ENTECA FILM-COATED TABLET 1MG

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

Entecavir Monohydrate eqv. Entecavir

MAH:

RANBAXY (MALAYSIA) SDN. BHD.

ATC_code:

J05AF10

pharmaceutical_form:

TABLET, FILM COATED

composition:

Entecavir Monohydrate eqv. Entecavir 1mg

administration_route:

ORAL

prescription_type:

Prescription Only

manufactured_by:

SUN PHARMACEUTICAL INDUSTRIES LIMITED

authorization_status:

ACTIVE

authorization_date:

2022-09-12

SPC

Page 1 of 26
For the Use of a Registered Medical Practitioner Only
PRESCRIBING INFORMATION
ENTECA
(Entecavir Tablets 0.5 mg/1 mg)
WARNING:
SEVERE
ACUTE
EXACERBATIONS
OF
HEPATITIS
B,
PATIENTS
CO-
INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
Severe acute exacerbations of hepatitis B have been reported in
patients who have
discontinued anti-hepatitis B therapy, including entecavir. Hepatic
function should be
monitored closely with both clinical and laboratory follow-up for at
least several months
in patients who discontinue anti-hepatitis B therapy. If appropriate,
initiation of anti-
hepatitis B therapy may be warranted.
Limited clinical experience suggests there is a potential for the
development of resistance
to HIV (human immunodeficiency virus) nucleoside reverse transcriptase
inhibitors if
entecavir is used to treat chronic hepatitis B virus (HBV) infection
in patients with HIV
infection that is not being treated. Therapy with entecavir is not
recommended for
HIV/HBV co-infected patients who are not also receiving highly active
antiretroviral
therapy (HAART).
Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been
reported
with
the
use
of
nucleoside
analogues
alone
or
in
combination
with
antiretrovirals.
COMPOSITION
ENTECA
Each film-coated tablet contains:
Entecavir (as monohydrate) ……………….…….0.5 mg/1 mg
List of excipients: Lactose, povidone, purified water,
microcrystalline cellulose, crospovidone, and
magnesium stearate
Physical description
0.5mg tablets: White to Off-White, triangular shaped film coated
tablets, debossed with ‘RL1’ on
one side and plain on other side.
1mg tablets: Light Pink to pink, triangular shaped film coated
tablets, debossed with ‘RL2’ on one
side and plain on other side
Page 2 of 26
DESCRIPTION
Entecavir is a guanosine nucleoside analogue with selective activity
against HBV. The chemical
name
for
entecavir
is
2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-
methylenecyclopentyl]-6H-purin-6-one