Usual Adult Dose for Hypogonadism - Male

10 to 50 mg orally once a day

• Adjust dose based on patient's response and appearance of adverse reactions

Comments:

• Prior to initiating, confirm hypogonadism diagnosis by ensuring serum testosterone concentrations have been measured in the morning on at least 2 separate days and these serum testosterone concentrations are below the normal range.
• Safety and efficacy in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.

Uses: For replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone such as congenital or acquired primary hypogonadism or congenital or acquired hypogonadotropic hypogonadism.

Usual Adult Dose for Breast Cancer-Palliative

50 to 200 mg orally once a day

Comments:

• Use of androgen therapy in women should be made by an oncologist with expertise in this field; androgen therapy occasionally appears to accelerate disease.
• Some premenopausal women with hormone-responsive therapy have benefited from androgen therapy.

Use: Adjunctive therapy in women with advancing inoperable breast cancer who are 1 to 5 years postmenopausal.

Usual Pediatric Dose for Delayed Puberty - Male

10 to 50 mg orally once a day

Delayed Puberty:

• Dosing generally starts at the lower end of the dosing range
• Titrate according to patient response and tolerance
• Duration of therapy should be limited to 4 to 6 months

Comments:

• If androgen deficiency occurs prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics; prolonged androgen treatment will be required to maintain sexual characteristics.
• Dosing should be adjusted based on patient's response and appearance of adverse reactions.

Uses:

• For replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone such as congenital or acquired primary hypogonadism or congenital or acquired hypogonadotropic hypogonadism.
• Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty

Usual Pediatric Dose for Hypogonadism - Male

10 to 50 mg orally once a day

Delayed Puberty:

• Dosing generally starts at the lower end of the dosing range
• Titrate according to patient response and tolerance
• Duration of therapy should be limited to 4 to 6 months

Comments:

• If androgen deficiency occurs prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics; prolonged androgen treatment will be required to maintain sexual characteristics.
• Dosing should be adjusted based on patient's response and appearance of adverse reactions.

Uses:

• For replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone such as congenital or acquired primary hypogonadism or congenital or acquired hypogonadotropic hypogonadism.
• Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

Precautions

CONTRAINDICATIONS:

• Men with carcinomas of the breast or with known or suspected carcinomas of the prostate
• Women who are or may become pregnant

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule III

Dialysis

Data not available

Other Comments

Administration advice:

• Administer orally

Storage requirements:

• Protect from light and moisture

General:

• Androgen therapy should be used very cautiously in children and only by specialists aware of the effects on bone maturation.

Monitoring:

• Periodic liver function tests should be performed
• Prepubertal males should have X-ray examinations of bone age every 6 months
• Periodically evaluate hemoglobin and hematocrit for polycythemia, especially with high doses
• Women should have frequent determinations of urine and serum calcium levels

Patient advice:

• Female patients should be instructed to report signs of virilization such as deepening voice, hirsutism, acne, clitoromegaly, and/or menstrual irregularities.
• Male patients should be instructed to report too frequent or persistent penile erections.
• All patients should be instructed to report signs and symptoms of jaundice or edema.
• Patients should understand this drug has been associated with venous thromboembolic events; they should be instructed to contact their healthcare provider promptly if signs or symptoms of DVT or PE develop.
• Patients should understand that this drug has been subject to abuse; steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions.