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estrogen-methyltestos h.s. tab generic covaryx h.s., eemt hs

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Uses

Methyltestosterone is used mainly for replacement or substitution of diminished or absent endogenous testicular hormone.

Uses in Males

In males, methyltestosterone is used for the management of congenital or acquired primary hypogonadism such as that resulting from orchiectomy or from testicular failure caused by cryptorchidism, bilateral torsion, orchitis, or vanishing testis syndrome. Methyltestosterone also is used in males for the management of congenital or acquired hypogonadotropic hypogonadism such as that resulting from idiopathic gonadotropin or gonadotropin releasing hormone (luteinizing hormone releasing hormone) deficiency or from pituitary-hypothalamic injury caused by tumors, trauma, or radiation. If any of these conditions occur before puberty, androgen replacement therapy will be necessary during adolescence for the development of secondary sexual characteristics and prolonged therapy will be required to maintain these characteristics. Prolonged androgen therapy also is required to maintain sexual characteristics in other males who develop testosterone deficiency after puberty.

When the diagnosis is well established, methyltestosterone may be used to stimulate puberty in carefully selected males with delayed puberty. These males usually have a family history of delayed puberty that is not caused by a pathologic disorder. Brief treatment with conservative doses of an androgen may occasionally be justified in these males if they do not respond to psychologic support. Because androgens may adversely affect bone maturation in these prepubertal males, this potential risk should be fully discussed with the patient and his parents prior to initiation of androgen therapy. (See Cautions: Pediatric Precautions.) If androgen therapy is initiated in these prepubertal males, radiographs of the hand and wrist should be obtained at 6-month intervals to determine the effect of therapy on the epiphyseal centers.

The safety and efficacy of methyltestosterone in patients with low testosterone concentrations related to aging (i.e., late-onset hypogonadism) have not been established. Although endogenous testosterone concentrations decline with aging and manifestations of hypogonadism such as decreased libido, impotence, decreased body hair growth, decreased muscle mass, increased risk of cardiovascular disease, and decreased bone mass and resultant osteoporosis may occur, it is unclear whether these symptoms are related to such decreased concentrations or to normal aging; therefore, the need to replace testosterone in aging men is unclear.

Other Uses

In females, methyltestosterone is used for the palliative treatment of androgen-responsive, advanced, inoperable, metastatic (skeletal) carcinoma of the breast in women who are 1-5 years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity include adrenalectomy, hypophysectomy, and/or antiestrogen therapy (e.g., tamoxifen). Androgen therapy also has been used in premenopausal women with carcinoma of the breast who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. The decision to use androgen therapy in women with carcinoma of the breast should be made by an oncologist with expertise in the treatment of this carcinoma.

Methyltestosterone also has been used for the prevention of postpartum breast pain and engorgement; however, the drug does not appear to prevent or suppress lactation.

In females, methyltestosterone is used in combination with estrogens for the management of moderate to severe vasomotor symptoms associated with menopause in patients who do not respond adequately to estrogens alone. While estrogen/androgen combinations were found to be effective for the management of vasomotor symptoms associated with menopause under a determination made by the FDA in 1976, formal administrative proceedings were initiated by the FDA in April 2003 to examine the effectiveness of estrogen/androgen combinations for this indication. FDA is undertaking this action because the agency does not believe there is substantial evidence available to establish the contribution of androgens to the effectiveness of estrogen/androgen combinations for the management of vasomotor symptoms in menopausal women who do not respond to estrogens alone. The FDA will allow continued marketing of combination estrogen/androgen products while the matter is under study.

Although methyltestosterone has been used in other conditions (e.g., fractures, surgery, convalescence, functional uterine bleeding), there is a lack of substantial evidence that androgens are effective in these conditions. In addition, the FDA states that there currently is no evidence to support the safety and efficacy of methyltestosterone as an aphrodisiac (i.e., to arouse or increase sexual desire or to improve sexual performance).

Misuse, Abuse, and Dependence

Because of their anabolic and androgenic effects on performance (ergogenic potential) and physique, androgens have been misused and abused by athletes, bodybuilders, weight lifters, and others, including high school- and college-aged individuals engaged in sports. Following review of data from published literature and case reports in October 2016, the FDA concluded that misuse and abuse of androgens are associated with serious adverse cardiovascular, hepatic, endocrine, and mental health effects. (See Cautions; also .)

