OXYTREX – 50mg – 100 Tab.

Description

Oxymetholone 50 mg/tab

100 Tablets For oral use

Therapeutic Class: Androgen

Composition:

Each tablet of OXYTREX contains:

• 50 mg Oxymetholone

Indications:

Anemia caused by deficient red cell production. Acquired aplastic anemia, congenital anemia, myelofibrosis, and hypoplastic anemias due to myelotoxic drugs.

Adults and Children:

Individualized. 1-5 mg/kg per day for at least 3-6 months; may attempt to lower dose or discontinue after remission. Congenital aplastic anemia: may need continued maintenance dose.

Contraindications:

Male breast or prostate carcinoma. Breast cancer in females with hypercalcemia. Nephrosis or the nephrotic phase of nephritis.

Severe hepatic dysfunction. Pregnancy (Cat.X).

Boxed Warning:

Peliosis hepatitis. Liver cell tumors. Increased risk of atherosclerosis due to blood lipid changes (eg, decreased HDL, increased LDL).

Warnings/Precautions:

Not a replacement for other supportive treatments (eg, transfusion; iron, folic acid, Vit. 812, Vit. 86 replacement). Discontinue if jaundice, abnormal liver function, hypercalcemia, or edema occurs. Cardiac, hepatic, or renal dysfunction. Monitor hepatic function, blood, and bone age. Elderly. Young children. Nursing mothers: not recommended.

Interactions:

May potentiate oral anticoagulants. May alter insulin or oral antihyperglycemic needs.

Adverse Reactions:

Peliosis hepatis, premature epiphyseal closure in adolescents, edema, hepatic carcinoma, prostatic hypertrophy or carcinoma, gynecomastia, priapism, oligospermia, nausea, jaundice, hirsutism, virilization, male pattern baldness, acne, polycythemia, headache, CNS excitation, insomnia, altered libido, fluid and electrolyte disturbances, suppression of clotting factors, increased serum cholesterol.

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.