Carvedilol AURUS

Carvedilol AURUS may be available in the countries listed below.

Ingredient matches for Carvedilol AURUS

Carvedilol

Carvedilol is reported as an ingredient of Carvedilol AURUS in the following countries:

• Germany

International Drug Name Search

Ofloxacine ratiopharm

Ofloxacine ratiopharm may be available in the countries listed below.

Ingredient matches for Ofloxacine ratiopharm

Ofloxacin

Ofloxacin is reported as an ingredient of Ofloxacine ratiopharm in the following countries:

• Belgium


• France


• Netherlands

International Drug Name Search

Diamsalina

Diamsalina may be available in the countries listed below.

Ingredient matches for Diamsalina

Dicloxacillin

Dicloxacillin sodium salt (a derivative of Dicloxacillin) is reported as an ingredient of Diamsalina in the following countries:

• Mexico

International Drug Name Search

Alpurase

Alpurase may be available in the countries listed below.

Ingredient matches for Alpurase

Allopurinol

Allopurinol is reported as an ingredient of Alpurase in the following countries:

• Philippines

International Drug Name Search

MetroGel

See also: Generic MetroCream, Generic MetroGel-Vaginal, Generic MetroLotion

MetroGel is a brand name of metronidazole topical, approved by the FDA in the following formulation(s):

METROGEL (metronidazole - gel; topical)

• 
  Manufacturer: GALDERMA LABS LP
  
  Approval date: November 22, 1988
  
  Strength(s): 0.75% ^[RLD][AB]


• 
  Manufacturer: GALDERMA LABS LP
  
  Approval date: June 30, 2005
  
  Strength(s): 1% ^[RLD][AB]

Has a generic version of MetroGel been approved?

A generic version of MetroGel has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to MetroGel and have been approved by the FDA:

metronidazole gel; topical

• 
  Manufacturer: FOUGERA PHARMS
  
  Approval date: June 6, 2006
  
  Strength(s): 0.75% ^[AB]


• 
  Manufacturer: G AND W LABS INC
  
  Approval date: January 19, 2011
  
  Strength(s): 0.75% ^[AB]


• 
  Manufacturer: TARO
  
  Approval date: July 18, 2006
  
  Strength(s): 0.75% ^[AB]


• 
  Manufacturer: TOLMAR
  
  Approval date: July 13, 2006
  
  Strength(s): 0.75% ^[AB]


• 
  Manufacturer: TOLMAR
  
  Approval date: July 22, 2011
  
  Strength(s): 1% ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of MetroGel. 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.

• 
  Aqueous compositions containing metronidazole
  Patent 6,881,726
  Issued: April 19, 2005
  Inventor(s): Chang; Yunik & Dow; Gordon J.
  Assignee(s): Dow Pharmaceutical Sciences
  An aqueous solution of metronidazole in which the concentration of metronidazole is higher than 0.75%. The solution contains a combination of solubility-enhancing agents, one of which is a cyclodextrin such as beta-cyclodextrin and the second is a compound other than a cyclodextrin. Methods of manufacture and therapeutic use of the solution are disclosed.
  
  Patent expiration dates:
  
  
  • February 21, 2022
    
    ✓ 
    Patent use: ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
    ✓ 
    Drug product
  
  



• 
  Aqueous compositions containing metronidazole
  Patent 7,348,317
  Issued: March 25, 2008
  Inventor(s): Chang; Yunik & Dow; Gordon J.
  Assignee(s): Dow Pharmaceutical Sciences
  An aqueous solution of metronidazole in which the concentration of metronidazole is higher than 0.75%. The solution contains a combination of solubility-enhancing agents, one of which is a cyclodextrin such as beta-cyclodextrin and the second is niacin or niacinamide. Methods of manufacture and therapeutic use of the solution are disclosed.
  
  Patent expiration dates:
  
  
  • February 21, 2022
    
    ✓ 
    Patent use: ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
    ✓ 
    Drug product
  
  

See also...

• MetroGel Cream Consumer Information (Wolters Kluwer)
• MetroGel Gel Consumer Information (Wolters Kluwer)
• MetroGel Consumer Information (Cerner Multum)
• Metrogel Topical Advanced Consumer Information (Micromedex)
• Metronidazole Cream Consumer Information (Wolters Kluwer)
• Metronidazole Emulsion Consumer Information (Wolters Kluwer)
• Metronidazole Gel Consumer Information (Wolters Kluwer)
• Metronidazole topical Consumer Information (Cerner Multum)
• Metronidazole vaginal Consumer Information (Cerner Multum)
• Flagyl Vaginal Advanced Consumer Information (Micromedex)
• Neo-Metric Advanced Consumer Information (Micromedex)
• Nidagel Advanced Consumer Information (Micromedex)
• Metronidazole Topical Advanced Consumer Information (Micromedex)
• Metronidazole Vaginal Advanced Consumer Information (Micromedex)
• Metronidazole topical AHFS DI Monographs (ASHP)

Claritromicina Edigen

Claritromicina Edigen may be available in the countries listed below.

Ingredient matches for Claritromicina Edigen

Clarithromycin

Clarithromycin is reported as an ingredient of Claritromicina Edigen in the following countries:

• Spain

International Drug Name Search

Quick-Pep

Ingredient matches for Quick-Pep

Caffeine

Caffeine is reported as an ingredient of Quick-Pep in the following countries:

• United States

International Drug Name Search

Corsim

Corsim may be available in the countries listed below.

Ingredient matches for Corsim

Simvastatin

Simvastatin is reported as an ingredient of Corsim in the following countries:

• Czech Republic

International Drug Name Search

Depam

Depam may be available in the countries listed below.

