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Halotestin (Fluoxymesterone) - Drug Interactions, Contraindications, Overdosage

 


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DRUG INTERACTIONS

Drug/Laboratory test interferences

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis, mutagenesis, impairment Of Fertility

Animal data: Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically-induced carcinomas of the liver in rats.

Human data: There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

This compound has not been tested for mutagenic potential. However, as noted above, carcinogenic effects have been attributed to treatment with androgenic hormones. The potential carcinogenic effects likely occur through a hormonal mechanism rather than by a direct chemical interaction mechanism.

Impairment of fertility was not tested directly in animal species. However, as noted below under Adverse Reactions, oligospermia in males and amenorrhea in females are potential adverse effects of treatment with HALOTESTIN Tablets. Therefore, impairment of fertility is a possible outcome of treatment with HALOTESTIN.

Pregnancy

Teratogenic effects

Pregnancy Category X. (See CONTRAINDICATIONS.)

OVERDOSAGE

There have been no reports of acute overdosage with the androgens.

CONTRAINDICATIONS

  1. Known hypersensitivity to the drug
  2. Males with carcinoma of the breast
  3. Males with known or suspected carcinoma of the prostate gland
  4. Women known or suspected to be pregnant
  5. Patients with serious cardiac, hepatic or renal disease
Page last updated: 2006-02-06

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