Trental

Trental®
Pentoxifylline
400mg

Composition
Each film-coated tablet with sustained release contains 400 mg pentoxifylline.

Properties
Trental 400 improves altered blood flow properties by its influence on phatologically impaired red cell deformability, by inhibiting platelet aggregation and by reducing increased blood viscosity. Consequently, Trental 400 enhances the nutritive microcirculation in areas with impaired blood flow.
The important feature of Trental 400 is the continuous release of the active substance resulting in constant absorption and long lasting blood levels.
Improvement of symptoms of cerebrovascular disoders has been demonstrated after administration of Trental 400.
Treatment of peripheral arterial diseases (e.g. intermittent claudication) results in an increase in walking distance and relief of nocturnal calf cramps and rest pain.

Indications
Peripheral occlusive arterial disease and arteriovenous disorders of an arteriosclerotic or diabetic nature (e.g. arteriosclerosis with intermittent claudication or rest pain, diabetic angiopathy) and trophic disturbances (post-thrombotic syndrome, leg ulcer and gangrene).
Vascular disturbances of the eye (acute, sub-acute and chronic impairment of retinal and choroidal perfusion). Cerebral circulatory disorders (sequelae of cerebral arteriosclerosis such as difficulties in concentration, vertigo, impairment of memory), ischaemic and post-apoplectic states.

Contraindications
Trental 400 must not be administered to patients with hypersensitivity to pentoxifylline, cerebral or extensive retinal haemorrhage, or acute myocardial infarction. Trental 400 should not be used during pregnancy. Trental should not be administered to patients intolerance to methylxantine derivates such as coffein, theophyllin and theobromine.

Precautions

• Administration to nursing mother is not recommended, or stop nursing if the drug is needed.
• Safety and effectiveness in children below the age of 18 years have not been decided.
• If side effects persist at this lower dosage, the administration of Trental 400 should be discontinued.
• Periodic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy.

Adverse reactions
Gastrointestinal complaints (e.g. sensations of pressure or repletation in the epigastrium, nausea, vomitting, diarrhoea), headache or dizziness may occur which, in isolated cases, could necessitate discontinuation of the treatment.
Agitation and sleep disorders may occur in individual cases. Redness of the face or sensation of heat (flush), arrhytmia (e.g. tachycardia), angina pectoris or fall in blood
pressure have been very rarely reported, particularly under high doses of pentoxifylline. In such cases, a reduction of the daily dosage or a discontinuation of the preparation is to be considered.
Hypersensitivity reactions such as pruritus, skin reddening, urticaria or local swelling of the skin (angioneurotic oedema) are rare and usually disappear rapidly after discontinuation of the drug treatment.
In occasional instance, hypersensitivity reactions, sometimes progressing to shock, have been reported.
A few very rare events of bleeding (e.g. skin, mucosa, gastrointestinal tract) have been reported in patients treated with Trental 400 with and without anticoagulants or platelet aggregation inhibitors. A causal relationship between Trental 400 therapy and bleeding has not been established, but cannot be excluded completely A decrease in the number of platelets (thrombocytopenia) oc.cured in a few cases.
Loss of consciousness, fever, agitation and convultions, may occur in overdosage.
Interactions
The effect of antihypertensives may be potentiated in case of concurrent administration of Trental 400.
In such event, the dosage should be adjusted.

Dosage and administration
Unless otherwise prescribed, the usual dose is one film coated tablet Trental 400 two or three times daily after meals, to be swallowed whole with some liquid.
In patients with low or labile blood pressure or with pronounced renal dysfunction, individual dosage adjustment is required.

Keep medicine out of the reach of children.

Storage :
Store below 25°C.

Expiry Date
Do not use later than the date of expiry.

This package insert is continually updated: Please read carefully before using a new pack.

Presentation
10 Blisters x 10 Film Coated Tablets of 400 mg.
Reg. No. DKL0121203317A1

HARUS DENGAN RESEP DOKTER
ON MEDICAL PRESCRIPTION ONLY

Manufactured by
PT Aventis Pharma, Jakarta,
Indonesia.

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