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Drug overview for METHYLTESTOSTERONE (methyltestosterone):
Generic name: METHYLTESTOSTERONE (METH-ill-tess-TOSS-ter-own)
Drug class: Androgens/Anabolic Steroids
Therapeutic class: Endocrine
Methyltestosterone is a synthetic androgenic anabolic steroid hormone.
Methyltestosterone is used mainly for replacement or substitution of diminished or absent endogenous testicular hormone.
Generic name: METHYLTESTOSTERONE (METH-ill-tess-TOSS-ter-own)
Drug class: Androgens/Anabolic Steroids
Therapeutic class: Endocrine
Methyltestosterone is a synthetic androgenic anabolic steroid hormone.
Methyltestosterone is used mainly for replacement or substitution of diminished or absent endogenous testicular hormone.
DRUG IMAGES
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The following indications for METHYLTESTOSTERONE (methyltestosterone) have been approved by the FDA:
Indications:
Androgen deficiency
Bilateral anorchia
Delayed puberty
Gonadotropin releasing factor deficiency
Hormone receptor positive breast cancer
Male hypogonadism
Primary hypogonadism due to bilateral torsion of testes
Primary hypogonadism due to orchitis
Professional Synonyms:
Absence of testes
GnRH deficiency
Gonadotropin releasing hormone deficiency
Hormone receptor positive malignant neoplasm of breast
LHRH Deficiency
Luliberin deficiency
Luteinizing hormone-releasing hormone deficiency
Primary failure of testis due to orchitis
Primary gonadal failure due to testitis
Primary hypogonadism due to bilateral testicular torsion
Primary male hypogonadism due to orchiditis
Sexual development delayed
Sexual development retardation
Testoid deficiency
Testosterone deficiency
Indications:
Androgen deficiency
Bilateral anorchia
Delayed puberty
Gonadotropin releasing factor deficiency
Hormone receptor positive breast cancer
Male hypogonadism
Primary hypogonadism due to bilateral torsion of testes
Primary hypogonadism due to orchitis
Professional Synonyms:
Absence of testes
GnRH deficiency
Gonadotropin releasing hormone deficiency
Hormone receptor positive malignant neoplasm of breast
LHRH Deficiency
Luliberin deficiency
Luteinizing hormone-releasing hormone deficiency
Primary failure of testis due to orchitis
Primary gonadal failure due to testitis
Primary hypogonadism due to bilateral testicular torsion
Primary male hypogonadism due to orchiditis
Sexual development delayed
Sexual development retardation
Testoid deficiency
Testosterone deficiency
The following dosing information is available for METHYLTESTOSTERONE (methyltestosterone):
Diagnosis of male hypogonadism must be confirmed by laboratory testing prior to initiation of methyltestosterone therapy. To confirm this diagnosis, serum testosterone concentrations should be measured in the morning on at least 2 separate days and must be consistently below the normal range. Serum testosterone concentrations may be low later in the day in men with or without hypogonadism; therefore, measuring testosterone concentrations later in the day should be avoided.
Dosage of methyltestosterone is variable and should be individualized according to the condition being treated, the severity of symptoms, and the patient's age, gender, and history of prior androgenic therapy.
Dosage of methyltestosterone is variable and should be individualized according to the condition being treated, the severity of symptoms, and the patient's age, gender, and history of prior androgenic therapy.
