Viranz 600 (Efavirenz Tablets USP 600mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EFAVIRENZ

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

EFAVIRENZ

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VIRANZ 600 (EFAVIRENZ TABLETS USP 600 MG)
Efavirenz 600mg
WHAT IS IN THIS LEAFLET
1.
What Efavirenz Tablets is used for
2.
How Efavirenz Tablets works
3.
Before you use Efavirenz Tablets
4.
How to use Efavirenz Tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Efavirenz
Tablets
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT EFAVIRENZ TABLETS IS USED FOR
Efavirenz Tablets are used in antiviral
combination treatment of HIV-1 infected
adults, adolescents and children.
HOW EFAVIRENZ TABLETS WORKS
Efavirenz belongs to a class of HIV
drugs
called
non-nucleoside
reverse
transcriptase
inhibitors
(NNRTIs).
NNRTIs attach to and block an HIV
enzyme called reverse transcriptase. By
blocking reverse transcriptase, NNRTIs
prevent HIV from multiplying and can
reduce the amount of HIV in the body.
BEFORE YOU USE EFAVIRENZ TABLETS
-
_When you must not use it _
Do not take Efavirenz Tablets if you:
•
are sensitive to Efavirenz or any
of the other ingredients of this
product
•
taking terfenadine or astemizole
(medicine used in the treatment
of allergic conditions)
•
taking
cisapride
(medicine
to
increase the mobility of food in
the stomach and intestine)
•
taking
midazolam
(medicine
used
to
produce
sleepiness
or
drowsiness
and
to
relieve
anxiety before surgery)
•
taking triazolam (medicine used
to treat a certain sleep problem)
•
taking pimozide (medicine used
in
treatment
of
Tourette’s
Syndrome-
disorder
that
involves
repetitive
movements
or unwanted sounds (tics) that
can't be easily controlled)
•
taking bepridil [medicine used
in the treatment of high blood
pressure and chronic chest pain
•
taking
ergot
derivatives
(medicine used to treat severe,
throbbing headaches)
•
taking
voriconazole
(medicine
used to treat a variety of fungal
infections)
_Pregnancy and lactation _
_ _
Do not take Efavirenz Tablets if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
VIRANZ 600 (EFAVIRENZ TABLETS USP 600MG)
RX ONLY
NAME OF THE FINISHED PHARMACEUTICAL PRODUCT :Efavirenz Tablets USP 600
mg
(TRADE) NAME OF THE PRODUCT: VIRANZ
STRENGTH: 600mg
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
Each film - coated tablet contains Efavirenz USP 600 mg.
Exicipients:
Tablets core: Microcrystalline cellulose, sodium lauryl sulfate,
croscarmellose sodium, hydroxypropyl cellulose,
lactose monohydrate and magnesium stearate
Film coat: Hypromellose, titanium dioxide, polyethylene glycol and
yellow iron oxide
DESCRIPTION
Yellow coloured oval biconvex film coated tablets with ‘D’ on one
side and ‘37’ on the other side.
PHARMACODYNAMICS:
Viranz 600 is a selective non-nucleoside reverse transcriptase
inhibitor (NNRTI) of human immunodeficiency virus
type 1 (HIV-1). Viranz 600 is a non-competitive inhibitor of HIV-1
reverse transcriptase (RT) with respect to template,
primer or nucleoside triphosphates, with a small component of
competitive inhibition. HIV-2 RT and human cellular
DNA polymerases alpha, beta, gama and omega are not inhibited by
concentrations of Viranz 600 well in excess of
those achieved clinically.
PHARMACOKINETIC METABOLISM:
Viranz 600 has been shown to induce P450 enzymes, resulting in the
induction of its own metabolism. The
degree of CYP3A4 induction is expected to be similar between a 400 mg
and 600 mg dose of Viranz 600 based on
pharmacokinetic interaction studies in which daily 400 mg or 600 mg
Viranz 600 doses in combination with indinavir
did not appear to cause any further reduction of indinavir compared to
a 200 mg dose of efavirenz.
ELIMINATION: Viranz 600 has a relatively long terminal half-life of 52
to 76 hours after single doses and 40 - 55 hours
after multiple doses. Approximately 14 - 34% of a radiolabelled dose
of Viranz 600 was recovered in the urine and less
than 1% of the dose was excreted in urine as unchanged Viranz 600.
INDICATION:
Viranz 600 are indicated in antiviral combination treatment of HIV-1
infected adults,