Clindagel

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take erythromycin (E.E.S., E-Mycin, Erythrocin). Clindamycin can make erythromycin less effective and usually these medications should not be combined, especially when treating serious infections.

This is not a complete list of clindamycin drug interactions. Ask your doctor or pharmacist for more information.

Before taking clindamycin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to clindamycin or to any of its ingredients
• are allergic to lincomycin (Lincocin)
• have or have had asthma
• have or have had eczema
• have liver problems
• have kidney problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Store clindamycin at room temperature
• Do not expose clindamycin to excess heat or moisture
• Keep this and all medicines out of the reach of children 

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficilemay need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

You should not use clindamycin topical if you have ulcerative colitis or enteritis (inflammation of your intestines), or if you have ever had severe diarrhea caused by antibiotic medicine.

It is not likely that other drugs you take orally or inject will have an effect on topically applied clindamycin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Clindagel® (clindamycin phosphate gel) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula represented below:      

The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-∝-D-galacto-octopyranoside 2-(dihydrogen phosphate).

General: Clindagel® should be prescribed with caution in atopic individuals.

Drug Interactions: Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenicity of a 1% clindamycin phosphate gel similar to Clindagel® was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 milliliters of Clindagel®, assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.

A 1% clindamycin phosphate gel similar to Clindagel® caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight.

Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative. Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.

Pregnancy

Teratogenic effects-Pregnancy Category B

Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride and clindamycin palmitate hydrochloride. These studies revealed no evidence of fetal harm. The highest dose used in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate dose of 432 mg/kg. For a rat, this dose is 84 fold higher and for a mouse 42 fold higher, than the anticipated human dose of clindamycin phosphate from Clindagel® based on a mg/m2 comparison. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether clindamycin is excreted in human milk following use of Clindagel®. 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 in children under the age of 12 have not been established.

Geriatric Use

The clinical study with Clindagel® did not include sufficient numbers of patients aged 65 and over to determine if they respond differently than younger patients.

Rx only

NDC 16781-462-75

Clindagel®

(clindamycin phosphate) topical gel

equivalent to 1% clindamycin

Topical Gel

For Topical Use Only

1%

75 mL

VALEANT

Applies to clindamycin topical: vaginal cream, vaginal suppository

Other dosage forms:

• topical foam, topical gel/jelly, topical lotion, topical pad, topical solution

Along with its needed effects, clindamycin topical (the active ingredient contained in Clindagel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

• Itching of the vagina or genital area
• pain during sexual intercourse
• thick, white vaginal discharge with no odor or with mild odor

• Diarrhea
• dizziness
• headache
• nausea or vomiting
• stomach pain or cramps

• Burning, itching, rash, redness, swelling or other signs of skin problems not present before use of this medicine

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Itching of the vagina or genital area
• pain during sexual intercourse
• thick, white vaginal discharge with no odor or with mild odor