Indications

This is indicated in- Peripheral arterial occlusive disease (PAOD) of arteriosclerotic or diabetic origin (e.g. with intermittent claudication and rest pain) Trophic lesions (e.g. leg ulcers and gangrene) Cerebral vascular diseases Circulatory disturbances of the eye in conjunction with degenerative vascular disorders.

Composition

Pharmacology

Pentoxifylline and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of pentoxifylline and the sequence of events leading to clinical improvement are still to be defined. Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation. Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of pentoxifylline in patients with peripheral arterial disease.

Dosage & Administration

In principle, dosage is based on the type and severity of the circulatory disorders and on how the individual patient tolerates the drug. Usual dosage is 400 mg pentoxifylline 2 to 3 times daily. Tablets are to be swallowed whole during or shortly after a meal with sufficient amounts of liquid (approx. ½ glass).

Contraindications

Pentoxifylline must not be used: in patients with hypersensitivity to pentoxifylline, other methylxanthines or any of the excipients of Pentoxifylline. in patients with massive bleeding (risk of increased bleeding). in patients with extensive retinal bleeding (risk of increased bleeding).

Side Effects

These adverse reactions have been reported in clinical trials or post-marketing- Investigations: Transaminases increased (Transaminase elevation), Blood pressure decreased (Fall in blood pressure) Cardiac disorders: Arrhythmia (Cardiac arrhythmia), Tachycardia, Angina Pectoris Blood and lymphatic system disorders: Thrombocytopenia (Thrombopenia), Leucopenia/neutropenia Nervous system disorders: Dizziness, headache, meningitis aseptic (Aseptic meningitis) Gastrointestinal disorders: Gastrointestinal disorder (Gastrointestinal complaints), Epigastric discomfort (Gastric pressure), Abdominal distension (Fullness), Nausea, Vomiting, Diarrhoea, Constipation, Hypersalivation Skin and subcutaneous tissue disorders: Pruritus, Erythema (Reddening of the skin), Urticaria, Rash Vascular disorders: Hot fush (Flushes), Haemorrhage (Bleedings) Immune system disorders: Anaphylactic reaction, Anaphylactoid reaction, Angioedema (Angioneurotic edema), Bronchospasm, Anaphylactic shock (shock) Hepatobiliary disorders: Cholestasis (Intrahepatic cholestasis) Psychiatric disorders: Agitation, Sleep disorder (Sleep disturbances)

Pregnancy & Lactation

Insufficient experience has been gained concerning use in pregnancy. Therefore, it is recommended that Pentoxifylline is not used during pregnancy. Pentoxifylline passes into breast milk in minute quantities. Because insufficient experience has been gained, the physician must carefully weigh the possible risks and benefits before administering Pentoxifylline in breast-feeding women.

Precautions & Warnings

At the first signs of an anaphylactic/anaphylactoid reaction, Pentoxifylline must be discontinued or the infusion be halted immediately, and a physician must be informed. Particularly careful monitoring is required: in patients with severe cardiac arrhythmias in patients with myocardial infarction in hypotensive patients in patients with impaired renal function (creatinine clearance below 30 ml/min) in patients with severely impaired liver function in patients with increased bleeding in patients treated concomitantly with pentoxifylline and anti-vitamin K or platelet aggregation inhibitors in patients treated concomitantly with pentoxifylline and antidiabetic agents in patients treated concomitantly with pentoxifylline and ciprofoxacin in patients treated concomitantly with pentoxifylline and theophylline

Therapeutic Class

Peripheral Vasodilator drugs: Intermittent Claudication

Storage Conditions

Keep in a cool and dry place, away from light. Do not use later than date of expiry. Keep all medicine out of the reach of children. To be dispensed only on the prescription of a registered physician.