clindamycin topical (Rx)

>10%

Dryness (18-23%)

Oiliness (1-18%)

Erythema (7-16%)

Peeling (7-11%)

Burning/itching (6-11%)

1-10%

Headache (3%)

Postmarketing Reports

Local skin effects

• Application site pain/erythema/rash
• Gram-negative folliculitis
• Hypersensitivity
• Seborrhea
• Urticaria

Systemic effects

• Abdominal discomfort
• Abdominal pain
• Colitis (including pseudomembranous colitis)
• Diarrhea
• Dizziness
• Hemorrhagic diarrhea
• Hypersensitivity
• Nausea

Postmarketing Reports

Eye pain

Contact dermatitis

Contraindications

Hypersensitivity to clindamycin or lincomycin or to any of its components

History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis)

Not indicated for inflammatory acne

Cautions

Systemic absorption of clindamycin has been demonstrated following topical use; discontinue immediately if significant diarrhea occurs

May cause irritation, especially when used with concomitant topical acne therapy, including with peeling, desquamating, or abrasive agents

Should be used with caution in atopic individuals

For external use only; avoid contact with eyes and mucous membranes

If applied to chest by nursing mothers, care should be taken to avoid accidental ingestion by infant

Pregnancy

In clinical trials with pregnant women, systemic administration of clindamycin during second and third trimesters has not been associated with increased frequency of congenital abnormalities; there are no adequate studies in pregnant women during first trimester of pregnancy; clindamycin should be used during first trimester of pregnancy only if clearly needed

Lactation

Not known whether clindamycin is excreted in human milk following therapy; however, orally and parenterally administered clindamycin has been reported to appear in breast milk; clindamycin has potential to cause adverse effects on breastfed infant's gastrointestinal flora; if oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred; monitor infant for possible adverse effects on gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis

Developmental and health benefits of breastfeeding should be considered along with mother's clinical need for clindamycin and any potential adverse effects on breastfed child from clindamycin or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Clindamycin is an antibacterial agent that binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis; reduces surface fatty acids on skin; exact mechanism of action in treating acne unknown, but clindamycin inhibits Propionibacterium acnes in vivo

Pharmacokinetics

Absorption: 5% (vaginal cream); 30% (vaginal suppository); minimal (topical solution of foam)

Half-life: 1.5-2.8 hr (following repeated dosing); 11 hr (vaginal suppository)

Peak serum time: 10-14 hr (vaginal cream); 5 hr (vaginal suppository)

Metabolism: Hepatic

Excretion: Urine (0.2% with topical foam and solution)