TENOLAURUS TABLET (TENOFOVIR DISOPROXIL FUMARATE 300 MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TENOFOVIR DISOPROXIL FUMARATE

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

TENOFOVIR DISOPROXIL FUMARATE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Laurus Labs Limited (Unit-2)

Risalah maklumat

TENOLAURUS TABLET
TENOFOVIR DISOPROXIL FUMARATE 300MG
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What TENOLAURUS is used for
2.
How TENOLAURUS works
3.
Before you use TENOLAURUS
4.
How to use TENOLAURUS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
TENOLAURUS
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT TENOLAURUS IS USED FOR
TENOLAURUS is used for the treatment
of Human Immunodeficiency Virus (HIV)
infection in adults over 12 years of age.
TENOLAURUS is also used to treat
chronic hepatitis B, an infection with
hepatitis B virus (HBV), in adults.
HOW TENOLAURUS WORKS
Tenofovir is a nucleotide reverse
transcriptase inhibitor, generally known
as an NRTI and works by interfering with
the normal working of enzymes (in HIV:
reverse transcriptase; in hepatitis B: DNA
polymerase) that are essential for the
viruses to reproduce themselves.
BEFORE YOU USE TENOLAURUS
-
_When you must not use it _
Do not take TENOLAURUS
If you are allergic (hypersensitive) to
tenofovir, or any of the other ingredients
of TENOLAURUS. If this applies to you,
tell your doctor immediately and don’t
take TENOLAURUS.
-
_Before you start use it _
Take special care with TENOLAURUS
•
Tell your doctor if you have had
kidney disease or if tests have shown
problems with your kidneys.
TENOLAURUS may affect your kidneys.
Before starting treatment, your doctor
may order blood tests to check your
kidney function and may advise you to
take the tablets less often. Your doctor
may also order blood tests during
treatment to monitor your kidneys.
TENOLAURUS are not usually taken
with other medicines that can damage
your kidneys (see
_taking other medicines_
).
If this is unavoidable, your doctor will
monitor your kidney function once a
week.
•
Talk to your doctor if you are over
65. TENOLAURUS has not been studied
in patients over 65 years of age. If you are
older than this and are prescribed
TENOLAURUS, your doctor will monitor
you carefully.
�

Ciri produk

1
TENOLAURUS TABLET (TENOFOVIR DISOPROXIL FUMARATE 300 MG)
1.
PRODUCT NAME
TENOLAURUS TABLET (Tenofovir Disoproxil Fumarate 300 mg)
2.
NAME AND STRENGTH OF ACTIVE INGREDIENTS(S)
Each film-coated tablet contains:
Tenofovir Disoproxil Fumarate 300 mg (equivalent to tenofovir
disoproxil 245 mg).
This medicinal product contains lactose monohydrate.
LIST OF EXCIPIENTS
_Tablet core _
Lactose
monohydrate,
microcrystalline cellulose,
pregelatinized
starch,
croscarmellose sodium,
purified water and magnesium stearate
_Film-coating _
Hypromellose, lactose monohydrate, titanium dioxide, triacetin, FD&C
Blue #2/Indigo Carmine AL and
FD&C Blue #2/Indigo Carmine Aluminum Lake.
3.
DOSAGE FORM
Film-coated tablet.
4.
PRODUCT DESCRIPTION
Blue coloured, oval shaped, film-coated tablets, with “LA16”
debossed on one side and plain on the other side
5.
PHARMACODYANAMICS/PHARMACOKINETICS
6.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and
nucleotide reverse transcriptase
inhibitors, ATC code: J05AF07
Mechanism of action and pharmacodynamic effects
Tenofovir disoproxil fumarate is the fumarate salt of the prodrug
tenofovir disoproxil. Tenofovir disoproxil is
absorbed and converted to the active substance tenofovir, which is a
nucleoside monophosphate (nucleotide)
analogue. Tenofovir is then converted to the active metabolite,
tenofovir diphosphate, an obligate chain
terminator, by constitutively expressed cellular enzymes. Tenofovir
diphosphate has an intracellular half-life
of 10 hours in activated and 50 hours in resting peripheral blood
mononuclear cells (PBMCs). Tenofovir
diphosphate inhibits HIV-1 reverse transcriptase and the HBV
polymerase by direct binding competition with
the natural deoxyribonucleotide substrate and, after incorporation
into DNA, by DNA chain termination.
Tenofovir diphosphate is a weak inhibitor of cellular polymerases α,
β, and γ.
2
6.1
PHARMACOKINETIC PROPERTIES
Tenofovir disoproxil fumarate is a water soluble ester prodrug which
is rapidly converted
_i