-[2-[(2-methoxyethyl)amino]-2-oxoethyl]-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato(3-)]- (USAN)

Foreign Names

• Gadoversetamidum (Latin)
• Gadoversetamid (German)
• Gadoversetamide (French)
• Gadoversetamida (Spanish)

Generic Names

• Gadoversetamide (OS: BAN, USAN)
• MP 1177 (IS: MallinckrodtMe)
• Gadoversetamide (PH: USP 32)

Brand Names

• OptiMARK
  Covidien, Austria; Covidien, Belgium; Covidien, Luxembourg; Covidien Deutschland, Greece; Mallinckrodt, Argentina; Mallinckrodt, United States; Tyco, Canada; Tyco, Denmark; Tyco, Norway; Tyco Healthcare, Slovenia



• Optimark
  Covidien, Sweden



• Optimark (Gadoversetamide and Gadoversetamide)
  Mallinckrodt, Switzerland



• Optimark (Gadoversetamide and Versetamide)
  Mallinckrodt, Switzerland

International Drug Name Search

Glossary

BAN	British Approved Name
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Tosseque

Tosseque may be available in the countries listed below.

Ingredient matches for Tosseque

Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Tosseque in the following countries:

• Portugal

International Drug Name Search

Diaprim

Diaprim may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Diaprim

Sulfadiazine

Sulfadiazine is reported as an ingredient of Diaprim in the following countries:

• Switzerland

Trimethoprim

Trimethoprim is reported as an ingredient of Diaprim in the following countries:

• Switzerland

International Drug Name Search

Ciprofloxacina Pharmakern

Ciprofloxacina Pharmakern may be available in the countries listed below.

Ingredient matches for Ciprofloxacina Pharmakern

Ciprofloxacin

Ciprofloxacin is reported as an ingredient of Ciprofloxacina Pharmakern in the following countries:

• Portugal

International Drug Name Search

Karbamazepin Dak

Karbamazepin Dak may be available in the countries listed below.

Ingredient matches for Karbamazepin Dak

Carbamazepine

Carbamazepine is reported as an ingredient of Karbamazepin Dak in the following countries:

• Denmark

International Drug Name Search

Riomet

Generic Name: metformin (met FOR min)

Brand Names: Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet

What is metformin?

Metformin is an oral diabetes medicine that helps control blood sugar levels.

Metformin is for people with type 2 diabetes. Metformin is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Metformin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about metformin?

You should not use this medication if you are allergic to metformin, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin.

Before taking metformin, tell your doctor if you have liver disease or a history of heart disease.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

What should I discuss with my healthcare provider before taking metformin?

Some people develop a life-threatening condition called lactic acidosis while taking metformin. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk. You should not use this medication if you are allergic to metformin, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin.

To make sure you can safely take metformin, tell your doctor if you have any of these other conditions:

• 
  

  liver disease; or

  
  


• 
  

  a history of heart disease.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using metformin. Metformin should not be given to a child younger than 10 years old. Extended-release metformin (Glucophage XR) should not be given to a child younger than 17 years old.

How should I take metformin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Take metformin with a meal, unless your doctor tells you otherwise. Some forms of metformin are taken only once daily with the evening meal. Follow your doctor's instructions.

Metformin is only part of a complete program of treatment that also includes diet, exercise, and weight control. It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not crush, chew, or break an extended-release tablet (Glucophage XR). Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking metformin for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your metformin dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Your doctor may have you take extra vitamin B12 while you are taking metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What should I avoid while taking metformin?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis while taking metformin.

Metformin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

• 
  

  muscle pain or weakness;

  
  


• 
  

  numb or cold feeling in your arms and legs;

  
  


• 
  

  trouble breathing;

  
  


• 
  

  feeling dizzy, light-headed, tired, or very weak;

  
  


• 
  

  stomach pain, nausea with vomiting; or

  
  


• 
  

  slow or uneven heart rate.

  
  

Call your doctor at once if you have any other serious side effect such as:

• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling or rapid weight gain; or

  
  


• 
  

  fever, chills, body aches, flu symptoms.

  
  

Less serious side effects may include:

• 
  

  headache or muscle pain;

  
  


• 
  

  weakness; or

  
  


• 
  

  mild nausea, vomiting, diarrhea, gas, stomach pain.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect metformin?

