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Trental Indications, Dosage, Storage, Stability - Pentoxifylline
INDICATIONS
TRENTAL is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. TRENTAL 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
TRENTAL in controlled-release tablet form
is one tablet (400 mg)
three times a day with meals.
While the effect of TRENTAL
may be seen within 2 to 4 weeks, it is recommended that treatment
be continued for at least 8 weeks. Efficacy has been demonstrated
in double-blind clinical
studies of 6 months duration.
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 TRENTAL should be discontinued.
HOW SUPPLIED
TRENTAL (pentoxifylline) is available for oral administration as
400 mg pink film-coated oblong
tablets imprinted TRENTAL®; supplied in bottles of 100 (NDC
0039-0078-10), Bulk Pack 5000 (NDC 0039-0078-80), and Unit Dose
Packs of 100 (NDC 0039-0078-11).
Store between 59 and 86 oF (15 and 30 oC).
Dispense in well-closed, light-resistant containers.
Protect blisters from light.
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