AkuriT-4 TABLET

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

RIFAMPIN USP; ETHAMBUTOL HYDROCHLORIDE; PYRAZINAMIDE USP; ISONIAZID USP

Доступна з:

PAHANG PHARMACY SDN. BHD.

ІПН (Міжнародна Ім'я):

RIFAMPIN USP; ETHAMBUTOL HYDROCHLORIDE; PYRAZINAMIDE USP; ISONIAZID USP

Одиниць в упаковці:

90 Tablets Tablets

Виробник:

Lupin Limited

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AKURIT-4 TABLETS
Rifampin /Isoniazid /Pyrazinamide /Ethambutol Hydrochloride
(150mg/75mg/400mg/275mg)
1
WHAT IS IN THIS LEAFLET
1.
What Akurit-4 is used for
2.
How Akurit-4 works
3.
Before you use Akurit-4
4.
How to use Akurit-4
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Akurit-4
8.
Product Description
9.
Manufacture
and
product
Registration Holder
10.
Date of revision.
WHAT AKURIT-4 IS USED FOR
Akurit-4 is used for the treatment of
tuberculosis.
HOW AKURIT-4 WORKS
AkuriT-4 contains four different medicines
called
rifampin,
isoniazid,
pyrazinamide
and
ethambutol
hydrochloride. They work by killing the
bacteria that cause tuberculosis.
BEFORE YOU USE AKURIT-4
−
_When you must not use it _
Do not take this medicine if you:
-
are
allergic
to
rifampin,
isoniazid,
pyrazinamide,
ethambutol
hydrochloride or to any of the other
ingredients of this medicine
-
had liver injury cause by medicine or
history
of
adverse
reaction
to
isoniazid such as fever, chills and
joint inflammation
-
have eye disorder caused by inflamed
optic nerve
−
_Before you start use it _
Ethambutol is not recommended for use in
children under 13 years old.
Tell your doctor if you have one of the
following
condition
before
taking
this
medicine:
•
Diabetes
•
Eye defects
•
Drink alcohol every day or you are
alcoholic
•
Kidney problem
•
Long term liver disease
−
_Pregnancy and lactation _
Akurit 4 may be secreted into breastmilk.
Please contact your doctor or pharmacist if
you
are
pregnant,
or
planning
for
pregnancy or breast feeding before using
any
medicine.
Your
doctor
will
assess
whether it is possible for you to continue
with the treatment of Akurit-4.
Akurit-4 may affect the results of some
blood tests like tests for folate, vitamin
B12 and liver function. If you are going to
have a blood test, it is important to tell your
doctor that you are taking Akurit 4.
−
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking, have recently taken

Характеристики продукта

XXXXX
AKuriT-4
For the use of a Registered Medical Practitioner
or a Hospital or a Laboratory only
Akurit-4 is a four drug Fixed Dose Combination (FDC) of anti-TB drugs
Rifampin, Isoniazid,
Pyrazinamide and Ethambutol developed as per the recommendations of
WHO, which offers the
ease of administrations and facilitates patient compliance in the
treatment of tuberculosis.
COMPOSITION:
EACH FILM COATED TABLET CONTAINS:
Rifampin USP
150 mg
Isoniazid USP
75 mg
Pyrazinamide USP
400 mg
Ethambutol HCL USP
275 mg
PRODUCT DESCRIPTION:
Brown colored, capsule shaped film-coated tablets with break line on
one side and plain on the other
side.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Antibacterial Activity
RIFAMPIN
Escherichia coli, Pseudomonas, Indole negative and indole positive
Proteus, Klebsiella,
Staphylococcus aureus, Coagulase-negative staphylococci, Neisseria
meningitides, Haemophilus
influenza, Legionella species, M tuberculosis, M kansassi, M
scrofulaceum, M intracellulare & M
avium.
ISONIAZID
It exerts an active bactericidal action on M tuberculosis which it
inhibits in concentrations of 0.05-2
mg/l. Other mycobacteria are generally resistant, although some
starins of M kansassi are
susceptible.
ETHAMBUTOL
M tuberculosis, M fortuitum, M kansassi, M intracellulare, M avium, M
ulcerans (some strains) & M
marinum (some strains)
PYRAZINAMIDE
Its activity against M. tuberculosis is highly pH dependent. It is
almost inactive at neutral pH; at pH 5.5
the MIC is 16-32 mg/l. Other Mycobacteria are resistant. Its action,
which depends on intracellular
conversion to pyrazinoic acid in M. tuberculosis but evidently not in
other mycobacteria, is
bactericidal.
PHARMACOKINETICS
RIFAMPIN
The oral administration of rifampin produces peak concentrations in
plasma in 2 to 4 hours. The half-
life of rifampin varies from 1.5 to 5 hours and is increased in the
presence of hepatic dysfunction; it
may be decreased in patients receiving isoniazid concurrently who are
slow inactivators of this drug.
Up to 30% of a dose of rifampin is excreted