Nomavar Tab

NOMAVAR-10

Oxandrolone Tablets USP

COMPOSITION:

Each film-coated tablet contains:

Oxandrolone USP 10mg

Excipients q.s.

Colour: Approved colour used in coang.

CLINICAL PHARMACOLOGY

Anabolic steroids are synthec derivaves of testosterone. Certain clinical effects and adverse reacons demonstrate the androgenic properes of this class of drugs. Complete dissociaon of anabolic and androgenic effects has not been achieved. The acons 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. Anabolic steroids suppress the gonadotropic funcons of the pituitary and may exert a direct effect upon the testes.

During exogenous administraon of anabolic androgens, endogenous testosterone release is inhibited through inhibion of pituitary luteinizing hormone (LH). At large doses, spermatogenesis may be suppressed through feedback inhibion of pituitary follicle-smulang hormone (FSH). Anabolic steroids have been reported to increase low-density lipoproteins and decrease high-density lipoproteins. These levels revert to normal on disconnuaon of treatment

In a single dose pharmacokinec study of oxandrolone in elderly subjects, the mean eliminaon half-life was 13.3 hours. In a previous single dose pharmacokinec study in younger volunteers, the mean eliminaon half-life was 10.4 hours. No significant differences between younger and elderly volunteers were found for me to peak, peak plasma concentraon or AUC aer a single dose of oxandrolone. The correlaon between plasma level and therapeuc effect has not been defined

INDICATIONS AND USAGE:

Nomavar 10 Tablets, USP are indicated as adjuncve therapy to promote weight gain aer weight loss following extensive surgery, chronic infecons, or severe trauma, and in some paents who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administraon of corcosteroids, and for the relief of the bone pain frequently accompanying osteoporosis (See DOSAGE AND ADMINISTRATION).

DRUG ABUSE AND DEPENDENCE:

Nomavar 10 is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule Ill (non-narcoc).

CONTRAINDICATIONS:

1. Known or suspected carcinoma of the prostrate or the male breast. 2.Carcinoma of the breast in females with hypercalcemia (androgenic anabolic Steroids may smulate osteolyc bone resorpon). 3.Pregnancy, because of possible masculinizaon of the fetus. Nomavar 10 has been shown to cause embryo toxicity, feto toxicity, inferlity, and masculinizaon of female offspring when given in doses 9 mes the human dose. 4.Nephrosis, the nephroc phase of nephris. 5. Hypercalcemia.

WARNINGS:

Cholestac hepas and jaundice may occur with 17-alpha-alkylated androgens at a relavely low dose. If cholestac hepas with jaundice appears or if liver funcon tests become abnormal, Nomavar 10 should be....

Disconnued and the eology should be determined. Drug-induced jaundice is reversible when the medicaon is disconnued in paents with breast cancer, anabolic steroid therapy may cause hypercalcemia by smulang osteolysis. Oxandrolone therapy should be disconnued if hypercalcemia occurs.

Edema with or without congesve heart failure may be a serious complicaon in paents with pre-exisng cardiac, renal, or hepac disease. Concomitant administraon of adrenal corcal steroid or ACTH may increase the edema. In children, androgen therapy may accelerate bone maturaon without producing compensatory gain in linear growth. This adverse effect results in compromised adult height. The younger the child, the greater the risk of compromising final mature height. The effect on bone maturaon should be monitored by assessing bone age of the le wrist and hand every 6 months. Geriatric paents treated with androgenic anabolic steroids may be at an increased risk for the development of prostac hypertrophy and prostac carcinoma.

ANABOLIC STEROIDS HAVE NOT BEEN SHOWN TO ENHANCE ATHLETIC ABILITY Concurrent dosing of Nomavar 10 and warfarin may result in unexpectedly large increases in the Internaonal Normalized Rao (INR) or prothrombin me (PT). When Nomavar 10 is prescribed to paents being treated with warfarin, doses of warfarin may need to be decreased significantly to maintain the desirable INR level and diminish the risk of potenally serious bleeding ( See PRECAUTIONS Drug Interacons) PRECAUTIONS

General:

Women should be observed for signs of virilizaon (deepening of the voice, hirsusm, acne, clitoromegaly). Disconnuaon of drug therapy at the me of evidence of mild virilism is necessary to prevent irreversible virilizaon. Some virilizing changes in women are irreversible even aer prompt disconnuance of therapy and are not prevented by concomitant use of estrogens. Menstrual irregularies may also occur. Anabolic steroids may cause suppression of clothing factors 11, V, VII, and X, and an increase in prothrombin me

DRUG INTERACTION:

Ancoagulants:

Anabolic steroids may increase sensivity to oral ancoagulants. Dosage of the ancoagulant may have to be decreased in order to maintain desired prothrombin me. Paents receiving oral ancoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.

Warfarin:

When Nomavar 10 therapy is iniated in a paent already receiving treatment with warfarin, the INR or prothrombin me (PT) should be monitored closely and the dose of warfarin adjusted as necessary unl a stable target INR or PT has been achieved. Furthermore, in paents receiving both drugs, careful monitoring of the INR orprothrombinme (PT), and adjustment of the warfarin dosage if indicated are recommended when the Nomavar 10 dose is changed or disconnued. Paents should be closely monitored for signs and symptoms of occult bleeding.