Serum testosterone concentrations should be evaluated in patients who may be misusing or abusing androgens (e.g., patients experiencing serious adverse cardiovascular or psychiatric effects); however, serum testosterone concentrations may be below or within the normal range in patients abusing synthetic derivatives of testosterone.

Dosage and Administration

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.

Administration

Methyltestosterone is administered orally; the drug usually is given in divided daily doses. Methyltestosterone also has been administered intrabuccally.

Dosage

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.

Male Hypogonadism

For replacement of endogenous testicular hormone in androgen-deficient males, the usual oral dosage of methyltestosterone is 10-50 mg daily as capsules. Alternatively, buccal tablets have been administered in a dosage of 5-25 mg daily. For the management of postpubertal cryptorchidism in patients with evidence of hypogonadism, several manufacturers recommend an oral methyltestosterone dosage of 30 mg daily as capsules. Alternatively, buccal tablets have been administered in a dosage of 15 mg daily.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males. Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels. Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty. The chronologic and skeletal ages of the patient must be considered when determining the initial dosage and subsequent dosage adjustment. In general, short-term administration (e.g., 4-6 months) of methyltestosterone and dosages in the lower end of the usual range for replacement (i.e., 10 mg daily) are used for the treatment of delayed puberty in males.

Inoperable Carcinoma of the Breast

For the palliative treatment of advanced, inoperable, metastatic carcinoma of the breast in women, the usual oral dosage of methyltestosterone is 50-200 mg daily as capsules. Alternatively, buccal tablets have been administered in a dosage of 25-100 mg daily.

Postpartum Breast Pain and Engorgement

For the prevention of postpartum breast pain and engorgement, the usual oral dosage of methyltestosterone is 80 mg daily as capsules for 3-5 days after parturition. Alternatively, buccal tablets have been administered in a dosage of 40 mg daily for 3-5 days after parturition.

Vasomotor Symptoms Associated with Menopause

When methyltestosterone is used in combination with an estrogen (i.e., conjugated estrogens or esterified estrogens) for the short-term management of moderate to severe vasomotor symptoms associated with menopause, the lowest possible effective dosage should be used and therapy should be discontinued as soon as possible. Attempts to reduce dosage or discontinue the drugs should be made at 3- to 6-month intervals. The combined drugs are administered for 21 consecutive days, followed by 7 days without the drugs, and then this regimen is repeated as necessary. The manufacturers' labeling for the respective drugs or drug combinations should be consulted for usual recommended dosages for combination therapy. Women with an intact uterus receiving combination therapy should be closely monitored for signs of endometrial carcinoma, and appropriate diagnostic measures should be employed if persistent or recurring abnormal vaginal bleeding occurs during therapy with the drugs.

Cautions

Adverse Effects

Cardiovascular events (e.g., myocardial infarction [MI], stroke) have been reported with methyltestosterone therapy. Long-term clinical safety studies have not been conducted to date to determine the cardiovascular effects of testosterone replacement therapy in men. Epidemiologic data and results from randomized, controlled clinical trials have been inconclusive for determining the risk of serious adverse cardiovascular events (i.e., nonfatal MI, nonfatal stroke, death) with testosterone use compared with nonuse.

Because the current evidence regarding the cardiovascular risk associated with testosterone replacement therapy is weak because of the limited scope, quality, design, and size of the clinical trials, the FDA has requested additional evidence from well-designed studies to further elucidate the cardiovascular risk associated with testosterone use. Following review of data from several observational studies and meta-analyses in March 2015, the FDA concluded that use of testosterone is associated with a possible increased risk of serious adverse cardiovascular events. Clinicians should inform patients of this potential increased risk when deciding whether to use or continue to use testosterone replacement therapy.

Venous thromboembolic events, including deep-vein thrombosis (DVT) and pulmonary embolism (PE), have been reported during postmarketing experience with testosterone preparations, including methyltestosterone. Patients reporting symptoms of pain, edema, warmth, and erythema in a lower extremity or presenting with acute shortness of breath should be evaluated for possible DVT or PE, respectively. If venous thromboembolism is suspected, methyltestosterone therapy should be discontinued and appropriate evaluation and management should be initiated.