Ingredient matches for Depam

Domperidone

Domperidone is reported as an ingredient of Depam in the following countries:

• India

Pantoprazole

Pantoprazole is reported as an ingredient of Depam in the following countries:

• India

International Drug Name Search

Flexure

Flexure may be available in the countries listed below.

Ingredient matches for Flexure

Chondroitin Polysulfate

Chondroitin Polysulfate is reported as an ingredient of Flexure in the following countries:

• Peru

Glucosamine

Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Flexure in the following countries:

• Peru

International Drug Name Search

Morphasol

Morphasol may be available in the countries listed below.

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

Ingredient matches for Morphasol

Butorphanol

Butorphanol tartrate (a derivative of Butorphanol) is reported as an ingredient of Morphasol in the following countries:

• Switzerland

International Drug Name Search

Coopers Ectoforce Sheep Dip

Coopers Ectoforce Sheep Dip may be available in the countries listed below.

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

Ingredient matches for Coopers Ectoforce Sheep Dip

Dimpylate

Dimpylate is reported as an ingredient of Coopers Ectoforce Sheep Dip in the following countries:

• United Kingdom

International Drug Name Search

Diltiazem 24-Hour Sustained-Release Capsules

Pronunciation: dil-TYE-a-zem
Generic Name: Diltiazem
Brand Name: Examples include Diltia XT and Dilt-XR

Diltiazem 24-Hour Sustained-Release Capsules are used for:

Treating high blood pressure and chronic stable angina (chest pain). It may be used alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Diltiazem 24-Hour Sustained-Release Capsules are a calcium channel blocker. It works by relaxing (dilating) your blood vessels, lowering blood pressure, and decreasing heart rate, which lowers the workload of the heart. It also dilates coronary arteries, which increases blood flow to the heart.

Do NOT use Diltiazem 24-Hour Sustained-Release Capsules if:

• you are allergic to any ingredient in Diltiazem 24-Hour Sustained-Release Capsules


• you have certain heart problems (eg, sick sinus syndrome, second- or third-degree heart block) and do not have a pacemaker, you have very low blood pressure, or you have fluid buildup in the lungs during or soon after a heart attack


• you are taking erythromycin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Diltiazem 24-Hour Sustained-Release Capsules:

Some medical conditions may interact with Diltiazem 24-Hour Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart failure, a recent heart attack with lung congestion, heart block, a very slow heart rate, or other heart problems; low blood pressure; certain stomach or intestine problems (eg, narrowing); liver disease; or kidney problems


• if you are taking other medicines for high blood pressure or heart conditions

Some MEDICINES MAY INTERACT with Diltiazem 24-Hour Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, amiodarone, dronedarone), cimetidine, clonidine, HIV protease inhibitors (eg, atazanavir, indinavir), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Diltiazem 24-Hour Sustained-Release Capsules's side effects, such as heart rhythm problems


• Benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), buspirone, carbamazepine, cilostazol, cisapride, colchicine, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, everolimus, fentanyl, HMG-CoA reductase inhibitors (eg, simvastatin), hydantoins (eg, phenytoin), lurasidone, macrolide antibiotics (eg, erythromycin ), macrolide immunosuppressants (eg, tacrolimus), nifedipine, quinidine, ranolazine, theophylline, or vasopressin antagonists (eg, tolvaptan) because the risk of their side effects, some potentially life-threatening, may be increased by Diltiazem 24-Hour Sustained-Release Capsules


• Moricizine or rifamycins (eg, rifampin) because they may decrease Diltiazem 24-Hour Sustained-Release Capsules's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diltiazem 24-Hour Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Diltiazem 24-Hour Sustained-Release Capsules:

Use Diltiazem 24-Hour Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Diltiazem 24-Hour Sustained-Release Capsules by mouth on an empty stomach at least 1 hour before or 2 hours after eating.


• Swallow Diltiazem 24-Hour Sustained-Release Capsules whole. Do not open, break, crush, or chew before swallowing.


• Taking Diltiazem 24-Hour Sustained-Release Capsules at the same time each day will help you remember to take it.


• Continue to take Diltiazem 24-Hour Sustained-Release Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Diltiazem 24-Hour Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Diltiazem 24-Hour Sustained-Release Capsules.

Important safety information:

• Diltiazem 24-Hour Sustained-Release Capsules may cause dizziness, lightheadedness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Diltiazem 24-Hour Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Diltiazem 24-Hour Sustained-Release Capsules may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Diltiazem 24-Hour Sustained-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Diltiazem 24-Hour Sustained-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Do not suddenly stop taking Diltiazem 24-Hour Sustained-Release Capsules. Your condition may get worse if you suddenly stop taking it. If you need to stop Diltiazem 24-Hour Sustained-Release Capsules or add a new medicine, your doctor will gradually lower your dose.


• Tell your doctor or dentist that you take Diltiazem 24-Hour Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.


• Be sure to have your blood pressure checked regularly while taking Diltiazem 24-Hour Sustained-Release Capsules.


• Lab tests, including blood pressure, electrocardiogram (ECG), and heart rate, may be performed while you use Diltiazem 24-Hour Sustained-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Diltiazem 24-Hour Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the ankles, feet, or hands; dizziness; and slow heartbeat.


• Diltiazem 24-Hour Sustained-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Diltiazem 24-Hour Sustained-Release Capsules while you are pregnant. Diltiazem 24-Hour Sustained-Release Capsules are found in breast milk. Do not breast-feed while taking Diltiazem 24-Hour Sustained-Release Capsules.

