Land: Singapore
Sprog: engelsk
Kilde: HSA (Health Sciences Authority)
Clarithromycin
HYPHENS PHARMA PTE. LTD.
J01FA09
200mg
CAPSULE, DELAYED RELEASE
Clarithromycin 200mg
ORAL
Prescription Only
SMB TECHNOLOGY S.A.
ACTIVE
2011-03-18
MONOCLARIUM 200 MG, prolonged release capsules. PHARMACEUTICAL FORM Prolonged release capsule, yellow/yellow, hard gelatine capsule (size 0) Each prolonged release capsule contains 200 mg clarithromycin. CAPSULE CONTENT : Cellulose microcrystalline, povidone K29/32, citric acid anhydrous, stearic acid. PELLET COATING Hypromellose, polysorbate 80, talc, titanium dioxide (E171), polyacrylate dispersion 30%. Antifoam C Emulsion: Dimethicone, Methylated silica, Octamethyl cyclotetrasiloxane, Methylcellulose, Sorbic acid, Benzoic acid. CAPSULE SHELL Titanium dioxide (E171), quinoline yellow (E104), erythrosine (E127), gelatin. PHARMACODYNAMIC PROPERTIES _GENERAL PROPERTIES _ ATC classification Pharmacotherapeutic group: macrolides ATC Code: J01FA09 Mode of action Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding to the 50s ribosomal sub-unit of susceptible bacteria and suppressing protein synthesis. The 14-hydroxy metabolite of clarithromycin, formed in man by first pass metabolism, also has antimicrobial activity. The MICs of this metabolite are equal or two-fold higher than the MICs of the parent compound except for _H. influenzae _where the 14-hydroxy metabolite is two- fold more active than the parent compound. Mechanisms of resistance Resistance of Gram-positive organisms to the macrolides usually involves an alteration of the antimicrobial binding site. The MLS B type of resistance, which may be constitutive or induced by exposure to certain macrolides in staphylococci and which is inducible in streptococci, is mediated by a variety of acquired genes (_erm _family) encoding methylases targeted at the peptidyl transferase centre of 23S ribosomal RNA. Methylation impedes binding of antibacterials to the ribosome and gives rise to cross-resistance to macrolides (all macrolides when constitutive), lincosamides and type B streptogramins Læs hele dokumentet
MONOCLARIUM 200 mg, prolonged release capsules. PHARMACEUTICAL FORM Prolonged release capsule, yellow/yellow, hard gelatine capsule (size 0) Each prolonged release capsule contains 200 mg clarithromycin. Capsule content : Cellulose microcrystalline, povidone K29/32, citric acid anhydrous, stearic acid. Pellet coating Hypromellose, polysorbate 80, talc, titanium dioxide (E171), polyacrylate dispersion 30%. Antifoam C Emulsion: Dimethicone, Methylated silica, Octamethyl cyclotetrasiloxane, Methylcellulose, Sorbic acid, Benzoic acid. Capsule shell Titanium dioxide (E171), quinoline yellow (E104), erythrosine (E127), gelatin. Pharmacodynamic properties _General properties _ ATC classification Pharmacotherapeutic group: macrolides ATC Code: J01FA09 Mode of action Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding to the 50s ribosomal sub-unit of susceptible bacteria and suppressing protein synthesis. The 14-hydroxy metabolite of clarithromycin, formed in man by first pass metabolism, also has antimicrobial activity. The MICs of this metabolite are equal or two-fold higher than the MICs of the parent compound except for _H. influenzae _where the 14-hydroxy metabolite is two- fold more active than the parent compound. Mechanisms of resistance Resistance of Gram-positive organisms to the macrolides usually involves an alteration of the antimicrobial binding site. The MLS B type of resistance, which may be constitutive or induced by exposure to certain macrolides in staphylococci and which is inducible in streptococci, is mediated by a variety of acquired genes (_erm _ family) encoding methylases targeted at the peptidyl transferase centre of 23S ribosomal RNA. Methylation impedes binding of antibacterials to the ribosome and gives rise to cross-resistance to macrolides (all macrolides when constitutive), lincosamides and type B streptogramins but not to type A streptogramins. Less frequent mechanisms of resistance include antimicrobial degradation by inactivatin Læs hele dokumentet