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Halotestin® 100 Tablets 10 mg


Fluoxymesterone, USP29 Micronized grade

Molecular Formula: C2oH29F03 (CAS-76-43-7, ATC-G03BA01)

MolecularWeight: 336.4457 gm/mol Active life: 6-8 hours DetectionTime:2 months Anabolic/Androgenic Ratio: 1,900:850


Halotestin®, brand of Fluoxymesterone tablets, is an anabolic steroid, a synthetic derivative of testosterone. Each tablet contains 10 mg of Fluoxymesterone USP29, micronized grade. It is designated chemically as 9a-Fluoro-11 (3,17(3-dihydroxy- 17a-methylandrost-4-en-3-one.

It occurs as white or practically white, odourless, crystalline powder. Practically insoluble in water; sparingly soluble in alcohol; slightly soluble in chloroform.

Each tablet also contains lactose monohydrate, sodium starch glycolate, polyvidone 25,000, microcrystalline cellulose and magnesium stearate as excipients and also contains yellow ferric oxide (EI72) and indigo carmine aluminium lake (EI32) as colouring agent.


Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorus, and decreased urinary excretion of calcium.

Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein. Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.

During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH). Inactivation of testosterone occurs primarily in the liver.

The half-life of Fluoxymesterone after oral administration is approximately 9.2 hours.


In the male—Halotestin® 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, 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® 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.


Controlled Substance Class: Fluoxymesterone is a controlled substance under the Anabolic Steroids Control Act, and Halotestin® has been assigned to Schedule III.


1.   Known hypersensitivity to the drug.

2.   Males with carcinoma ofthe breast.

3.   Males with known or suspected carcinoma ofthe prostate gland.

4.   Women known or suspected to be pregnant.

5.   Patients with serious cardiac, hepatic or renal disease.

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