Testosterone Cypionate: Package Insert and Label Information (Page 2 of 2)

OVERDOSAGE

There have been no reports of acute overdosage with the androgens.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

Manufactured by:

HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A, e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL

Distributed By

Perrigo®

Minneapolis, MN 55427

Revised: December 2018

PIN523-PER/1

8Z100 RC J6

or

462-794-00

8Z1E4RCJ1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

NDC 0574-0827 -10

CIII

Testosterone Cypionate Injection, USP

2000 mg/10 mL

(200 mg/mL)

For Intramuscular Use Only

Contains Benzyl Alcohol as a Preservative

One 10 mL Sterile Multiple-Dose Vial

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TESTOSTERONE CYPIONATE
testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0827
Route of Administration INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE CYPIONATE (TESTOSTERONE) TESTOSTERONE CYPIONATE 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE
COTTONSEED OIL
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-0827-10 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 10 mL in 1 VIAL, GLASS This package is contained within the CARTON (0574-0827-10)
2 NDC:0574-0827-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
2 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (0574-0827-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091244 05/01/2014
Labeler — Padagis US LLC (967694121)

Revised: 09/2021 Padagis US LLC

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