testosterone cypionate 200 MG/ML Injectable Solution
Generic Name: TESTOSTERONE CYPIONATE
Brand Name: Testosterone Cypionate
- Substance Name(s):
- TESTOSTERONE CYPIONATE
WARNINGS
Hypercalcemia may occur in immobilized patients.
If this occurs, the drug should be discontinued.
Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis – all potentially life-threatening complications.
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.
Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.
Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.
This product contains benzyl alcohol.
Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
Androgen therapy should be used cautiously in healthy males with delayed puberty.
The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months.
In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth.
This adverse effect may result in compromised adult stature.
The younger the child the greater the risk of compromising final mature height.
This drug has not been shown to be safe and effective for the enhancement of athletic performance.
Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.
DRUG INTERACTIONS
Drug interactions: Androgens may increase sensitivity to oral anticoagulants.
Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.
Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
OVERDOSAGE
There have been no reports of acute overdosage with the androgens.
DESCRIPTION
Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air.
It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.
The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-.
Its molecular formula is C27H40O3, and the molecular weight 412.61.
The structural formula is represented below: Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate.
Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.
Chemical Structure
HOW SUPPLIED
Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows: 1 mL vials NDC 54868-3618-1 10 mL vials NDC 54868-3618-0 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.
INDICATIONS AND USAGE
Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
PEDIATRIC USE
Pediatric use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
PREGNANCY
Pregnancy: Teratogenic Effects.
Pregnancy Category X.
(See CONTRAINDICATIONS.)
NUSRING MOTHERS
Nursing mothers: Testosterone cypionate is not recommended for use in nursing mothers.
INFORMATION FOR PATIENTS
Information for patients: Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.
DOSAGE AND ADMINISTRATION
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.