Indications and usage:
Males:
Testosterone Propionate is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone; A.Primary hypogonadism(congenital or acquired)–testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy B.Hypogonadotropichypogonadism (congenital or acquired)—idiopathic gonadotropin or LHRH deficiency or pituitary-hypothalamic injury from tumours, trauma, or radiation.
Females:
Testosterone Propionate may be used secondarily in women with advancing in operable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal.
Testosterone Propionate has been used for the management of postpartum breast pain and engorgement.
Contraindications:
1.Known hypersensitivity to the drugs.
Males with carcinoma of the breast.
Males with known or suspected carcinoma of the prostate gland
Women who are or who may become pregnant.
Patients with serious cardiac, hepatic or renal disease.
Drug interactions:
1.Oxyphenbutazone-Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
2.Insulin-In diabetic patients, the metabolic effects of androgens may decrease blood glucose and insulin requirements.
Overdosage: There have been no reports of acute overdosage with the anabolics.
Precautions:
General: Patients with benign prostatic hypertrophy maydevelop acute urethral obstruction. Priapism or excessive sexual stimulation may develop.
Oligospermia may occur after prolonged administration or excessive dosage.
If any of these effects appears, the androgen should be stopped and if restarted, a lower dosage should be utilized. Testosterone Propionate should not be used interchangeably with testosterone cypionate because of differences in duration of action.
Testosterone Propionate is not for intravenous use. Information for patients:
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.
Laboratory tests Hemoglobin and hematocrit levels (to detect polycythemia) should be check periodically in patients receiving long-term androgen administration. Serum cholesterol may increaseduring androgen therapy.
Drug/Laboratory test interferences: Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4 Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction,Carcinogenesis:
There are rare reports of hepatocellular carcinoma in patients receiving long term therapy with androgens in high doses.
Withdrawal of the drugs did not lead to regression of the tumours in all cases.
Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic caricinoma although conclusive evidence to support this concept is lacking.
Pregenancy: Teratogenic Effects. Pregenancy Category X.
Nursing mother:
recommended for used in nursing monthers.
Dosage and administration:
Testosterone Propionate is administered by intramuscular injection. It must not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle. The suggested dosage varies. Depending on the age, sex, and diagnosis of the individual patient Replacement therapy in androgen deficient males should be in the range of 25-50mg 2 or 3 times a week.
Dusages used in delayed puberty generally are in the lower ranges and are for a limited duration, for examples, 4-6 months.Carcin of the Breast:
In inoperable carcinoma of the breast.Temporary palliation may be obtained in some cases by therapy with androgens. A dosage of 50-100mg of Testosterone Propionate administered intramuscularly 3 times weekly in recommended.
The above high dosage is likely to have masculinisingeffects, particularly in young women. There many be a disturbing increase in libido, for which sedation may be helpful. It should be remembered that acceleration of tumour growth may be encountered occasionally during androgen therapy, in which case immediate cessation of the hormone is indicated. In some of these cases, the use of estrogen at this point causes regression.
Postpartum Engorgement of the Breasts: A dosage of 25- 50mg of Testosterone Propionate daily for 3-4 days starting at the time of delivery should be adequate in most cases.
Warnings:
In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis, In this case, the drug should be discontinued.
Prolonged use of high doses of androgens has been associated with the development of peliosishepatic and hepatic neoplasms, including hepatocellular carcinoma hepatic can be a life-threatening or fatal complication.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.
In addition to discontinuation of the drug.
diuretic therapy may be required.
Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.
Androgen therapy should be used cautiously in health males with delayed puberty.
The effect on bone maturation should be monitored by addressing 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.
Do not give Testosterone Propionate to elderly asthenic males who may react adversely to overstimulation by androgens.
Supplied / storage:
Testosterone Propionate is supplied in 10 x1ml ampules.
Ampules should be stored at controlled room temperatures below 30 C and protected from light.Parenteral drug products
should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and
container permit. Warming and shaking the ampules should redissolve any crystals that may have formed during storage at
temperature lower than recommended. If it has expired or is damaged, retum to your pharmacist.
Keep out of the reach and sight of children.