CLEOCIN-T GEL

CLEOCIN T (clindamycin topical) Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each CLEOCIN T (clindamycin topical) Topical Solution pledget applicator contains approximately 1 mL of topical solution.

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.

The solution contains isopropyl alcohol 50% v/v, propylene glycol, and water.

The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water.

Before using topical clindamycin,

• tell your doctor and pharmacist if you are allergic to clindamycin, lincomycin (Lincocin), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention erythromycin (E.E.S., E-Mycin, Erythrocin, others) and any other medications that are applied to the skin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had inflammatory bowel disease (IBD; condition in which all or part of the lining of the intestine is swollen, irritated, or has sores) or severe diarrhea caused by an antibiotic. Your doctor may tell you not to use topical clindamycin.
• tell your doctor if you have or have ever had asthma, eczema (sensitive skin that often becomes itchy or irritated) or allergies.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using topical clindamycin, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using topical clindamycin.
• you should know that abrasive or medicated soaps and skin products that contain alcohol may make the side effects of topical clindamycin worse. Talk to your doctor about the skin care products you plan to use during your treatment with topical clindamycin.

Contraindications
CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of 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. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro. If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

In clinical trials totaling 368 women treated with a single dose of Clindesse™, 1.6% of the patients discontinued therapy due to adverse events. Medical events judged to be definitely related, probably related, or possibly drug-related were reported for 10.6% of the patients after receiving a single dose of Clindesse™ and in 17.6% of patients treated with placebo. Adverse events occurred in 126 of 368 patients (34.2%) treated with Clindesse™ and in 32 of 85 patients (37.6%) treated with placebo.

Other events not necessarily related to Clindesse™ but reported by < 1% of those women treated with Clindesse™:

• Dermatologic: dermatitis, dry skin, pruritic rash
• Gastrointestinal: diarrhea, dyspepsia, flatulence, hemorrhoids, vomiting
• General: fatigue, pain, pyrexia, increased tendency to bruise, palpable lymph node
• Immune System: hypersensitivity, food allergy
• Infections: bladder infection, fungal infection, Herpes simplex, influenza, papilloma virus infection, sinusitis, tooth abscess, upper respiratory tract infection, vaginal infection, vulvovaginal trichomoniasis
• Musculoskeletal: arthralgia, myalgia, neck pain, sciatica
• Nervous System: dizziness, hypoesthesia
• Psychiatric: anxiety disorder
• Renal and Urinary Tract: bladder spasm
• Reproductive System: pregnancy, cervical dysplasia, dysfunctional uterine bleeding, dysmennorrhea, intermenstrual bleeding, pelvic pain, uterine cervical disorder, uterine spasm, vaginal burning, vaginal irritation, atrophic vaginitis, vulvar erythema, vulvar laceration, vulvitis, vulvovaginal discomfort, vulvovaginal dryness, vulvovaginitis
• Respiratory Tract: cough, epistaxis, pharyngitis, rhinorrhea, sinusitis, wheezing

###

Topical clindamycin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry or peeling skin
• itching or burning skin
• redness of skin
• oily skin
• new pimples or blemishes
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• diarrhea
• watery or bloody stools
• stomach cramps

Topical clindamycin may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online or by phone [1-800-332-1088].