Tell your doctor about all other medicines you use, especially:

• 
  

  furosemide (Lasix);

  
  


• 
  

  nifedipine (Adalat, Procardia);

  
  


• 
  

  cimetidine (Tagamet) or ranitidine (Zantac);

  
  


• 
  

  amiloride (Midamor) or triamterene (Dyrenium);

  
  


• 
  

  digoxin (Lanoxin);

  
  


• 
  

  morphine (MS Contin, Kadian, Oramorph);

  
  


• 
  

  procainamide (Procan, Pronestyl, Procanbid);

  
  


• 
  

  quinidine (Quin-G) or quinine (Qualaquin);

  
  


• 
  

  trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra); or

  
  


• 
  

  vancomycin (Vancocin, Lyphocin).

  
  

You may be more likely to have hyperglycemia (high blood sugar) if you take metformin with other drugs that can raise blood sugar, such as:

• 
  

  isoniazid;

  
  


• 
  

  diuretics (water pills);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  heart or blood pressure medication (Cartia, Cardizem, Covera, Isoptin, Verelan, and others);

  
  


• 
  

  niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

  
  


• 
  

  phenothiazines (Compazine and others);

  
  


• 
  

  thyroid medicine (Synthroid and others);

  
  


• 
  

  birth control pills and other hormones;

  
  


• 
  

  seizure medicines (Dilantin and others); and

  
  


• 
  

  diet pills or medicines to treat asthma, colds or allergies.

  
  

These lists are not complete and other drugs may interact with metformin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Riomet resources

• Riomet Side Effects (in more detail)
• Riomet Use in Pregnancy & Breastfeeding
• Riomet Drug Interactions
• Riomet Support Group
• 0 Reviews for Riomet - Add your own review/rating

• Riomet Prescribing Information (FDA)


• Riomet Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Riomet Advanced Consumer (Micromedex) - Includes Dosage Information


• Riomet Consumer Overview


• Fortamet Prescribing Information (FDA)


• Glucophage MedFacts Consumer Leaflet (Wolters Kluwer)


• Glucophage Prescribing Information (FDA)


• Glucophage Consumer Overview


• Glucophage XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Glucophage XR Prescribing Information (FDA)


• Glumetza Prescribing Information (FDA)


• Metformin Prescribing Information (FDA)


• Metformin Hydrochloride Monograph (AHFS DI)

Compare Riomet with other medications

• Diabetes, Type 2
• Insulin Resistance Syndrome

Where can I get more information?

• Your pharmacist can provide more information about metformin.

See also: Riomet side effects (in more detail)

Gluconate de Chlorhexidine Alcoolique Gifrer

Gluconate de Chlorhexidine Alcoolique Gifrer may be available in the countries listed below.

Ingredient matches for Gluconate de Chlorhexidine Alcoolique Gifrer

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Gluconate de Chlorhexidine Alcoolique Gifrer in the following countries:

• France

International Drug Name Search

Efforeen

Efforeen may be available in the countries listed below.

Ingredient matches for Efforeen

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Efforeen in the following countries:

• China

International Drug Name Search

Rid Topical

Generic Name: pyrethrum extract and piperonyl butoxide (Topical route)

pye-REE-thrum EX-trackt, PIP-er-oh-nil byoo-TOX-ide

Commonly used brand name(s)

In the U.S.

• A200 Maximum Strength


• A200 Time-Tested Formula


• Lice-X


• Licide


• Medi-Lice Maximum Strength


• Pronto Maximum Strength


• Pyrinex


• Pyrinyl


• Rid


• Tisit

Available Dosage Forms:

• Gel/Jelly


• Liquid


• Shampoo


• Kit


• Foam

Therapeutic Class: Pediculicide

Chemical Class: Pyrethrums

Uses For Rid

Medicine containing pyrethrins is used to treat head, body, and pubic lice infections. This medicine is absorbed by the lice and destroys them by acting on their nervous systems. It does not affect humans in this way. The piperonyl butoxide is included to make the pyrethrins more effective in killing the lice. This combination medicine is known as a pediculicide.

