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Flutamide

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Overview

What is Flutamide?

Flutamide Capsules contain flutamide, an acetanilid, nonsteroidal, orally active antiandrogen having the chemical name, 2-methyl--[4-nitro-3-(tri­fluoro­methyl)phenyl] propanamide. The compound is a buff to Yellow powder and has the following structural formula:

Each capsule, for oral administration, contains 125 mg flutamide and has the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and sodium lauryl sulfate.

The ingredients in the capsule shell are black iron oxide, gelatin, red iron oxide, yellow iron oxide, and titanium dioxide.

The ingredients in the imprinting ink are D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol, and synthetic black iron oxide.



What does Flutamide look like?



What are the available doses of Flutamide?

Sorry No records found.

What should I talk to my health care provider before I take Flutamide?

Sorry No records found

How should I use Flutamide?

Flutamide capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B-C and Stage D metastatic carcinoma of the prostate.

The recommended dosage is 2 capsules 3 times a day at 8-hour intervals for a total daily dose of 750 mg.


What interacts with Flutamide?

Sorry No Records found


What are the warnings of Flutamide?

Sorry No Records found


What are the precautions of Flutamide?

Sorry No Records found


What are the side effects of Flutamide?

Sorry No records found


What should I look out for while using Flutamide?

Flutamide capsules are contraindicated in patients who are hypersensitive to flutamide or any component of this preparation.

Flutamide capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).

Hepatic Injury: See

.


What might happen if I take too much Flutamide?

In animal studies with flutamide alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia, and/or lacrimation, anorexia, tranquilization, emesis, and methemoglobinemia.

Clinical trials have been conducted with flutamide 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 flutamide ordinarily associated with symptoms of overdose or considered to be life-threatening has not been established.

Flutamide 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.


How should I store and handle Flutamide?

Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2Flutamide Capsules, USP are available as:125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “”.                     Available in bottles of:                     180 NDC-0591-2466-18Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Manufactured by:Distributed by:Revised: July 2014195814-2


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

In animal studies, flutamide demonstrates potent antiandrogenic effects. It exerts its antiandrogenic action by inhibiting androgen uptake and/or by inhibiting nuclear binding of androgen in target tissues or both. Prostatic carcinoma is known to be androgen-sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen, e.g., castration. Elevations of plasma testosterone and estradiol levels have been noted following flutamide administration.

Non-Clinical Toxicology
Flutamide capsules are contraindicated in patients who are hypersensitive to flutamide or any component of this preparation.

Flutamide capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).

Hepatic Injury: See

.

Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after flutamide was initiated. Therefore close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when flutamide capsules are administered concomitantly with warfarin.

In clinical trials, gynecomastia occurred in 9% of patients receiving flutamide together with medical castration.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).