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standards of non-Merck sources.
Pronunciation
(meth il tes TOS te rone)
Generic Available (U.S.)
No
Controlled Substance
C-III
U.S. Brand Names
Pharmacologic Category
Use: Labeled Indications
Male: Hypogonadism; delayed puberty; impotence and climacteric symptoms
Female: Palliative treatment of metastatic breast cancer
Use: Unlabeled/Investigational
Hypogonadism (male); delayed puberty (male)
Pregnancy Risk Factor
X
Lactation
Excretion in breast milk unknown/contraindicated
Contraindications
Males with carcinoma of the breast or the prostate (known or suspected); pregnancy
Warnings/Precautions
Concerns related to adverse effects:
• Hepatic effects: Prolonged use and/or high doses may cause peliosis hepatis or liver cell tumors which may not be apparent until liver failure or intra-abdominal hemorrhage develops. Discontinue in case of cholestatic hepatitis with jaundice or abnormal liver function tests.
Disease-related concerns:
• Breast cancer: Use with caution in patients with breast cancer; may cause hypercalcemia by stimulating osteolysis.
• Diabetes: Use with caution in patients with diabetes mellitus; monitor carefully.
• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal impairment); may cause fluid retention.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
Special populations:
• Elderly: May be inappropriate in this age group due to increased risk of prostatic hypertrophy and cardiac problems (Beers Criteria). In addition, elderly patients may be at greater risk for fluid retention and transaminase elevations.
• Pediatrics: May accelerate bone maturation without producing compensatory gain in linear growth in children; 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.
• Women: Discontinue with evidence of mild virilization in women.
Adverse Reactions
Frequency not defined.
Male: Gynecomastia, impotence, oligospermia (at high doses), priapism, prostatic carcinoma, prostatic hyperplasia, testicular atrophy, virilism
Female: Atrophy, breast soreness, hirsutism, menstrual problems (amenorrhea), virilism
Cardiovascular: Edema
Central nervous system: Anxiety, depression, headache
Dermatologic: Acne, “male pattern” baldness
Endocrine & metabolic: Hypercalcemia, hypercholesterolemia, libido (changes in)
Gastrointestinal: Nausea, vomiting
Hematologic: Polycythemia, suppression of clotting factors
Hepatic: Cholestatic hepatitis, hepatic dysfunction, hepatic necrosis, hepatocellular neoplasm (rare), jaundice, liver function tests (abnormal), peliosis hepatitis
Neuromuscular & skeletal: Paresthesia
Miscellaneous: Anaphylactoid reactions (rare)
Drug Interactions
CycloSPORINE: Androgens may enhance the hepatotoxic effect of CycloSPORINE. Androgens may increase the serum concentration of CycloSPORINE. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification
Mechanism of Action
Stimulates receptors in organs and tissues to promote growth and development of male sex organs and maintains secondary sex characteristics in androgen-deficient males
Pharmacodynamics/Kinetics
Metabolism: Hepatic
Excretion: Urine
Dosage
Oral: Adults:
Male:
Hypogonadism; delayed puberty: Individualize dose based on response and tolerability.
Androgen deficiency: 10-50 mg/day
Female: Breast cancer: 50-200 mg/day
Monitoring Parameters
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.
Patient Education
If you have diabetes, monitor serum glucose closely and notify prescriber of changes; this medication can alter hypoglycemic requirements. May cause acne, growth of body hair, loss of libido, impotence, menstrual irregularity (usually reversible), nausea, or vomiting. Report changes in menstrual pattern, deepening of voice or unusual growth of body hair, gynecomastia or breast soreness, priapism, fluid retention (swelling of ankles, feet, or hands, respiratory difficulty, or sudden weight gain), change in color of urine or stool, yellowing of eyes or skin, unusual bruising or bleeding, or unusual fatigue or weakness.
Geriatric Considerations
Since elderly males have prostate changes with age, it would be best to obtain a PSA initially and periodically. Retention of sodium and water could be a problem in patients with CHF and hypertension.
This medication is considered to be potentially inappropriate in this patient population (Beers Criteria severity: High).
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
May cause leukopenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Use extreme caution in presence of hepatic, renal, or cardiovascular disease. Monitor for virilism (male and female), edema, CNS changes (anxiety, depression), acne, baldness, GI irritation, leukopenia, and hepatic dysfunction frequently during therapy. Caution patients with diabetes; effects of hypoglycemic agents may be increased.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, oral:
Android®: 10 mg
Testred®: 10 mg
Tablet, oral:
Methitest™: 10 mg [scored]
Pricing: U.S. (www.drugstore.com)
Capsules (Android)
10 mg (60): $776.02
Capsules (Testred)
10 mg (60): $1208.99
International Brand Names
Lexi-Comp.com
Last full review/revision May 2011
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