DALACIN

What it is

DALACIN T is a lotion containing clindamycin phosphate equivalent to clindamycin 10 mg/mL, in an aqueous base. It is a white to off-white emulsion. Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit and affecting both ribosome assembly and the translation process.

Approved indications

— Treatment of acne vulgaris, particularly forms in which comedones, papules and pustules predominate.

Dosing overview

Apply a thin film of DALACIN T topical lotion twice daily to the affected area. The efficacy of DALACIN T lotion has not been demonstrated beyond 12 weeks' duration.

Key safety warnings

Oral and parenteral clindamycin have been associated with severe diarrhoea and pseudomembraneous colitis which may result in patient death. Use of the clindamycin phosphate topical lotion results in absorption of the antibiotic from the skin surface. Diarrhoea, bloody diarrhoea and pseudomembraneous colitis have been reported with the use of topical and systemic clindamycin. It is important to consider the diagnosis of antibiotic-associated colitis in patients who develop diarrhoea or colitis associated with antibiotic use. Antibiotic-associated colitis appears to result from a toxin produced by Clostridium difficile in the alimentary tract. The severity of the colitis may range from mild watery diarrhoea to severe, persistent, life-threatening bloody diarrhoea. DALACIN T should be prescribed with caution in atopic individuals. It is for external use only. Avoid contact with sensitive surfaces such as the eyes, lips and mucous membranes. Use of topical clindamycin has been associated with the development of strains of Propionibacterium acnes resistant to clindamycin in some patients. If there is evidence of the development of clinical resistance during treatment, consideration should be given to discontinuation of treatment with topical antibiotics.

Contraindications

DALACIN T topical lotion is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. DALACIN T topical lotion is also contraindicated in individuals with a history of inflammatory bowel disease or a history of antibiotic-associated colitis.

Regulatory history

DALACIN T 1% clindamycin 10 mg/mL (as phosphate) lotion was first listed on the ARTG on 22 February 1999.