clindamycin phosphate- Clindamycin Phosphate solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

E. FOUGERA & CO.

INN (Tarptautinis Pavadinimas):

Clindamycin Phosphate

Vaisto forma:

SOLUTION

Sudėtis:

10 mg in 1 mL

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Clindamycin Phosphate Topical Solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: Carton of 60 single-use pledget applicators NDC 0168-0201-01 Store at 20° to 25°C (68°to 77°F)[see USP Controlled Room Temperature]. Protect from freezing. E. FOUGERA & CO. a division of Altana Inc. MELVILLE, NEW YORK 11747 IF5263 R10/05 #51

Prekės savybės

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION
E. FOUGERA & CO.
----------
CLINDAMYCIN PHOSPHATE PLEDGETS 1%
(CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%)
RX ONLY
FOR EXTERNAL USE
DESCRIPTION
Clindamycin Phosphate Topical Solution USP, 1% contains clindamycin
phosphate, at a concentration
equivalent to 10 mg clindamycin per milliliter. Each Clindamycin
Phosphate Topical Solution pledget
applicator contains approximately 1 mL of topical solution.
The solution contains isopropyl alcohol 50% v/v, propylene glycol, and
purified water. 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 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). pH between 4.0 and 7.0.
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
USP, 1% 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 hav