CLINDAMYCIN PHOSPHATE- clindamycin phosphate gel usp, 1% gel

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Preferred Pharmaceuticals Inc.

Rute administrasi :

TOPICAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Clindamycin phosphate gel, 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 gel 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.

Ringkasan produk:

Clindamycin phosphate gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 60 gram tube - NDC 68788-8423-6 To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Rx only Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa – 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Revised: 03/2021 Relabeled By: Preferred Pharmaceuticals Inc.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE GEL USP, 1% GEL
PREFERRED PHARMACEUTICALS INC.
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CLINDAMYCIN PHOSPHATE GEL USP, 1%
FOR EXTERNAL USE
DESCRIPTION
lindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP,
at a
concentration equivalent to 10 mg clindamycin per gram.
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 gel contains allantoin, carbomer 934P, methylparaben, polyethylene
glycol 400,
propylene glycol, purified water and sodium hydroxide.
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 to 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 i _n
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, cross
resistance is
s