CLINDAMYCIN PHOSPHATE- clindamycin phosphate solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Preferred Pharmaceuticals Inc.

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 USP, 1% 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.

Produktsammanfattning:

Clindamycin Phosphate Topical Solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 60 mL applicator bottle — NDC NDC 68788-7057-6 Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 09/16 Relabeled By: Preferred Pharmaceuticals Inc.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION
PREFERRED PHARMACEUTICALS INC.
----------
CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%
FOR EXTERNAL USE
DESCRIPTION
Clindamycin Phosphate Topical Solution USP, 1% contains clindamycin
phosphate 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,
sodium hydroxide and water.
The structural formula is represented below:
Molecular Formula: C
H CIN O PS
Molecular Weight: 504.97
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
18
34
2
8
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.
INDICATIONS AND U