Flutamide

Flutamide

Flutamide Recall

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Questions & Answers

Side Effects & Adverse Reactions

Hepatic Injury

SEE WARNINGS SECTION.

Use in Women

Flutamide Capsules are for use only in men. This product has no indication for women, and should not be used in this population, particularly for nonserious or nonlife-threatening conditions.

Fetal Toxicity

Flutamide may cause fetal harm when administered to a pregnant woman (see Pregnancy).

Aniline Toxicity

One metabolite of flutamide is 4-nitro-3-fluoro-methylaniline. Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia, and cholestatic jaundice have been observed in both animals and humans after flutamide administration. In patients susceptible to aniline toxicity (e.g., persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, and smokers), monitoring of methemoglobin levels should be considered.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Flutamide 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.

Stage B2-C Prostatic Carcinoma

Treatment with Flutamide Capsules and the goserelin acetate implant should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Stage D2 Metastatic Carcinoma

To achieve benefit from treatment, Flutamide Capsules should be initiated with the LHRH- agonist and continued until progression.

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Flutamide Manufacturers


  • Genpharm
    Flutamide (Flutamide) Capsule [Genpharm]
  • Watson Laboratories, Inc.
    Flutamide Capsule [Watson Laboratories, Inc.]
  • Par Pharmaceutical Inc.
    Flutamide Capsule [Par Pharmaceutical Inc.]
  • Golden State Medical Supply, Inc.
    Flutamide Capsule [Golden State Medical Supply, Inc.]
  • Ivax Pharmaceuticals, Inc.
    Flutamide Capsule [Ivax Pharmaceuticals, Inc.]

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