Halotest 10

COMPOSITION:

Each tablet ccntains: Fluoxymesterone 10 mg
Excipients.......q.s.

DESCRIPTION:

Fluoxymesterone is a man-made form of testosterone, a naturally occurring sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system. Fluoxymesterone is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty or other hormonal imbalances. Fluoxymesterone is also used in women to treat breast cancer that has spread to other parts of the body. Fluoxymesterone treats only the symptoms of metastatic breast cancer but does not treat the cancer itself. Fluoxymesterone may also be used for purposes not listed in this medication guide.

CLINICAL PHARMACOLOGY

Endogenous androgens such as testosterone are responsible for the development and growth of the male sexual organs and post-adolescent secondary sex characteristics. Androgen effects include but are not limited to the maturation of the penis, scrotum, prostate, seminal tubules, laryngeal enlargement, vocal ccrd thickening, changes in muscle mass and fat distribution, and the development and distribution of male hair (facial, pubic, chest, back, axillary). Androgens are responsible for the growth spurt of adolescence and the aromatization of androgens to estrogens for the eventual termination of linear growth, which is brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates but may cause a 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 the production of red blood cells by enhancing the production of erythropoietin stimulating factor. Androgens may suppress gonadotrophic function of the pituitary. During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). With large doses, spennatogenesis may be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).

DRUG INTERACTIONS:

Anti-diabetic drugs and Insulin: In diabetic patients, the metabolic effects of androgens may reduce blood glucose, insulin, and anti-diabetic medication requirements. Adrenal steroids or ACTH: May exacerbate edema in patients on concurrent adrenal-cortical steroids or ACTH therapy. Anticoagulants: Patients on anticoagulants such as warfarin should be carefully monitored during androgen therapy as androgens may increase sensitivity to oral anticoagulants which may require a concomitant reduction in anticoagulant dosage to achieve a desirable prothrombin time (PT). Concurrent use of anti-diabetic agents, insulin, cyclosporines, hepatotoxic medications, and/or human growth hormone (somatropin) has been reported to decrease anticoagulant requirements. Anticoagulant patients should be monitored regularly during androgen therapy, particularly during initiation and termination of therapy.

CONTRAINDICATIONS :

Not intended for use in children. Known or suspected prostatic carcinoma and mammary carcinoma in the male. Not intended foruse in female patients other than those with disseminated breast cancer. Contraindicated in nephrosis or the nephrotic phase of nephritis, cardiac and renal failure,hypercalcaemia, oedema, jaundice, liver disease with impaired bilirubin excretion, testicular and hepatic carcinoma.

WARNINGS:

This product can be used only by healthy adults over 18 years old. Carefully read directions before using this product. Consult your physician before using this product if you are taking any prescription or over the ccunter drugs or supplements. KEEP AWAY FROM CHILDREN.

SIDE EFFECTS:

Males: Frequent or persistent penile erections and increases in the appearance of acne vulgaris. Females: Hoarseness of the voice, acne, changes in menstrual periods, or more facial hair.

DOSAGE AND ADMINISTRATION:

Adult male: Daily dosage of 10 mg to 20 mg in 2 to 4 divided doses may be required to achieve the desired response.

STORAGE:

Do not refrigerate or freeze. Do not store above 30 C. Protect from direct sunlight.

PACKAGE :

60 Tablets USP