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warnings
WARNINGS Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued. Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis – all potentially life-threatening complications. Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease. Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants. Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height. This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.
ADVERSE REACTIONS The following adverse reactions in the male have occurred with some androgens: Endocrine and Urogenital Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages. Skin and Appendages Hirsutism, male pattern of baldness, seborrhea, and acne. Fluid and Electrolyte Disturbances Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. Gastrointestinal Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (See WARNINGS ). Hematologic Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia. Nervous System Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Allergic Hypersensitivity, including skin manifestations and anaphylactoid reactions. Miscellaneous Inflammation and pain at the site of intramuscular injection.