Saturday 28 February 2009

Axol




Axol may be available in the countries listed below.


Ingredient matches for Axol



Ambroxol

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


  • Mexico

  • Singapore

International Drug Name Search

Tuesday 24 February 2009

Albendazol Best




Albendazol Best may be available in the countries listed below.


Ingredient matches for Albendazol Best



Albendazole

Albendazole is reported as an ingredient of Albendazol Best in the following countries:


  • Colombia

International Drug Name Search

Sunday 22 February 2009

Heartgard Plus




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

Ingredient matches for Heartgard Plus



Ivermectin

Ivermectin is reported as an ingredient of Heartgard Plus in the following countries:


  • Australia

  • South Africa

Praziquantel

Praziquantel is reported as an ingredient of Heartgard Plus in the following countries:


  • United States

Pyrantel

Pyrantel embonate (a derivative of Pyrantel) is reported as an ingredient of Heartgard Plus in the following countries:


  • Australia

  • South Africa

  • United States

International Drug Name Search

Quinapril comp. Heumann




Quinapril comp. Heumann may be available in the countries listed below.


Ingredient matches for Quinapril comp. Heumann



Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Quinapril comp. Heumann in the following countries:


  • Germany

Quinapril

Quinapril hydrochloride (a derivative of Quinapril) is reported as an ingredient of Quinapril comp. Heumann in the following countries:


  • Germany

International Drug Name Search

Sunday 15 February 2009

Rondamine


Generic Name: carbinoxamine and pseudoephedrine (kar bi NOX a meen and soo doe e FED rin)

Brand Names: Andec, Cordron-D NR, Rondamine


What is Rondamine (carbinoxamine and pseudoephedrine)?

Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of carbinoxamine and pseudoephedrine is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.


Carbinoxamine and pseudoephedrine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Rondamine (carbinoxamine and pseudoephedrine)?


Always ask a doctor before giving a cold or allergy medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children. Do not use carbinoxamine and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine and pseudoephedrine before the MAO inhibitor has cleared from your body. Carbinoxamine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.


What should I discuss with my doctor before taking Rondamine (carbinoxamine and pseudoephedrine)?


Do not use carbinoxamine and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine and pseudoephedrine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to carbinoxamine or pseudoephedrine, or if you have:


  • kidney disease;

  • liver disease;


  • diabetes;




  • glaucoma;




  • heart disease or high blood pressure;




  • thyroid disease;




  • emphysema or chronic bronchitis; or




  • an enlarged prostate or urination problems.



If you have any of these conditions, you may not be able to use carbinoxamine and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Carbinoxamine and pseudoephedrine 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.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take Rondamine (carbinoxamine and pseudoephedrine)?


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. Cold medicine is usually taken only for a short time until your symptoms clear up.


Always ask a doctor before giving a cold or allergy medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

The chewable tablet should be chewed before you swallow it.


Measure the liquid form of carbinoxamine and pseudoephedrine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.


Store carbinoxamine and pseudoephedrine at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.

Symptoms of a carbinoxamine and pseudoephedrine overdose may include confusion, blurred vision, feeling restless or nervous, dry mouth, hallucinations, fainting, and seizure (convulsions).


What should I avoid while taking Rondamine (carbinoxamine and pseudoephedrine)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines and decongestants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by carbinoxamine and pseudoephedrine.


Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Rondamine (carbinoxamine and pseudoephedrine) 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;




  • urinating less than usual or not at all;




  • wheezing, tightness in your chest;




  • severe dizziness, anxiety, restless feeling, or nervousness;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).



Continue taking this medication and talk to your doctor if you have any of these less serious side effects:



  • drowsiness, dizziness;




  • lack of coordination;




  • upset stomach;




  • stuffy nose, chest congestion;




  • sleep problems (insomnia);




  • feeling restless or excited (especially in children);




  • dry mouth or nose; or




  • blurred vision.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Rondamine (carbinoxamine and pseudoephedrine)?


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



  • a diuretic (water pill), or blood pressure medicine;




  • medication to treat irritable bowel syndrome;




  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);




  • aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);




  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or




  • antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.



If you are using any of these drugs, you may not be able to use carbinoxamine and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.


There may be other drugs that can affect carbinoxamine and pseudoephedrine. 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 Rondamine resources


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


  • Coldec MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mintex PSE Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Rondamine with other medications


  • Cold Symptoms
  • Hay Fever


Where can I get more information?


  • Your pharmacist has information about carbinoxamine and pseudoephedrine written for health professionals that you may read.

What does my medication look like?


