Estiva 600 (EFAVIRENZ TABLETS 600mg)

국가: 말레이시아

언어: 영어

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

유효 성분:

EFAVIRENZ

제공처:

CAMBER LABORATORIES SDN. BHD.

INN (International Name):

EFAVIRENZ

패키지 단위:

30tablet Tablets

Manufactured by:

Hetero Labs Limited

환자 정보 전단

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ESTIVA 600 (EFAVIRENZ TABLETS 600MG)
Efavirenz (600mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_ESTIVA-600(Efavirenz _
_Tablets 600 mg) _
is used for
2.
How
_ESTIVA-600 (Efavirenz) _
works
_3._
_ _
Before
you
use
_ESTIVA-_
_600 (Efavirenz) _
_4._
_ _
How to use
_ESTIVA-600 _
_(Efavirenz) _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_ESTIVA- _
_600 (Efavirenz) _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ESTIVA-600 (EFAVIRENZ) _IS USED
FOR
_ESTIVA-600 (EFAVIRENZ) _
contains an
active ingredient efavirenz. Your doctor
has
prescribed
Efavirenz
for
you
because
you
have
HIV
infection.
Efavirenz
taken
in
combination
with
other antiretroviral medicines reduces
the amount of the virus in the blood.
HOW _ESTIVA-600 (EFAVIRENZ) _WORKS
Efavirenz
works
by
lowering
the
amount of HIV-1 in the blood (viral
load).
Efavirenz
must
be
taken
with
other anti- HIV medicines. When taken
with
other
anti-HIV
medicines,
efavirenz has been shown to reduce viral
load and increase the number of CD4+
cells, a type of immune cell in blood.
BEFORE
YOU
USE
_ESTIVA-600 _
_(EFAVIRENZ) _
-
_When you must not use it Pregnancy _
_and lactation _
Do not take
_ESTIVA-600 (EFAVIRENZ) _
if
you
are
pregnant,
trying
to
get
pregnant or think you may be pregnant.
Do not take
_ESTIVA-600 (EFAVIRENZ) _
if
you are breast-feeding. Ask your doctor
or pharmacist for advice before taking
any medicine.
-
_Before you start to use it _
Tell your doctor if you
•
have any heart disorder
•
have problems with your liver or
have hepatitis.
•
have ever had mental illness or are
using drugs or alcohol.
•
have ever had seizures or are taking
medicine for seizures [for example,
phenytoin, carbamazepine or
phenobarbital].
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any
that
you buy without a prescription from a
pharmacy,
supermarket
or
health
food shop.
Efavirenz may change the effect of
oth

제품 특성 요약

1
ESTIVA-600 (EFAVIRENZ TABLETS 600MG)
NAME OF THE PRODUCT
ESTIVA-600 (Efavirenz Tablets 600mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT
Name
: Efavirenz
Strength
: 600mg
PRODUCT DESCRIPTION
Efavirenz Tablets 600mg
Yellow, capsule shaped, film coated tablets debossed with ‘H’ on
one side and ‘4’ on the
other side.
PHARMACODYNAMICS/PHARMACOKINETICS
PHARMACOLOGY:
Mechanism of Action: Efavirenz is a selective non-nucleoside reverse
transcriptase inhibitor of human immunodeficiency virus type 1
(HIV-1). Efavirenz 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 α, β, γ and δ are not inhibited by
concentrations of
efavirenz.
PHARMACODYNAMICS
DRUG RESISTANCE_: _
The potency of efavirenz in cell culture against viral variants with
amino
acid substitutions at positions 48, 108, 179, 181 or 236 in RT or
variants with amino acid
substitutions in the protease was similar to that observed against
wild type viral strains. The
single substitutions which led to the highest resistance to efavirenz
in cell culture correspond
to a leucine-to-isoleucine change at position 100 (L100I, 17- to
22-fold resistance) and a
lysine-to-asparagine at position 103 (K103N, 18- to 33-fold
resistance). Greater than 100-
fold loss of susceptibility was observed against HIV variants
expressing K103N in addition
to other amino acid substitutions in RT. K103N was the most frequently
observed RT
substitution in viral isolates from patients who experienced a
significant rebound in viral load
during
clinical
studies
of
efavirenz
in
combination
with
indinavir
or
zidovudine
+
lamivudine. Substitutions at RT positions 98, 100, 101, 108, 138, 188,
190 or 225 were also
2
observed, but at lower frequencies, and often only in combination with
K103N. The pattern
of amino acid substitutions in RT associated with resistance to
efavirenz was independent of
the other antiviral medica