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  • Android (Methyltestosterone) is an oral form of testosterone that's easy to take. This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Methyltestosterone is similar to the natural testosterone produced by your body. It belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Methyltestosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty.

     

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    The androgens are steroids that develop and maintain primary and secondary male sex characteristics. Androgens are derivatives of cyclopentanoperhydrophenanthrene. Endogenous androgens are c-19 steroids with a side chain at c-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. In their active form, all drugs in the class have a 17-beta hydroxy group. 17-alpha alkylation (methyltestosterone) increases the pharmacologic activity per unit weight compared to testosterone when given orally. Methyltestosterone, a synthetic derivative of testosterone, is an androgenic preparation given by the oral route in a capsule form. Each capsule contains 10 mg of methyltestosterone usp.

    Dosage & indications

    For androgen replacement therapy, related to cryptorchidism.

    Oral dosage (capsules or tablets)
    Adults
    The recommended dose is 10 mg PO 3 times per day.

    Buccal dosage (buccal tablets)
    Adults
    The recommended dose is 5 mg 3 times per day, dissolved in the buccal cavity.

    For the treatment of delayed puberty in males.
    Oral dosage (capsules or tablets)
    Adolescents
    The recommended dose is 5 to 25 mg PO per day for a limited period, usually for 4 to 6 months.

    Buccal dosage (buccal tablets)
    Adolescents
    The recommended dose is 2.5 to 12.5 mg per day, dissolved in the buccal cavity, for a limited period, usually for 4 to 6 months.

    For palliative treatment of breast cancer in women.
    Oral dosage (capsules or tablets)
    Adults
    The recommended dose is 50 mg PO once daily up to 4 times per day. If a suitable response occurs within 2 to 4 weeks, the dose may be reduced to 50 mg 2 times per day.

    Buccal dosage (buccal tablets)
    Adults
    The recommended dose is 25 mg dissolved in the buccal cavity once daily up to 4 times per day. If a suitable response occurs within 2 to 4 weeks, the dose may be reduced to 25 mg 2 times per day.

    For androgen replacement therapy, including symptoms consistent with andropause, erectile dysfunction (ED), or hypogonadism. In the management of erectile dysfunction (ED), methyltestosterone therapy may increase libido and may or may not be effective at improving erectile function in hypogonadal men. Testosterone therapy, however, is not indicated for the treatment of erectile dysfunction in the patient with a normal serum testosterone concentration.

    Oral dosage (capsules or tablets)
    Adult males
    The recommended dose is 10 to 50 mg PO per day.

    Buccal dosage (buccal tablets)
    Adult males
    The recommended dose is 5 to 25 mg per day, dissolved in the buccal cavity.

    Adults
    The maximum dosage is dependent on indication for therapy.

    Elderly
    The maximum dosage is dependent on indication for therapy.

    Adolescents
    The maximum dosage is dependent on indication for therapy.

    Children
    Safety and efficacy have not been established.

    Dosing considerations

    Hepatic Impairment
    Generally, androgen use is contraindicated in patients with severe hepatic dysfunction. Specific guidelines for dosage adjustment in hepatic impairment are not available; use caution in patients with mild to moderate hepatic disease.

    Renal Impairment
    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    Side Effects

    Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects when it is used at normal doses.

    Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as anxiety, depression, increased anger), trouble sleeping/snoring, signs of serious liver disease (such as persistent abdominal pain/nausea, unusual tiredness, yellowing eyes/skin, dark urine), hands/ankles/feet swelling, unusual tiredness, fast/irregular heartbeat.

    Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.

    If you are male, tell your doctor right away if you have any serious side effects, including: trouble urinating, breast swelling/tenderness, too frequent/prolonged erections.

    Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

    This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

    If you are female, tell your doctor right away if you have any serious side effects, including: deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris, irregular menstrual periods.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    Contraindications and precautions

    Android (Methyltestosterone) does not recommend for these situations as follow:

    Breast cancer, geriatric, hypercalcemia, prostate cancer, prostatic hypertrophy: Methyltestosterone may stimulate the growth of cancerous tissue and is contraindicated in male patients with prostate cancer or breast cancer. Patients with prostatic hypertrophy should be treated with caution because of the possible development of malignancy; geriatric male patients may be more likely to have prostatic hypertrophy as an underlying condition. Methyltestosterone has induced osteolysis and should be used with caution in hypercalcemia, which may be exacerbated in patients with metastatic breast cancer; discontinue methyltestosterone in the event of new onset hypercalcemia. According to the Beers Criteria, methyltestosterone is considered a potentially inappropriate medication (PIM) for use in geriatric patients and should be avoided due to the potential for cardiac problems and its contraindication in men with prostate cancer. The Beers expert panel considers use of methyltestosterone for confirmed hypogonadism with clinical symptoms as acceptable in the elderly.

    Cardiac disease, coronary artery disease, heart failure, hepatic disease, myocardial infarction, renal disease: During treatment with androgens, peripheral edema occurs because of water retention in association with sodium retention. Methyltestosterone should be used cautiously in severe cardiac disease, severe hepatic disease, and severe renal disease because of possible exacerbation of these conditions. Patients with heart failure, nephritis, nephrosis, coronary artery disease, myocardial infarction, or existing edema should also be treated with caution. Patients with severe hepatic disease or hepatic dysfunction also may be at risk of drug accumulation because of reduced clearance.

    Pregnancy: Methyltestosterone is classified as FDA pregnancy category X; its use is absolutely contraindicated during pregnancy because of probable adverse effects on the fetus. Androgens have caused virilization of the external genitalia 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 dependent on the amount of drug given and the age of the fetus; these effects are most likely to occur in the female fetus when the drugs are given in the first trimester. Females of childbearing potential should use adequate methods of contraception, and should commence therapy during menstruation to ensure a nonpregnant state. If pregnancy occurs, the drug should be immediately discontinued and the patient should be counseled concerning the potential risks to the fetus.

    Breast-feeding: Methyltestosterone distribution into breast milk has not been determined, but exposure to this androgen via breast-feeding may have adverse androgenic effects on the infant and the drug may also interfere with proper establishment of lactation in the mother. Because methyltestosterone is both structurally and mechanistically similar to testosterone, and testosterone products are to be avoided in lactating women, methyltestosterone should also be avoided in lactating women. Alternative methods to breast-feeding are recommended if methyltestosterone therapy is necessary. Historically, testosterone/androgens have been used adjunctively for lactation suppression.

    Diabetes mellitus: Androgen therapy, such as methyltestosterone, can result in loss of diabetic control and should be used with caution in patients with diabetes mellitus. Close monitoring of blood glucose is recommended.

    Children: Use of methyltestosterone in children should be undertaken only with extreme caution. Methyltestosterone may accelerate bone maturation without stimulating compensatory linear growth, sometimes resulting in compromised adult stature. If testosterone is administered to prepubertal males, radiographic examinations of the hand and wrist should be performed every 6 months to assess the rate of bone maturation and the effect of the drug on epiphyseal centers.