Oxifyl CR400 mg

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.

Peripheral Vasodilator drugs: Intermittent Claudication

Oxifyl CR 400 mg 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 Oxifyl CR 400 mg and the sequence of events leading to clinical improvement are still to be defined. Oxifyl CR 400 mg 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. Oxifyl CR 400 mg 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 Oxifyl CR 400 mg in patients with peripheral arterial disease.

The usual dosage of Oxifyl CR 400 mg tablet is one tablet (400 mg) two to three times a day with meals. While the effect of Oxifyl CR 400 mg tablet may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Oxifyl CR 400 mg tablet should be discontinued.

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 Oxifyl CR 400 mg 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).

Precautions for use: The blood-sugar-lowering effect of insulin or oral antidiabetics may be potentiated. Therefore it is recommended that patients under medication for diabetes mellitus be carefully monitored. Post-marketing cases of increased anti-coagulant activity have been reported in patients concomitantly treated with Oxifyl CR 400 mg and anti-vitamin K. Monitoring of anti-coagulant activity in these patients is recommended when Oxifyl CR 400 mg is introduced or the dose is changed. Take into account: The blood-pressure-lowering efect of antihypertensive agents and other drugs with blood-pressure-lowering potential may be increased by Oxifyl CR 400 mg. Concomitant administration of Oxifyl CR 400 mg and theophylline may increase theophylline levels in some patients. Therefore, there may be an increase in and intensifcation of adverse reactions from theophylline. Concomitant administration with ciprofoxacin may increase the serum concentration of Oxifyl CR 400 mg in some patients. Therefore, there may be an increase in and intensifcation of adverse reactions associated with co-administration. Potential additive efect with platelet aggregation inhibitors: Because of the increased risk of bleeding, the concomitant administration of a platelet aggregation inhibitor (such as clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs other than selective COX-2 inhibitors, acetylsalicylates [ASA/LAS], ticlopidine, dipyridamole) with Oxifyl CR 400 mg should be undertaken with caution. Concomitant administration with cimetidine may increase the plasma concentration of Oxifyl CR 400 mg and the active Metabolite.

Oxifyl CR 400 mg must not be used: in patients with hypersensitivity to Oxifyl CR 400 mg, other methylxanthines or any of the excipients of Oxifyl CR 400 mg. in patients with massive bleeding (risk of increased bleeding). in patients with extensive retinal bleeding (risk of increased bleeding).

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)

Oxifyl CR 400 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oxifyl CR 400 mg and its metabolites are excreted in human milk. Because of the potential for tumorigenicity shown for Oxifyl CR 400 mg in rats, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

At the first signs of an anaphylactic/anaphylactoid reaction, Oxifyl CR 400 mg 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 Oxifyl CR 400 mg and anti-vitamin K or platelet aggregation inhibitors in patients treated concomitantly with Oxifyl CR 400 mg and antidiabetic agents in patients treated concomitantly with Oxifyl CR 400 mg and ciprofoxacin in patients treated concomitantly with Oxifyl CR 400 mg and theophylline

Initial symptoms of acute overdose with Oxifyl CR 400 mg may be nausea, dizziness, tachycardia or a fall in blood pressure. Furthermore, signs such as fever, agitation, flush, loss of consciousness, areflexia, tonic -clonic convulsions and as a sign of gastrointestinal bleeding - coffee-ground vomiting may occur. No specific antidote is known. If ingestion has only just taken place, attempts may be made to prevent further systemic absorption of the active ingredient by primary elimination of the toxin (e.g. gastric lavage) or by delaying its absorption (e.g. activated charcoal).

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.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Peripheral Vasodilator drugs: Intermittent Claudication

Oxifyl CR 400 mg 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 Oxifyl CR 400 mg and the sequence of events leading to clinical improvement are still to be defined. Oxifyl CR 400 mg 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. Oxifyl CR 400 mg 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 Oxifyl CR 400 mg in patients with peripheral arterial disease.

Insufficient experience has been gained concerning use in pregnancy. Therefore, it is recommended that Oxifyl CR 400 mg is not used during pregnancy. Oxifyl CR 400 mg 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 Oxifyl CR 400 mg in breast-feeding women.

Hepatic impairment: A dose reduction- guided by individual tolerance- is necessary in patients with severely impaired liver function.Renal impairment: In patients with impairment of renal function (creatinine clearance below 30 mL/min) a dose reduction by approx. 30% to 50% may be necessary guided by individual tolerance. Other: Treatment must 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.