REBETOL CAPSULE 200 mg

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

RIBAVIRIN

Dostupné s:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC kód:

J05AB04

Dávkování:

200 mg

Léková forma:

CAPSULE

Složení:

RIBAVIRIN 200 mg

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

MSD International GmbH (Puerto Rico Branch) LLC

Stav Autorizace:

ACTIVE

Datum autorizace:

2001-03-26

Informace pro uživatele

1 

REBETOL™ Capsules 

Brand of ribavirin 
FOR ORAL ADMINISTRATION 

DESCRIPTION: REBETOL Capsules consist of a white, crystalline powder, which is 
freely soluble in water and slightly soluble in dehydrated alcohol, in a white opaque 
gelatin  capsule.  Each  REBETOL  Capsule  contains  ribavirin  200  mg.  Inactive 
ingredients: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium 
and magnesium stearate. 

ACTIONS:  Ribavirin  is  a  synthetic  nucleoside  analogue  that  has  shown 
in  vitro 
activity  against  some  RNA  and  DNA  viruses.  Oral  formulations  of  ribavirin 
monotherapy  have  been  investigated  as  therapy  for  chronic  hepatitis  C  in  several 
clinical trials. Results of these investigations showed that ribavirin monotherapy had 
no  effect  on  eliminating  hepatitis  virus  (HCV-RNA)  or  improving  hepatic  histology 
after  6  to  12  months  of  therapy  and  6  months  of  follow-up.  However, clinical trials 
combining  ribavirin  with  peginterferon  alfa-2b  or  interferon  alfa-2b  resulted  in  an 
increased response rate over treatment with pegylated interferon or interferon alfa-2b 
alone. The mechanism by which ribavirin in combination with peginterferon alfa-2b or 
interferon alfa-2b exerts its effects against HCV is unknown. 

CLINICAL  PHARMACOKINETICS:  Ribavirin  is  absorbed  rapidly  following  oral 
administration  of  a  single  dose  (mean  T
max
  =  1.5  hours),  followed  by  rapid 
distribution and prolonged  elimination  phases  (single  dose  half-lives  of  absorption, 
distribution and elimination are 0.05, 3.73 and 79 hours, respectively). Absorption is 
extensive  with  approximately  10%  of  a  radiolabel

Charakteristika produktu

S-CCDS-MK8908-SG-082014
REBETOL™ Capsules
Brand of ribavirin
FOR ORAL ADMINISTRATION
DESCRIPTION: REBETOL Capsules consist of a white, crystalline powder,
which is
freely soluble in water and slightly soluble in dehydrated alcohol, in
a white opaque
gelatin
capsule.
Each
REBETOL
Capsule
contains
ribavirin
200 mg.
Inactive
ingredients: Microcrystalline cellulose, lactose monohydrate,
croscarmellose sodium
and magnesium stearate.
ACTIONS: Ribavirin is a synthetic nucleoside analogue that has shown
in vitro
activity
against
some
RNA
and
DNA
viruses.
Oral
formulations
of
ribavirin
monotherapy have been investigated as therapy for chronic hepatitis C
in several
clinical trials. Results of these investigations showed that ribavirin
monotherapy had
no effect on eliminating hepatitis virus (HCV-RNA) or improving
hepatic histology
after 6 to 12 months of therapy and 6 months of follow-up. However,
clinical trials
combining ribavirin with peginterferon alfa-2b or interferon
alfa-2b resulted in an
increased response rate over treatment with pegylated interferon or
interferon alfa-2b
alone. The mechanism by which ribavirin in combination with
peginterferon alfa-2b or
interferon alfa-2b exerts its effects against HCV is unknown.
CLINICAL
PHARMACOKINETICS:
Ribavirin
is
absorbed
rapidly
following
oral
administration
of
a
single
dose
(mean
T
max
=
1.5
hours),
followed
by
rapid
distribution and prolonged elimination phases (single dose half-lives
of absorption,
distribution and elimination are 0.05, 3.73 and 79 hours,
respectively). Absorption is
extensive with approximately 10% of a radiolabelled dose excreted in
the feces.
However, absolute bioavailability is approximately 45%-65%, which
appears to be
due to first pass metabolism. There is a linear relationship between
dose and AUC
tf
following
single
dose
of
200-1,200 mg
ribavirin.
Volume
of
distribution
is
approximately 5,000L. Ribavirin does not bind to plasma proteins.
Ribavirin has been shown to produce high inter- and intra-subject
pharmacokinetic
variability following