Medically reviewed by Drugs.com. Last updated on Sep 19, 2020.
(meth il tes TOS te rone)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Android: 10 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]
Testred: 10 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]
Generic: 10 mg
Methitest: 10 mg [scored]
Brand Names: U.S.
- Android [DSC]
- Testred [DSC]
Endogenous androgen stimulates receptors in organs and tissues to promote growth and development of male sex organs and maintains secondary sex characteristics in androgen-deficient males
Urine (~90%); feces (~6%)
Variable: 10 to 100 minutes
98% bound to sex hormone-binding globulin
Use: Labeled Indications
Breast cancer, metastatic (females): Secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal; has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.
Delayed puberty (males): To stimulate puberty in carefully selected males with clearly delayed puberty.
Men with breast cancer or with known or suspected prostate cancer; women who are or may become pregnant.
Documentation of allergenic cross-reactivity for androgens is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Breast cancer, metastatic (females): Oral: 50 to 200 mg daily.
Delayed puberty (males): Oral: 10 to 50 mg daily; limit treatment duration to 4 to 6 months; use lower range of dosing and individualize dose based on response and tolerability.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
Delayed puberty: Adolescent males: Oral: Refer to adult dosing.
Hypogonadotropic hypogonadism (congenital or acquired) and primary hypogonadism (congenital or acquired): Adolescent males: Oral: Refer to adult dosing.
Store at 15°C and 30°C (59°F and 86°F). Protect Methitest from light, moisture, and heat.
Agents with Blood Glucose Lowering Effects: Androgens may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Ajmaline: Androgens may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Monitor therapy
C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy
Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Monitor therapy
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider avoiding concomitant use of androgens and cyclosporine. If concomitant use is unavoidable, monitor serum cyclosporine concentrations and for signs and symptoms of hepatotoxicity. Cyclosporine dose reductions may be required. Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Management: Monitor for increased effects of vitamin K antagonists if an androgen is initiated/dose increased, or decreased effects if androgen is discontinued/dose decreased. Significant reductions in vitamin K antagonist dose are likely required. Consider therapy modification
May decrease thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4; free thyroid hormone levels are not changed.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined.
Central nervous system: Anxiety, depression, headache, paresthesia
Dermatologic: Acne vulgaris, androgenetic alopecia
Endocrine & metabolic: Change in libido, gynecomastia (males), hirsutism (females), hypercalcemia, hypercholesterolemia, menstrual disease (includes amenorrhea)
Gastrointestinal: Nausea, vomiting
Genitourinary: Benign prostatic hypertrophy (males), impotence (males), mastalgia (females), oligospermia (males; at high doses), priapism (males), testicular atrophy (males), virilization (males and females)
Hematologic & oncologic: Clotting factors suppression, polycythemia, prostate carcinoma (males)
Hepatic: Abnormal liver function tests, cholestatic hepatitis, hepatic insufficiency, hepatic necrosis, jaundice, peliosis hepatitis
<1%, postmarketing, and/or case reports: Anaphylactoid reaction, hepatocellular neoplasm, hepatotoxicity (idiosyncratic; Chalasani 2014)
Concerns related to adverse effects:
• Cardiovascular events: Available studies are inconclusive regarding the risk of developing major adverse cardiovascular events such as nonfatal myocardial infarction, stroke, or cardiovascular death following testosterone use; most data are specific to men who were prescribed testosterone therapy (Basaria 2010; Corona 2014; Finkle 2014; Morgentaler 2015; Vigen 2013). Evaluate patients for cardiovascular risk factors prior to initiating therapy and monitor closely during therapy for cardiovascular events.
• Hepatic effects: Prolonged use and/or high doses may cause peliosis hepatis, hepatic neoplasms including hepatocellular carcinoma, cholestatic hepatitis, and jaundice. Discontinue if cholestatic hepatitis with jaundice or abnormal liver function tests occur.
• Oligospermia: May cause oligospermia and reduced ejaculatory volume after prolonged administration or excessive dosage.
• Polycythemia: May increase hematocrit requiring dose adjustment or discontinuation. Withhold initial treatment in patients with hematocrit >48% or >50% if living at higher altitudes. Discontinue therapy if hematocrit exceeds 54% (Endocrine Society [Bhasin 2018]).
• Priapism: Priapism or excessive sexual stimulation may occur.
