CLINDAMYCIN PHOSPHATE lotion CLINDAMYCIN PHOSPHATE solution 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:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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 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 Topical Solution, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 30 mL applicator bottle NDC 0168-0201-30 60 mL applicator bottle NDC 0168-0201-60 Clindamycin Phosphate Gel, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 30 gram tube NDC 0168-0202-30 60 gram tube NDC 0168-0202-60 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 0168-0203-60 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 46263755A R01/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE LOTION
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION
CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE GEL
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: D4371159-B58A-40A4-8060-D345843B5468
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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
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 cli