Oral Hypoglycemic Agents:

Nomavar 10 may inhibit the metabolism of oral hypoglycemic agents.

Adrenal Steroids or ACTH:

In paents with edema, concomitant administraon with adrenal corcal steroids or ACTH may increase the edema.

Drug/Laboratory Test Interacons:

Anabolic steroids may decrease levels of thyroxine-binding globulin, resulng in decreased total T₄ serum levels and increased resin uptake of T₃ and T₄. Free thyroid hormone levels remain unchanged. In addion, a decrease in PBI and radioacve iodine uptake may occur.

Carcinogenesis, Mutagenesis, Impairment of Ferlity

Animal Data:

Nomavar 10 has not been tested in laboratory animals for carcinogenic or mutagenic effects. In 2-year chronic oral rat studies, a dose-related reducon of spermatogenesis and decreased organ weights (tested, prostate, seminal vesicles, ovaries, uterus, adrenals, and pituitary) were shown.

Human Data:

Liver cell tumors have been reported in paents receiving long term therapy with androgenic anabolic steroids in high doses (see WARNINGS). Withdrawal of the drugs did not lead to regression of the tumors in all cases. Geriatric paents treated with androgenic anabolic steroids may be at an increased risk for the development of prostac hypertrophy and prostac carcinoma.

Pregnancy:

Teratogenic effects Pregnancy Category X(See CONTRAINDICTIONS).

Nursing Mothers:

It is not known whether anabolic steroids are excreted in human milk. Because of the potenal of serious adverse reacons in nursing infants from Nomavar 10, a decision should be made whether to disconnue nursing or to disconnue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Anabolic agents may accelerate epiphyseal maturaon more rapidly than linear growth in children and the effect may connue for 6 months aer the drug has been stopped. Therefore, therapy should be monitored by x-ray studies at 6- month intervals in order to avoid the risk of compromising adult height. Androgenic anabolic steroid therapy should be used very cauously in children and only be specialists who are aware of the effects on bone maturaon (see WARNINGS).

ADVERSE REACTIONS:

Paents with moderate to severe COPD or COPD paents who are unresponsive to bronchodilators should be monitored closely for COPD exacerbaon and fluid retenon. The following adverse reacons have been associated with us of anabolic steroids:

Hepac:

Cholestac jaundice with, rarely, hepac necrosis and death. Hepatocellular neoplasms and pellosishepatls with long-term therapy (see WARNINGS). Reversible changes in liver funcon tests also occur including increased bromsulfophthalein (BSP) retenon, changes in alkaline phosphatase and increases in serum bilirubin, aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT,SPGT)

In Males:

Prepubertal: Phallic enlargement and increase frequency or persistence of erecons. Postpubertal: Inhibion of tescular funcon, tescular atrophy and oligospermia, impotence, chronic priapism, epididymis, and bladder irritability.

In Females:

Clitoral enlargement, menstrual irregularies.

CNS: Habituaon, excitaon, insomnia, depression, and changes in libido

Hematologic: Bleeding in paents on concomitant ancoagulant therapy.

Breast: Gynecomasa.

Larynx: Deepening of the voice in females

Skin: Acne (especially in females and prepubertal males).

Skeletal: Premature closure of epiphyses in children (see PRECAUTIONSPediatric Use).

Larynx: Deepening of the voice in females

Larynx: Deepening of the voice in females

Fluid and Electrolytes: Edema, retenon of serum electrolytes (sodium Chloride, potassium, phosphate, calcium).

Metabolic/Endocrine: Decreased glucose tolerance (see PRECAUTIONS Laboratory Tests), increased creanine excreon. increased serum levels of creanine phosphokinase (CPK). Masculinizaon of the fetus. Inhibion of gonadotrophin secreon

OVERDOSAGE: No symptoms or signs associated with over dosage have been reported. It is possible that sodium and water retenon may occur. The oral LD50 of oxandrolone in mice and dogs is greater than 5,000 mg/kg. No specific andote is known, but gastric lavage may be used.

DOSAGE AND ADMINISTRATION: Therapy with anabolic steroids is adjuncve to and not a replacement for convenonal therapy. The duraon of therapy with Nomavar 10 Tablets, USP will depend on the response of the paent and the possible appearance of adverse reacons. Therapy should be intermient.

Adults: The response of individuals to anabolic steroids varies. The daily dosage is 2.5 mg to 20 mg given in 2 to 4 divided doses. The desired response may be achieved with as lile as 2.5 mg or as much as 20 mg daily. A course of therapy of 2 to 4 weeks is usually adequate. This may be repeated intermiently as indicated.

Children:

For children the total daily dosage of Nomavar 10 Tablets, USP is <0.1 mg per kilogram body weight or <0.045 mg per pound of body weight. This may be repeated intermiently as indicated.

Geriatric Use:

Recommended dose for geriatric paents is 5 mg bid

PRESENTATION:

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

OR

100 Tablets in Plasc Bole.

STORAGE INSTRUCTIONS:

Store at room temperature <25° C, Protect from sunlight. Keep out of reach of children!