Depo-testosterone

Depo-testosterone

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Questions & Answers

Side Effects & Adverse Reactions

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.

There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as testosterone cypionate. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with testosterone cypionate and initiate appropriate workup and management.

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.

The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

2. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

History

There is currently no drug history available for this drug.

Other Information

DEPO-Testosterone 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:

Chemical Structure

DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.

Each mL of the 100 mg/mL solution contains:
    Testosterone cypionate................................................................................... 100 mg
    Benzyl benzoate .............................................................................................. 0.1 mL
    Cottonseed oil ................................................................................................ 736 mg
    Benzyl alcohol (as preservative) ..................................................................... 9.45 mg

Each mL of the 200 mg/mL solution contains:
    Testosterone cypionate .................................................................................. 200 mg
    Benzyl benzoate .............................................................................................. 0.2 mL
    Cottonseed oil ................................................................................................ 560 mg
    Benzyl alcohol (as preservative) ..................................................................... 9.45 mg

Depo-testosterone Manufacturers


  • A-s Medication Solutions Llc
    Depo-testosterone (Testosterone Cypionate) Injection, Solution [A-s Medication Solutions Llc]
  • Physicians Total Care, Inc.
    Depo-testosterone (Testosterone Cypionate) Injection, Solution [Physicians Total Care, Inc.]
  • A-s Medication Solutions Llc
    Depo-testosterone (Testosterone Cypionate) Injection, Solution [A-s Medication Solutions Llc]
  • Pharmacia And Upjohn Company
    Depo-testosterone (Testosterone Cypionate) Injection, Solution [Pharmacia And Upjohn Company]
  • Pharmacia And Upjohn Company
    Depo-testosterone (Testosterone Cypionate) Injection, Solution [Pharmacia And Upjohn Company]
  • Pharmacia And Upjohn Company
    Depo-testosterone (Testosterone Cypionate) Injection, Solution [Pharmacia And Upjohn Company]
  • A-s Medication Solutions Llc
    Depo-testosterone (Testosterone Cypionate) Injection, Solution [A-s Medication Solutions Llc]

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