Testosterone Cypionate Injection USP 250 mg
Male sex hormones
In the eunuch and eunuchoid male, androgens act to stimulate and maintain the secondary sexual characteristics associated with the adult male. Androgens influence closure of the epiphyseal lines in males and some females, administration of androgens reduces urinary excretion of nitrogen, sodium, potassium, chloride, phosphorus and water.
Based on a review by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications for certain androgens as follows:
Effective – In the male:
1.Eunuchism, eunuchoidism, deficiency after castration.
2.Male climacteric symptoms when these are secondary to androgen deficiency,
Probably Effective – in the female or male:
1. Postmenopausal or senile osteoporosis. Androgens are without value as a primary therapy, but may be of value as adjunctive therapy. Equal or greater consideration should be given to diet, calcium balance, physiotherapy, and good general health-promoting measures.
Final classification of the less-than-effective indications requires further investigation.
Carcinoma of the male breast.
Carcinoma known or suspected of the prostate.
Cardiac, hepatic or renal decompensation.
Liver function impairment.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Hypercatcaemia may occur in immobilized patients, and in patients with breast cancer. In patients with cancer this may indicate progression of bony metastasis. If this occurs the drug should be discontinued. Testosterone propionate must not be used interchangeably with testosterone cypionate, enanthate or phenylacetate due to the difference in duration of action.
Do not give intravenously.Watch female patients closely for signs of virilization. Some effects such as voice changes may not be reversible when the drug is stopped.
Due to the prolonged action of this drug, it should be administered with caution to patients with organic heart disease of debilitation. Patients with cardiac, renal or hepatic derangement may retain sodium and water thus forming oedema. Priapism or excessive sexual stimulation may develop. Oligospermia and reduced ejaculatory volume may occur after prolonged administration or excessive dosage. Hypersensitivity and gynecomastia may occur.
When any of these effects appear the androgen should be stopped and if restarted, a lower dosage should be utilized. The PBI may increase during androgen therapy without clinical significance.
Acne carcinoma Decreased ejaculatory volume Local irritation Gynecomastia Virilization in females Oedema Hypersensitivity, including skin manifestations and anaphylactiod reactions Priapism Hypercalcaemia (especially in immobile patients and those with metastatic breast
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See”side-effects and special precautions”.
Treatment should be symptomatic and supportive.
STORAGE INSTRUCTIONS :
Store at room temperature below 30° C.
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keep drugs out of children’s reach