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standards of non-Merck sources.
Medication Safety Issues
Sound-alike/look-alike issues:
MethylTESTOSTERone may be confused with medroxyPROGESTERone
Virilon® may be confused with Verelan®
Pronunciation
(meth il tes TOS te rone)
U.S. Brand Names
Generic Available
No
Pharmacologic Category
Use: Labeled Indications
Male: Hypogonadism; delayed puberty; impotence and climacteric symptoms
Female: Palliative treatment of metastatic breast cancer
Restrictions
C-III
Pregnancy Risk Factor
X
Lactation
Excretion in breast milk unknown/contraindicated
Contraindications
Hypersensitivity to methyltestosterone or any component of the formulation; in males, known or suspected carcinoma of the breast or the prostate; 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: Use with caution in elderly patients, they may be at greater risk for prostatic hyperplasia, 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: Virilism, priapism, prostatic hyperplasia, prostatic carcinoma, impotence, testicular atrophy, gynecomastia
Female: Virilism, menstrual problems (amenorrhea), breast soreness, hirsutism (increase in pubic hair growth), atrophy
Cardiovascular: Edema
Central nervous system: Headache, anxiety, depression
Dermatologic: Acne, “male pattern” baldness, seborrhea
Endocrine & metabolic: Hypercalcemia, hypercholesterolemia
Gastrointestinal: GI irritation, nausea, vomiting
Hematologic: Leukopenia, polycythemia
Hepatic: Hepatic dysfunction, hepatic necrosis, cholestatic hepatitis
Miscellaneous: Hypersensitivity reactions
Drug Interactions
CycloSPORINE: Androgens may enhance the hepatotoxic effect of CycloSPORINE. Androgens may increase the serum concentration of CycloSPORINE. 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
Adults (buccal absorption produces twice the androgenic activity of oral tablets):
Male:
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
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
Take as directed; do not discontinue without consulting prescriber. 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, or menstrual irregularity (usually reversible); or 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; 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; unusual fatigue or weakness; or other adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant or cause a pregnancy (males) 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.
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.
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. Assess potential for interactions with other pharmacological agents patient may be taking (eg, effects of hypoglycemic agents may be increased). Assess therapeutic effects (according to purpose for use) and adverse response (eg, virilism [male and female], edema, CNS changes [anxiety, depression], acne, baldness, GI irritation, leukopenia, hepatic dysfunction) frequently during therapy. Caution patients with diabetes; effects of hypoglycemic agents may be increased. Teach patient proper use, possible side effects/appropriate interventions, and adverse symptoms to report. Pregnancy risk factor X: Determine that patient is not pregnant before beginning treatment. Instruct patients of childbearing age or males who may have intercourse with women of childbearing age on appropriate contraceptive measures. Breast-feeding is contraindicated.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule (Android®, Testred®, Virilon®): 10 mg
Tablet (Methitest™): 10 mg
Pricing: U.S. (www.drugstore.com)
Capsules (Android)
10 mg (60): $527.77
Capsules (Testred)
10 mg (60): $527.77
International Brand Names
Lexi-Comp.com
Last full review/revision March 2009
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