CLINDAMYCIN PHOSPHATE solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Physicians Total Care, Inc.

INN (Internationale Bezeichnung):

CLINDAMYCIN PHOSPHATE

Zusammensetzung:

CLINDAMYCIN 10 mg in 1 mL

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Clindamycin Phosphate Topical Solution USP, 1% is available as follows: 60 count jar single-use pledget applicators     NDC 54868-4805-0 Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing. MANUFACTURED BY PERRIGO BRONX, NY 10457 DISTRIBUTED BY PERRIGO® ALLEGAN, MI 49010 Rev. 02/11 0T900 RC J4 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK       74146

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CLINDAMYCIN PHOSPHATE - CLINDAMYCIN PHOSPHATE SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
FOR EXTERNAL USE
RX ONLY
DESCRIPTION
Clindamycin Phosphate Topical Solution contains clindamycin phosphate,
USP, at a concentration
equivalent to 10 mg clindamycin per milliliter. Each Clindamycin
Phosphate Topical Solution pledget
applicator contains approximately 1 mL of topical solution.
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 (to adjust the pH to between 4.0 - 7.0).
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% fol