NOMADROL

Oxymetholone Tablets BP

COMPOSITION:

Each film-coated tablet contains:

Oxymetholone BP 50mg

Excipients q.s.

Colour: Approved colour used in coang.

CLINICAL PHARMACOLOGY

Anabolic steroids are synthec derivaves of testosterone. Oxymetholone enhances the producon and urinary excreon of erythropoien in paents with anemias due to bone marrow failure and oen smulates erythropoiesis in anemias due to deficient red cell producon. The acons of aaabolic steroids are 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 funcons of the pituitary and may exert a direct effect upon the testes.

INDICATIONS AND USAGE:

Nomadrol Tablet is indicated in the treatment of anemias caused by deficient red cell producon. Acquired a plasc anemia, congenital aplasc anemia, myelofibrosis and the hypoplasc anemias due to the administraon of myelotoxic drugs oen respond. Nomadrol Tablets should not replace other supporve measures such as transfusion, correcon of iron, folic acid, vitamin B＆#8321;＆#8322; or pyridoxine deficiency, anbacterial therapy and the appropriate use of corcosteroids.

Drug Abuse And Dependence:

Nomadrol Tablet is considered to be a controlled substance and is listed in Schedule Ill.

CONTRAINDICATIONS:

1. Carcinoma of the prostate or breast in male paents. 2. Carcinoma of the breast in females with hypercalcemia; androgenic anabolic steroids may smulate osteolyc resorpon of bones. 3. Oxymetholone can cause fetal harm when administered to pregnant women. It is contraindicated in women who are or may become pregnant. If the paent becomes pregnant while taking the drug, she should be apprised of the potenal hazard to the fetus. 4. Nephrosis or the nephroc phase of nephris. 5. Hypersensivity to the drug. 6. Severe hepac dysfuncon.

WARNINGS:

The following condions have been reported in paents receiving androgenic anabolic steroids as a general class of drugs:

Peliosishepas, a condion in which liver and somemes splenic ssue is replaced with blood-filled cysts, has been reported in paents receiving androgenic anabolic steroid therapy. These cysts are somemes present with minimal hepacdys funcon, but at other mes they have been associated with liver failure. They are oen not recognized unl 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 oen these tumors are benign and androgen-dependent, but fatal malignant tumors have been reported. Withdrawal of drug oen results in regression or cessaon of progression of the tumor. However, hepac tumors associated with androgens or anabolic steroids are much more vascular than other hepac tumors and may be silent unl life threatening intra-abdominal hemorrhage develops

Blood lipid changes that are known to be associated with increased risk of atherosclerosis are seen in paents treated with androgens and anabolic steroids. These changes include decreased high density lipoprotein and somemes 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.

Cholestac hepas and jaundice occur with 17-alpha-alkylated androgens at relavely low doses. Clinical jaundice may be painless, with or without pruritus. It may also be associated with acute hepac enlargement and right upper quadrant pain, which has been mistaken for acute (surgical) obstrucon of the bileduct. Drug-induced jaundice is usually reversible when the medicaon is disconnued. Connued therapy has been associated with hepac coma and death. Because of the hepatoxicity associated with oxymetholone administraon, periodic liver funcon tests are recommended

In paents with breast cancer, anabolic steroid therapy may cause hypercalcemia by smulang osteolysis. In this case, the drug should be disconnued.

Edema with or without congesve heart failure may be a serious complicaon in paents with pre-exisng cardiac, renal or hepac disease. Concomitant administraon with adrenal steroids or ACTH may add to the edema. This is generally controllable with appropriate diurec and/or digitalis therapy.

Geriatric male paents treated with androgenic anabolic steroids may be at an increased risk for the development of prostate hypertrophy and prostac carcinoma.

Anabolic steroids have not been shown to enhance athlec ability.

PRECAUTIONS :

Women should be observed for signs of virilizaon (deepening of the voice, hirsusm, acne and clitoromegaly). To prevent irreversible change, drug therapy must be disconnued when mild virillsm Is first detected. Such virilizaon is usual following androgenic anabolic steroid use at high doses. Some virilizing changes in women are irreversible even aer prompt disconnuance of therapy and are not prevented by concomitant use of estrogens. Menstrual irregularies, including amenorrhea, may also occur:

The insulin or oral hypoglycemic dosage may need adjustment in diabec paents who receive anabolic steroids. Anabolic steroids may cause suppression of clong factors II, V, VII and X, and an increase in prothrombin me.

