Halotestin

>10%

Edema

Acne

Breast soreness

Priapism

Menstrual irregularities

Virilization

Frequency Not Defined

Gynecomastia

Suppression of clotting factors II, V, VII

Anaphylaxsis

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

While using fluoxymesterone, you may need frequent blood tests.

Store at room temperature away from moisture, heat, and light.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

The structural formula is represented below:

Each HALOTESTIN (fluoxymesterone) 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.

In the male—HALOTESTIN (fluoxymesterone) Tablets are indicated for:

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

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].

Distributed by Pharmacia and Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised May 2002. FDA Rev date: 4/6/1992

Hypercalcemia may occur in immobilized patients and in patients with breast cancer. If this occurs, the drug should be discontinued.

Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis—all potentially life-threatening complications.

Cholestatic hepatitis and jaundice may occur with 17-α-alkyl-androgens. Should this occur, the drug should be discontinued. This is reversible with discontinuation of the drug.

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.

Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.

Androgen therapy should be used cautiously in males with delayed puberty. Androgens can accelerate bone maturation without producing compensatory gain in linear growth. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months.

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

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

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.

Applies to fluoxymesterone: oral tablets

Side effects include:

Males: Gynecomastia, frequent or persistent penile erections.

Females: Amenorrhea, other menstrual irregularities, inhibition of gonadotropin secretion, virilization (e.g., deepening of the voice, clitoral enlargement).