DESCRIPTION

Testosterone cypionate injection, USP, because that intramuscular injection, contains testosterone cypionate i m sorry is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.

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Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and also stable in air. That is insoluble in water, openly soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.

The chemical surname for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and also the molecular load 412.61.

The structure formula is represented below:


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Testosterone cypionate injection, USP is accessible in two strengths, 100 mg/mL and also 200 mg/mL testosterone cypionate.

Each mL that the 100 mg/mL systems contains:

Testosterone cypionate100 mg
Benzyl benzoate0.1 mL
Cottonseed oil736 mg
Benzyl alcohol (as preservative)9.45 mg

Each mL the the 200 mg/mL equipment contains:

Testosterone cypionate200 mg
Benzyl benzoate0.2 mL
Cottonseed oil560 mg
Benzyl alcohol (as preservative)9.45 mg

CLINICAL PHARMACOLOGY

Endogenous androgens room responsible because that normal growth and advance of the male sex organs and for maintain of second sex characteristics. These impacts include growth and maturation that the prostate, seminal vesicles, penis, and also scrotum; advance of male hair distribution, such together beard, pubic, chest, and also axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in human body musculature and fat distribution. Medicine in this class additionally cause retention of nitrogen, sodium, potassium, and phosphorous, and also decreased urinary excretion of calcium. Androgens have been report to rise protein anabolism and decrease protein catabolism. Nitrogen balance is enhanced only once there is sufficient intake that calories and also protein.

Androgens are responsible for the growth spurt of adolescence and for ultimate termination of straight growth, brought about by blend of the epiphyseal expansion centers. In children, exogenous androgens accelerate linear expansion rates, but may reason disproportionate advance in bone maturation. Usage over lengthy periods may an outcome in combination of the epiphyseal development centers and also termination that the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production the erythropoietic stimulation factor.

During exogenous administration of androgens, endogenous testosterone relax is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses that exogenous androgens, spermatogenesis may likewise be suppressed with feedback inhibition of pituitary follicle stimulating hormone (FSH).

There is a lack of comprehensive evidence that androgens are efficient in fractures, surgery, convalescence, and also functional uterine bleeding.


Pharmacokinetics

Testosterone esters are much less polar than cost-free testosterone. Testosterone esters in oil injected intramuscularly are soaked up slowly from the lipid phase; thus, testosterone cypionate can be provided at intervals of two to 4 weeks.

Testosterone in plasma is 98 percent bound come a details testosterone-estradiol binding globulin, and around 2 percent is free. Generally, the quantity of this sex-hormone binding globulin in the plasma will determine the circulation of testosterone between free and tied forms, and also the totally free testosterone concentration will determine its half-life.

About 90 percent that a dose of testosterone is excreted in the urine together glucuronic and sulfuric mountain conjugates the testosterone and also its metabolites; around 6 percent that a sheep is excreted in the feces, mainly in the conjugated form. Inactivation the testosterone occurs generally in the liver. Testosterone is metabolized to various 17-keto steroids through two various pathways.

The half-life that testosterone cypionate as soon as injected intramuscularly is approximately eight days.

In plenty of tissues the activity of testosterone shows up to rely on palliation to dihydrotestosterone, which binds to cytosol receptor proteins. The steroid-receptor facility is transported come the nucleus where it initiates transcription events and cellular transforms related to androgen action.


INDICATIONS and USAGE

Testosterone cypionate injection, USP is suggested for replacement treatment in the masculine in conditions associated with symptom of deficiency or lack of endogenous testosterone.

Primary hypogonadism (congenital or acquired) testicular failure because of cryptorchidism, bilateral torsion, orchitis, noodles testis syndrome; or orchidectomy.Hypogonadotropic hypogonadism (congenital or acquired) idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury native tumors, trauma, or radiation.

CONTRAINDICATIONSKnown hypersensitivity to the drugMales through carcinoma that the breastMales with known or suspected carcinoma of the prostate glandWomen who are or who may end up being pregnantPatients with severe cardiac, hepatic or renal disease

WARNINGS

Hypercalcemia may occur in immobilized patients. If this occurs, the drug have to be discontinued.

Prolonged usage of high doses of androgens (principally the 17-α alkyl-androgens) has actually been connected with advance of hepatic adenomas, hepatocellular carcinoma, and also peliosis hepatis – all possibly life-threatening complications.

Geriatric patients treated v androgens may be at an enhanced risk of occurring prostatic hypertrophy and prostatic carcinoma although conclusive proof to assistance this ide is lacking.

Edema, v or there is no congestive love failure, may be a serious complication in patients v pre-existing cardiac, renal or hepatic disease.

Gynecomastia might develop and also occasionally stubborn in patients gift treated because that hypogonadism.

This product includes benzyl alcohol. Benzyl alcohol has actually been reported to be linked with a deadly “Gasping Syndrome” in premature infants.

Androgen therapy have to be provided cautiously in healthy and balanced males through delayed puberty. The impact on bone maturation should be monitored through assessing bone age of the wrist and also hand every 6 months. In children, androgen treatment might accelerate bone maturation without producing compensatory acquire in linear growth. This adverse impact may result in jeopardized adult stature. The younger the son the greater the risk of compromising final mature height.

This drug has not been shown to be safe and also effective for the improvement of athletic performance. Because of the potential risk of severe adverse wellness effects, this drug need to not be offered for together purpose.


PRECAUTIONS

General

Patients with benign prostatic hypertrophy may construct acute urethral obstruction. Priapism or excessive sexual stimulation might develop. Oligospermia may take place after prolonged administration or excessive dosage. If any of these results appear, the androgen need to be stopped and if restarted, a reduced dosage must be utilized.

Testosterone cypionate need to not be provided interchangeably v testosterone propionate since of differences in expression of action.

Testosterone cypionate is no for intravenous use.


Information for Patients

Patients must be instructed come report any kind of of the following: nausea, vomiting, changes in skin color, fishing eye swelling, too constant or persistent erections of the penis.


Laboratory Tests

Hemoglobin and also hematocrit level (to finding polycythemia) must be checked periodically in patients receiving irreversible androgen administration.

Serum cholesterol might increase during androgen therapy.


Drug Interactions

Androgens may rise sensitivity to dental anticoagulants. Dosage that the anticoagulant may require palliation in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent management of oxyphenbutazone and also androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic impacts of androgens might decrease blood glucose and, therefore, insulin requirements.


Drug/Laboratory test Interferences

Androgens may decrease levels of thyroxine­binding globulin, bring about decreased total T4 serum levels and increased resin uptake of T3 and T4. Totally free thyroid hormone levels stay unchanged, however, and also there is no clinical evidence of thyroid dysfunction.


Carcinogenesis


Animal Data

Testosterone has been tested by subcutaneous injection and also implantation in mice and rats. The implant induced cervical-uterine tumors in mice, i m sorry metastasized in some cases. Over there is suggestive proof that injection that testosterone into some strains of female mice increases their susceptibility come hepatoma. Testosterone is also known to rise the number of tumors and decrease the level of differentiation of chemically induced carcinomas that the liver in rats.


Human Data

There are rare reports the hepatocellular carcinoma in patient receiving long-term therapy through androgens in high doses. Withdrawal of the drugs did not cause regression that the tumors in all cases.

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Geriatric patient treated v androgens may be in ~ an enhanced risk of emerging prostatic hypertrophy and also prostatic carcinoma although conclusive evidence to support this ide is lacking.