Methyltestosterone is administered orally; the drug usually is given in divided daily doses. Methyltestosterone also has been administered intrabuccally.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| METHYLTESTOSTERONE 10 MG CAP | Maintenance | Adults take 1 capsule (10 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| METHYLTESTOSTERONE 10 MG CAP | Maintenance | Adults take 1 capsule (10 mg) by oral route once daily |
The following drug interaction information is available for METHYLTESTOSTERONE (methyltestosterone):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Selected Anticoagulants (Vit K antagonists)/Selected Anabolic Steroids SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown. It has been hypothesized that the C-17 alkylated androgens may increase turnover of clotting factors and decrease their synthesis. Increased affinity for the anticoagulant receptor site has also been hypothesized. The C-17 alkylated androgens have not been shown to alter the metabolism of anticoagulants. CLINICAL EFFECTS: The concurrent use of anticoagulants and anabolic steroids may result in an increased risk for bleeding. PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). PATIENT MANAGEMENT: Patients should be closely monitored for increased anticoagulant activity. The dose of the anticoagulant may need to be adjusted. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug. When concurrent therapy is warranted, also monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. DISCUSSION: Danazol, methandrostenolone, methyltestosterone, oxymetholone, and stanozolol have been shown to increase the hypoprothrombinemic actions of warfarin. Methyltestosterone has also been shown to increase the effects of dicumarol. Oxymetholone and ethylestrenol have been shown to increase the effects of phenindione. Limited data suggest that the non-C-17-alkylated androgens do not affect anticoagulants. |
ANISINDIONE, DICUMAROL, JANTOVEN, PHENINDIONE, WARFARIN SODIUM |
| Cyclosporine/Selected Androgens SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Danazol and methyltestosterone may inhibit the metabolism of cyclosporine. CLINICAL EFFECTS: Concurrent therapy may result in increased levels of cyclosporine, which may produce hepatic and renal dysfunction. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If possible, avoid giving patients receiving cyclosporine danazol or methyltestosterone. If concurrent therapy is warranted, monitor cyclosporine levels as well as renal and hepatic function carefully. Cyclosporine dosage adjustments may be necessary when these agents are initiated or discontinued, as well as during concurrent therapy. Discontinuation of the androgen may be necessary. DISCUSSION: Four case reports have documented increased cyclosporine levels during concurrent therapy with danazol.(1-4) In two of these reports, elevated cyclosporine levels persisted even after decreases in cyclosporine dosages.(1,2) One patient also experienced decreased renal function, as indicated by an increase in serum creatinine levels.(1) Cyclosporine levels returned to baseline following the discontinuation of danazol.(1-4) Two case reports have documented increased cyclosporine levels during concurrent therapy with methyltestosterone. Both patients experienced elevated cyclosporine, bilirubin, and serum creatinine levels during concurrent therapy.(5,6) In one patient, elevated cyclosporine levels persisted despite a 40% decrease in cyclosporine dosage.(5) Discontinuation of methyltestosterone resulted in a gradual return of cyclosporine levels to previous values.(5,6) |
CYCLOSPORINE, CYCLOSPORINE MODIFIED, GENGRAF, NEORAL, SANDIMMUNE |
There are 0 moderate interactions.
The following contraindication information is available for METHYLTESTOSTERONE (methyltestosterone):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Malignant tumor of male breast |
| Pregnancy |
| Prostatic carcinoma |
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute myocardial infarction |
| Benign prostatic hyperplasia |
| Cerebrovascular accident |
| Chronic heart failure |
| Coronary artery disease |
| Disease of liver |
| Hypercalcemia |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Diabetes mellitus |
| Edema |
| Hypertension |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Neoplasm of liver |
The following adverse reaction information is available for METHYLTESTOSTERONE (methyltestosterone):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 35 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Amenorrhea Bladder irritability Gynecomastia Irregular menstrual periods Mastalgia Priapism Urinary tract infection Virilism |
Benign prostatic hyperplasia Dizziness Edema Epididymitis Fatigue Flushing Headache disorder Hypercalcemia Hypertension Nausea Prostatic carcinoma Vomiting |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute myocardial infarction Cerebrovascular accident Cholestatic hepatitis Deep venous thrombosis Drug-induced hepatitis Erythrocytosis Heart failure Hepatic necrosis Jaundice Leukopenia Malignant neoplasm of liver Peliosis hepatis Pulmonary thromboembolism Venous thrombosis |
There are 13 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Acne vulgaris Diarrhea Erectile dysfunction Increased pubic hair Insomnia Libido changes Testicular atrophy |
| Rare/Very Rare |
|---|
|
Aggressive behavior Anorexia Depression Hostility Irritability Oligospermia |
The following precautions are available for METHYLTESTOSTERONE (methyltestosterone):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Methyltestosterone may cause fetal harm when administered to pregnant women. Androgenic effects including clitoral hypertrophy, labial fusion of the external genital fold to form a scrotal-like structure, abnormal vaginal development, and persistence of a urogenital sinus have occurred in the female offspring of women who were given androgens during pregnancy. The degree of masculinization is related to the amount of drug given to the woman and the age of the fetus; masculinization is most likely to occur in a female fetus when exposure to androgens occurs during the first trimester.