This medicine is available without a prescription.

Before Using Rid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of pyrethrins and piperonyl butoxide combination in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pyrethrins and piperonyl butoxide combination medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Inflammation of the skin (severe)—Use of pyrethrins and piperonyl butoxide combination may make the condition worse

Proper Use of pyrethrum extract and piperonyl butoxide

This section provides information on the proper use of a number of products that contain pyrethrum extract and piperonyl butoxide. It may not be specific to Rid. Please read with care.

Pyrethrins and piperonyl butoxide combination medicine usually comes with patient directions. Read them carefully before using this medicine.

Use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label. To do so may increase the chance of absorption through the skin and the chance of side effects.

Keep pyrethrins and piperonyl butoxide combination medicine away from the mouth and do not inhale it. This medicine is harmful if swallowed or inhaled.

To lessen the chance of inhaling this medicine, apply it in a well-ventilated room (for example, one with free flowing air or with a fan turned on).

Keep this medicine away from the eyes and other mucous membranes, such as the inside of the nose, mouth, or vagina, because it may cause irritation. If you accidentally get some in your eyes, flush them thoroughly with water at once.

Do not apply this medicine to the eyelashes or eyebrows . If they become infected with lice, check with your doctor.

To use the gel or solution form of this medicine:

• Apply enough medicine to thoroughly wet the dry hair and scalp or skin. Allow the medicine to remain on the affected areas for exactly 10 minutes.


• Then, thoroughly wash the affected areas with warm water and soap or regular shampoo. Rinse thoroughly and dry with a clean towel.

To use the shampoo form of this medicine:

• Apply enough medicine to thoroughly wet the dry hair and scalp or skin. Allow the medicine to remain on the affected areas for exactly 10 minutes.


• Then use a small amount of water and work shampoo into the hair and scalp or skin until a lather forms. Rinse thoroughly and dry with a clean towel.

After rinsing and drying, use a nit removal comb (special fine-toothed comb, usually included with this medicine) to remove the dead lice and eggs (nits) from hair.

Immediately after using this medicine, wash your hands to remove any medicine that may be on them.

This medicine should be used again in 7 to 10 days after the first treatment in order to kill any newly hatched lice.

Lice can easily move from one person to another by close body contact. This can happen also by direct contact with such things as clothing, hats, scarves, bedding, towels, washcloths, hairbrushes and combs, or the hair of infected persons. Therefore, all members of your household should be examined for lice and receive treatment if they are found to be infected.

To use this medicine for pubic (crab) lice:

• Your sexual partner may also need to be treated, since the infection may spread to persons in close contact. If your partner is not being treated or if you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (gel, solution shampoo, and topical solution):
  
  • For head, body, or pubic lice:
    
    • Adults and children—Use one time, then repeat one time in seven to ten days.
    
    
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Rid

To prevent reinfection or spreading of the infection to other people, good health habits are also required. These include the following:

• For head lice
  
  • Machine wash all clothing (including hats, scarves, and coats), bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.
  
  
  • Shampoo all wigs and hairpieces.
  
  
  • Wash all hairbrushes and combs in very hot soapy water (above 130 °F) for 5 to 10 minutes and do not share them with other people.
  
  
  • Clean the house or room by thoroughly vacuuming upholstered furniture, rugs, and floors.
  
  


• For body lice
  
  • Machine wash all clothing, bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.
  
  
  • Clean the house or room by thoroughly vacuuming upholstered furniture, rugs, and floors.
  
  


• For pubic lice
  
  • Machine wash all clothing (especially underwear), bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.
  
  
  • Scrub toilet seats frequently.
  
  

Rid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Skin irritation not present before use of this medicine


• skin rash or infection


• sneezing (sudden attacks of)


• stuffy or runny nose


• wheezing or difficulty in breathing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Rid Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Ditropan

Dosage Form: tablet
Ditropan®

(oxybutynin chloride)

Tablets

Ditropan Description

Each scored biconvex, engraved blue Ditropan® (oxybutynin chloride) Tablet contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3•HCl. The structural formula appears below:

Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis.

Ditropan Tablets also contain calcium stearate, FD&C Blue #1 Lake, lactose, and microcrystalline cellulose.

