APO-PENTOXIFYLLINE SR

In general, dose selection for a geriatric patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

2 CONTRAINDICATIONS APO-PENTOXIFYLLINE SR (pentoxifylline) is contraindicated in patients: • who are hypersensitive to pentoxifylline or other xanthines such as caffeine, theophylline and theobromine, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see

1 Adverse Reaction Overview The adverse events in the sections below were identified during clinical trials or post market use. The most frequent adverse effect reported with pentoxifylline is nausea (14%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The clinical trial adverse events below are considered common and occurred at a frequency of greater than 1%.

Individual signs/symptoms marked with an asterisk occurred at an incidence between 1% and 3%. 4%), abdominal discomfort*, bloating*, diarrhea*, dyspepsia*. 9%).

Vascular disorders:

Flushing*. 3 Less Common Clinical Trial Adverse Reactions The less common clinical trial adverse events listed below occurred at an incidence below 1%; for some adverse events (with the + symbol), the causal relationship was uncertain.

Blood and lymphatic system disorders:

Leukopenia+.

Cardiac disorders:

Chest pain, dyspnea+, edema+.

Ear and labyrinth disorders:

Earache+.

Eye disorders:

Blurred vision+, scotoma+, lacrimation, conjunctivitis+.

Gastrointestinal disorders:

Abdominal burning, abdominal pain, flatus, constipation+, heartburn, salivation+, dry mouth/thirst+, bad taste in mouth+.

Cardiovascular Arrhythmias Patients with severe cardiac arrhythmias should be closely monitored during pentoxifylline therapy. Arterial Disease of the Limbs Patients with chronic occlusive arterial disease of the limbs frequently show other manifestations of arteriosclerotic disease.

Pentoxifylline has been used safely for treatment of peripheral arterial disease in patients with concurrent coronary artery and cerebrovascular diseases, but there have been occasional reports of angina, hypotension, and arrhythmia.

Controlled trials do not show that pentoxifylline causes such adverse effects more often than placebo, but, as it is a methylxanthine derivative, it is possible some individuals will experience such responses. Low, Labile Blood Pressure Caution should be exercised when administering APO-PENTOXIFYLLINE SR (pentoxifylline) to patients with low or labile blood pressure.

In such patients any dose increase should be done gradually and careful monitoring is required. Hematologic Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 400 mg Carnauba wax, colloidal silicon dioxide, FD&C red #3, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, and titanium dioxide.

, recent surgery, peptic ulceration, cerebral and/or retinal bleeding) should have periodic examinations for bleeding including, hematocrit and/or hemoglobin. Hepatic/Biliary/Pancreatic Since pentoxifylline is extensively metabolized in the liver, the use of this drug is not recommended in patients with marked impairment of liver function.

Patients with less severe impairment of liver function should be closely monitored during pentoxifylline therapy and they may require lower doses. Immune At the first sign of anaphylactic/anaphylactoid reaction, APO-PENTOXIFYLLINE SR (pentoxifylline) must be discontinued.

Renal Since pentoxifylline is eliminated through the kidneys, the use of this drug is not recommended in patients with marked impairment of kidney function. Patients with less severe impairment of kidney function should be closely monitored during pentoxifylline therapy and they may require lower doses.

APO-PENTOXIFYLLINE SR (pentoxifylline) is contraindicated in patients: • who are hypersensitive to pentoxifylline or other xanthines such as caffeine, theophylline and theobromine, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • with acute myocardial infarction, • with severe coronary artery disease when, in the physician's judgment, myocardial stimulation might prove harmful, • with recent cerebral and/or retinal hemorrhage, • with peptic ulcers or recent history thereof.