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Halotestin (Fluoxymesterone) - Indications and Dosage

 
 



INDICATIONS AND USAGE

In the male —HALOTESTIN Tablets are indicated for

  1. Replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
      Primary hypogonadism (congenital or acquired) testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
    1. 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.

In the female —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.

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 fortemporary 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 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].

Rx only

810 804 708

692851

May 2002

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