Fluoxymesterone is a white or nearly white, odorless, crystalline powder, melting at or about 240° C, with some decomposition. It is practically insoluble in water, sparingly soluble in
alcohol, and slightly soluble in
chloroform.
The chemical name for
fluoxymesterone is androst-4-en-3-one, 9-fluoro-11,17- dihydroxy-17-methyl-, (11? ,17? )-. The molecular formula is
C20H29FO3. GP Halotest (Halotestin) Each tablet, for oral administration, contains 2 mg, 5 mg or 10 mg
fluoxymesterone. Inactive ingredients: calcium stearate, corn starch, FD&C Yellow No. 5, lactose, sorbic acid, sucrose, tragacanth. In addition, the 2 mg tablet contains FD&C Yellow No. 6 and the 5 mg and 10 mg contain FD&C Blue No. 2.
INDICATIONS: For Male - GP Halotest (Halotestin) Tablets are indicated for:
1. Replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
a. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis , vanishing testis syndrome; or orchidectomy.
b. Hypogonadotropic hypogonadism (congenital or acquired) -idiopathic gonadotropin or LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma, or radiation.
2. Delayed puberty, provided it has been definitely established as such, and is not just a familial trait.
For female - GP Halotest (Halotestin) Tablets are indicated for palliation of androgen-responsive recurrent mammary cancer in women who are more than one year but less than five years postmenopausal, or who have been proven to have a hormone-dependent tumor as shown by previous beneficial response to castration.
The dosage will vary depending upon the individual, the condition being treated, and its severity. The total daily oral dose may be administered singly or in divided (three or four) doses. Male hypogonadism: For complete replacement in the hypogonadal male, a daily dose of 5 to 20 mg will suffice in the majority of patients. It is usually preferable to begin treatment with full therapeutic doses which are later adjusted to individual requirements. Priapism is indicative of excessive dosage and is indication for temporary withdrawal of the drug. Delayed puberty: Dosage should be carefully titrated utilizing a low dose, appropriate skeletal monitoring, and by limiting the duration of therapy to four to six months.
Inoperable
carcinoma of the breast in the
female: The recommended total daily dose for palliative therapy in advanced inoperable carcinoma of the breast is 10 to 40 mg. Because of its short action,
fluoxymesterone should be administered to patients in divided, rather than single, daily doses to ensure more stable
blood levels. In general, it appears necessary to continue therapy for at least one month for a satisfactory subjective response, and for two to three months for an objective response. Allergic
Hypersensitivity, including skin manifestations and anaphylactoid reactions.
Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.
Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
DRUG INTERACTIONS
Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.
Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
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.
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
Drug Abuse And Dependence
Controlled Substance Class: Fluoxymesterone is a controlled substance under the Anabolic Steroids Control Act, and GP Halotest (Halotestin) Tablets has been assigned to Schedule III.