Carcinogenesis, Mutagenesis, Impairment of Ferlity:

A two-year carcinogenicity study in rats given oxymetholone orally was conducted under the auspices of the US Naonal Toxicology Program (NTP). A wide spectrum of neoplasc and non-neoplasc effects was observed. In male rats, no effects were classified as neoplasc in response to doses up to 150 mg/kg/day (5 mes therapeuc exposures with 5 mg/kg based on body surface area). Female rats given 30 mg/kg/day (1 fold the maximum recommended clinical dose of 5 mg/kg/day based on the body surface area) had increased incidences of lung alveolar/bronchiolar adenoma and adenoma or carcinoma

combined. At 100 mg/kg/day (about 3fold the maximum recommended clinical dose of 5 mg/kg/ day based on BSA), female rats had increased incidences of hepatocellular adenoma and adenoma or carcinoma combined; the combined incidence of squamous cell carcinoma and carcinoma of the sweat glands also was increased.

Human Data:

There are rare reports of hepatocellular carcinoma in paents receiving longterm therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Geriatric paents treated with androgens may be at an increased risk of developing prostac hypertrophy and prostac carcinoma although conclusive evidence to support this concept is lacking.

Impairment of ferlity was not tested directly in animal species. However, oligospermia in males and amenorrhea in females are potenal adverse effects of treatment with Nomadrol Tablets. Therefore, impairment of ferlity is a possible outcome of treatment with Nomadrol Tablets.

Pregnancy:

Oxymetholone can cause fetal harm when administered to pregnant women. It is contraindicated in women who a re or may become pregnant. If the paent becomes pregnant while taking the drug, she should be apprised of the potenal hazard to the fetus.

Nursing Mothers:

It is not known whether anabolics are excreted in human milk. Because of the potenal for sefious adverse reacons in nursed infants from anabolics, women who take oxymetholone should not nurse

DRUG INTERACTION:

Warfarin: Clinicaliy significant pharmacokinec and pharmacodynamic interacons between anabolic steroids and warfarin have been reported in healthy volunteers. In paents receiving both Nomadrol Tablets and warfarin, careful monitoring of the INR or PT and adjustment of the warfarin dosage, if indicated, are recommended when the Nomadrol dose is changed or disconnued. Paents should be closely monitored for signs and symptoms of occult bleeding. Ancoagulants: Anabolic steroids may increase sensivity to oral ancoagulants. Dosage of the ancoagulant may have to be decreased in order to maintain the desired prothrombin me.

Drug/Laboratory Test Interferences:

Therapy with androgenic anabolic steroids may decrease levels of thyroxine binding globulin resulng in decreased total T＆#8324; serum levels and increased resin uptake of T＆#8323; and T＆#8324; Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfuncon. Altered tests usually persist for 2 to 3 weeks aer stopping anabolic therapy.

Anabolic steroids may cause an increase in prothrombin me. Anabolic steroids have been shown to alter fasng blood sugar and glucose tolerance tests.

ADVERSE REACTIONS:

Hepoc: Cholestac jaundice with, rarely, hepac necrosis and death. Hepatocellular neoplasms and peliosis hepas have been reported in associaon with long-term androgenic anabolic steroid therapy.

Genitourinory System:

In Men:

Prepubertal: Phallic enlargement and increased frequency of erecons.

Postpubertal: Inhibion of tescular funcon, tescular atrophy and oligospermia, impotence, chronicpriapism, epididymis, bladder irritability and decrease in seminal volume.

In Women:

Clitoral enlargement, menstrual irregularies.

In Both Sexes:

Increased or decreased libido.

CNS: Excitaon, insomnia.

Gastrointesanl: Nausea, voming, diarrhea.

Hematologic: Bleeding in paents on concomitant ancoagulant therapy, irondeficiency anemia.

Leukemia has been observed in paents with aplasc anemia treated with oxymetholone. The role, if any, of oxymetholone is unclear because malignant transformaon has been seen in paents with blood dyscrasias and leukemia has been reported in paents with aplasc anemia who have not been treated with oxymetholone.

Breast: Gynecomasa

Larynx:Deepening of the voice in women.

Hair: Hirsusm and male-paern baldness in women, male-paern 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, retenon 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 creane and creanine excreon, increased serum levels of creanine phosphokinase (CPK). Reversible changes in liver funcon tests also occur, including increased Bromsulphalein (BSP) retenon and increases in serum bilirubin, glutamic-oxaloacec transaminase (SGOT), and alkaline phosphatase

OVER DOSAGE:

There have been no reports of acute over dosage with anabolics.

DOSAGE AND ADMINISTRATION:

The recommended daily dose in children and adults is 1-5 mg/kg body weight per day. The usual effecve dose is 1-2 mg/kg/day but higher doses may be required, and the dose should be individualized: Response is not oen immediate, and a minimum trial of three to six months should be given. Following remission, some paents may be maintained without the drug; others may be maintained on an established lower daily dosage. A connued maintenance dose is usually necessary in paents with congenital aplasc anemia.

PRESENTATION:

2 blister strips of 25 tablets are packed in a printed carton along with a leaflet. OR

50 Tablets in Plasc Bole.

STORAGE INSTRUCTIONS:

Store at room temperature <25° C, Protect from sunlight.

Keep out of reach of children!