Monoclarium Prolonged Release Capsule 200 mg

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Clarithromycin

Beschikbaar vanaf:

HYPHENS PHARMA PTE. LTD.

ATC-code:

J01FA09

Dosering:

200mg

farmaceutische vorm:

CAPSULE, DELAYED RELEASE

Samenstelling:

Clarithromycin 200mg

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

SMB TECHNOLOGY S.A.

Autorisatie-status:

ACTIVE

Autorisatie datum:

2011-03-18

Bijsluiter

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

Productkenmerken

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