Metandren (Methyltestosterone)

METANDREN®

Novartis

Methyltestosterone

Oral Androgen

Indications And Clinical Uses: In the male: replacement therapy in hypogonadism, eunuchoidism, the climacteric, and other conditions due to loss, atrophy or hypofunction of the testes. In the female: palliation of androgen-responsive, advancing, inoperable breast cancer in women who are more than 1 year, but less than 5 years, postmenopausal or who have been proven to have a hormone dependent tumor, as shown by previous beneficial response to castration.

Contra-Indications: Severe liver damage, cardiac or renal decompensation, hypercalcemia, prepuberal males, pregnancy, and in male patients with suspected or proven carcinoma of the prostate or breast. Do not give to elderly, asthenic males who may react adversely to overstimulation by androgens.

Precautions: Alterations in liver function tests, such as increases in bromsulphalein retention and AST levels, and rarely jaundice, have been reported with methyltestosterone. These changes appear to be directly related to the dose of the drug. Therefore, in the presence of any changes in liver function tests, reduce dosage or discontinue the drug. Use cautiously in young boys to avoid possible premature epiphyseal closure or precocious sexual development. Since androgens can produce virilization in females, watch for hoarseness or deepening of the voice, acne, hirsutism, enlarged clitoris, stimulation of libido, and menstrual irregularities. Androgens may cause retention of sodium and water, occasionally producing edema. Therefore, use cautiously in patients with cardiac or renal disease. Hypercalcemia may occur, particularly in immobilized patients; withdraw the drug if this occurs.

Adverse Reactions: In addition to reactions listed under Precautions, hypersensitivity and gynecomastia may occur rarely. Prolonged administration or excessive dosage may cause inhibition of testicular function in the male, resulting in oligospermia and decrease in ejaculatory volume. If priapism occurs, withdraw therapy temporarily.

There have been rare reports of hepatocellular carcinoma, particularly in association with long-term therapy, in patients receiving methyltestosterone or other androgenic anabolic steroids.

Dosage And Administration: Since patients vary widely in requirements, dosage must be strictly individualized. Daily requirements are best administered in divided doses.

Metandren Dosage, Tablets In the male:, Hypogonadism Maintenance, 10 to 40 mg daily Eunuchoidism Maintenance, 10 to 40 mg daily In the female:, Carcinoma of the breast, 100 mg twice daily for 2 to 4 weeks then halved if response is evident

SuppliedSupplied: 10 mg: Each white, round, biconvex, scored tablet, fully bisected between J and L, imprinted CIBA on one side and JL on the other, contains: methyltestosterone 10 mg. Nonmedicinal ingredients: cornstarch, gelatin, lactose, magnesium stearate and talc. Energy: 3.7 kJ (0.89 kcal). Alcohol-, bisulfite-, gluten-, parabens-, sodium- and tartrazine-free. Bottles of 100.

25 mg: Each white, round, biconvex, scored tablet, fully bisected between K and M, imprinted CIBA on one side and KM on the other, contains: methyltestosterone 25 mg. Nonmedicinal ingredients: cornstarch, gelatin, lactose, magnesium stearate and talc. Energy: 3.5 kJ (0.83 kcal). Alcohol-, bisulfite-, gluten-, parabens-, sodium- and tartrazine-free. Bottles of 100.

METANDREN® Novartis Methyltestosterone Oral Androgen

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