INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TRENTAL 400 tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

TRENTAL 400 tablets

COMPOSITION
Per sustained-release tablet:
Pentoxifylline         400 mg

PHARMACOLOGICAL CLASSIFICATION
A 8 Medicines acting on the blood and haemopoietic system.

PHARMACOLOGICAL ACTION
TRENTAL 400 improves altered blood flow properties.
An influence on pathologically impaired red cell deformability and inhibition of platelet aggregation, has been demonstrated in vitro.
A reduction in blood viscosity has only been demonstrated two hours after an intravenous administration of pentoxifylline. TRENTAL 400 continuously releases the active substance over a period of 8 to 12 hours.

INDICATIONS
Peripheral occlusive arterial diseases with or without trophic disorders and lower leg ulcers.

CONTRA-INDICATIONS
TRENTAL 400 must not be used
- in patients with known hypersensitivity to the active constituent pentoxifylline or other methyl xanthines.
- in the presence of massive haemorrhage (including cerebral haemorrhage) or in acute myocardial infarction.
- in patients with extensive retinal bleeding (risk of increased bleeding).
- in patients with porphyria.
Pregnancy and lactation:
The safety in pregnancy and lactation has not been established.

WARNINGS
Particularly careful monitoring is required in:
- patients with severe cardiac arrhythmias.
- patients with myocardial infarction.
- hypotensive patients.
- patients with ischemic heart disease.
- patients with impaired renal function (creatinine clearance below 30 mL/min).
- patients with severe impaired liver function.
- patients with increased bleeding tendency due to e.g. anticoagulant medication or coagulation disorders.

DOSAGE AND DIRECTIONS FOR USE
Unless otherwise prescribed by a physician, the average dose is one TRENTAL 400 tablet taken two to three times daily after meals, swallowed whole with sufficient amounts of liquid (approximately half a glass).
In patients with impairment of renal function (creatinine clearance below 30 mL/min) a dose reduction of approximately 30% to 50% may be necessary.
A dose reduction is necessary in patients with severely impaired liver function.
Treatment should be started at low-dose levels in hypotensive patients or patients whose circulation is unstable as well as in patients, who would be at particular risk from a reduction in blood pressure (e.g. patients with severe coronary heart disease or relevant stenoses of blood vessels supplying the brain); in such cases, the dose must only be increased gradually.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Frequent side-effects of TRENTAL 400 include flushes, gastrointestinal complaints such as gastric pressure, fullness, nausea, vomiting or diarrhoea and, less frequently; cardiac arrhythmias (e.g. tachycardia), palpitations, dizziness, headaches, agitation, sleep disturbances, intrahepatic cholestasis, transaminase elevation and thrombopenia.
Side-effects rarely occurring are angina pectoris fall in blood pressure and especially in patients with increased bleeding tendency - haemorrhage (e.g. on the skin and/or mucosae, in stomach and/or intestine).
Additionally, pruritus, reddening of the skin and urticaria may less frequently develop, as may, severe anaphylactic/anaphylactoid reactions with e.g. angioneurotic oedema, bronchospasm, and sometimes even shock.
At the first signs of an anaphylactic/anaphylactoid reaction, Trental 400 must be discontinued, and a physician must be informed.
Interactions:
The blood-pressure-lowering effect of antihypertensive agents and other medicines with blood-pressure-lowering potential may be increased by TRENTAL 400.
The blood-sugar-lowering effect of insulin or oral antidiabetics may be potentiated. Therefore it is recommended that patients on medication for diabetes mellitus be carefully monitored.
Concomitant administration of pentoxifylline and theophylline may increase theophylline levels in some patients.
Therefore, there may be an increase in and intensification of adverse effects from theophylline.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Initial symptoms of acute overdose with pentoxifylline may be nausea, dizziness, tachycardia or fall in blood pressure. Furthermore, signs such as fever, agitation, flushing, loss of consciousness, areflexia, tonic-clonic convulsions and - as a sign of gastrointestinal bleeding - coffee-ground vomiting may occur.
No specific antidote is known. In addition to general measures for the management of poisoning, blood pressure should be closely monitored. A drip infusion of a plasma-expander should be applied if there is a severe drop in blood pressure.
An adequate airway must be maintained.
Convulsions can be controlled with diazepam.

IDENTIFICATION
Pink-violet oblong sugar coated tablets.

PRESENTATION
30 and 100 tablets in securitainers.

STORAGE INSTRUCTIONS
Store below 25°C.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER
M/8/512

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Aventis Pharma (Pty) Ltd
2 Bond Street, Midrand, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
19 October 1982

Aventis Pharma (Pty) Ltd
2 Bond Street
Midrand
1685

                TL2-B0202
                Pro-Print

Updated on this site: October 2004
Source: Community Pharmacy

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