Possible side effects of Diltiazem 24-Hour Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; facial flushing; headache; lightheadedness; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes; personality changes; reddened, blistered, or swollen skin; severe or persistent dizziness, lightheadedness, nausea, or vomiting; shortness of breath; sudden weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); tender, bleeding, or swollen gums; unusual bleeding or bruising; unusual or persistent tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Diltiazem side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; difficulty breathing, especially when lying down; dizziness; drowsiness; fainting; lightheadedness, especially when standing; loss of consciousness; nausea; nervousness; slurred speech; unusual weakness; very slow heart rate.

Proper storage of Diltiazem 24-Hour Sustained-Release Capsules:

Store Diltiazem 24-Hour Sustained-Release Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diltiazem 24-Hour Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Diltiazem 24-Hour Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Diltiazem 24-Hour Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Diltiazem 24-Hour Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Diltiazem resources

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

Compare Diltiazem with other medications

• Angina Pectoris Prophylaxis
• Atrial Fibrillation
• Atrial Flutter
• Heart Failure
• High Blood Pressure
• Raynaud's Syndrome
• Supraventricular Tachycardia

Ascal

Ascal may be available in the countries listed below.

Ingredient matches for Ascal

Carbasalate Calcium

Carbasalate Calcium is reported as an ingredient of Ascal in the following countries:

• Netherlands

International Drug Name Search

Gabatur

Gabatur may be available in the countries listed below.

Ingredient matches for Gabatur

Gabapentin

Gabapentin is reported as an ingredient of Gabatur in the following countries:

• Spain

International Drug Name Search

Blenamax

Blenamax may be available in the countries listed below.

Ingredient matches for Blenamax

Bleomycin

Bleomycin is reported as an ingredient of Blenamax in the following countries:

• Indonesia


• Peru


• Taiwan

Bleomycin sulfate (a derivative of Bleomycin) is reported as an ingredient of Blenamax in the following countries:

• Australia


• Latvia


• South Africa

International Drug Name Search

Inibsacain Hiperbarica

Inibsacain Hiperbarica may be available in the countries listed below.

Ingredient matches for Inibsacain Hiperbarica

Bupivacaine

Bupivacaine hydrochloride (a derivative of Bupivacaine) is reported as an ingredient of Inibsacain Hiperbarica in the following countries:

• Spain

International Drug Name Search

Penglobe

Penglobe may be available in the countries listed below.

Ingredient matches for Penglobe

Bacampicillin

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

• India


• Luxembourg


• Philippines

International Drug Name Search

Klonastin

Klonastin may be available in the countries listed below.

Ingredient matches for Klonastin

Simvastatin

Simvastatin is reported as an ingredient of Klonastin in the following countries:

• Argentina


• Peru

International Drug Name Search

Ondansetrón GMP

Ondansetrón GMP may be available in the countries listed below.

Ingredient matches for Ondansetrón GMP

Ondansetron

Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Ondansetrón GMP in the following countries:

• Venezuela

International Drug Name Search

Clopidogrel Dexcel

Clopidogrel Dexcel may be available in the countries listed below.

Ingredient matches for Clopidogrel Dexcel

Clopidogrel

Clopidogrel besilate (a derivative of Clopidogrel) is reported as an ingredient of Clopidogrel Dexcel in the following countries:

• Germany

International Drug Name Search

Neusinol

Neusinol may be available in the countries listed below.

Ingredient matches for Neusinol

Naphazoline

Naphazoline nitrate (a derivative of Naphazoline) is reported as an ingredient of Neusinol in the following countries:

• Belgium

International Drug Name Search

Kinzalmono

Kinzalmono may be available in the countries listed below.

Ingredient matches for Kinzalmono

Telmisartan

Telmisartan is reported as an ingredient of Kinzalmono in the following countries:

• Belgium


• Finland


• Germany


• Luxembourg


• Netherlands

International Drug Name Search

Carbamazepina Alter

Carbamazepina Alter may be available in the countries listed below.

Ingredient matches for Carbamazepina Alter

Carbamazepine

Carbamazepine is reported as an ingredient of Carbamazepina Alter in the following countries:

• Portugal


• Spain

International Drug Name Search

Mann

Mann may be available in the countries listed below.

Ingredient matches for Mann

Caffeine

Caffeine is reported as an ingredient of Mann in the following countries:

• Belgium

Paracetamol

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

• Belgium

International Drug Name Search

Zindacline

Zindacline may be available in the countries listed below.

Ingredient matches for Zindacline

Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Zindacline in the following countries:

• France

International Drug Name Search

dicloxacillin

Generic Name: dicloxacillin (dye klox a SIL in)

Brand Names: Dycill, Dynapen

What is dicloxacillin?

Dicloxacillin is an antibiotic in the penicillin group of drugs. It fights bacteria in your body.

Dicloxacillin is used to treat many different types of infections caused by bacteria such as bronchitis, pneumonia, or staphylococcal (also called "staph") infections.

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

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

Do not use this medication if you are allergic to dicloxacillin or to any other penicillin antibiotic, such as amoxicillin (Amoxil), ampicillin (Omnipen, Principen), carbenicillin (Geocillin), oxacillin (Bactocill), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.

Before using dicloxacillin, tell your doctor if you are allergic to cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others, or if you have asthma, liver disease, kidney disease, or a history of any type of allergy.

Dicloxacillin can make birth control pills less effective, which may result in pregnancy. Before taking dicloxacillin, tell your doctor if you use birth control pills. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Dicloxacillin will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

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

Do not use this medication if you are allergic to dicloxacillin or to any other penicillin antibiotic, such as:

• 
  

  amoxicillin (Amoxil, Amoxicot, Biomox, Dispermox, Trimox);

  
  


• 
  

  ampicillin (Omnipen, Principen);

  
  


• 
  

  carbenicillin (Geocillin);

  
  


• 
  

  oxacillin (Bactocill); or

  
  


• 
  

  penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others).

