CLINDAMYCIN PHOSPHATE solution CLINDAMYCIN PHOSPHATE lotion CLINDAMYCIN PHOSPHATE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)

Available from:

Greenstone LLC

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin phosphate topical solution, clindamycin phosphate topical gel and clindamycin phosphate 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). Clindamycin phosphate topical solution, clindamycin phosphate topical gel and clindamycin phosphate 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.

Product summary:

Clindamycin phosphate topical solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 30 mL applicator bottle—NDC 59762-3728-1 60 mL applicator bottle—NDC 59762-3728-2 Carton of 60 single-use pledget applicators—NDC 59762-3728-3 Clindamycin phosphate topical gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 30 gram tube—NDC 59762-3743-1 60 gram tube—NDC 59762-3743-2 Clindamycin phosphate topical lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL plastic squeeze bottle—NDC 59762-3744-1 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE LOTION
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE GEL
GREENSTONE LLC
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CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, USP
CLINDAMYCIN PHOSPHATE TOPICAL GEL
CLINDAMYCIN PHOSPHATE TOPICAL LOTION
FOR EXTERNAL USE
DESCRIPTION
Clindamycin phosphate topical solution and clindamycin phosphate
topical lotion contain
clindamycin phosphate, USP, at a concentration equivalent to 10 mg
clindamycin per
milliliter. Clindamycin phosphate topical gel contains clindamycin
phosphate, USP, at a
concentration equivalent to 10 mg clindamycin per gram. Each
clindamycin phosphate
topical solution pledget applicator contains approximately 1 mL of
topical solution.
Clindamycin phosphate is a water soluble ester of the semi-synthetic
antibiotic produced
by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent
antibiotic
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