Testosterone Enanthate Injection

Description

Product Description: Testosterone Enanthate Injection is a pharmaceutical formulation containing testosterone enanthate, a synthetic derivative of the primary male hormone testosterone. It is indicated for the treatment of conditions associated with testosterone deficiency, such as hypogonadism and delayed puberty. This injection provides a convenient and effective way to administer testosterone replacement therapy for therapeutic purposes.

Indications and Usage: Testosterone Enanthate Injection is indicated for testosterone replacement therapy in males with conditions associated with testosterone deficiency, including primary hypogonadism, secondary hypogonadism, and delayed puberty. It is used to restore normal testosterone levels and alleviate symptoms such as fatigue, decreased libido, and erectile dysfunction.

Dosage and Administration: The dosage of Testosterone Enanthate Injection varies depending on the patient's age, weight, and the severity of testosterone deficiency. It is administered via intramuscular injection under the supervision of a healthcare professional. The injection site should be rotated to minimize the risk of local tissue irritation. The dosage regimen should be individualized based on the patient's clinical response and any underlying medical conditions.

Dosage Forms and Strengths: Testosterone Enanthate Injection is available as a sterile solution in single-dose vials. Each mL of solution contains testosterone enanthate equivalent to 200 mg or 250 mg of testosterone.

Contraindications: Testosterone Enanthate Injection is contraindicated in patients with known or suspected prostate or breast cancer, male breast carcinoma, or hypersensitivity to testosterone enanthate or any of the excipients. It should not be used in females, especially during pregnancy or lactation, due to the risk of virilization in the fetus or newborn.

Warnings and Precautions: Administration of Testosterone Enanthate Injection requires careful monitoring of the patient's clinical response and any signs of adverse effects. It should be used with caution in patients with a history of cardiovascular disease, hepatic impairment, or renal dysfunction, as testosterone replacement therapy may exacerbate these conditions. Long-term use may be associated with an increased risk of prostate enlargement or prostate cancer.

Adverse Reactions/Side Effects: Common adverse reactions associated with Testosterone Enanthate Injection include injection site reactions, such as pain, swelling, or redness. Other adverse effects may include acne, fluid retention, gynecomastia, and changes in mood or libido. Rare but serious adverse reactions may include cardiovascular events, such as myocardial infarction or stroke, or thromboembolic events, such as deep vein thrombosis or pulmonary embolism.

Drug Interactions: Testosterone Enanthate Injection may interact with other medications that affect hormonal balance or liver metabolism, such as corticosteroids, anticoagulants, or insulin. Concurrent use with drugs that induce hepatic enzymes, such as barbiturates or rifampin, may increase the metabolism of testosterone, leading to decreased efficacy. Close monitoring is recommended when administering testosterone with other medications affecting the cardiovascular system or coagulation cascade.

Use In Specific Populations Description: The safety and efficacy of Testosterone Enanthate Injection in pediatric patients, geriatric patients, and pregnant or lactating women have not been established. Use with caution in these populations, and only if the potential benefits outweigh the risks. Close monitoring is recommended in patients with renal or hepatic impairment.

How Supplied/Storage and Handling: Testosterone Enanthate Injection is supplied as a sterile solution in single-dose vials. It should be stored at controlled room temperature between 20°C to 25°C (68°F to 77°F), protected from light and moisture. Do not freeze. Discard any unused portion of the solution.