Efavir-600 mg Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

EFAVIRENZ

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

EFAVIRENZ

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

CIPLA LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
EFAVIR TABLET_ _
Efavirenz (600 mg)
__________________________________________________________________________________________ 1
WHAT IS IN THIS LEAFLET
1.
What Efavir is used for
2.
How Efavir works
3.
Before you use Efavir
4.
How to use Efavir
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Efavir
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT EFAVIR IS USED FOR
Efavir Tablet is used together with other
antiretroviral medicines for the treatment
of HIV infection.
HOW EFAVIR WORKS
Efavir
contains
efavirenz
which
is
an
antiretroviral
medicine
called
non-
nucleoside reverse transcriptase inhibitors
(NNRTIs). It works by fighting the HIV
virus by reducing the amount of virus in
blood.
BEFORE YOU USE EFAVIR
_- When you must not use it _
Do not take this medicine if:
•
you are allergic to Efavirenz or any
other
ingredients
of
this
medicine
(listed in
_Product Description_
)
Do
not
take
Efavir
with
the
following
medicines as it may be fatal:
•
Terfenadine,
Astemizole
(medicines
for allergy reaction)
•
Cisapride (medicines for digestion)
•
Midazolam, triazolam (medicines for
sedation)
•
Ergot
alkaloids,
such
as
dihydroergotamine,
ergonovine,
ergotamine,
methylergonovine
(medicines for migraine)
•
Bepridil (medicines for heart disease)
•
Pimozide
(medicines
for
mental
disorder)
•
St. John’s wort (herbal medicine for
depression)
_ _
-_ Before you start to use it _
Tell your doctor before using Efavir if you
have:
•
problems with your kidney or liver
•
liver infection
•
ever had mental illness or seizures
•
any heart disorders
_Pregnancy and Lactation _
Please consult your doctor or pharmacist if
you are pregnant, planning for pregnancy
or
breast-feeding
before
using
any
medicine.
Pregnancy should be avoided in women
taking Efavir. If you could get pregnant
while receiving Efavir, a reliable form of
barrier contraception (e.g. condom) should
always
be
used
with
other
methods
of

Ciri produk

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only _
EFAVIR-600 MG TABLET
Efavirenz Tablets USP 600 mg
COMPOSITION
Each film coated tablet contains:
Efavirenz USP ……….. 600 mg
Colour: Yellow Oxide of iron, Titanium Dioxide
DOSAGE FORM
Oral, film-coated tablet
DESCRIPTION
Yellow Colored, Capsule shaped biconvex tablets debossed with
“EFV” on one side and plain
on other side.
PHARMACOLOGY
_PHARMACODYNAMICS _
Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor
(NNRTI) of human
immunodeficiency virus type 1 (HIV-1). Efavirenz activity is mediated
predominantly by non-
competitive inhibition of HIV-1 reverse transcriptase (RT). HIV-2 RT
and human cellular DNA
polymerases alpha, beta, gamma and delta are not inhibited by
efavirenz.
Cardiac Electrophysiology
The effect of Efavir on the QTc interval was evaluated in an
open-label, positive and placebo
controlled, fixed single sequence 3-period, 3-treatment crossover QT
study in 58 healthy
subjects enriched for CYP2B6 polymorphisms. The mean Cmax of efavirenz
in subjects with
CYP2B6 *6/*6 genotype following the administration of 600mg daily dose
for 14 days was 2.25-
fold the mean Cmax observed in subjects with CYP2B6 *1/*1 genotype. A
positive relationship
between efavirenz concentration and QTc prolongation was observed.
Based on the
concentration-QTc relationship, the mean QTc prolongation and its
upper bound 90%
confidence interval are 8.7 ms and 11.3 ms in subjects with
CYP2B6*6/*6 genotype following
the administration of 600 mg daily dose for 14 days. (see _SECTION
WARNINGS AND _
_PRECAUTIONS & SECTION DRUG INTERACTIONS_).
_PHARMACOKINETICS _
Absorption
Peak efavirenz plasma concentrations of 1.6–9.1 μM were attained by
5 hours following single
oral doses of 100 mg to 1600 mg administered to uninfected volunteers.
Dose-related increase
in Cmax and AUC were less than proportional, suggesting diminished
absorption at higher
doses.
In HIV-1-infected patients at steady state, mean Cmax, mean Cmin, and
mean A