DALACIN C KAPSUL 300 MG

国家: 印度尼西亚

语言: 印度尼西亚文

来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

可用日期:

PFIZER INDONESIA - Indonesia

剂量:

300 MG

药物剂型:

KAPSUL

每包单位数:

DUS, 3 BLISTER @ 10 KAPSUL

厂商:

PFIZER INDONESIA - Indonesia

授权日期:

2014-03-07

产品特点

Generic Name: Clindamycin hydrochloride
Trade Name: DALACIN C
CDS Effective Date: October 30, 2020
Supersedes: June 13, 2018
Approved by BPOM:
2019-0057289
Page 1 of 12
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Clindamycin hydrochloride
Trade Name: DALACIN C
CDS Effective Date: October 30, 2020
Supersedes: June 13, 2018
DESCRIPTION
Clindamycin
hydrochloride
is
the
hydrated
hydrochloride
salt
of
clindamycin.
Clindamycin is a semi synthetic antibiotic produced by a
7(S)-chloro-substitution of
the 7(R)-hydroxyl group of the parent compound lincomycin.
DALACIN C HCl capsules contain clindamycin hydrochloride equivalent to
150 mg
or 300 mg of clindamycin.
The structural formula is represented below:
The chemical name for clindamycin hydrochloride is Methyl
7-chloro-6,7,8-trideoxy-
6-(1-methyl-trans-4-progyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-

-D-galacto-
octopyranoside monohydrochloride.
PHARMACOLOGICAL PROPERTIES
Mechanism of action
Clindamycin is a lincosamide antibiotic that inhibits bacterial
protein synthesis. It
binds to the 50S ribosomal subunit and affects both ribosome assembly
and the
translation process. Although clindamycin phosphate is inactive _in
vitro_, rapid _in vivo_
hydrolysis, converts this compound to the antibacterially active
clindamycin. At usual
doses, clindamycin exhibits bacteriostatic activity _in vitro_.
Pharmacodynamic effects
Efficacy is related to the time period over which the agent level is
above the minimum
inhibitory concentration (MIC) of the pathogen (%T/MIC).
Resistance
Resistance to clindamycin is most often due to mutations at the rRNA
antibiotic
binding site or methylation of specific nucleotides in the 23S RNA of
the 50S
ribosomal
subunit.
These
alterations
can
determine
_in _
_vitro_
cross
resistance
to
macrolides and streptogramins B (MLS
B
phenotype). Resistance is occasionally due to
DISETUJUI OLEH BPOM : 08/12/2021
ID REG : EREG10024112100614;
EREG10024112100615.
Generic Name: Clindamycin hydrochloride
Trade Name: DALACIN C
CDS Effective Date: