Nilutamide (Page 3 of 3)

OVERDOSAGE

One case of massive overdosage has been published. A 79-year-old man attempted suicide by ingesting 13 g of nilutamide (i.e., 43 times the maximum recommended dose). Despite immediate gastric lavage and oral administration of activated charcoal, plasma nilutamide levels peaked at 6 times the normal range 2 hours after ingestion. There were no clinical signs or symptoms or changes in parameters such as transaminases or chest X-ray. Maintenance treatment (150 mg/day) was resumed 30 days later.

In repeated-dose tolerance studies, doses of 600 mg/day and 900 mg/day were administered to 9 and 4 patients, respectively. The ingestion of these doses was associated with gastrointestinal disorders, including nausea and vomiting, malaise, headache, and dizziness. In addition, a transient elevation in hepatic enzyme levels was noted in one patient.

Since nilutamide is protein bound, dialysis may not be useful as treatment for overdose. 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.

DOSAGE AND ADMINISTRATION

The recommended dosage is 300 mg once a day for 30 days, followed thereafter by 150 mg once a day. Nilutamide Tablets can be taken with or without food.

HOW SUPPLIED

Nilutamide Tablets, 150 mg, are supplied in boxes of 30 tablets. Each box contains 3 child-resistant, PVC, aluminum foil-backed blisters of 10 tablets (NDC 62559-173-31). Each round, biconvex, white to off-white tablet is debossed with “ANI” and “173” on one side and plain on the other side.

Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep out of reach of children.

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
ani-logo
9625 Rev 07/17

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Nilutamide Tablets, 150 mg
NDC 62559-173-31
Rx only
30 (3 x 10) Unit-of-Use Tablets

carton
(click image for full-size original)

NILUTAMIDE
nilutamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-173
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NILUTAMIDE (NILUTAMIDE) NILUTAMIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
POVIDONE K30
DOCUSATE SODIUM
TALC
CALCIUM STEARATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code ANI;173
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-173-31 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (62559-173-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207631 07/18/2016
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 09/2020 ANI Pharmaceuticals, Inc.

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