Adverse effects associated with methyltestosterone are similar to those of other synthetic or natural androgens and include acne, gynecomastia, and edema. If edema is present before or develops during therapy, administration of diuretics may be required. Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.

Oligospermia and decreased ejaculatory volume may occur in males receiving excessive dosage or prolonged administration of the drug. Priapism or excessive sexual stimulation in males, especially geriatric patients, also may occur. If priapism or excessive sexual stimulation develops during methyltestosterone therapy, the drug should be discontinued temporarily, since these are signs of excessive dosage; if therapy with methyltestosterone is reinstituted, a lower dosage should be used. Male pattern of baldness also may occur.

Amenorrhea and other menstrual irregularities and inhibition of gonadotropin secretion occur commonly in females. Virilization, including deepening of the voice, hirsutism, and clitoral enlargement, also occur commonly in females; these changes may not be reversible following discontinuance of the drug.

Hypersensitivity reactions, including skin manifestations and anaphylactoid reactions, have occurred rarely with methyltestosterone.

Hypercalcemia resulting from osteolysis, especially in immobile patients and those with metastatic carcinoma of the breast, has been reported in patients receiving methyltestosterone. The drug should be discontinued if hypercalcemia occurs in patients with cancer since this may indicate progression of metastases to the bone. Retention of water, sodium, chloride, potassium, and inorganic phosphates also has occurred in patients receiving the drug.

Cholestatic hepatitis and jaundice and abnormal liver function test results may occur in patients receiving 17-α-alkylandrogens such as methyltestosterone. These adverse hepatic effects may occur at relatively low doses of the drug. Drug-induced jaundice usually is reversible following discontinuance of the drug. Methyltestosterone should be discontinued if cholestatic jaundice or hepatitis occurs, or if liver function test results become abnormal during therapy with the drug, and the etiology of these disorders should be determined. Peliosis of the liver and hepatic neoplasms, including hepatocellular carcinoma, have been reported rarely in patients receiving long-term administration of androgenic anabolic steroids. Peliosis of the liver can be a life-threatening or fatal complication of androgen therapy.

Serious adverse effects (e.g., increased aggression, antisocial behavior, manic episode, hostility, depression, changes in libido, increased risk of cardiovascular events, hepatotoxicity, testicular atrophy, sperm abnormalities) are associated with misuse and abuse of androgens (see Uses: Misuse, Abuse, and Dependence). Methyltestosterone preparations currently are subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as schedule III (C-III) drugs.

Manifestations of withdrawal (e.g., depressed mood, major depression, fatigue, cravings, restlessness, irritability, anorexia, insomnia, decreased libido, hypogonadotropic hypogonadism) may occur if androgens are discontinued abruptly or dosage is substantially reduced in physically dependent patients or in those taking supratherapeutic dosages of such drugs; withdrawal symptoms may persist for weeks or months.

Other adverse effects associated with methyltestosterone therapy include nausea, polycythemia, headache, anxiety, mental depression, generalized paresthesia, and suppression of clotting factors II, V, VII, and X. Serum cholesterol concentration may increase during androgen therapy.

Precautions and Contraindications

Methyltestosterone shares the toxic potentials of other androgens, and the usual precautions of androgen therapy should be observed. When methyltestosterone is used in combination with estrogens, the usual precautions associated with estrogen therapy also should be observed. Clinicians prescribing estrogens should be aware of the risks associated with these drugs, and the manufacturers' labeling should be consulted for further discussion of these risks and associated precautions.

Methyltestosterone should be used with caution in patients with cardiac, renal, or hepatic dysfunction since edema, with or without congestive heart failure, may occur as a result of sodium and water retention. If edema occurs during methyltestosterone therapy and it is considered a serious complication, the drug should be discontinued; diuretic therapy also may be necessary. Liver function should be evaluated periodically during use of methyltestosterone.

Some experts recommend that methyltestosterone be used with caution in patients at high risk for cardiovascular disease, such as older men or those with diabetes mellitus or obesity, since serious adverse cardiovascular events (i.e., MI, stroke, death) may occur.(See Cautions: Adverse Effects.)

