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:

Physicians Total Care, Inc.

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN PHOSPHATE 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 gram is available in the following sizes: 30 mL applicator bottle NDC 54868-2875-1 60 mL applicator bottle NDC 54868-2875-0 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 54868-4654-1 60 gram tube NDC 54868-4654-0 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 54868-4806-0 Store at 20°-25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing. Keep all liquid dosage forms in containers tightly closed. November 2007 E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 IFI201A Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146

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
PHYSICIANS TOTAL CARE, INC.
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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%) contains 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 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
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 1