ANADROL(oxymetholone) Tablets for oral administration each contain 50 mg of the steroid oxymetholone, a potent anabolic and androgenic drug, oxymetholone is white to creamy white, crystalline powder. Practically insoluble in water, freely soluble in chloroform, soluble in dioxane, sparingly soluble in alcohol and slightly in water.
When there is sufficient intake of calories and protein, nitrogen balance is improved with anabolic agents but only. It has not been established if this positive nitrogen balance is of primary benefit in the utilization of protein-building dietary substances. ANADROL enhances the production and urinary excretion of erythropoietin in patients with anemias due to bone marrow failure and often stimulates erythropoiesis in anemias due to deficient red cell production.
The androgenic properties of this class of drugs was demonstrated by some certain clinical effects and adverse reactions. Complete dissociation of anabolic and androgenic effects has not been achieved. The actions of anabolic steroids are therefore similar to those of male sex hormones with the possibility of causing serious disturbances of growth and sexual development if given to young children. They suppress the gonadotropic functions of the pituitary and may affect the testes directly.
Indications and usage:
ANADROL Tablets is generally used for the treatment of anemias caused by deficient red cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond. ANADROL Tablets should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy and the appropriate use of corticosteroids.
Dosage and administration:
Usually, the effective dose is 1-2 mg/kg/day but higher doses may be required, and the dose should be individualized. Response is not often immediate, and a minimum trial of three to six months should be given. The dose in Children and adults is recommended daily 1-5 mg/kg body weight per day. Following remission, some patients may be maintained without the drug; others may be maintained on an established lower daily dosage. It is usually necessary for patients with congenital aplastic anemia to take a continued maintenance dose.
1. Male patients with carcinoma of the prostate or breast.
2. Females with hypercalcemia carcinoma of the breast; androgenic anabolic steroids may stimulate osteolytic resorption of bones.
3. Fetal harm will be cuased oxymetholone by when administered to pregnant women.
4. Nephrosis or the nephrotic phase of nephritis.
5. Hypersensitivity to the drug.
6. Severe hepatic dysfunction.
Warnings and precautions:
The conditions reported in patients receiving androgenic anabolic steroids as a general class of drugs is as following:
Peliosis hepatis, a condition in which liver and sometimes splenic tissue is replaced with blood-filled cysts, has been reported in patients receiving androgenic anabolic steroid therapy. These cysts are sometimes present with minimal hepatic dysfunction, but at other times they have been associated with liver failure. They are often not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.
Liver cell tumors are also reported. Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have been reported. Withdrawal of drug often results in regression or cessation of progression of the tumor. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening intra-abdominal hemorrhage develops.
Blood lipid changes that are known to be associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high density lipoprotein and sometimes increased low density lipoprotein. The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.
Cholestatic hepatitis and jaundice occur with 17-alpha-alkylated androgens at relatively low doses. Clinical jaundice may be painless, with or without pruritus. It may also be associated with acute hepatic enlargement and right upper-quadrant pain, which has been mistaken for acute (surgical) obstruction of the bile duct. Drug-induced jaundice is usually reversible when the medication is discontinued. Continued therapy has been associated with hepatic coma and death. Because of the hepatoxicity associated with oxymetholone administration, periodic liver function tests are recommended.
In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued.
Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease. Concomitant administration with adrenal steroids or ACTH may add to the edema. This is generally controllable with appropriate diuretic and/or digitalis therapy.
Geriatric male patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostate hypertrophy and prostatic carcinoma.
Anabolic steroids have not been shown to enhance athletic ability.
Warfarin: Clinically significant pharmacokinetic and pharmacodynamic interactions between anabolic steroids and warfarin have been reported in healthy volunteers. When anabolic steroid therapy is initiated in a patient already receiving treatment with warfarin, the INR (international normalized ratio) or prothrombin time (PT) should be monitored closely and the dose of warfarin adjusted as necessary until a stable target INR or PT has been achieved. Furthermore, in patients receiving both ANADROL Tablets and warfarin, careful monitoring of the INR or PT and adjustment of the warfarin dosage, if indicated, are recommended when the ANADROL dose is changed or discontinued. Patients should be closely monitored for signs and symptoms of occult bleeding.
Anticoagulants: Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain the desired prothrombin time. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.
Pregnancy and lactation:
Pregnancy category X
It is not known whether anabolics are excreted in human milk. Because of the potential for serious adverse reactions in nursed infants from anabolics, women who take oxymetholone should not nurse.
Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis have been reported in association with long-term androgenic anabolic steroid therapy.
Prepubertal: Phallic enlargement and increased frequency of erections.
Postpubertal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, bladder irritability and decrease in seminal volume.
Clitoral enlargement, menstrual irregularities.
In Both Sexes:
Increased or decreased libido.
CNS: Excitation, insomnia.
Gastrointestinal: Nausea, vomiting, diarrhea.
Hematologic: Bleeding in patients on concomitant anticoagulant therapy, iron-deficiency anemia.
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 seen in patients with blood dyscrasias and leukemia has been reported in patients with aplastic anemia who have not been treated with oxymetholone.
Larynx: Deepening of the voice in women.
Hair: Hirsutism and male-pattern baldness in women, male-pattern of hair loss in postpubertal males.
Skin: Acne (especially in women and prepubertal boys).
Skeletal: Premature closure of epiphyses in children, muscle cramps.
Body as a Whole: Chills.
Fluid and Electrolytes: Edema, retention of serum electrolytes (sodium, chloride, potassium, phosphate, calcium).
Metabolic/Endocrine: Decreased glucose tolerance, increased serum levels of low-density lipoproteins and decreased levels of high-density lipoproteins, increased creatine and creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Reversible changes in liver function tests also occur, including increased Bromsulphalein (BSP) retention and increases in serum bilirubin, glutamic-oxaloacetic transaminase (SGOT), and alkaline phosphatase.
There have been no reports of acute overdosage with anabolics.
Store in cool dry place below 30℃. Protect from light.ay