Carbinoxamine and pseudoephedrine is available with a prescription under many different brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


See also: Rondamine side effects (in more detail)


Saturday 14 February 2009

Ogestrel-28


Generic Name: ethinyl estradiol and norgestrel (ETH in il ess tra DYE ol and nor JESS trel)

Brand Names: Cryselle 28, Lo/Ovral-28, Low-Ogestrel, Ogestrel-28


What is Ogestrel-28 (ethinyl estradiol and norgestrel)?

Ethinyl estradiol and norgestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.


Ethinyl estradiol and norgestrel is used as contraception to prevent pregnancy.


Ethinyl estradiol and norgestrel may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Ogestrel-28 (ethinyl estradiol and norgestrel)?


Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, unusual vaginal bleeding, liver disease or liver cancer, severe high blood pressure, severe migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use.


What should I discuss with my healthcare provider before taking Ogestrel-28 (ethinyl estradiol and norgestrel)?


This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

  • a history of a stroke or blood clot;




  • circulation problems (especially if caused by diabetes);




  • a hormone-related cancer such as breast or uterine cancer;




  • unusual vaginal bleeding;




  • liver disease or liver cancer;




  • severe high blood pressure;




  • severe migraine headaches;




  • a heart valve disorder; or




  • a history of jaundice caused by birth control pills.



If you have any of these other conditions, you may need a dose adjustment or special tests:



  • high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;




  • high cholesterol or if you are overweight;




  • a history of depression;




  • gallbladder disease;




  • diabetes;




  • seizures or epilepsy;




  • a history of irregular menstrual cycles; or




  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.




The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. You should not breast-feed while you are taking birth control pills.

How should I take Ogestrel-28 (ethinyl estradiol and norgestrel)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).


You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period should begin while you are using these reminder pills.


You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.


If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Missing a pill increases your risk of becoming pregnant.


If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.


If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.


If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.


If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.


If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Ogestrel-28 (ethinyl estradiol and norgestrel)?


Do not smoke while taking birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.


Ogestrel-28 (ethinyl estradiol and norgestrel) 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;




  • sudden headache, confusion, problems with vision, speech, or balance;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • a change in the pattern or severity of migraine headaches;




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




  • swelling in your hands, ankles, or feet;




  • a breast lump; or




  • symptoms of depression (sleep problems, weakness, mood changes).



Less serious side effects may include:



  • mild nausea, vomiting, bloating, stomach cramps;




  • breast pain, tenderness, or swelling;




  • freckles or darkening of facial skin;




  • changes in weight or appetite;




  • problems with contact lenses;




  • vaginal itching or discharge;




  • changes in your menstrual periods, decreased sex drive; or




  • nervousness, dizziness, tired feeling.



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 Ogestrel-28 (ethinyl estradiol and norgestrel)?


Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:



  • acetaminophen (Tylenol) or ascorbic acid (vitamin C);




  • modafinil (Provigil);




  • dexamethasone (Decadron, Hexadrol);




  • an antibiotic;




  • seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and others;




  • a barbiturate such as phenobarbital (Solfoton) and others; or




  • HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.



This list is not complete and other drugs may interact with birth control pills. 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 Ogestrel-28 resources


  • Ogestrel-28 Side Effects (in more detail)
  • Ogestrel-28 Use in Pregnancy & Breastfeeding
  • Drug Images
  • Ogestrel-28 Drug Interactions
  • Ogestrel-28 Support Group
  • 2 Reviews for Ogestrel-28 - Add your own review/rating


  • Low-Ogestrel Prescribing Information (FDA)



Compare Ogestrel-28 with other medications


  • Abnormal Uterine Bleeding
  • Birth Control
  • Emergency Contraception
  • Endometriosis
  • Gonadotropin Inhibition


Where can I get more information?


  • Your pharmacist can provide more information about ethinyl estradiol and norgestrel.

See also: Ogestrel-28 side effects (in more detail)


Wednesday 11 February 2009

Geroprostan




Geroprostan may be available in the countries listed below.


Ingredient matches for Geroprostan



Tamsulosin

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


  • Slovakia

International Drug Name Search

Tuesday 10 February 2009

Coleira Antiparasitária DFV




Coleira Antiparasitária DFV may be available in the countries listed below.


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

Ingredient matches for Coleira Antiparasitária DFV



Dimpylate

Dimpylate is reported as an ingredient of Coleira Antiparasitária DFV in the following countries:


  • Portugal

International Drug Name Search

Tuesday 3 February 2009

BenzaClin





Dosage Form: topical gel

Topical Gel: clindamycin (1%) as clindamycin phosphate, benzoyl peroxide (5%)

For Dermatological Use Only - Not for Ophthalmic Use

*SAMPLE. NO RECONSTITUTION NECESSARY*



BenzaClin Description


BenzaClin® Topical Gel contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.


Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below:



Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7 - chloro - 6,7,8 - trideoxy - 6 - (1 - methyl - trans - 4 - propyl - L - 2 - pyrrolidinecarboxamido) - 1 - thio - L - threo - alpha - D - galacto - octopyranoside 2-(dihydrogen phosphate).


