Dalacin-T: Product Information

Clindamycin phosphate USP 1% Topical Solution.

Presentation

Dalacin-T Topical Solution is a clear alcoholic solution containing clindamycin phosphate at a concentration equivalent to 10mg clindamycin per millilitre.

Action

Clindamycin has been shown to have in vitro activity against isolates of Propionibacterium acnes.

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10mg clindamycin per ml (1%) in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0 - 3 nanograms/ml) and approximately 0.25% of the dose is recovered in urine as clindamycin.

Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of Dalacin-T Solution for four weeks was 597mcg/g of comedonal material (range 0-1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4mcg/ml). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.

Indications

Dalacin-T (topical clindamycin phosphate) is indicated in the treatment of mild to moderate acne.

Dosage and Administration

Apply a thin film of Dalacin-T Topical (clindamycin phosphate) twice daily to affected area. If condition worsens or does not respond within 21 days, seek medical advice.

Contraindications

Dalacin-T Topical (clindamycin phosphate) is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Warnings and Precautions

Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe diarrhoea and pseudomembranous colitis. Diarrhoea and colitis have been reported infrequently with topical clindamycin. However, the physician should be alert to the possible development of antibiotic-associated diarrhoea or colitis. If significant or prolonged diarrhoea occurs, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary.

Safety for use of Dalacin-T Topical in pregnancy has not been established.

It is not known whether clindamycin is excreted in human milk following use of Dalacin-T Topical. However, orally and parenterally administered clindamycin has been reported to appear in breast 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.

Dalacin-T Topical should be prescribed with caution in atopic individuals.

Adverse Effects

Reports of side effects with Dalacin-T Topical (clindamycin phosphate) have been infrequent, with skin dryness being the most common adverse effect seen with the solution.

Effects which have been reported in association with the use of topical formulations of clindamycin include:

• oily skin
• skin irritation
• contact dermatitis
• stinging of the eye
• gastrointestinal disturbances
• abdominal pain
• gram-negative folliculitis

Interactions

Nil

Overdosage

Nil