Dalacin T Topical Solution (Clindamycin Phosphate)

DALACINĀ® T TOPICAL SOLUTION

Pharmacia & Upjohn

Clindamycin Phosphate

Antibiotic

Action And Clinical Pharmacology: Clindamycin phosphate is inactive in vitro but in vivo hydrolysis converts this compound to the antibacterially active clindamycin. Clindamycin has been shown to have in vitro activity against isolates of P. acnes which may account for its usefulness in acne. Clindamycin activity has been demonstrated in serum, urine and in comedonal extracts from acne patients.

The mean concentration of antibiotic activity in extracted comedones after application of clindamycin topical solution for 4 weeks was 597 g/g of comedonal material (range 60 to 1 490). Clindamycin in vitro inhibits P. acnes cultures tested.

Indications And Clinical Uses: For the treatment of acne vulgaris.

Contra-Indications: 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.

Pregnancy: Safety in pregnancy has not been established.

Manufacturers’ Warnings In Clinical States: As with most antibiotics, oral and parenteral clindamycin have been associated with severe diarrhea and pseudomembranous colitis. Diarrhea and colitis including pseudomembranous colitis have been reported infrequently with topical clindamycin. Symptoms can occur after a few days, weeks or months following initiation of clindamycin therapy. They have also been observed to begin up to several weeks after cessation of therapy with clindamycin. Therefore, the physician should be alert to the possible development of antibiotic-associated diarrhea or colitis. If significant or prolonged diarrhea occurs, the drug should be discontinued.

Studies indicate that a toxin produced by C. difficile is the major cause of antibiotic-associated colitis which is characterized by severe persistent diarrhea, severe abdominal cramps and in some cases with passage of blood and mucus in the stool. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for C. difficile and assay for C. difficile toxin may be helpful diagnostically.

Mild cases of colitis may respond to simple drug discontinuance. Vancomycin is effective in the treatment of antibiotic-associated colitis produced by C. difficile. The usual dose is 125 to 500 mg orally, every 6 to 8 hours for 7 to 10 days. Additional supportive medical care may be necessary.

Cholestyramine and colestipol resins have been shown to bind C. difficile toxin in vitro, and cholestyramine has been effective in the treatment of some mild cases of antibiotic-associated colitis. Cholestyramine resins have been shown to bind vancomycin; therefore, when both cholestyramine and vancomycin are used concurrently, their administration should be separated by at least 2 hours.

Anticholinergics and antiperistaltic agents may worsen colitis.

Precautions: Clindamycin contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water.

The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.

Clindamycin should be prescribed with caution in atopic individuals.

Pregnancy: Safety for use in pregnancy has not been established.

Lactation: It is not known whether clindamycin when topically applied is excreted in human milk. However, oral and parenteral clindamycin have been reported to appear in breast milk and therefore, nursing should not be undertaken while a patient is on the drug.

Adverse Reactions: In a large U.S. postmarketing surveillance study among 1 298 patients treated only with topical clindamycin phosphate solution, skin dryness/irritation, diarrhea or gastrointestinal symptoms were the most commonly reported medical events. Of those, 258 (19.9%) reported 1 or more of the following dermatological events: dry skin, acne worse, rash/redness, peeling, discoloration, irritation, itching, new acne, sunburn and contact dermatitis. Among patients treated with oral antibiotics only, or no antibiotics, the percentage of patients reporting dermatologic event(s) was 20.8% and 25.4% respectively.

The following new gastrointestinal problems were reported in this surveillance study by 18.7% of the clindamycin treated patients, 22.9% of the oral antibiotic treated patients, and 18.4% of the patients with no antibiotic exposure: abdominal pain/cramps, nausea, flu/virus, indigestion, gas/bloating, nervous stomach, ulcers, vomiting and colon problems (not colitis).

Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with topical formulations of clindamycin. Diarrhea was reported in 5% of clindamycin patients, compared to 3.9% of control patients.

In addition to the above, the following side effects have also been occasionally reported during drug treatment with clindamycin topical solution: oily skin and gram-negative folliculitis.

Dosage And Administration: Apply a thin film of topical solution twice daily to the clean and dry skin in the area to be treated. Patients responding to clindamycin topical solution should show improvement in 8 weeks. Treatment beyond 12 weeks may call for evaluation by the physician.

Availability And Storage: Each mL of topical solution contains: clindamycin phosphate equivalent to clindamycin 10 mg. Nonmedicinal ingredients: isopropyl alcohol 50% v/v, propylene glycol and water. Bottles of 30 and 60 mL. A dab-o-matic applicator and cap is provided external to each bottle for placement into the bottle. To assist the patient, the pharmacist may assemble the bottle upon dispensing as follows: remove cap from bottle and discard, firmly press applicator into bottle, seal firmly by tightening domed-cap. Store in an upright fashion.

DALACINĀ® T TOPICAL SOLUTION Pharmacia & Upjohn Clindamycin Phosphate Antibiotic

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