BenzaClin Topical Gel also contains benzoyl peroxide, for topical use.

Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula:



Benzoyl peroxide has a molecular weight of 242.23.


Each gram of BenzaClin Topical Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water.



BenzaClin - Clinical Pharmacology


An in vitro percutaneous penetration study comparing BenzaClin Topical Gel and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in BenzaClin Topical Gel is suggested to be less than 1%.


Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic acid. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle.



Pharmacokinetics


The pharmacokinetics (plasma and urine) of clindamycin from BenzaClin Topical Gel was studied in male and female patients (n=13) with acne vulgaris. BenzaClin Topical Gel (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1ng/mL) clindamycin plasma concentrations were obtained in six of thirteen subjects (46.2%) on Day 1 and twelve of thirteen subjects (92.3%) on Day 5. Peak plasma concentrations (Cmax) of clindamycin ranged from 1.47 ng/mL to 2.77 ng/mL on Day 1 and 1.43 ng/mL to 7.18 ng/mL on Day 5. The AUC (0-12h) ranged from 2.74 ng.h/mL to 12.86 ng.h/mL on Day 1 and 11.4 ng.h/mL to 69.7 ng.h/mL on Day 5.


The amount of clindamycin excreted in the urine during the 12 hour dosing interval increased from a mean (SD) of 5745 (3130) ng on Day 1 to 12069 (7660) ng on Day 5. The mean % (SD) of the administered dose that was excreted in the urine ranged from 0.03% (0.02) to 0.08% (0.04).


A comparison of the single (Day 1) and multiple (Day 5) dose plasma and urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of BenzaClin Topical Gel. The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold.



Microbiology


The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with this product.



Clinical Studies


In two adequate and well controlled clinical studies of 758 patients, 214 used BenzaClin, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. BenzaClin applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10. The primary efficacy measures were the lesion counts and the investigator's global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face. Non-medicated make-up could be applied at one hour after the BenzaClin application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure. Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below:


























Study 1
BenzaClinBenzoyl peroxideClindamycinVehicle
n=120n=120n=120n=120
Mean percent reduction in inflammatory lesion counts
46%32%16%+ 3%
Mean percent reduction in non-inflammatory lesion counts
22%22%9%+1%
Mean percent reduction in total lesion counts
36%28%15%0.2%
























Study 2
BenzaClinBenzoyl peroxideClindamycinVehicle
n=95n=95n=49n=48
Mean percent reduction in inflammatory lesion counts
63%53%45%42%
Mean percent reduction in non-inflammatory lesion counts
54%50%39%36%
Mean percent reduction in total lesion counts
58%52%42%39%

The BenzaClin group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.



Indications and Usage for BenzaClin


BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.



Contraindications


BenzaClin Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.



Warnings


ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC CLINDAMYCIN. STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium Difficile AND STOOL ASSAY FOR C. difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN.


Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.



Precautions



General


For dermatological use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.


The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use of this medication and take appropriate measures.


Avoid contact with eyes and mucous membranes.


Clindamycin and erythromycin containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.



Information for Patients


Patients using BenzaClin Topical Gel should receive the following information and instructions:


  1. BenzaClin Topical Gel is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating.

  2. This medication should not be used for any disorder other than that for which it was prescribed.

  3. Patients should not use any other topical acne preparation unless otherwise directed by physician.

  4. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using BenzaClin Topical Gel. To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn, and a sunscreen with SPF 15 rating or higher should be used.

  5. Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue BenzaClin Topical Gel and contact their physician immediately. In addition, patients should report any signs of local adverse reactions to their physician.

  6. BenzaClin Topical Gel may bleach hair or colored fabric.

  7. BenzaClin Topical Gel can be stored at room temperature 25°C (77°F). Do not freeze. Discard any unused product after expiration date on sample.

  8. Before applying BenzaClin Topical Gel to affected areas wash the skin gently, then rinse with warm water and pat dry.


Carcinogenesis, Mutagenesis, Impairment of Fertility


Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown.


Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.


In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of BenzaClin Topical Gel with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation).


In a 2-year dermal carcinogenicity study in rats, treatment with BenzaClin Topical Gel at doses of 100, 500 and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats. The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g BenzaClin Topical Gel, based on mg/m2) was statistically significantly higher than that in the sham- and vehicle-controls.


Genotoxicity studies were not conducted with BenzaClin Topical Gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benzoyl peroxide, was not clastogenic in a mouse micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Studies have not been performed with BenzaClin Topical Gel or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g BenzaClin Topical Gel, based on mg/m2) revealed no effects on fertility or mating ability.



