CLINDAMYCIN PHOSPHATE- clindamycin phosphate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clindamycin Phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C)

Available from:

Actavis Pharma, 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, USP 1% is 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 is 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. Safety and effectiveness in pediatric patients under the age of 12 have not been established. Clinical studies for clindamycin phosphate topical solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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 bottles – NDC 0472-0987-91 60 mL applicator bottles – NDC 0472-0987-92 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from freezing. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. 11/2017 8-0321ACT6

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION
ACTAVIS PHARMA, INC.
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CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, USP 1%
RX ONLY
FOR EXTERNAL USE
DESCRIPTION
Clindamycin Phosphate Topical Solution, USP 1% contains clindamycin
phosphate, USP, at a
concentration equivalent to 10 mg clindamycin per milliliter.
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,
purified water and sodium
hydroxide. Sodium hydroxide or hydrochloric acid may be added to
adjust pH.
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
present in the serum (0-3 ng/mL) and less than 0.2% of the dose is
recovered in urine as clindamycin.
Clindamycin activity has been demonstrated in comedones from acne
patients. The mean concentration of
antibiotic activity in extracted comedones after application of
Clindamycin Phosphate Topical Solution
for 4 weeks was 597 mcg/g of comedonal material (range 0-1490).
Clindamycin _in vitro_ inhibits all
_Propionibacterium acnes_ cultures tested (MICs 0.4 mcg/mL). Free
fatty acids on the skin surface have
been decreased from approximately 14% to 2% following application of
clindamycin.
INDICATIO