Source: FDA, National Drug Code (US) Revision Year: 2020
DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Prior to initiating DEPO-Testosterone (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.
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.
There have been no reports of acute overdosage with the androgens.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
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