Testosterone Cypionate

Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency, or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. …

• Prior to initiating testosterone cypionate, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range
• Testosterone cypionate injection is for intramuscular use only
• It should not be given intravenously
• Intramuscular injections should be given deep in the gluteal muscle
• The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient
• Dosage is adjusted according to the patient’s response and the appearance of adverse reactions
• Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels
• Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty
• The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose
• For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
• Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended

• Safety and effectiveness
• In pediatric patients below the age of 12 years have not been established

Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

• Known hypersensitivity to the drug 2
• Males with carcinoma of the breast 3
• Males with known or suspected carcinoma of the prostate gland 4
• Women who are pregnant (see PRECAUTIONS, Pregnancy ) 5
• Patients with serious cardiac, hepatic or renal disease (see WARNINGS )

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia. Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

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. …

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. Cardiovascular Disorders: Myocardial infarction, stroke. 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 ). …

Pregnancy Teratogenic Effects The use of testosterone in women who are pregnant is contraindicated. Testosterone is teratogenic and may cause fetal harm. Testosterone is known to cause virilization of the female fetus when administered to pregnant women. Benzyl alcohol can cross the placenta. See WARNINGS .

There have been no reports of acute overdosage with the androgens.

Controlled Substance Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Abuse Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.