  
  

Before using dicloxacillin, tell your doctor if you are allergic to any drugs (especially cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others), or if you have:

• 
  

  asthma;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease;

  
  


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  a history of diarrhea caused by taking antibiotics; or

  
  


• 
  

  a history of any type of allergy.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take dicloxacillin.

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. Dicloxacillin can make birth control pills less effective, which may result in pregnancy. Before taking dicloxacillin, tell your doctor if you use birth control pills. Dicloxacillin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take dicloxacillin?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take the medicine with a full glass of water. Dicloxacillin should be taken on an empty stomach, at least 1 hour before or 2 hours after eating a meal.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Dicloxacillin will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using dicloxacillin.

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

See also: Dicloxacillin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, behavior changes, a severe skin rash, urinating less than usual, or seizure (black-out or convulsions).

What should I avoid while taking dicloxacillin?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Dicloxacillin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

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

  
  


• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  severe skin rash, itching, or peeling;

  
  


• 
  

  agitation, confusion, unusual thoughts or behavior; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, stomach pain;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  headache;

  
  


• 
  

  swollen, black, or "hairy" tongue; or

  
  


• 
  

  thrush (white patches or inside your mouth or throat).

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Dicloxacillin Dosing Information

Usual Adult Dose for Bronchitis:

250 to 500 mg orally every 6 hours for 10 days, depending on the nature and severity of the infection.

Usual Adult Dose for Pharyngitis:

250 mg orally every 6 hours for 10 days, depending on the nature and severity of the infection.

Usual Adult Dose for Pneumonia:

500 mg orally every 6 hours for up to 21 days, depending on the nature and severity of the infection.

Usual Adult Dose for Skin or Soft Tissue Infection:

500 mg orally every 6 hours for 7 days, or for 3 days after acute inflammation resolves, depending on the nature and severity of the infection.

Usual Adult Dose for Upper Respiratory Tract Infection:

250 mg orally every 6 hours for 7 to 21 days, depending on the nature and severity of the infection.

Usual Pediatric Dose for Skin or Soft Tissue Infection:

>40 kg: 125 to 250 mg orally every 6 hours.

Usual Pediatric Dose for Upper Respiratory Tract Infection:

>40 kg: 125 to 250 mg orally every 6 hours.

Usual Pediatric Dose for Osteomyelitis:

Following initial intravenous therapy:
>= 1 year:

>40 kg: 250 mg orally every 6 hours, not to exceed 2000 mg/24 hours.

Usual Pediatric Dose for Pneumonia:

>40 kg: 250 mg orally every 6 hours.

What other drugs will affect dicloxacillin?

Before taking dicloxacillin, tell your doctor if you are using any of the following drugs:

• 
  

  methotrexate (Rheumatrex, Trexall); or

  
  


• 
  

  probenecid (Benemid).

  
  

This list is not complete and there may be other drugs that can interact with dicloxacillin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More dicloxacillin resources

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

• Dicloxacillin Prescribing Information (FDA)


• Dicloxacillin MedFacts Consumer Leaflet (Wolters Kluwer)


• Dicloxacillin Sodium Monograph (AHFS DI)


• Dynapen Advanced Consumer (Micromedex) - Includes Dosage Information

Compare dicloxacillin with other medications

• Bone infection
• Bronchitis
• Pharyngitis
• Pneumonia
• Skin Infection
• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist can provide more information about dicloxacillin.

See also: dicloxacillin side effects (in more detail)

Amoxicilina Ratiopharm

Amoxicilina Ratiopharm may be available in the countries listed below.

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Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilina Ratiopharm in the following countries:

• Spain

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Mycazole

Mycazole may be available in the countries listed below.

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Fluconazole

Fluconazole is reported as an ingredient of Mycazole in the following countries:

• Greece

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Amplobiotic

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Chloramphenicol

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

• Brazil

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Captopril / Hydrochlorothiazide Biogaran

Captopril/Hydrochlorothiazide Biogaran may be available in the countries listed below.

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Captopril

Captopril is reported as an ingredient of Captopril/Hydrochlorothiazide Biogaran in the following countries:

• France

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Captopril/Hydrochlorothiazide Biogaran in the following countries:

• France

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Médroxyprogestérone

Médroxyprogestérone may be available in the countries listed below.

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Medroxyprogesterone

Médroxyprogestérone (DCF) is known as Medroxyprogesterone in the US.

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Glossary

DCF	Dénomination Commune Française

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

Prevender

Prevender may be available in the countries listed below.

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

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Dimpylate

Dimpylate is reported as an ingredient of Prevender in the following countries:

• Netherlands


• Portugal


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• United Kingdom

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Dihydrostreptomycin Sulfate

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

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Dihydrostreptomycin

Dihydrostreptomycin sulfate (a derivative of Dihydrostreptomycin) is reported as an ingredient of Dihydrostreptomycin Sulfate in the following countries:

• United States

Streptomycin

Streptomycin sulfate (a derivative of Streptomycin) is reported as an ingredient of Dihydrostreptomycin Sulfate in the following countries:

• United States

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Finul

Finul may be available in the countries listed below.

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Sulpiride

Sulpiride is reported as an ingredient of Finul in the following countries:

• Peru

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Klamycin

Klamycin may be available in the countries listed below.

