Flutamide (2 brand names, 1 dosage form, 1 route)
Available dosage forms: CAPSULE.
Routes of administration: ORAL.
Brand Names
- EULEXIN
- FLUTAMIDE
Indications and Usage
Eulexin® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.
Dosage and Administration
The recommended dosage is 2 capsules 3 times a day at 8 hour intervals for a total daily dose of 750 mg.
Contraindications
Eulexin® capsules are contraindicated in patients who are hypersensitive to Eulexin® or any component of this preparation. Eulexin® capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).
Drug Interactions
Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after Eulexin® was initiated. Therefore close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when Eulexin® capsules are administered concomitantly with warfarin.
Overdosage
In animal studies with Eulexin ® alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia, and/or lacrimation, anorexia, tranquilization, emesis, and methemoglobinemia. Clinical trials have been conducted with Eulexin ® in doses up to 1500 mg per day for periods up to 36 weeks with no serious adverse effects reported. Those adverse reactions reported included gynecomastia, breast tenderness, and some increases in SGOT. The single dose of Eulexin ® ordinarily associated with symptoms of overdose or considered to be life-threatening has not been established. Eulexin ® is highly protein bound, and is not cleared by hemodialysis. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting does not occur spontaneously, it should be induced if the patient is alert. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.