Since the risks clearly outweigh the possible benefits in women who are or may become pregnant, methyltestosterone is contraindicated in such women. Women who become pregnant while receiving the drug should be informed of the potential hazard to the fetus.
Since the risks clearly outweigh the possible benefits in women who are or may become pregnant, methyltestosterone is contraindicated in such women. Women who become pregnant while receiving the drug should be informed of the potential hazard to the fetus.
It is not known whether methyltestosterone is distributed into milk. Because of the potential for serious adverse reactions to androgens in nursing infants, a decision should be made whether to discontinue nursing or to not use methyltestosterone, taking into account the importance of the drug to the woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for METHYLTESTOSTERONE (methyltestosterone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for METHYLTESTOSTERONE (methyltestosterone)'s list of indications:
| Androgen deficiency | |
| E29.1 | Testicular hypofunction |
| Bilateral anorchia | |
| Q55.0 | Absence and aplasia of testis |
| Delayed puberty | |
| E30.0 | Delayed puberty |
| Gonadotropin releasing factor deficiency | |
| E23.3 | Hypothalamic dysfunction, not elsewhere classified |
| Hormone receptor positive breast cancer | |
| C50 | Malignant neoplasm of breast |
| C50.1 | Malignant neoplasm of central portion of breast |
| C50.11 | Malignant neoplasm of central portion of breast, female |
| C50.111 | Malignant neoplasm of central portion of right female breast |
| C50.112 | Malignant neoplasm of central portion of left female breast |
| C50.119 | Malignant neoplasm of central portion of unspecified female breast |
| C50.12 | Malignant neoplasm of central portion of breast, male |
| C50.121 | Malignant neoplasm of central portion of right male breast |
| C50.122 | Malignant neoplasm of central portion of left male breast |
| C50.129 | Malignant neoplasm of central portion of unspecified male breast |
| C50.2 | Malignant neoplasm of upper-inner quadrant of breast |
| C50.21 | Malignant neoplasm of upper-inner quadrant of breast, female |
| C50.211 | Malignant neoplasm of upper-inner quadrant of right female breast |
| C50.212 | Malignant neoplasm of upper-inner quadrant of left female breast |
| C50.219 | Malignant neoplasm of upper-inner quadrant of unspecified female breast |
| C50.22 | Malignant neoplasm of upper-inner quadrant of breast, male |
| C50.221 | Malignant neoplasm of upper-inner quadrant of right male breast |
| C50.222 | Malignant neoplasm of upper-inner quadrant of left male breast |
| C50.229 | Malignant neoplasm of upper-inner quadrant of unspecified male breast |
| C50.3 | Malignant neoplasm of lower-inner quadrant of breast |
| C50.31 | Malignant neoplasm of lower-inner quadrant of breast, female |
| C50.311 | Malignant neoplasm of lower-inner quadrant of right female breast |
| C50.312 | Malignant neoplasm of lower-inner quadrant of left female breast |
| C50.319 | Malignant neoplasm of lower-inner quadrant of unspecified female breast |
| C50.32 | Malignant neoplasm of lower-inner quadrant of breast, male |
| C50.321 | Malignant neoplasm of lower-inner quadrant of right male breast |
| C50.322 | Malignant neoplasm of lower-inner quadrant of left male breast |
| C50.329 | Malignant neoplasm of lower-inner quadrant of unspecified male breast |
| C50.4 | Malignant neoplasm of upper-outer quadrant of breast |
| C50.41 | Malignant neoplasm of upper-outer quadrant of breast, female |
