Oxabone®

Therapy with anabolic steroids is adjunctive to and not a replacement for conventional therapy. The duration of therapy with oxandrolone will depend on the response of the patient and the possible appearance of adverse reactions. Therapy should be intermittent.

Adults: The response of individuals to anabolic steroids varies. The daily adult dosage is 2.5 mg to 20 mg given in 2 to 4 divided doses. The desired response may be achieved with as little 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 intermittently as indicated.

Children: For children the total daily dosage of oxandrolone is ≤ 0.1 mg per kilogram body weight or ≤ 0.045 mg per pound of body weight. This may be repeated intermittently as indicated.

Geriatric Use: Recommended dose for geriatric patients is 5 mg bid.

 

Contraindications:

1.  Known or suspected carcinoma of the prostate or the male breast.
2. Carcinoma of the breast in females with hypercalcemia (androgenic anabolic steroids may stimulate osteolytic bone resorption).
3. Pregnancy, because of possible masculinization of the fetus. Oxandrolone has been shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when given in doses 9 times the human dose.
4. Nephrosis, the nephrotic phase of nephritis.
5. Hypercalcemia.

Interactions:

Anticoagulants

Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain 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 anabolic steroids are excreted in human milk. Because of the potential of serious adverse reactions in nursing infants from oxandrolone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Warning and Precaution:

Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly). Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens. Menstrual irregularities may also occur.
Anabolic steroids may cause suppression of clotting factors II, V, VII, and X, and an increase in prothrombin time.

Adverse Reactions:

In males

Prepubertal: Phallic enlargement and increased frequency or persistence of erections.

Postpuberal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, and bladder irritability.

In females

Clitoral enlargement, menstrual irregularities.

CNS: Habituation, excitation, insomnia, depression, and changes in libido.

Hematologic: Bleeding in patients on concomitant oral anticoagulant therapy.

Breast: Gynecomastia.

Larynx: Deepening of the voice in females.

Hair: Hirsutism and male pattern baldness in females.

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

Skeletal: Premature closure of epiphyses in children

Fluid and electrolytes: Edema, retention of serum electrolytes (sodium chloride, potassium, phosphate, calcium).

Metabolic/Endocrine: Decreased glucose tolerance, increased creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Masculinization of the fetus. Inhibition of gonadotropin secretion.

Storage:

Store below 30 and protect from light and moisture.