TRENTAL 400 TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PENTOXIFYLLINE

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PENTOXIFYLLINE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

SANOFI-AVENTIS DE MEXICO SA DE CV

Risalah maklumat

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_Consumer Medication Information Leaflet (RiMUP) _
TRENTAL
® TABLET
Pentoxifylline 400 mg
_ _
WHAT IS IN THIS LEAFLET
1. What Trental is used for
2. How Trental works
3. Before you use Trental
4. How to use Trental
5. While you are using it
6. Side effects
7. Storage and Disposal of Trental
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT TRENTAL IS USED FOR
Trental can be used to treat:
• Peripheral vascular disease (poor
circulation to the arms and legs).
• Intermittent claudication (pain on
walking or at rest caused by poor
circulation to the legs).
• Cerebral circulatory disorders (poor
circulation to brain which cause many
conditions related to neurological
function eg: vertigo & impairment of
memory)
HOW TRENTAL WORKS
Trental contains a medicine called
pentoxifylline.
This belongs to a group of medicines
called peripheral vasodilators. It
causes changes in your blood that help
improve blood flow thus enhancing
circulation in areas with impaired
blood flow.
BEFORE YOU USE TRENTAL
_WHEN YOU MUST NOT USE IT _
Do not take Trental if:
- You are allergic (hypersensitive) to
pentoxifylline, other similar medicines
such as theophylline or aminophylline
or to any of the other ingredients of
Trental (see Section 8: Product
description) Signs of an allergic
reaction include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue
- You have major bleeding
- You have had bleeding in the eye
(retinal haemorrhage)
Do not take this medicine if any of the
above applies to you. If you are not
sure, talk to your doctor or pharmacist
before taking Trental.
_BEFORE YOU START TO USE IT _
TAKE SPECIAL CARE WITH TRENTAL
- You feel dizzy, light-headed or faint
when you stand or sit up too quickly
(hypotension)
- You have problems with the blood
supply to your heart caused by
hardening or narrowing of the arteries
- You have liver or kidney problems
If you are not sure if any of the above
applies to you, talk to your doctor or
pharma

Ciri produk

TRENTAL ® 400mg
Description and Composition
Oblong pink coated tablets. Each film -coated tablet with sustained release contains 400mg pentoxifylline.
Colouring agent -D&C Red No. 27
Pharmacodynamics :
Trental 400 incr eases the altered erythrocyte deformability, reduces erythrocyte and platelets
aggregation, decreases fibrinogen levels, reduces the adhesion of leukocytes to the endothelium,
reduces leukocyte activation and resultant endothelial damage, and decreases blo od viscosity.
Consequently , Trental 400 promotes microcirculation perfusion optimizing blood flow and exerting
antithrombotic effects. Peripheral resistance can be reduced slightly if pentoxifylline is administered in
high doses or rapid infusion. TRE NTAL® exerts a discrete positive inotropic effect on the heart.
Pharmacokinetics :
Wh en pentoxyphylline is administered orally , its absorption is rapid and almost complete.
After taking TRENTAL ® tablets, the active substance is released slowly for 10 to 12 hours , so that
constant plasma levels are maintained for approximately 12 hours.
After almost completely absorbed, pentoxyphylline undergoes “first pass” metabolism by the liver. The
absolute bioavailability of pentoxyphylline is 19 +/ - 13%. The concentration of the principal active
metabolite, 1 -(5-hydroxyethyl) -3,7 -dimethylxanthine {metabolite 1} is calculated as two times the plasma
concentration of pentoxyphylline, and so the biochemical redox equilibriu m is reversible. For this reason,
pentoxyphylline and metabolite 1 are seen as one active unit, and the availability of the active substance
is therefore significantly greater.
Following either the oral or the intravenous administration of the drug, th e half life of elimination of
pentoxyphylline is approximately 1.6 hours.
Pentoxyphylline is completely metabolized and more than 90% is eliminated through the kidneys in the
form of polar, non -conjugated, water -soluble metabolites.
Special condition s
In patients with abnormal function of the liver, the half -life of eliminati