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Clarithromycin

Clarithromycin is reported as an ingredient of Klamycin in the following countries:

• New Zealand

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Fructose

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

Scheme

USP

ATC (Anatomical Therapeutic Chemical Classification)

V06DC02

CAS registry number (Chemical Abstracts Service)

0000057-48-7

Chemical Formula

C6-H12-O6

Molecular Weight

180

Therapeutic Category

Dietary agent

Chemical Name

D-Fructose

Foreign Names

• Fructosum (Latin)
• Fructose (German)
• Fructose (French)

Generic Names

• Fructose (OS: JAN, DCF)
• Laevfructose (IS)
• Laevulosum (IS: Fructosum)
• Lévulose (IS: DCF vieille)
• D-Fructose (PH: BP 2010)
• Fructose (PH: JP XIV, USP 32, Ph. Eur. 6, BP 2007)
• Fructosum (PH: Ph. Eur. 6)

Brand Names

• Fructin
  Beximco, Bangladesh



• Fructon
  Otsuka, Japan



• Fructose
  Otsuka, Taiwan



• Fruttosio (veterinary use)
  Acme, Italy; Galenica Senese, Italy



• Glycenon (Fructose and Glycerol)
  I'rom SeiyakuAiromu, Japan



• Glyceol (Fructose and Glycerol)
  Chugai, Japan



• Glycereb (Fructose and Glycerol)
  Terumo, Japan



• Glymacken (Fructose and Glycerol)
  Mylan Pharmaceutical, Japan



• Glypose (Fructose and Glycerol)
  Fuso Pharmaceutical, Japan



• Grenol (Fructose and Glycerol)
  Ajinomoto, Japan



• Gycerin F (Fructose and Glycerol)
  Hikari Seiyaku, Japan



• Hisiceol (Fructose and Glycerol)
  Nipro PharmaNipurofama, Japan



• Laevulose
  Actavis, Georgia



• Levose
  Fuso Pharmaceutical, Japan



• Lévulose Aguettant
  Aguettant, France



• Lévulose Biosedra
  Fresenius, France



• Levuloza
  Hemofarm, Serbia; Pliva, Bosnia & Herzegowina



• Esafosfina
  Biomedica Foscama, China; Biomedica Foscama, Georgia; Biomedica Foscama, Hong Kong; Biomedica Foscama, Italy



• FDP Fisiopharma
  Fisiopharma, Italy

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
USP	Pharmacopoeia of the United States

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

Kenolan

Kenolan may be available in the countries listed below.

Ingredient matches for Kenolan

Captopril

Captopril is reported as an ingredient of Kenolan in the following countries:

• Mexico

International Drug Name Search

Asmanil-Inga

Asmanil-Inga may be available in the countries listed below.

Ingredient matches for Asmanil-Inga

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Asmanil-Inga in the following countries:

• Sri Lanka

International Drug Name Search

NV Halo

NV Halo may be available in the countries listed below.

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

Ingredient matches for NV Halo

Hyaluronic Acid

Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of NV Halo in the following countries:

• New Zealand

International Drug Name Search

Gabapentin Actavis

Gabapentin Actavis may be available in the countries listed below.

Ingredient matches for Gabapentin Actavis

Gabapentin

Gabapentin is reported as an ingredient of Gabapentin Actavis in the following countries:

• Austria


• Denmark


• Germany


• Slovakia


• Sweden

International Drug Name Search

Darby Topical Fuoride Gel

Generic Name: sodium fluoride

Dosage Form: gel
Darby 60 Sec Gel 2.72 % Topical Sodium Fluoride Gel Grape

Darby 60 Sec Fluoride Gel

952-1547

2.72 % Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Grape

16.23 fl oz / 480mL

NDC 66467-2150-1

A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavored.

Directions:

1. Use after thorough prophylaxis

2. To dispense, fill tray(s) 1/3 with gel

3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds

4. Remove tray(s) and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the application

Medicinal ingredients: Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)

Non-Medicinal ingredients: Carboxy methyl cellulose, phosphoric acid, purified water, saccharin sodium (anhydrous), titanium dioxide, red 33, blue 1, grape flavor

Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only. Do not swallow.

Not recommended for use by children under 18 months of age.

Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F.

Do not use if seal is broken.

Made in USA

Distributed by:

Darby Dental Supply, LLC

Jericho, NY 11753

UPC 952-1547

Rev.00

DARBY   TOPICAL SODIUM FLUORIDE sodium fluoride  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2150 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) fluoride ion .0272 g  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color purple Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66467-2150-1 480 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/12/2010

Labeler - Darby Dental Supply Co Inc (825137818)

Revised: 11/2010Darby Dental Supply Co Inc

More Darby Topical Fuoride Gel resources

• Darby Topical Fuoride Gel Use in Pregnancy & Breastfeeding
• Darby Topical Fuoride Gel Support Group
• 3 Reviews for Darby Topical Fuoride - Add your own review/rating

Compare Darby Topical Fuoride Gel with other medications

• Prevention of Dental Caries

Gliadel Wafer

Ingredient matches for Gliadel Wafer

Carmustine

Carmustine is reported as an ingredient of Gliadel Wafer in the following countries:

• Israel


• United States

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Naton

Naton may be available in the countries listed below.

Ingredient matches for Naton

Naproxen

Naproxen is reported as an ingredient of Naton in the following countries:

• Taiwan

International Drug Name Search

Gris O.D.

Gris O.D. may be available in the countries listed below.

Ingredient matches for Gris O.D.

Griseofulvin

Griseofulvin is reported as an ingredient of Gris O.D. in the following countries:

• Sri Lanka

International Drug Name Search

Majamil

Majamil may be available in the countries listed below.

