Viraday Tablets (Tenofovir Disoproxil Fumarate 300mg + Emtricitabine 200mg + Efavirenz 600 mg)

Country: Malaysia

Language: English

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

Active ingredient:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Available from:

CIPLA MALAYSIA SDN BHD

INN (International Name):

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Units in package:

30tablet Tablets

Manufactured by:

CIPLA LTD

Summary of Product characteristics

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only_
VIRADAY TABLETS
(Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg +
Efavirenz 600 mg Tablets)
WARNING
LACTIC
ACIDOSIS/SEVERE
HEPATOMEGALY
WITH
STEATOSIS
AND
POST
TREATMENT EXACERBATION OF HEPATITIS B
LACTIC
ACIDOSIS
AND
SEVERE
HEPATOMEGALY
WITH
STEATOSIS,
INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGS,
INCLUDING TENOFOVIR DISOPROXIL FUMARATE, A COMPONENT OF VIRADAY, IN
COMBINATION WITH OTHER ANTIRETROVIRALS.
VIRADAY IS NOT APPROVED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS
(HBV) INFECTION AND THE SAFETY AND EFFICACY OF VIRADAY HAVE NOT BEEN
ESTABLISHED IN PATIENTS CO-INFECTED WITH HVB AND HIV-1. SEVERE ACUTE
EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO HAVE
DISCONTINUED EMTRICITABINE, OR TENOFOVIR DISOPROXIL FUMARATE, WHICH
ARE
COMPONENTS
OF
VIRADAY.
HEPATIC
FUNCTION
SHOULD
BE
MONITORED
CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST
SEVERAL MONTHS IN PATIENTS WHO ARE COINFECTED WITH HIV-1 AND HBV AND
DISCONTINUE
VIRADAY.
IF
APPROPRIATE,
INITIATION
OF
ANTI-HEPATITIS
B
THERAPY MAY BE WARRANTED.
COMPOSITION
EACH FILM-COATED TABLET CONTAINS
Tenofovir disoproxil fumarate ..................... 300 mg
Equivalent to Tenofovir disoproxil ............... 245 mg
Emtricitabine ...............................................200 mg
Efavirenz ..................................................... 600 mg
Colours: Red Oxide of iron, Yellow Oxide of Iron, Titanium Dioxide
DOSAGE FORM
Oral, fixed-dose tablet
DESCRIPTION
Pink coloured, capsule shaped, biconvex film coated tablets with
“V” debossed on one side and plain on
other side.
PHARMACOLOGY
PHARMACODYNAMICS
_Efavirenz: _
Efavirenz is a non-nucleoside reverse transcriptase (RT) inhibitor of
HIV-1. Efavirenz activity
is mediated predominantly by the noncompetitive inhibition of HIV-1
reverse transcriptase (RT). HIV-2
RT and human cellular DNA polymerases, α, β, γ and δ are not
inhibited by efavirenz.
_ _
_