G01AA10 - Clindamycin |
Propably not porphyrinogenic |
PNP |
Rationale
Clindamycin (ATC code: G01A A10) for vaginal treatment is safety classified as Probably not porphyrinogenic because of minimal hepatic exposure.
For more details on the metabolism of clindamycin please refer to the monograph of clindamycin for systemic use (ATC code: J01F F01).
Therapeutic characteristics
Clindamycin cream and vaginal suppositories are indicated for the treatment of bacterial vaginosis.
Metabolism and pharmakokinetics
Vaginal cream
Clindamycin phosphate is a prodrug and is hydrolyzed to the active clindamycin. After 7 days of intravaginal treatment with 100 mg of clindamycin cream on healthy women, the average serum concentration is 25 ng/mL. This is equivalent to 0.06 µM and thus the hepatic exposure is < 1 µM. The average serum concentration on women with bacterial vaginosis was lower.
Vaginal suppositories
After three days of intravaginal treatment with 100 mg of clindamycin suppositories on healthy women, about 30 % (ranging from 6.5%-70%) was absorbed systemic, opposed to vaginal treatment with cream where 5% was absorbed. This means that the average serum concentration could potentially reach 350 ng/mL, which is still < 1 µM hepatic exposure.
References
- Summary of Product Characteristics
- Norwegian medicines agency. Summary of Product Characteristics (SPC). Dalacin vaginalkrem. #1393
- Norwegian medicines agency. Summary of Product Characteristics (SPC). Dalacin vagitorier. #1394
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