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Depo-Testosterone (Testosterone Cypionate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

DEPO-Testosterone Injection 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)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

DOSAGE AND ADMINISTRATION

DEPO-Testosterone 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 DEPO-Testosterone 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, 50–400 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.

HOW SUPPLIED

DEPO-Testosterone Injection is available as follows:

100 mg/mL
    10 mL vials                    NDC 0009-0347-02

200 mg/mL
    1 mL vials                      NDC 0009-0417-01
    10 mL vials                    NDC 0009-0417-02

Vials should be stored at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from light.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

Rx only

LAB-0245-7.0

June 2014

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