Methyltestosterone
Generic Name: methyltestosterone
Brand Names:
Methitest
DESCRIPTION METHITEST™ (methyltestosterone) tablets, USP contain methyltestosterone USP, a synthetic androgen. Androgens are steroids that develop and maintain primary and secondary male sex characteristics. METHITEST™ (methyltestosterone) tablets, USP are to be taken orally. Androgens are derivatives of cyclopentanoperhydrophenanthrena. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen.
Overview
DESCRIPTION METHITEST™ (methyltestosterone) tablets, USP contain methyltestosterone USP, a synthetic androgen. Androgens are steroids that develop and maintain primary and secondary male sex characteristics. METHITEST™ (methyltestosterone) tablets, USP are to be taken orally. Androgens are derivatives of cyclopentanoperhydrophenanthrena. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen.
Uses
INDICATIONS AND USAGE 1. Males Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) — Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Dosage
DOSAGE AND ADMINISTRATION Prior to initiating METHITEST™ (methyltestosterone) tablets, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Dosage must be strictly individualized. The suggested dosage for androgens varies depending on the age, sex, and diagnosis of the individual patient. Adjustments and duration of dosage will depend upon the patient’s response and the appearance of adverse reactions. Males: In the androgen-deficient male the guideline for replacement therapy indicates the usual initial dosage of 10 mg to 50 mg daily.
Side Effects
ADVERSE REACTIONS 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 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 (see CLINICAL PHARMACOLOGY ). Skin and Appendages: Hirsutism, male pattern of baldness, and acne.
Warnings
WARNINGS In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued. Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see PRECAUTIONS: CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY ). Peliosis hepatis can be a life-threatening or fatal complication. Cholestatic hepatitis and jaundice occur with 17-alpha-alkylandrogens (such as methyltestosterone) at a relatively low dose. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined. CONTRAINDICATIONS METHITEST™ (methyltestosterone) tablets are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate, and in women who are or may become pregnant. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus.
Storage
HOW SUPPLIED METHITEST™ (methyltestosterone) Tablets USP, 10 mg : Each compressed, single-scored, round, white tablet contains 10 mg of methyltestosterone USP, for oral use. Each tablet is debossed with “7037” on one side, and scored on the other side.
Frequently Asked Questions
What is Methyltestosterone used for?▼
INDICATIONS AND USAGE 1. Males Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) — Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
What are the side effects of Methyltestosterone?▼
ADVERSE REACTIONS 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 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 (see CLINICAL PHARMACOLOGY ). Skin and Appendages: Hirsutism, male pattern of baldness, and acne.
What are the important warnings for Methyltestosterone?▼
WARNINGS In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued. Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see PRECAUTIONS: CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY ). Peliosis hepatis can be a life-threatening or fatal complication. Cholestatic hepatitis and jaundice occur with 17-alpha-alkylandrogens (such as methyltestosterone) at a relatively low dose. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined. CONTRAINDICATIONS METHITEST™ (methyltestosterone) tablets are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate, and in women who are or may become pregnant. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.