Pregnancy


Teratogenic Effects Pregnancy Category C

Animal reproductive/developmental toxicity studies have not been conducted with BenzaClin Topical Gel or benzoyl peroxide. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity.


There are no well-controlled trials in pregnant women treated with BenzaClin Topical Gel. It also is not known whether BenzaClin Topical Gel can cause fetal harm when administered to a pregnant woman.



Nursing Women


It is not known whether BenzaClin Topical Gel is excreted in human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.



Adverse Reactions


During clinical trials, the most frequently reported adverse event in the BenzaClin treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin and vehicle groups.



























Local Adverse Events - all causalities in >/= 1% of patients
BenzaClinVehicle
n = 420n = 168
Application site reaction13 (3%)1 (<1%)
Dry skin50 (12%)10 (6%)
Pruritus8 (2%)1 (<1%)
Peeling9 (2%)-
Erythema6 (1%)1 (<1%)
Sunburn5 (1%)-

The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.


Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions 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.



BenzaClin Dosage and Administration


BenzaClin Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.



How is BenzaClin Supplied


BenzaClin Topical Gel is supplied in 6 gram plastic jars.



Store at room temperature 25°C (77°F).

Do not freeze. Refrigeration is not required. Keep tightly closed. Keep out of the reach of children.



Prescribing Information as of June 2010.


Dermik Laboratories

a business of sanofi-aventis U.S. LLC

Bridgewater, NJ 08807


©2010 sanofi-aventis U.S. LLC



PRINCIPAL DISPLAY PANEL - 6 g Jar Label


0066-0494-06

Rx ONLY 50095578


50084131C


BenzaClin®

(Clindamycin and Benzoyl Peroxide) gel 1%/5%


FOR TOPICAL USE ONLY

No Reconstitution Necessary

PHYSICIAN SAMPLE—NOT TO BE SOLD

ONE 6g Jar


Peel Here










BenzaClin 
clindamycin phosphate and benzoyl peroxide  gel










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0066-0494
Route of AdministrationTOPICALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
clindamycin phosphate (clindamycin)clindamycin phosphate10 mg  in 1 g
benzoyl peroxide (benzoyl peroxide)benzoyl peroxide50 mg  in 1 g








Inactive Ingredients
Ingredient NameStrength
sodium hydroxide 
water 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10066-0494-066 g In 1 JARNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA05075606/01/2009


Labeler - Dermik Laboratories (824676584)









Establishment
NameAddressID/FEIOperations
Sanofi-Aventis Canada Inc.251046934MANUFACTURE, ANALYSIS, LABEL, PACK
Revised: 12/2011Dermik Laboratories

Sunday 1 February 2009

Tambocor


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


TAMBOCOR (flecainide acetate - tablet; oral)



  • Manufacturer: MEDICIS

    Approval date: October 31, 1985

    Strength(s): 100MG [AB]


  • Manufacturer: MEDICIS

    Approval date: June 3, 1988

    Strength(s): 150MG [RLD][AB]


  • Manufacturer: MEDICIS

    Approval date: August 23, 1988

    Strength(s): 50MG [AB]

Has a generic version of Tambocor been approved?


Yes. The following products are equivalent to Tambocor:


flecainide acetate tablet; oral



  • Manufacturer: AMNEAL PHARM

    Approval date: July 31, 2001

    Strength(s): 100MG [AB], 150MG [AB], 50MG [AB]


  • Manufacturer: APOTEX INC

    Approval date: July 9, 2009

    Strength(s): 100MG [AB], 150MG [AB], 50MG [AB]


  • Manufacturer: BARR

    Approval date: October 28, 2002

    Strength(s): 100MG [AB], 150MG [AB], 50MG [AB]


  • Manufacturer: RANBAXY

    Approval date: March 28, 2003

    Strength(s): 100MG [AB], 150MG [AB], 50MG [AB]


  • Manufacturer: ROXANE

    Approval date: January 14, 2003

    Strength(s): 100MG [AB], 150MG [AB], 50MG [AB]

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

There are no current U.S. patents associated with Tambocor.

See also...

  • Tambocor Consumer Information (Wolters Kluwer)
  • Tambocor Consumer Information (Cerner Multum)
  • Tambocor Advanced Consumer Information (Micromedex)
  • Tambocor AHFS DI Monographs (ASHP)
  • Flecainide Consumer Information (Wolters Kluwer)
  • Flecainide Consumer Information (Cerner Multum)
  • Flecainide Advanced Consumer Information (Micromedex)
  • Flecainide Acetate AHFS DI Monographs (ASHP)

Rispond




Rispond may be available in the countries listed below.


Ingredient matches for Rispond



Risperidone

Risperidone is reported as an ingredient of Rispond in the following countries:


  • Israel

  • Myanmar

International Drug Name Search