Yes

Androgen

Male: Hypogonadism; delayed puberty; impotence and climacteric symptoms

Female: Palliative treatment of metastatic breast cancer; postpartum breast pain and/or engorgement

C-III

X

Hypersensitivity to methyltestosterone or any component, known or suspected carcinoma of the breast or the prostate, pregnancy

Use with extreme caution in patients with liver or kidney disease or serious heart disease; may accelerate bone maturation without producing compensatory gain in linear growth

>10%:

Cardiovascular: Edema

Males: Virilism, priapism

Females: Virilism, menstrual problems (amenorrhea), breast soreness

Dermatologic: Acne

1% to 10%:

Males: Prostatic hypertrophy, prostatic carcinoma, impotence, testicular

Females: Hirsutism (increase in pubic hair growth) atrophy

Gastrointestinal: GI irritation, nausea, vomiting

Hepatic: Hepatic dysfunction

<1%: Gynecomastia, amenorrhea, hypercalcemia, leukopenia, polycythemia, hepatic necrosis, cholestatic hepatitis, hypersensitivity reactions

Abnormal liver function tests

Decreased effect: Oral anticoagulant effect or decrease insulin requirements

Stimulates receptors in organs and tissues to promote growth and development of male sex organs and maintains secondary sex characteristics in androgen-deficient males

Absorption: From GI tract and oral mucosa

Metabolism: Hepatic

Elimination: In urine

Adults (buccal absorption produces twice the androgenic activity of oral tablets):

Hypogonadism, male climacteric and impotence: Oral: 10-40 mg/day

Androgen deficiency:

Oral: 10-50 mg/day

Buccal: 5-25 mg/day

Postpubertal cryptorchidism: Oral: 30 mg/day

Female:

Breast pain/engorgement:

Oral: 80 mg/day for 3-5 days

Buccal: 40 mg/day for 3-5 days

Breast cancer:

Oral: 50-200 mg/day

Buccal: 25-100 mg/day

None reported

May cause leukopenia; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Take as directed; do not discontinue without consulting prescriber. Diabetics should monitor serum glucose closely and notify prescriber of changes; this medication can alter hypoglycemic requirements. You may experience acne, growth of body hair, loss of libido, impotence, or menstrual irregularity (usually reversible); nausea or vomiting (small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help). Report changes in menstrual pattern; deepening of voice or unusual growth of body hair; fluid retention (swelling of ankles, feet, or hands, difficulty breathing, or sudden weight gain); change in color of urine or stool; yellowing of eyes or skin; unusual bruising or bleeding; or other adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month following therapy. Consult prescriber for instruction on appropriate contraceptive measures. This drug may cause severe fetal defects. Do not breast-feed.

In prepubertal children, perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers

Capsule: 10 mg

Tablet: 10 mg, 25 mg

Tablet, buccal: 5 mg, 10 mg