INDICATIONS

Peripheral occlusive arterial disease, 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.

CONTRAINDICATION

Hypersensitivity to pentoxyfilline, cerebral or extensive retinal haemorrhage, or acute myocardial infarction, patients intolerance to methylxantine derivatives such as coffein, theophyllin and theobromine.

PRECAUTIONS

Trental should not be used during pregnancy. 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 mg film-coated tablet should be discontinued. Periodic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy. At the first signs of an anaphylactic/anaphylactoid reaction, must be discontinued or the infusion be halted immediately, and a physician must be informed. The blood-sugar-lowering effect of insulin or oral antidiabetics may be potentiated. Monitoring of anti-coagulant activity is recommended when pentoxifylline is introduced or the dose is changed.

ADVERSE REACTIONS

Transaminases increased, Blood pressure decreased, Arrhythmia, Angina Pectoris, hrombocytopenia, Leucopenia/neutropenia, Dizziness, headache, meningitis aseptic, Gastrointestinal disorder, Abdominal distension, Nausea, Constipation, Hypersalivation, Pruritus, Rash, Haemorrhage, Anaphylactic shock, Cholestasis, Sleep disorder, etc.

INTERACTIONS

The effect of antihypertensives may be potentiated in case of concurrent administration of Trental 400 mg film-coated tablet. Concomitant administration with ciprofloxacin may increase the serum concentration of pentoxifylline in some patients. Meanwhile, with cimetidine may increase the plasma concentration of pentoxifylline and the active Metabolite I.

DOSAGE AND ADMINISTRATION

The usual dose is one film coated tablet Trental 400 mg film-coated tablet 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.

PHARMACODYNAMIC PROPERTIES

Trental tablet improves altered blood flow properties by its influence on phatologically impaired red cell deformability, by inhibiting platelet aggregation and by reducing increased blood viscosity.

Presentation :

10 Blisters x 10 Film Coated Tablets of 400 mg

Reg. No. DKL0121203317A1

Manufactured by:

PT Aventis Pharma

Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210

More detailed Information on request:

PT Aventis Pharma

Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210

(021) 4892208 - 4895608

Date of revision: 30-Dec-2021 (based on BPOM approval 14-Agt-2018) CCDSv 05, 06 & 07.

This information is intended for Health Care Professional only. See local product information for full details information.

Trental Tablet 400mg