Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4 . Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically-induced carcinomas of the liver in rats.
There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.
Pregnancy Category X. (See CONTRAINDICATIONS.)
Testosterone cypionate is not recommended for use in nursing mothers.
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
The following adverse reactions in the male have occurred with some androgens:
Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.
Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.
Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS).
Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.
Vascular Disorders — venous thromboembolism
Miscellaneous: Inflammation and pain at the site of intramuscular injection.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Testosterone is a controlled substance under the Anabolic Steroids Control Act, and Testosterone Cypionate Injection has been assigned to Schedule III.
There have been no reports of acute overdosage with the androgens.
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 available as follows:
1 mL vials NDC 0574-0820-01
10 mL vials NDC 0574-0820-10
Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.
Hilliard, OH 43026
Minneapolis, MN 55427
9Z800 RC J2
Rev 06-14 B
Sterile Alcohol Prep Pad
Active Ingredient Purpose
Isopropyl Alcohol 70% v/v Antiseptic
For preparation of the skin prior to injection.
- For external use only
- Flammable, keep away from flame or fire
- Not for use with electrocautinary devices or procedures
- Do not use in eyes
- Irritation or redness develops
- condition persists for more than 72 hours
- Cleansing of an injection site
In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Wipe injection site vigorously and discard
- Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F
- avoid excessive heat
NDC 0574-0820 -01
Testosterone Cypionate Injection, USP CIII
For Intramuscular Use Only
One 1 mL Sterile Vial
1 Pad Medium
Sterile Alcohol Prep Pad
For External Use Only
Sterile unless pouch is opened or damaged
Saturated with 70% Isopropyl Alcohol
Made in China Reorder No. 1113
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