CLINDAMYCIN PHOSPHATE- clindamycin phosphate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate 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 Gel, and Clindamycin Phosphate 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 Lotion (Clindamycin Phosphate Topical Suspension, USP 1%) containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL bottle NDC 68788-7040-6 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Fougera PHARMACEUTICALS INC. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 46206122A/46206123A R03/18 Relabeled By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE LOTION
PREFERRED PHARMACEUTICALS INC.
----------
CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%,
CLINDAMYCIN PHOSPHATE GEL USP, 1%,
CLINDAMYCIN PHOSPHATE LOTION
(CLINDAMYCIN PHOSPHATE TOPICAL SUSPENSION USP, 1%)
RX ONLY
FOR EXTERNAL USE.
DESCRIPTION
Clindamycin Phosphate Topical Solution and Clindamycin Phosphate
Lotion (Clindamycin Phosphate
Topical Suspension USP, 1%) contain clindamycin phosphate, USP, at a
concentration equivalent to 10
mg clindamycin per milliliter. Clindamycin Phosphate Gel contains
clindamycin phosphate, USP, at a
concentration equivalent to 10 mg clindamycin per gram. 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
purified water.
The gel contains allantoin, carbomer 974P, 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
Although clindamycin phosphate is inactive _in vitro_, rapid _in vivo_
hydrolysis converts this compound to
the antibacterially active clindamycin.
Cross resistance has been demonstrated between clindamycin and
lincomycin.
Antagonism has been demonstrated between clindamycin and erythromycin.
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
p