Anapolon Instructions for Use, Dosage, Composition, Analogues, Side Effects

Anabolic/androgenic steroids should be used with extreme caution in children and only by specialists familiar with their effects on bone maturation. Due to the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically. In patients with breast cancer, anabolic steroid therapy can cause hypercalcemia by stimulating osteolysis.

Due to the hepatotoxicity associated with oxymetholone administration, periodic liver function tests are recommended. Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of anabolic-androgenic steroid therapy (see WARNING). The recommended daily dose in children and adults is 1–5 mg/kg of body weight per day. The ordinary effective dose is 1–2 mg/kg/day, but higher doses may be required, and the dosage should be individualized. The response is not usually immediate, and a minimum trial of three to six months should be conducted. After remission, some patients can be maintained off the drug, while others can be maintained on a lower, established daily dose.

• Because iron deficiency anemia has been observed in some patients treated with oxymetholone, periodic determination of serum iron and iron-binding capacity is recommended.
• Anabolic steroids have been reported to reduce the level of high-density lipoproteins and raise the level of low-density lipoproteins.
• This can usually be controlled with appropriate diuretic and/or digitalis therapy.
• After remission, some patients can continue without the medication, while others can continue on a lower, established daily dose.

Laboratory Tests

In most cases, these tumors are benign and androgen-dependent, but fatal malignant tumors have been reported. Drug withdrawal often results in regression or cessation of tumor progression. However, liver tumors associated with androgens or anabolic steroids are much more vascular than other liver tumors and may remain asymptomatic until life-threatening intra-abdominal hemorrhage develops. Anabolic agents can accelerate epiphyseal maturation more rapidly than linear growth in children, and this effect can continue for up to 6 months after the drug has been discontinued. Therefore, therapy should be monitored with X-ray studies at 6-month intervals to avoid the risk of compromising adult height.

A continued maintenance dose is generally necessary in patients with congenital aplastic anemia. Geriatric male patients treated with anabolic-androgenic steroids may have an increased risk of developing prostatic hypertrophy and prostate carcinoma. A two-year carcinogenicity study was conducted in rats receiving oral oxymetholone under the auspices of the U.S. National Toxicology Program.

Anapolon

Peliosis hepatis, a condition in which the liver and sometimes spleen tissue is replaced with blood-filled cysts, has been reported in patients receiving anabolic-androgenic steroid therapy. These cysts are sometimes present with minimal liver dysfunction, but at other times have been associated with liver failure. They are often not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of the drug usually results in complete resolution of the lesions. Periodic (every 6 months) bone age X-ray examinations should be performed during treatment of prepubertal patients to determine the rate of bone maturation and the effects of anabolic-androgenic steroid therapy on the epiphyseal centers. Anabolic steroids have been reported to reduce high-density lipoprotein levels and raise low-density lipoprotein levels.

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Changes in blood lipids known to be associated with an increased risk of atherosclerosis are observed in patients treated with androgens and anabolic steroids. These changes include a decrease in high-density lipoprotein (HDL) and, sometimes, an increase in low-density lipoprotein (LDL). These changes can be very pronounced and could have a significant impact on the risk of atherosclerosis and coronary artery disease.

Anapolon Tablets are indicated for the treatment of anemias caused by deficient red blood cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis, and hypoplastic anemias due to the administration of myelotoxic drugs often respond. However, as indicated below in ADVERSE REACTIONS, oligospermia in men and amenorrhea in women are potential adverse effects of treatment with Anapolon Tablets. Therefore, impaired fertility is a possible outcome of treatment with Anapolon Tablets. Because iron deficiency anemia has been observed in some patients treated with oxymetholone, periodic determination of serum iron and iron-binding capacity is recommended.

Elevated low-density lipoproteins (LDL) and decreased high-density lipoproteins (HDL) are considered cardiovascular risk factors. Serum lipids and HDL cholesterol should be measured periodically. Clinical studies of Anapolon tablets did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently to younger subjects.

Some virilizing changes in women are irreversible even after immediate discontinuation of therapy and are not prevented by concomitant estrogen use. Cholestatic hepatitis and jaundice occur with 17-alpha-alkylated androgens at relatively low doses. It can also be associated with acute liver enlargement and right upper quadrant pain, which has been mistaken for acute (surgical) bile duct obstruction. Drug-induced jaundice is usually reversible upon discontinuation of the drug.

In male rats, no effects were classified as neoplastic in response to doses up to 150 mg/kg/day (5 times the therapeutic exposure of 5 mg/kg based on body surface area). Leukemia has been observed in patients with aplastic anemia treated with oxymetholone. The role, if any, of oxymetholone is unclear because malignant transformation has been observed in patients with blood dyscrasias and leukemia has been reported in patients with aplastic anemia who have not been treated with oxymetholone. Edema, with or without congestive heart failure, can be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. Concomitant administration with adrenal steroids or ACTH may increase edema. This can usually be controlled with appropriate diuretic and/or digitalis therapy .