- Product description: Fluoxymesterone 10mg
Uses for Fluoxymesterone
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.
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; prolonged therapy required to maintain these characteristics. Prolonged androgen therapy also required to maintain sexual characteristics in other males who develop testosterone deficiency after puberty
May be used to stimulate puberty in carefully selected males with delayed puberty(family history of delayed puberty not secondary to a pathologic disorder) Brief treatment with conservative doses of an androgen occasionally may be justified in these males if they do not respond to psychologic support.
Palliative treatment of androgen-responsive, advanced, inoperable, metastatic (skeletal) breast cancer in women who are 1–5 years postmenopausal and in premenopausal women who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.
Poorly tolerated (see Virilization under Cautions); other hormonal agents (e.g., tamoxifen, anastrozole, letrozole, exemestane) currently are preferred for this use.
Misuse, Abuse, and Dependence
Has been misused and abused by athletes, bodybuilders, weight lifters, and others to enhance athletic performance and physique
Based on review of data, FDA concluded that misuse and abuse of androgens associated with serious adverse cardiovascular, hepatic, endocrine, and mental health effects. (See Misuse, Abuse, and Dependence under Cautions.)
Medical and sport experts (e.g., International Olympic Committee) consider such use to be inappropriate and unacceptable because of known adverse effects and potential for long-term sequelae. Such use by athletes is contrary to the rules and ethical principles of athletic competition.
Evaluate serum testosterone concentrations if misuse or abuse of androgens suspected (e.g., patients experiencing serious adverse cardiovascular or psychiatric effects). Serum testosterone concentrations may be below or within the normal range in patients abusing synthetic derivatives of testosterone.
Fluoxymesterone Dosage and Administration
Individualize dosage according to condition being treated, severity of symptoms, and patient age, gender, and history of prior androgenic therapy.
Adjust dosage carefully according to individual therapeutic response and appearance of adverse effects.
Take into consideration the chronological and skeletal ages of the patient, both in determining the initial dosage and in adjusting the dosage.
Perform radiographic examination of the hand and wrist at 6-month intervals to determine the rate of bone maturation and to assess the effect of therapy on the epiphyseal centers. (See Pediatric Use under Cautions.)
Administer only under the supervision of a qualified clinician experienced in the treatment of breast cancer.
Occasionally, may appear to accelerate progression of the disease; monitor patients closely.
Administer orally, usually as a single daily dose or in 3 or 4 divided doses.
For development of secondary sexual characteristics during adolescence: 5–20 mg daily. Generally, therapy initiated at a higher level within the range (e.g., 10 mg daily). Prolonged therapy is required to maintain sexual characteristics.
Use dosages in the lower end of the usual range for replacement (i.e., 10 mg daily) for 4–6 months. Usual range: 2.5–20 mg daily; however, most patients respond to 2.5–10 mg daily. Titrate carefully using low doses.
Some clinicians recommend lower dosages 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.
Usual dosage: 5–20 mg daily; prolonged therapy is required to maintain sexual characteristics.
Usual dosage: 10–40 mg daily in divided doses.
Generally, ≥1 month of therapy is necessary to obtain a satisfactory subjective response; ≥2–3 months of continuous therapy is required to obtain a satisfactory objective response.
No special population dosage recommendations at this time.
Cautions for Fluoxymesterone
Males with breast cancer or known or suspected prostate cancer.
Known or suspected pregnancy.
Some manufacturers state that fluoxymesterone is contraindicated in patients with serious cardiac, hepatic, or renal disease.
Known hypersensitivity to fluoxymesterone or any ingredient in the formulation.
May cause fetal harm; dose-related virilization of the external genitalia (e.g., clitoral hypertrophy, labial fusion of the external genital fold to form a scrotal-like structure, abnormal vaginal development, persistence of a urogenital sinus) of female fetus reported, particularly when exposure to androgens occurs during the first trimester. If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard; contraindicated in pregnant women. (See Contraindications under Cautions.)
Potentially serious and/or life-threatening adverse hepatic effects (e.g., peliosis hepatis, hepatic adenomas, hepatocellular carcinoma) associated with prolonged use of high dosages of androgens. Discontinuance of androgen therapy following development of hepatocellular carcinoma dose not always result in regression of the tumor.
If cholestatic hepatitis or jaundice occurs, or if liver function test results become abnormal during therapy, discontinue the drug and investigate the etiology of these disorders. Drug-induced jaundice usually is reversible following discontinuance of the drug.
Periodic liver function evaluation recommended.
Priapism or excessive sexual stimulation possible, especially in geriatric men. Oligospermia and decreased ejaculatory volume also may occur in men receiving excessive dosage or prolonged administration. Acute urethral obstruction possible in patients with benign prostatic hypertrophy. If any of these adverse effects occur, discontinue the drug temporarily. If therapy is restarted, use lower dosages.
Possible increased risk for the development of prostatic hyperplasia and prostate cancer, particularly in geriatric patients.
Possible increased or decreased libido.
Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.
Edema, with or without CHF, possible as a result of sodium and water retention and may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. (See Contraindications under Cautions.) If edema occurs and is considered a serious complication, discontinue drug and, if necessary, initiate diuretic therapy. If therapy is restarted, use lower dosages.
Retention of potassium and inorganic phosphates also has occurred.
Possible hypercalcemia resulting from osteolysis, especially in immobile patients and those with metastatic breast cancer. In patients with cancer, hypercalcemia may indicate progression of metastases to the bone. Monitor urine and serum calcium concentrations frequently during the course of androgen therapy in women with metastatic breast cancer. If hypercalcemia occurs, discontinue the drug and institute appropriate measures.
Misuse, Abuse, and Dependence
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) associated with misuse and abuse of androgens (see Misuse, Abuse, and Dependence under Uses); fluoxymesterone preparations currently subject to control 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 discontinued abruptly or dosage substantially reduced in physically dependent patients or in those taking supratherapeutic dosages of such drugs; withdrawal symptoms may persist for weeks or months.
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