Ingredient matches for Majamil

Diclofenac

Diclofenac is reported as an ingredient of Majamil in the following countries:

• Lithuania

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Majamil in the following countries:

• Latvia


• Poland

International Drug Name Search

Rowasa

mesalamine

Dosage Form: rectal suspension (Enema)

Rx only

Rowasa Description

The active ingredient in Rowasa® (Mesalamine) Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid.

The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is:

Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.

Rowasa - Clinical Pharmacology

Sulfasalazine is split by bacterial action in the colon into sulfapyridine (SP) and mesalamine (5-ASA). It is thought that the mesalamine component is therapeutically active in ulcerative colitis [A.K. Azad Khan et al, Lancet 2:892-895 (1977)]. The usual oral dose of sulfasalazine for active ulcerative colitis in adults is two to four grams per day in divided doses. Four grams of sulfasalazine provide 1.6 g of free mesalamine to the colon. Each Rowasa® (Mesalamine) Rectal Suspension Enema delivers up to 4 g of mesalamine to the left side of the colon.

The mechanism of action of mesalamine (and sulfasalazine) is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes (LTs) and hydroxyeicosatetraenoic acids (HETEs) is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.

Preclinical Toxicology

Preclinical studies have shown the kidney to be the major target organ for mesalamine toxicity. Adverse renal function changes were observed in rats after a single 600 mg/kg oral dose, but not after a 200 mg/kg dose. Gross kidney lesions, including papillary necrosis, were observed after a single oral >900 mg/kg dose, and after I.V. doses of >214 mg/kg. Mice responded similarly. In a 13-week oral (gavage) dose study in rats, the high dose of 640 mg/kg/day mesalamine caused deaths, probably due to renal failure, and dose-related renal lesions (papillary necrosis and/or multifocal tubular injury) were seen in most rats given the high dose (males and females) as well as in males receiving lower doses 160 mg/kg/day. Renal lesions were not observed in the 160 mg/kg/day female rats. Minimal tubular epithelial damage was seen in the 40 mg/kg/day males and was reversible. In a six-month oral study in dogs, the no-observable dose level of mesalamine was 40 mg/kg/day and doses of 80 mg/kg/day and higher caused renal pathology similar to that described for the rat. In a combined 52-week toxicity and 127-week carcinogenicity study in rats, degeneration in kidneys was observed at doses of 100 mg/kg/day and above admixed with diet for 52 weeks, and at 127 weeks increased incidence of kidney degeneration and hyalinization of basement membranes and Bowman's capsule were seen at 100 mg/kg/day and above. In the 12-month eye toxicity study in dogs, Keratoconjunctivitis Sicca (KCS) occurred at oral doses of 40 mg/kg/day and above. The oral preclinical studies were done with a highly bioavailable suspension where absorption throughout the gastrointestinal tract occurred. The human dose of 4 grams represents approximately 80 mg/kg but when mesalamine is given rectally as a suspension, absorption is poor and limited to the distal colon (see Pharmacokinetics). Overt renal toxicity has not been observed (see ADVERSE REACTIONS and PRECAUTIONS), but the potential must be considered.

Pharmacokinetics

Mesalamine administered rectally as Rowasa® (Mesalamine) Rectal Suspension Enema is poorly absorbed from the colon and is excreted principally in the feces during subsequent bowel movements. The extent of absorption is dependent upon the retention time of the drug product, and there is considerable individual variation. At steady state, approximately 10 to 30% of the daily 4-gram dose can be recovered in cumulative 24-hour urine collections. Other than the kidney, the organ distribution and other bioavailability characteristics of absorbed mesalamine in man are not known. It is known that the compound undergoes acetylation but whether this process takes place at colonic or systemic sites has not been elucidated.

Whatever the metabolic site, most of the absorbed mesalamine is excreted in the urine as the N-acetyl-5-ASA metabolite. The poor colonic absorption of rectally administered mesalamine is substantiated by the low serum concentration of 5-ASA and N-acetyl-5-ASA seen in ulcerative colitis patients after dosage with mesalamine. Under clinical conditions patients demonstrated plasma levels 10 to 12 hours post mesalamine administration of 2 µg/mL, about two-thirds of which was the N-acetyl metabolite. While the elimination half-life of mesalamine is short (0.5 to 1.5 h), the acetylated metabolite exhibits a half-life of 5 to 10 hours [U. Klotz, Clin. Pharmacokin. 10:285-302 (1985)]. In addition, steady state plasma levels demonstrated a lack of accumulation of either free or metabolized drug during repeated daily administrations.

Efficacy

In a placebo-controlled, international, multicenter trial of 153 patients with active distal ulcerative colitis, proctosigmoiditis or proctitis, Rowasa® (Mesalamine) Rectal Suspension Enema reduced the overall disease activity index (DAI) and individual components as follows:

