Composition:
Each controlled release tablet contains Pentoxifylline BP 400 mg.
Mode of Action:
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.
Indications:
Oxifyl® CR tablet is indicated for the treatment of peripheral vascular disease evident as
intermittent claudication, venous leg ulcers, Oxifyl® CR tablet can improve function and
symptoms but is not intended to replace more definitive therapy, such as surgical bypass,
or removal of arterial obstructions when treating peripheral vascular disease.
Dosage and administration:
The usual dosage of Oxifyl® CR tablet is one tablet (400 mg) two to three times a day with
meals. While the effect of Oxifyl® CR 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 tablet should be
discontinued.
Contraindications:
Pentoxifylline should not be used in patients with recent cerebral and/or retinal
hemorrhage or in patients who have previously exhibited intolerance to this product or
methylxanthines such as caffeine, theophylline, and theobromine.
Precautions:
Patients on warfarin should have frequent monitoring of prothrombin times, while patients
with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration,
cerebral and/or retinal bleeding) should have periodic examinations for bleeding including,
hematocrit and/or hemoglobin.
Side-effects:
Cardiovascular – dyspnea, edema, hypotension. Digestive – anorexia, cholecystitis,
constipation, dry mouth/thirst. Nervous – anxiety, confusion, depression, seizures.
Respiratory – epistaxis, flu-like symptoms, laryngitis, nasal congestion. Skin and
Appendages – brittle fingernails, pruritus, rash, urticaria, angioedema. Special Senses –
blurred vision, conjunctivitis, earache, scotoma. Miscellaneous – bad taste, excessive
salivation, leukopenia, malaise, sore throat/swollen neck glands, weight change.
Drug interactions:
Patients on warfarin should have frequent monitoring of prothrombin times, while patients
with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration)
should have periodic examinations for bleeding including hematocrit and/or hemoglobin.
Concomitant administration of Pentoxifylline and theophylline-containing drugs leads to
increased theophylline levels and theophylline toxicity in some individuals. Such patients
should be closely monitored for signs of toxicity and have their theophylline dosage
adjusted as necessary. Pentoxifylline has been used concurrently with antihypertensive
drugs, beta blockers, digitalis, diuretics, antidiabetic agents, and antiarrhythmics, without
observed problems. Small decreases in blood pressure have been observed in some
patients treated with Pentoxifylline; periodic systemic blood pressure monitoring is
recommended for patients receiving concomitant antihypertensive therapy. If indicated,
dosage of the antihypertensive agents should be reduced.
Use in pregnancy and lactation:
Pentoxifylline should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Pentoxifylline and its metabolites are excreted in human milk. Because of the potential for
tumorigenicity shown for pentoxifylline 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.