Females should be carefully monitored for signs of virilization (e.g., deepening of the voice, hirsutism, clitoromegaly, menstrual irregularities) during methyltestosterone therapy. The drug should generally be discontinued when mild virilization is evident, since some adverse androgenic effects (e.g., voice changes) may not subside following discontinuance of the drug. The woman and physician may decide that some virilization is acceptable during treatment for carcinoma of the breast.

Males should be carefully monitored for the development of priapism or excessive sexual stimulation since these are signs of excessive dosage. Males, especially geriatric patients, may become overly stimulated. Stimulation to the point of increasing the nervous, mental, and physical activities beyond the patient's cardiovascular capacity should be avoided when methyltestosterone is used to treat climacteric in males. (See also Cautions: Adverse Effects.) Geriatric males may be at increased risk of developing prostatic hypertrophy and carcinoma during androgen therapy.

Adult or adolescent males should be advised to report too frequent or persistent penile erections to their physician. Females should be advised to report hoarseness, acne, menstrual changes, or the growth of facial hair to their physician. All patients should be advised to report nausea, vomiting, changes in skin color, or ankle swelling to their physician.

Patients receiving high dosages of methyltestosterone should have periodic hemoglobin and hematocrit determinations, since polycythemia may occur.

Methyltestosterone is contraindicated in males with carcinoma of the breast or known or suspected carcinoma of the prostate. Some manufacturers state that the drug also is contraindicated in patients with cardiac, renal, or hepatic decompensation; hypercalcemia; impaired liver function; and in patients who are easily sexually stimulated. Because of the potential risk of serious adverse health effects, methyltestosterone should not be used for enhancement of athletic performance or physique. Patients should be informed of the serious adverse effects associated with misuse and abuse of androgens.

Pediatric Precautions

Androgens should be used with extreme caution in children and only by specialists who are aware of the adverse effects of these drugs on bone maturation. Methyltestosterone should be used cautiously to stimulate puberty, and only in carefully selected males with delayed puberty. (See Uses: Uses in Males.) In children, methyltestosterone may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child, the greater the risk of methyltestosterone compromising final mature stature. If methyltestosterone is administered to prepubertal children (e.g., to stimulate puberty in males), the drug should be used with extreme caution, and radiographic examination of the hand and wrist should be performed every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers. If methyltestosterone is to be used to stimulate puberty in a male with delayed puberty, the potential risk of therapy should be fully discussed with the patient and his parents prior to initiation of the drug.

Mutagenicity and Carcinogenicity

Hepatocellular carcinoma reportedly has occurred in patients receiving long-term therapy with high dosages of androgens. Regression of the tumor does not always occur following discontinuance of androgen therapy. Geriatric patients may be at increased risk of developing prostatic hypertrophy and carcinoma during androgen therapy.

Following implantation of testosterone in mice, cervical-uterine tumors developed and occasionally metastasized. There is some evidence to suggest that injection of testosterone into some strains of female mice increases their susceptibility to hepatomas. Testosterone also has been shown to increase the number of tumors and decrease the degree of differentiation of chemically induced tumors in rats. It is not known whether androgens, including methyltestosterone, are mutagenic.

Pregnancy, Fertility, and Lactation

Pregnancy

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.

Fertility

Although the effect of methyltestosterone on fertility in humans has not been conclusively determined, the drug produces oligospermia and decreased ejaculatory volume in males. Priapism and excessive sexual stimulation also have occurred in males receiving the drug. (See Cautions: Adverse Effects and Precautions and Contraindications.) Increased or decreased libido also has been reported.

Lactation

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.

Drug Interactions

Methyltestosterone may potentiate the action of oral anticoagulants, causing bleeding in some patients. When methyltestosterone therapy is initiated in patients receiving oral anticoagulants, dosage reduction of the anticoagulant may be required to prevent an excessive hypoprothrombinemic response. Patients receiving oral anticoagulants also should be closely monitored when androgen therapy is discontinued.

The metabolic effects of androgens may decrease blood glucose concentrations and insulin requirements in patients with diabetes.

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