Ditropan Tablets are for oral administration.

Therapeutic Category: Antispasmodic, anticholinergic.

Ditropan - Clinical Pharmacology

Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Oxybutynin chloride exhibits only one fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic activity. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).

Oxybutynin chloride relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin chloride increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. Oxybutynin chloride thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.

Antimuscarinic activity resides predominately in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies.

Pharmacokinetics

Absorption

Following oral administration of Ditropan, oxybutynin is rapidly absorbed achieving Cmax within an hour, following which plasma concentration decreases with an effective half-life of approximately 2 to 3 hours. The absolute bioavailability of oxybutynin is reported to be about 6% (range 1.6 to 10.9%) for the tablets. Wide interindividual variation in pharmacokinetic parameters is evident following oral administration of oxybutynin.

The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 1. The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin.

Table 1 Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following Three Doses of Ditropan 5 mg Administered every 8 Hours (n=23)

Parameters (units)	R-Oxybutynin	S-Oxybutynin
Cmax (ng/mL)	3.6 (2.2)	7.8 (4.1)
Tmax (h)	0.89 (0.34)	0.65 (0.32)
AUCt (ng∙h/mL)	22.6 (11.3)	35.0 (17.3)
AUCinf (ng∙h/mL)	24.3 (12.3)	37.3 (18.7)

Figure 1. Mean R-oxybutynin plasma concentrations following three doses of Ditropan 5 mg administered every 8 hours for 1 day in 23 healthy adult volunteers

Ditropan steady-state pharmacokinetics were also studied in 11 pediatric patients with detrusor overactivity associated with a neurological condition (e.g., spina bifida). These pediatric patients were on Ditropan tablets with total daily dose ranging from 7.5 mg to 15 mg (0.22 to 0.53 mg/kg). Overall, most patients (86.9%) were taking a total daily Ditropan dose between 10 mg and 15 mg. Sparse sampling technique was used to obtain serum samples. When all available data are normalized to an equivalent of 5 mg twice daily Ditropan, the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 2. The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg twice daily.

Table 2 Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters In Children Aged 5–15 Following Administration of 7.5 mg to 15 mg Total Daily Dose of Ditropan Tablets (N=11)

All Available Data Normalized to an Equivalent of Ditropan Tablets 5 mg BID or TID at Steady State
	R-Oxybutynin	S-Oxybutynin	R- Desethyloxybutynin	S- Desethyloxybutynin
* Reflects Cmax for pooled data † AUC0–end of dosing interval
Cmax* (ng/mL)	6.1± 3.2	10.1 ± 7.5	55.4 ± 17.9	28.2 ± 10.0
Tmax (hr)	1.0	1.0	2.0	2.0
AUC† (ng.hr/mL)	19.8 ± 7.4	28.4 ± 12.7	238.8 ± 77.6	119.5 ± 50.7

Figure 2. Mean steady-state (±SD) R-oxybutynin plasma concentrations following administration of total daily Ditropan Tablet dose of 7.5 mg to 15 mg (0.22 mg/kg to 0.53 mg/kg) in children 5–15 years of age. – Plot represents all available data normalized to the equivalent of Ditropan 5 mg BID or TID at steady state

Food Effects

Data in the literature suggests that oxybutynin solution co-administered with food resulted in a slight delay in absorption and an increase in its bioavailability by 25% (n=18).1

Distribution

Oxybutynin is widely distributed in body tissues following systemic absorption. The volume of distribution is 193 L after intravenous administration of 5 mg oxybutynin chloride. Both enantiomers of oxybutynin are highly bound (>99%) to plasma proteins. Both enantiomers of desethyloxybutynin are also highly bound (>97%) to plasma proteins. The major binding protein is alpha-1 acid glycoprotein.

Metabolism

Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4 found mostly in the liver and gut wall. Its metabolic products include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and desethyloxybutynin, which is pharmacologically active.

Excretion

Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the metabolite desethyloxybutynin.

Clinical Studies

Ditropan was well tolerated in patients administered the drug in controlled studies of 30 days' duration and in uncontrolled studies in which some of the patients received the drug for 2 years.

Indications and Usage for Ditropan

Ditropan® (oxybutynin chloride) is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).

