Halotestin

What is Halotestin and how is it used?

Halotestin is a prescription medicine used to treat the symptoms of Hyopgonadism in Males and Metastatic Breast Cancer in Females. Halotestin may be used alone or with other medications.

Halotestin belongs to a class of drugs called Anabolic Steroids.

What are possible side effects of Halotestin?

Side effects of Halotestin include:

• mood changes,
• anxiety,
• depression,
• aggression,
• trouble sleeping,
• snoring,
• decreased exercise ability,
• swelling of the hands, ankles, or feet,
• unusual tiredness,
• yellowing of the eyes or skin (jaundice),
• dark urine,
• rash,
• itching,
• swelling of the face, tongue, or throat,
• severe dizziness, and
• trouble breathing

Specifically, in men:

• trouble urinating,
• breast swelling or tenderness,
• too frequent or prolonged erections, and
• an erection that is painful or last 4 or more hours

Specifically, in women:

• deepening of the voice,
• hoarseness,
• unusual facial or body hair growth,
• enlarged clitoris, and
• irregular menstrual periods

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Halotestin include:

• nausea,
• vomiting,
• headache,
• skin color changes,
• increased or decreased sexual interest,
• oily skin,
• hair loss, and
• acne

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Halotestin. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

HALOTESTIN Tablets contain fluoxymesterone, an androgenic hormone.

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-, (11β,17β)-. The molecular formula is C₂₀H₂₉FO₃ and the molecular weight 336.45.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

HALOTESTIN (fluoxymesterone) Tablets, round and scored, are available in the following strengths and colors:

2 mg (peach)

Bottles of 100 NDC 0009-0014-01

5 mg (light green)

Bottles of 100 NDC 0009-0019-06

10 mg (green)

Bottles of 30 NDC 0009-0036-03
Bottles of 100 NDC 0009-0036-04

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

SIDE EFFECTS

Endocrine and urogenital

Female: the most common side effects of androgen therapy are amenorrhea and other menstrual irregularities; inhibition of gonadotropin secretion; and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens can cause virilization of external genitalia of the female fetus.

Male: Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosage.

Skin and appendages

Hirsutism, male pattern of baldness, seborrhea, and acne.

Fluid and electrolyte disturbances

Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal

Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (See WARNINGS).

Hematologic

Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Nervous system

Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Allergic

Hypersensitivity, including skin manifestations and anaphylactoid reactions.

Drug Abuse And Dependence

Controlled Substance Class: Fluoxymesterone is a controlled substance under the Anabolic Steroids Control Act, and HALOTESTIN (fluoxymesterone) Tablets has been assigned to Schedule III.

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.