Cleocin T - Clindamycin Phosphate solution prescribing information
INDICATIONS AND USAGE
CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).
DOSAGE AND ADMINISTRATION
Apply a thin film of, CLEOCIN T Topical Lotion, CLEOCIN T Topical Gel, CLEOCIN T Topical Solution, or use a CLEOCIN T Topical Solution pledget for the application of CLEOCIN T twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded.
CLEOCIN T Topical Solution is flammable. Avoid fire, flame, and smoking during and immediately following application.
Lotion: Shake well immediately before using.
Pledget: Remove pledget from foil just before use. Do not use if the seal is broken. Discard after single use.
Keep all liquid dosage forms in containers tightly closed.
CONTRAINDICATIONS
CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
ADVERSE REACTIONS
In 18 clinical studies of various formulations of CLEOCIN T using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].
| Treatment Emergent Adverse Event | Solution n=553(%) | Gel n=148(%) | Lotion n=160(%) |
|---|---|---|---|
| # not recorded | |||
Burning | 62 (11) | 15 (10) | 17 (11) |
Itching | 36 ( 7) | 15 (10) | 17 (11) |
Burning/Itching | 60 (11) | # ( – ) | # ( – ) |
Dryness | 105 (19) | 34 (23) | 29 (18) |
Erythema | 86 (16) | 10 ( 7) | 22 (14) |
Oiliness/Oily Skin | 8 ( 1) | 26 (18) | 12 of 126 subjects (10) |
Peeling | 61 (11) | # ( – ) | 11 ( 7) |
Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.
Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS ).
Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.
Drug Interactions
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.
DESCRIPTION
CLEOCIN T Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each CLEOCIN T Topical Solution pledget applicator contains approximately 1 mL of topical solution.
Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
The solution contains isopropyl alcohol 50% v/v, propylene glycol, and water.
The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.
The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water.
The structural formula is represented below:
The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside 2-(dihydrogen phosphate).
CLINICAL PHARMACOLOGY
Mechanism of Action
The mechanism of action of clindamycin in treating acne vulgaris is unknown.
Pharmacokinetics
Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.
Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.
Microbiology
Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.
Antimicrobial Activity
Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.
Resistance
Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.
HOW SUPPLIED
CLEOCIN T Topical Solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes:
30 mL applicator bottle—NDC 0009-3116-01
60 mL applicator bottle—NDC 0009-3116-02
Carton of 60 single-use pledget applicators—NDC 0009-3116-14
CLEOCIN T Topical Gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:
60 gram tube—NDC 0009-3331-01
30 gram tube—NDC 0009-3331-02
CLEOCIN T Topical Lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size:
60 mL plastic squeeze bottle—NDC 0009-3329-01
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Protect from freezing.
CLEOCIN T Topical Solution is flammable. Keep away from heat, sparks or open flames.
Mechanism of Action
The mechanism of action of clindamycin in treating acne vulgaris is unknown.