| C50.411 | Malignant neoplasm of upper-outer quadrant of right female breast |
| C50.412 | Malignant neoplasm of upper-outer quadrant of left female breast |
| C50.419 | Malignant neoplasm of upper-outer quadrant of unspecified female breast |
| C50.42 | Malignant neoplasm of upper-outer quadrant of breast, male |
| C50.421 | Malignant neoplasm of upper-outer quadrant of right male breast |
| C50.422 | Malignant neoplasm of upper-outer quadrant of left male breast |
| C50.429 | Malignant neoplasm of upper-outer quadrant of unspecified male breast |
| C50.5 | Malignant neoplasm of lower-outer quadrant of breast |
| C50.51 | Malignant neoplasm of lower-outer quadrant of breast, female |
| C50.511 | Malignant neoplasm of lower-outer quadrant of right female breast |
| C50.512 | Malignant neoplasm of lower-outer quadrant of left female breast |
| C50.519 | Malignant neoplasm of lower-outer quadrant of unspecified female breast |
| C50.52 | Malignant neoplasm of lower-outer quadrant of breast, male |
| C50.521 | Malignant neoplasm of lower-outer quadrant of right male breast |
| C50.522 | Malignant neoplasm of lower-outer quadrant of left male breast |
| C50.529 | Malignant neoplasm of lower-outer quadrant of unspecified male breast |
| C50.6 | Malignant neoplasm of axillary tail of breast |
| C50.61 | Malignant neoplasm of axillary tail of breast, female |
| C50.611 | Malignant neoplasm of axillary tail of right female breast |
| C50.612 | Malignant neoplasm of axillary tail of left female breast |
| C50.619 | Malignant neoplasm of axillary tail of unspecified female breast |
| C50.62 | Malignant neoplasm of axillary tail of breast, male |
| C50.621 | Malignant neoplasm of axillary tail of right male breast |
| C50.622 | Malignant neoplasm of axillary tail of left male breast |
| C50.629 | Malignant neoplasm of axillary tail of unspecified male breast |
| C50.8 | Malignant neoplasm of overlapping sites of breast |
| C50.81 | Malignant neoplasm of overlapping sites of breast, female |
| C50.811 | Malignant neoplasm of overlapping sites of right female breast |
| C50.812 | Malignant neoplasm of overlapping sites of left female breast |
| C50.819 | Malignant neoplasm of overlapping sites of unspecified female breast |
| C50.82 | Malignant neoplasm of overlapping sites of breast, male |
| C50.821 | Malignant neoplasm of overlapping sites of right male breast |
| C50.822 | Malignant neoplasm of overlapping sites of left male breast |
| C50.829 | Malignant neoplasm of overlapping sites of unspecified male breast |
| C50.9 | Malignant neoplasm of breast of unspecified site |
| C50.91 | Malignant neoplasm of breast of unspecified site, female |
| C50.911 | Malignant neoplasm of unspecified site of right female breast |
| C50.912 | Malignant neoplasm of unspecified site of left female breast |
| C50.919 | Malignant neoplasm of unspecified site of unspecified female breast |
| C50.92 | Malignant neoplasm of breast of unspecified site, male |
| C50.921 | Malignant neoplasm of unspecified site of right male breast |
| C50.922 | Malignant neoplasm of unspecified site of left male breast |
| C50.929 | Malignant neoplasm of unspecified site of unspecified male breast |
| Z17.0 | Estrogen receptor positive status [Er+] |
| Z19.1 | Hormone sensitive malignancy status |
| Male hypogonadism | |
| E29.1 | Testicular hypofunction |
| Primary hypogonadism due to bilateral torsion of testes | |
| E29.1 | Testicular hypofunction |
| Primary hypogonadism due to orchitis | |
| E29.1 | Testicular hypofunction |
Formulary Reference Tool