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.

CONTRAINDICATIONS

Hypersensitivity to pentoxyfilline, cerebral or extensive retinal haemorrhage, or recent myocardial infarction, patients intolerance to methylxantine derivatives such as coffein, theophyllin and theobromine. Meanwhile, patient with Severe coronary and cerebral sclerosis with hypertension, and severe cardiac arrhythmias are relative contraindications for a parenteral treatment

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 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, Thrombocytopenia, 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. High-dose parentral administration of Trental to diabetic patients, stabilized on insulin or oral hypoglycaemic agents, may intensify the hypoglycaemic action of these preparations. Concomitant administration with ciprofloxacin may increase the serum concentration of pentoxifylline in some patients.

DOSAGE

Intravenous infusion therapy is the most effective and best tolerated form of parenteral administration. However, trental can also be injected via the intravenous route. The 24-hour dose of Trental for parenteral administration should not exceed 1200 mg pentoxifylline, and the individual dose may be based on the formula: 0.6 mg pentoxifylline/kg bodyweight/hour. The infusion volume should be established on the basis of underlying diseases and generally will be between 1000 and 1500 ml/24 hours. The intravenous injection of one ampoule of 5 ml must be given slowly over a 5-minute period with the patient lying down.

Trental 400 mg film-coated tablet can be prescribed to supplement parenteral treatment. After the onset of improvement, treatment may be continued with oral medication alone. Dosage adjustment is necessary in patients with impaired renal function.

PHARMACODYNAMIC PROPERTIES

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

PRESENTATION:

Box contains 5 ampoules@ 15 ml netto

Reg. No. DKl0159200349A1

Manufactured by:

Sanofi-Aventis Deutschland GmbH,

Frankfurt ( Main) - Germany

More detailed Information on request:

PT Aventis Pharma

Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210

(021) 4892208 - 4895608

Date of revision: 17-Mar-2022 (based on BPOM approval 08-Agt-2018) CCDSv 05, 06 & 07.

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

Trental 20mg/mL