clindamycin topical (Cleocin T, Clindagel, Clindacin P, ClindaReach, ClindaDerm, ClindaMax, Clindets, Evoclin)

Dosing and uses of Cleocin T, Clindagel (clindamycin topical)

• Adult
• Pediatric

 

Adult dosage forms and strengths

gel/lotion/solution/foam/swaB

• 1%

vaginal suppository

• 100mg

vaginal cream

• 2%

 

Acne Vulgaris

Gel/lotion/solution (Cleocin, ClindaMax): Apply a thin film to affected area q12hr

Foam/gel (Evoclin, Clindagel): Apply a thin film to affected area qDay

Swab: Use a swab to apply a thin film of clindamycin to affected area q12hr; each swab should be used only once, and then discarded

 

Bacterial Vaginosis

Suppository: Insert 1 suppository into vagina qHS for 3 days

Vaginal cream: 1 full applicator inserted intravaginally qHS for 3 days in nonpregnant patients and for 7 days in pregnant patients

 

Gardnerella Vaginalis (Off-label)

Suppository: Insert 1 suppository into vagina qHS for 3 days

Vaginal cream: 1 full applicator inserted intravaginally qHS for 3 days in nonpregnant patients and for 7 days in pregnant patients

 

Pediatric dosage forms and strengths

gel/lotion/solution/foam/swaB

• 1%

 

Acne Vulgaris

<12 years old

• Safety and efficacy not established

>12 years

• Gel/lotion/solution (Cleocin T, ClindaMax): Apply a thin film to affected area q12hr
• Foam/gel (Evoclin, Clindagel): Apply a thin film to affected area qDay
• Swab: Use a swab to apply a thin film of clindamycin to affected area q12hr; each swab should be used only once, and then discarded

 

Cleocin T, Clindagel (clindamycin topical) adverse (side) effects

>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

 

Warnings

Black box warnings

Pseudomembranous colitis reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening; orally and parenterally administered clindamycin associated with severe colitis which may end fatally; diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) reported with use of orally and parenterally administered clindamycin, as well as with topical (dermal and vaginal) formulations of clindamycin; important to consider this diagnosis in patients who present with diarrhea subsequent to administration of clindamycin, even when administered by vaginal route, because approximately 5% of clindamycin dose is systemically absorbed from vagina

 

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 and lactation

Pregnancy category: B

Lactation: Excretion in milk unknown; use with caution

 

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.

 

Pharmacology of Cleocin T, Clindagel (clindamycin topical)

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)