CLINDAMYCIN PHOSPHATE solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Bryant Ranch Prepack

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Rx Only 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.

Produkt oversigt:

Clindamycin Phosphate Topical Solution USP, 1% is available as follows: 30 mL applicator bottle (NDC 63629-8633-1). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION
BRYANT RANCH PREPACK
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CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%
FOR EXTERNAL USE
RX ONLY
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 (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
MECHANISM OF ACTION
The mechanism of action of clindamycin in treating acne vulgaris is
unknown.
PHARMACOKINETICS
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.
Although clindamycin phosphate is inactive _in vitro_, rapid _in vivo
_hydrolysis converts this
compound to the antibacterially active clindamycin.
MICROBIOLOGY
Clindamycin inhibits bacterial protein synthesis by binding to the 23S
RNA of the 50S
subunit of the ribosome. Clindamycin is bacteriostatic.
Antimicrobial Activity
Clindamycin is active in vitro against most isolates of
_Propionibacterium acnes_; however,
the clinical significance is unknown.
Resistance
Resistance to clindamycin is most often caused by modification of
specific bases of the
23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin
is complete.
Because the binding sites for these antibacterial drugs overlap,