OXATREX – 5mg – 100 Tab.

OXATREX – 5mg – 100 Tab.

Oxandrolone 5 mg/tab

100 Tablets For oral use

Therapeutic Class: Androgen

Composition:

Each tablet of OXATREX contains: 5 mg Oxandrolone

Indications:

As an adjunct to promote weight gain after extensive surgery, chronic infections, severe trauma, and without definite cause, to offset protein catabolism associated with prolonged corticosteroid administration, and for relief of osteoporotic bone pain.

Adult:

Individualize. 2.5-20 mg daily given in 2-4 divided doses. Treat for 2-4 weeks; may repeat intermittently as needed. Elderly: 5 mg twice daily.

Children:

s0.1 mg/kg/day; may repeat intermittently as needed.

Contraindications:

Breast (women with hypercalcemia, men) or prostate carcinoma. Nephrosis. Hypercalemia. Pregnancy (Cat.X).

Boxed Warning:

Peliosis hepatis. Liver cell tumors. Blood lipid changes.

Warnings/Precautions:

Risk of peliosis hepatis, liver cell tumors, blood lipid changes associated with atherosclerosis. Discontinue if cholestatic hepatitis, jaundice, abnormal liver function tests, or hypercalcemia occurs.

Cardiovascular disease. COPD. Edematous conditions. Hepatic or renal dysfunction. Monitor hepatic function, serum lipids, Hgb/Hct, and bone age (children) periodically. Monitor for signs of virilization in women; discontinue if mild virilism occurs to prevent irreversible condition. Elderly. Young children. Nursing mothers: not recommended.

Interactions:

May potentiate warfarin (monitor INR/PT), oral hypoglycemics. Increased risk of edema with ACTH, corticosteroids. May suppress clotting factors 11, V, VII and X. May decrease thyroxine-binding globulin and radioactive iodine uptake.

Adverse Reactions:

Peliosis hepatis, premature epiphyseal closure in children, edema, dyslipidemia, hepatic carcinoma, prostatic hypertrophy or carcinoma, gynecomastia, priapism, oligospermia, jaundice, hirsutism, virilization, menstrual irregularities, male pattern baldness, acne, polycythemia, excitation, depression, altered libido, fluid and electrolyte disturbances, decreased glucose tolerance.

Storage:

Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Store away from heat, moisture, and light.

Do not store in the bathroom. Keep out of the reach of children and away from pets.