Tenolam (Tenofovir Disoproxil Fumarate & Lamivudine Tablets Film-coated tablet 300mg300mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

TENOLAM (TENOFOVIR DISOPROXIL FUMARATE &
LAMIVUDINE FILM-COATED TABLETS 300 MG/ 300 MG)
Tenofovir Disoproxil Fumerate and Lamivudine Tablets 300 mg / 300 mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_ Tenolam tablet _
is used for
2.
How
_Tenolam tablet _
works
3.
Before you use
_Tenolam tablet_
4.
How to use
_ Tenolam tablet_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Tenolam _
_tablet_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _TENOLAM TABLET_ IS USED FOR
_Tenolam tablet_
contains Lamivudine and
Tenofovir disoproxil
fumarate
which are
medicine
used
with
other
antiviral
medicines
to
treat
Human
Immunodeficiency Virus (HIV) in adults
and adolescents older than 12 years of
age or weighing at least 35kg. HIV is the
virus
that
causes
AIDS
(Acquired
Immune Deficiency Syndrome).
HOW _TENOLAM TABLET_ WORKS
_Tenolam tablet_
may reduce the amount
of HIV in your blood.
_Tenolam tablet_
may also help to increase the number of
CD4 (T) cells in your blood which help
fight off other infections. Reducing the
amount of HIV and increasing the CD4
(T) cell count may improve your immune
system.
BEFORE YOU USE _TENOLAM TABLET_
- _When you must not use it _
If you have any allergy to Lamivudine,
Tenofovir disoproxil
fumarate or any of
its ingredients.
_ _
_Pregnancy and lactation _
_ _
Do not take
_Tenolam tablet_
if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take
_Tenolam tablet_
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 liver disease
- have kidney disease
- taking any other medicines
-
_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.
TELL YOUR HEALTHCARE PROVIDER ABOUT ALL
THE
MEDICINES
YOU
TAKE,
including
prescription
and
no

Ciri produk

Hetero
Name of the product
Tenolam Tablet
Name and strength of Active Ingredient
Name : Tenofovir Disproxil Fuma rate and Lamivudine
Strength : 300 mg/300 mg
Dosage form
Oral
Product Description
Light blue to blue, capsule shaped, biconvex film coated tablets debossed with ‘129’ on one side
and ‘H’ on other side.
Pharmacodynamics/Pharmacokinetics
Pharmacodynamics:
Lamivudine and Tenofovir disoproxil fumarate Tablets are a fixed dose combination of antiviral
drugs lamivudine and tenofovir disoproxil fumarate.
Mechanism of Action
Lamivudine
Intracellularly, lamivudine is phosphorylated to its active 5’ -triphosphate metabolite, lamivudine
triphosphate (3TC -TP). The principal mode of action of 3TC -TP is the inhibition of HIV -1
reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide
analogue into viral DNA. 3TC -TP is a weak inhibitor of mammalian DNA polymerases α, β, and
γ.
Tenofovir Disoproxil Fumara te
Tenofovir disoproxil fumarate is an acyclic nucleoside phosphonate diester analog of adenosine
monophosphate. Tenofovir disoproxil fumarate requires initial diester hydrolysis for conversion
to tenofovir and subsequent phosphorylations by cellular enzym es to form tenofovir diphosphate,
an obligate chain terminator. Tenofovir diphosphate inhibits the activity of HIV -1 reverse
transcriptase and HBV reverse transcriptase by competing with the natural substrate
deoxyadenosine 5’ -triphosphate and, after incor poration into DNA, by DNA chain termination.