Χώρα: Ινδονησία
Γλώσσα: Ινδονησιακά
Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PFIZER INDONESIA - Indonesia
300 MG
KAPSUL
DUS, 3 BLISTER @ 10 KAPSUL
PFIZER INDONESIA - Indonesia
2014-03-07
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: Διαβάστε το πλήρες έγγραφο