Contraindications

Ditropan® (oxybutynin chloride) is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions.

Ditropan is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

Warnings

Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

Precautions

Central Nervous System Effects

Oxybutynin is associated with anticholinergic central nervous system (CNS) effects (See ADVERSE REACTIONS). A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Ditropan should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

General

Ditropan® (oxybutynin chloride) should be used with caution in the frail elderly, in patients with hepatic or renal impairment, and in patients with myasthenia gravis.

Ditropan may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, myasthenia gravis, and prostatic hypertrophy.

Urinary Retention

Ditropan should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention (see CONTRAINDICATIONS).

Gastrointestinal Disorders

Ditropan should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (see CONTRAINDICATIONS).

Administration of Ditropan to patients with ulcerative colitis may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease.

Ditropan, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, and intestinal atony.

Ditropan should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.

Information for Patients

Patients should be informed that oxybutynin may produce angioedema that could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.

Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin chloride are administered in the presence of high environmental temperature.

Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence), or blurred vision, patients should be advised to exercise caution.

Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.

Drug Interactions

The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.

Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index.

Mean oxybutynin chloride plasma concentrations were approximately 3–4 fold higher when Ditropan was administered with ketoconazole, a potent CYP3A4 inhibitor.

Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., Cmax and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at dosages of oxybutynin chloride of 20, 80, and 160 mg/kg/day showed no evidence of carcinogenicity. These doses are approximately 6, 25, and 50 times the maximum human exposure, based on surface area.

Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae and Salmonella typhimurium test systems.

Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility.

Pregnancy

Category B

Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility or harm to the animal fetus. The safety of Ditropan administered to women who are or who may become pregnant has not been established. Therefore, Ditropan should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ditropan is administered to a nursing woman.

Pediatric Use

The safety and efficacy of Ditropan administration have been demonstrated for pediatric patients 5 years of age and older (see DOSAGE AND ADMINISTRATION).

The safety and efficacy of Ditropan Tablets were studied in 30 children in a 24-week, open-label trial. Patients were aged 5–15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that the administration of Ditropan was associated with improvement in clinical and urodynamic parameters.

At total daily doses ranging from 5 mg to 15 mg, treatment with Ditropan Tablets was associated with an increase from baseline in mean urine volume per catheterization from 122 mL to 145 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 168 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 43% to 61%. Urodynamic results in these patients were consistent with the clinical results. Treatment with Ditropan Tablets was associated with an increase from baseline in maximum cystometric capacity from 230 mL to 279 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 36 cm H2O to 33 cm H2O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H2O) from 39% to 20%.

As there is insufficient clinical data for pediatric populations under age 5, Ditropan is not recommended for this age group.

Geriatric Use

Clinical studies of Ditropan did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between healthy elderly and younger patients; however, a lower initial starting dose of 2.5 mg given 2 or 3 times a day has been recommended for the frail elderly due to a prolongation of the elimination half-life from 2–3 hours to 5 hours.2,3,4 In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

The safety and efficacy of Ditropan® (oxybutynin chloride) was evaluated in a total of 199 patients in three clinical trials. These participants were treated with Ditropan 5–20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients.

Table 3 Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using Ditropan (5–20 mg/day)

Body System	Adverse Event	Ditropan (5–20 mg/day) (n=199)
Infections and Infestations	Urinary tract infection	6.5%
Psychiatric Disorders	Insomnia	5.5%
	Nervousness	6.5%
Nervous System Disorders	Dizziness	16.6%
	Somnolence	14.0%
	Headache	7.5%
Eye Disorders	Blurred vision	9.6%
Gastrointestinal Disorders	Dry mouth	71.4%
	Constipation	15.1%
	Nausea	11.6%
	Dyspepsia	6.0%
Renal and Urinary Disorders	Urinary Hesitation	8.5%
	Urinary Retention	6.0%

The most common adverse events reported by patients receiving Ditropan 5–20 mg/day were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.

In addition, the following adverse events were reported by 1 to <5% of patients using Ditropan (5–20 mg/day) in all studies. Infections and Infestations: nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition Disorders: fluid retention; Psychiatric Disorders: confusional state; Nervous System Disorders: dysgeusia, sinus headache; Eye Disorders: keratoconjunctivitis sicca, eye irritation; Cardiac Disorders: palpitations, sinus arrhythmia; Vascular Disorders: flushing; Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, asthma, nasal congestion; Gastrointestinal Disorders: diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain upper, dysphagia, aptyalism, eructation, tongue coated; Skin and Subcutaneous Tissue Disorders: dry skin, pruritis; Musculoskeletal and Connective Tissue Disorders: back pain, arthralgia, pain in extremity, flank pain; Renal and Urinary Disorders: dysuria, pollakiuria; General Disorders and Administration Site Conditions: fatigue, edema peripheral, asthenia, pain, thirst, edema; Investigations: blood pressure increased, blood glucose increased, blood pressure decreased; Injury, Poisoning, and Procedural Complications: fall.

Postmarketing Surveillance

Because postmarketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse events have been reported from worldwide postmarketing experience with Ditropan: Psychiatric Disorders: psychotic disorder, agitation, hallucination, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: cycloplegia, mydriasis, glaucoma; Cardiac Disorders: tachycardia, QT interval prolongation; Gastrointestinal Disorders: decreased gastrointestinal motility; Skin and Subcutaneous Tissue Disorders: rash, decreased sweating; Renal and Urinary Disorders: impotence; Reproductive System and Breast Disorders: Suppression of lactation; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment.

Overdosage

Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered.

Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Other symptoms may include hypotension or hypertension, respiratory failure, paralysis, and coma.

Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.

Ditropan Dosage and Administration

Adults

The usual dose is one 5-mg tablet two to three times a day. The maximum recommended dose is one 5-mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly.

Pediatric patients over 5 years of age

The usual dose is one 5-mg tablet two times a day. The maximum recommended dose is one 5-mg tablet three times a day.

How is Ditropan Supplied

Ditropan® (oxybutynin chloride) Tablets are supplied in bottles of 100 tablets (NDC 17314-9200-1). Blue scored tablets (5 mg) are engraved with Ditropan on one side with 92 and 00, separated by a horizontal score, on the other side.

Pharmacist: Dispense in tight, light-resistant container as defined in the USP.

Store at controlled room temperature 59–86°F (15–30°C).

REFERENCES

1. Yong C et al. Effect of Food on the Pharmacokinetics of Oxybutynin in normal subjects. Pharm Res. 1991; 8 (Suppl.): S-320.


2. Hughes KM et al. Measurement of oxybutynin and its N-desethyl metabolite in plasma, and its application to pharmacokinetic studies in young, elderly and frail elderly volunteers. Xenobiotica. 1992; 22 (7): 859–869.


3. Ouslander J et al. Pharmacokinetics and Clinical Effects of Oxybutynin in Geriatric Patients. J. Urol. 1988; 140: 47–50.


4. Yarker Y et al. Oxybutynin: A review of its Pharmacodynamic and Pharmacokinetic Properties, and its Therapeutic Use in Detrusor Instability. Drugs & Aging. 1995; 6(3): 243–262.

Manufactured by sanofi-aventis U.S. LLC, Kansas City, MO 64137.

Marketed by Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ 08869

(OMP Logo)

Revised December 20, 2011

PRINCIPAL DISPLAY PANEL - 5 mg - 100 Tablet Bottle

NDC 17314-9200-1

Ditropan®

(oxybutynin chloride)

5 mg

ORTHO-McNEIL

100 Tablets

© OMP 1998, 2003

Ditropan  oxybutynin chloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17314-9200 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength oxybutynin chloride (oxybutynin) oxybutynin chloride 5 mg

Inactive Ingredients Ingredient Name Strength calcium stearate   FD&C Blue no. 1   Aluminum Oxide   lactose   cellulose, microcrystalline

Product Characteristics Color BLUE Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code Ditropan;92;00 Contains

Packaging # NDC Package Description Multilevel Packaging 1 17314-9200-1 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017577	07/16/1975

Labeler - ALZA Corporation (175417641)

Establishment
Name	Address	ID/FEI	Operations
sanofi aventis		783243835	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
PCAS France (API)		396133998	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Janssen Ortho LLC		084894661	ANALYSIS

Revised: 01/2012ALZA Corporation