Gel: A clear transparent gel containing 1.2% w/w of Clindamycin Phosphate (equivalent to 1% Clindamycin) with 0.05% w/w of Methyl Paraben and 0.025% w/w of Propyl Paraben as preservatives.
Clindamycin Phosphate, a lincosamide antibiotic, is a chlorinated derivative of the antibiotic lincomycin and is used in the treatment of serious anaerobic infections.
Pharmacology: Although Clindamycin Phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterialy active Clindamycin, Clindamycin has been shown to have in vivo activity against isolates of Propionibacterium acnes. This may account for its usefulness in acne. Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/ml). Free fatty acids on the skin surface have been reduced from approximately 14% to 2% following application of Clindamycin. Clindamycin undergoes metabolism presumably in the liver. About 10% of a dose is excreted in the urine as active drug or metabolites and about 4% in the faeces, the remainder as excreted as inactive metabolites. Excretion is slow and takes place over several days.
Indicated for the treatment of acne vulgaris. In view of the potential for diarrhoea, bloody diarrhoea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.
Apply a thin film of Clindamycin Gel twice daily to affected area.
Pseudomembranous colitis has been reported. Mild cases usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile.
Hypersensitivity to lincomycin, propylene glycol and Clindamycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Use in pregnancy: Safety for use in pregnancy has not been established.
Use in children: Usage in new born and infants: Appropriate studies on the relationship of age to the effect of topical Clindamycin have not been performed in children up to 12 years of age. Safety and efficacy have not been established.
Use in lactation: It is not known whether Clindamycin is excreted in human milk following use of Clindamycin Gel. 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 drug since many drugs are excreted in human milk. When significant diarrhoea occurs, the drug should be discontinued. Clindamycin Phosphate should be prescribed with caution in atopic individuals. Orally and parenterally administered Clindamycin has been associated with severe colitis which may result in patient death. Use of topical formulation of Clindamycin results in absorption of the antibiotic from the skin surface. Diarrhoea, bloody diarrhoea and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic Clindamycin. Studies indicated a toxin(s) produced by clostridia is one primary cause of antibiotic associated colitis. The colitis is usually characterized by severe persistent diarrhoea and severe abdominal cramps and may be associated with the passage of blood and mucous. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhoea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in case of severe diarrhoea.
Usage in pregnancy: Safety for use in pregnancy has not been established.
Nursing mothers: It is not known whether Clindamycin is excreted in human milk following use of Clindamycin Gel. 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 drug since many drugs are excreted in human milk. When significant diarrhoea occurs, the drug should be discontinued. Clindamycin Phosphate should be prescribed with caution in atopic individuals. Orally and parenterally administered Clindamycin has been associated with severe colitis which may result in patient death. Use of topical formulation of Clindamycin results in absorption of the antibiotic from the skin surface. Diarrhoea, bloody diarrhoea and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic Clindamycin. Studies indicated a toxin(s) produced by clostridia is one primary cause of antibiotic associated colitis. The colitis is usually characterized by severe persistent diarrhoea and severe abdominal cramps and may be associated with the passage of blood and mucous. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhoea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in case of severe diarrhoea.
Clindamycin has been associated with severe colitis which may end fatally. Cases of diarrhoea, bloody diarrhoea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with topical formulations of Clindamycin. Other local effects include contact dermatitis, irritation (e.g. erythema, peeling and burning), oily skin, skin dryness and gram-negative folliculitis. Clindamycin can also cause systemic effect such as abdominal pain, gastrointestinal disturbances.
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. Antagonism has been demonstrated between Clindamycin and Erythromycin in vitro. Because of possible clinical significance, the two drugs should not be administered concurrently.
Keep container well closed. Protect from strong light. Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
D10AF01 - clindamycin ; Belongs to the class of topical antiinfective preparations used in the treatment of acne.
T3 Mycin lotion 1.2 %
30 mL x 1's
T3 Mycin topical gel 1.2 %
(plastic tubes) 25 g x 1's
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