EFFECT OF TREATMENT ON SEVERITY OF DISEASE DATA FROM U.S.-CANADA TRIAL COMBINED RESULTS OF EIGHT CENTERS Activity Indices, mean
		N	Baseline	Day 22	End Point	Change Baseline to End Point *
Each parameter has a 4-point scale with a numerical rating:
0=normal, 1=mild, 2=moderate, 3=severe. The four parameters are added together to produce a maximum overall DAI of 12.
* Percent change for overall DAI only (calculated by taking the average of the change for each individual patient). † Significant Rowasa®/placebo difference. p<0.01 ‡ Significant Rowasa®/placebo difference. p<0.001 § Significant Rowasa®/placebo difference. p<0.05
Overall DAI	Rowasa® Placebo	76 77	7.42 7.40	4.05† 6.03	3.37‡ 5.83	-55.07%‡ -21.58%
Stool Frequency	Rowasa® Placebo		1.58 1.92	1.11§ 1.47	1.01† 1.50	-0.57§ -0.41
Rectal Bleeding	Rowasa® Placebo		1.82 1.73	0.59‡ 1.21	0.51‡ 1.11	-1.30‡ -0.61
Mucosal Inflammation	Rowasa® Placebo		2.17 2.18	1.22† 1.74	0.96‡ 1.61	-1.21† -0.56
Physician's Assessment of Disease Severity	Rowasa® Placebo		1.86 1.87	1.13‡ 1.62	0.88‡ 1.55	-0.97‡ -0.30

Differences between Rowasa® (Mesalamine) Rectal Suspension Enema and placebo were also statistically different in subgroups of patients on concurrent sulfasalazine and in those having an upper disease boundary between 5 and 20 or 20 and 40 cm. Significant differences between Rowasa® (Mesalamine) Rectal Suspension Enema and placebo were not achieved in those subgroups of patients on concurrent prednisone or with an upper disease boundary between 40 and 50 cm.

Indications and Usage for Rowasa

Rowasa® (Mesalamine) Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

Contraindications

Rowasa® (Mesalamine) Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.

Warnings

Rowasa® (Mesalamine) Rectal Suspension Enema contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low. Sulfite sensitivity is seen more frequently in asthmatic or in atopic nonasthmatic persons. Epinephrine is the preferred treatment for serious allergic or emergency situations even though epinephrine injection contains sodium or potassium metabisulfite with the above-mentioned potential liabilities. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite(s) in epinephrine injection should not deter the administration of the drug for treatment of serious allergic or other emergency situations.

Precautions

Mesalamine has been implicated in the production of an acute intolerance syndrome characterized by cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required. The patient's history of sulfasalazine intolerance, if any, should be re-evaluated. If a rechallenge is performed later in order to validate the hypersensitivity it should be carried out under close supervision and only if clearly needed, giving consideration to reduced dosage. In the literature one patient previously sensitive to sulfasalazine was rechallenged with 400 mg oral mesalamine; within eight hours she experienced headache, fever, intensive abdominal colic, profuse diarrhea and was readmitted as an emergency. She responded poorly to steroid therapy and two weeks later a pancolectomy was required.

Although renal abnormalities were not noted in the clinical trials with Rowasa® (Mesalamine) Rectal Suspension Enema, the possibility of increased absorption of mesalamine and concomitant renal tubular damage as noted in the preclinical studies must be kept in mind. Patients on Rowasa® (Mesalamine) Rectal Suspension Enema, especially those on concurrent oral products which liberate mesalamine and those with preexisting renal disease, should be carefully monitored with urinalysis, BUN (blood urea nitrogen), and creatinine studies.

In a clinical trial most patients who were hypersensitive to sulfasalazine were able to take mesalamine enemas without evidence of any allergic reaction. Nevertheless, caution should be exercised when mesalamine is initially used in patients known to be allergic to sulfasalazine. These patients should be instructed to discontinue therapy if signs of rash or fever become apparent.

While using Rowasa® (Mesalamine) Rectal Suspension Enema, some patients have developed pancolitis. However, extension of upper disease boundary and/or flare-ups occurred less often in the Rowasa® (Mesalamine) Rectal Suspension Enema treated group than in the placebo-treated group.

Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, may occur after commencing mesalamine.

Rare instances of pericarditis have been reported with mesalamine containing products including sulfasalazine. Cases of pericarditis have also been reported as manifestations of inflammatory bowel disease. In the cases reported with Rowasa® (Mesalamine) Rectal Suspension Enema, there have been positive rechallenges with mesalamine or mesalamine containing products. In one of these cases, however, a second rechallenge with sulfasalazine was negative throughout a 2-month follow-up. Chest pain or dyspnea in patients treated with Rowasa® (Mesalamine) Rectal Suspension Enema should be investigated with this information in mind. Discontinuation of Rowasa® (Mesalamine) Rectal Suspension Enema may be warranted in some cases, but rechallenge with mesalamine can be performed under careful clinical observation should the continued therapeutic need for mesalamine be present.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mesalamine caused no increase in the incidence of neoplastic lesions over controls in a 2-year study of Wistar rats fed up to 320 mg/kg/day of mesalamine admixed with diet. Mesalamine is not mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537, TA1538. There were no reverse mutations in an assay using E. coli strain WP2UVRA. There were no effects in an in vivo mouse micronucleus assay at 600 mg/kg and in an in vivo sister chromatid exchange at doses up to 610 mg/kg. No effects on fertility were observed in rats receiving up to 320 mg/kg/day. The oligospermia and infertility in men associated with sulfasalazine has very rarely been reported among patients treated with mesalamine.

Pregnancy (Category B)

Teratologic studies have been performed in rats and rabbits at oral doses up to five and eight times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus. There are, however, no adequate and well-controlled studies in pregnant women for either sulfasalazine or 5-ASA. Because animal reproduction studies are not always predictive of human response, 5-ASA should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether mesalamine or its metabolite(s) are excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Clinical Adverse Experience

Rowasa® (Mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient.

ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF Rowasa® (MESALAMINE) RECTAL SUSPENSION ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO)

SYMPTOM	Rowasa® N=815 N	%	PLACEBO N=128 N	%
Abdominal Pain/Cramps/Discomfort	66	8.10	10	7.81
Headache	53	6.50	16	12.50
Gas/Flatulence	50	6.13	5	3.91
Nausea	47	5.77	12	9.38
Flu	43	5.28	1	0.78
Tired/Weak/Malaise/Fatigue	28	3.44	8	6.25
Fever	26	3.19	0	0.00
Rash/Spots	23	2.82	4	3.12
Cold/Sore Throat	19	2.33	9	7.03
Diarrhea	17	2.09	5	3.91
Leg/Joint Pain	17	2.09	1	0.78
Dizziness	15	1.84	3	2.34
Bloating	12	1.47	2	1.56
Back Pain	11	1.35	1	0.78
Pain on Insertion of Enema Tip	11	1.35	1	0.78
Hemorrhoids	11	1.35	0	0.00
Itching	10	1.23	1	0.78
Rectal Pain	10	1.23	0	0.00
Constipation	8	0.98	4	3.12
Hair Loss	7	0.86	0	0.00
Peripheral Edema	5	0.61	11	8.59
UTI/Urinary Burning	5	0.61	4	3.12
Rectal Pain/Soreness/Burning	5	0.61	3	2.34
Asthenia	1	0.12	4	3.12
Insomnia	1	0.12	3	2.34

In addition, the following adverse events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease.

Hair Loss

Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss.

Overdosage

There have been no documented reports of serious toxicity in man resulting from massive overdosing with mesalamine. Under ordinary circumstances, mesalamine absorption from the colon is limited.

Rowasa Dosage and Administration

The usual dosage of Rowasa® (Mesalamine) Rectal Suspension Enema in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. While the effect of Rowasa® (Mesalamine) Rectal Suspension Enema may be seen within 3 to 21 days, the usual course of therapy would be from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Studies available to date have not assessed if Rowasa® (Mesalamine) Rectal Suspension Enema will modify relapse rates after the 6-week short-term treatment. Rowasa® (Mesalamine) Rectal Suspension Enema is for rectal use only.

Patients should be instructed to shake the bottle well to make sure the suspension is homogeneous. The patient should remove the protective sheath from the applicator tip. Holding the bottle at the neck will not cause any of the medication to be discharged. The position most often used is obtained by lying on the left side (to facilitate migration into the sigmoid colon); with the lower leg extended and the upper right leg flexed forward for balance. An alternative is the knee-chest position. The applicator tip should be gently inserted in the rectum pointing toward the umbilicus. A steady squeezing of the bottle will discharge most of the preparation. The preparation should be taken at bedtime with the objective of retaining it all night. Patient instructions are included with every seven units.

How is Rowasa Supplied

Rowasa® (Mesalamine) Rectal Suspension Enema for rectal administration is an off-white to tan colored suspension. Each disposable enema bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Enema bottles are supplied in boxed, foil-wrapped trays as follows:.

NDC 68220-066-07........................... Carton of 7 Bottles

NDC 68220-066-28........................... Carton of 28 Bottles

Rowasa® (Mesalamine) Rectal Suspension Enemas are for rectal use only.

KEEP OUT OF REACH OF CHILDREN

Patient instructions are included.

Storage

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted, please refer to current USP. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.

NOTE: Rowasa® (Mesalamine) Rectal Suspension Enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

Rev 10/06

© ALAVEN Pharmaceutical LLC

ALAVEN Pharmaceutical LLC

2260 Northwest Parkway, Suite A

Marietta, GA 30067

For Medical inquiries, Call Toll Free:

1-888-317-0001

PATIENT INSTRUCTIONS

How to Use this Medication.

Best results are achieved if the bowel is emptied immediately before the medication is given.

NOTE: Rowasa® (Mesalamine) Rectal Suspension Enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

1

Remove the Bottles

a.

Remove the bottles from the protective foil pouch by tearing or by using scissors as shown, being careful not to squeeze or puncture bottles. Rowasa® (Mesalamine) Rectal Suspension Enema is an off-white to tan colored suspension. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.

2

Prepare the Medication for Administration

a.

Shake the bottle well to make sure that the medication is thoroughly mixed.

b.

Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the medication to be discharged.

3

Assume the Correct Body Position

 

a.

Best results are obtained by lying on the left side with the left leg extended and the right leg flexed forward for balance.

b.

An alternative to lying on the left side is the "knee-chest" position as shown here.

4

Administer the Medication

 

a.

Gently insert the lubricated applicator tip into the rectum to prevent damage to the rectal wall, pointed slightly toward the navel.

 

b.

Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back, squeeze slowly to instill the medication. Steady hand pressure will discharge most of the medication. After administering, withdraw and discard the bottle.

c.

Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the medication all night, if possible.

Rev 10/06

© ALAVEN Pharmaceutical LLC

ALAVEN Pharmaceutical LLC

2260 Northwest Parkway, Suite A

Marietta, GA 30067

Rowasa  mesalamine  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68220-066 Route of Administration RECTAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Mesalamine (Mesalamine) Active 4 GRAM  In 60 MILLILITER carbomer 934P Inactive   edetate disodium Inactive   potassium acetate Inactive   potassium metabisulfite Inactive   water Inactive   xanthan gum Inactive   Sodium benzoate Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68220-066-07 7 BOTTLE In 1 CARTON contains a BOTTLE, DISPENSING 1 60 mL (MILLILITER) In 1 BOTTLE, DISPENSING This package is contained within the CARTON (68220-066-07) 2 68220-066-28 28 BOTTLE In 1 CARTON contains a BOTTLE, DISPENSING 2 60 mL (MILLILITER) In 1 BOTTLE, DISPENSING This package is contained within the CARTON (68220-066-28)

Revised: 04/2008ALAVEN Pharmaceutical LLC

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