• Venous thromboembolism: Venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported with testosterone products. Evaluate patients with symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those with acute shortness of breath for PE. Discontinue therapy if a venous thromboembolism is suspected. Use in patients with thrombophilia is not recommended (Endocrine Society [Bhasin 2018]).
• Benign prostatic hyperplasia: Androgens may worsen benign prostatic hyperplasia (BPH); do not use in patients with severe lower urinary tract symptoms (American Urological Association [AUA]/International Prostate Symptom Score [IPSS] >19) (Endocrine Society [Bhasin 2018]). Discontinue therapy if urethral obstruction develops in patients with BPH (use lower dose if restarted).
• Breast cancer: May cause hypercalcemia (by stimulating osteolysis) in patients with breast cancer; discontinue if hypercalcemia occurs.
• Diseases exacerbated by fluid retention: Use with caution in patients with diseases that may be exacerbated by fluid retention, including cardiac impairment; may cause fluid retention.
• Hepatic impairment: Use with caution in patients with hepatic impairment; may cause fluid retention.
• Prostate cancer: May increase the risk of prostate cancer. Withhold therapy pending urological evaluation in patients with palpable prostate nodule or induration, PSA >4 ng/mL, or PSA >3 ng/mL in men at high risk of prostate cancer (Endocrine Society [Bhasin 2018]).
• Renal impairment: Use with caution in patients with renal impairment; may cause fluid retention.
• Sleep apnea: May potentiate sleep apnea in some male patients, especially those with risk factors (eg, obesity or chronic lung disease). Withhold initial treatment in patients with untreated obstructive sleep apnea (Endocrine Society [Bhasin 2018]).
• Pediatric: May accelerate bone maturation (without producing compensatory gain in linear growth) and premature closure of the epiphyses 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. Use with caution in males with delayed puberty.
• Women: During treatment for metastatic breast cancer, women should be monitored for signs of virilization (eg, deepening of voice, hirsutism, acne, clitoromegaly, menstrual irregularities); discontinue if mild virilization is present to prevent irreversible symptoms.
• Abuse/misuse/diversion: Anabolic steroids may be abused, typically at doses higher than recommended and in combination with other anabolic androgenic steroids; abuse may be associated with serious cardiovascular and psychiatric adverse reactions. Inform patients of the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids; if abuse is suspected, check serum testosterone levels (testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives). Consider the possibility of abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
• Dependence: Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented; however, dependence may occur when used outside of approved dosage/indications.
LFTs, lipid panel, hemoglobin and hematocrit (at 3 to 6 months then annually). Monitor urine and serum calcium and signs of virilization in women treated for breast cancer. Serum glucose (may be decreased by testosterone, monitor patients with diabetes). Monitor for cardiovascular events closely during therapy. Monitor PSA if clinically indicated. In prepubertal patients, perform radiologic examination of wrist and hand every 6 months.
Use is contraindicated in women who may become pregnant. Use of methyltestosterone may impair fertility; oligospermia may occur in males and amenorrhea may occur in females.
Pregnancy Risk Factor X Pregnancy Considerations
Use is contraindicated in women who are pregnant. Exposure during pregnancy may cause virilization of the external genitalis of the female fetus, including clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is dose related and most likely to occur when androgens are administered in the first trimester. If a patient becomes pregnant while taking androgens, she should be counseled on the potential hazard to the fetus.
What is this drug used for?
• It is used to treat low testosterone levels.
• It is used to treat breast cancer in women.
• It may be given to you for other reasons. Talk with the doctor.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Emotional instability
• Enlarged breasts (males)
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• High calcium like weakness, confusion, fatigue, headache, nausea and vomiting, constipation, or bone pain
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
• Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight
• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood
• Virilization like in females a deep voice, facial hair, acne, or menstrual changes
• Enlarged clitoris
• Chest pain
• Arm pain
• Shoulder pain
• Shortness of breath
• Excessive weight gain
• Swelling of arms or legs
• Erection that lasts more than 4 hours
• Sexual dysfunction
• Severe anxiety
• Lump in breast
• Breast pain or soreness
• Skin discoloration
• Mood changes
• Burning or numbness feeling
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
More about methyltestosterone
- Side Effects
- During Pregnancy
- Dosage Information
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- Drug class: androgens and anabolic steroids
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