There have been no reports of acute overdosage with the androgens.
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.
Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular administration available as:
- 1 mL Vial, Cartons of 1 vial NDC 0574-0827-01
- 10 mL Multiple Dose Vials, Cartons of 1 vial NDC 0574-0827-10
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light.
HIKMA FARMACÊUTICA (PORTUGAL), S.A.
Estrada do Rio da Mó, 8, 8A, e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL
Minneapolis, MN 55427
Revised: December 2018
8Z100 RC J6
NDC 0574-0827 -10
Testosterone Cypionate Injection, USP
2000 mg/10 mL
For Intramuscular Use Only
Contains Benzyl Alcohol as a Preservative
One 10 mL Sterile Multiple-Dose Vial
- The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.
| TESTOSTERONE CYPIONATE |
testosterone cypionate injection, solution
|Labeler — Padagis US LLC (967694121)|
Revised: 09/2021 Padagis US LLC
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