Testosterone Undecanoate Injection
- Packing: 1 Ml Ampoule, 4 ml Ampoule, 1 ml PFS
- Available Strength : 100 Mg/Ml, 250 mg/ml
Description
Product Description: Testosterone Undecanoate Injection is a medication used for testosterone replacement therapy. It contains testosterone undecanoate, a long-acting ester of testosterone, formulated for intramuscular injection. This formulation provides sustained release of testosterone, allowing for less frequent dosing compared to shorter-acting testosterone preparations.
Indications and Usage: Testosterone Undecanoate Injection is indicated for the treatment of hypogonadism, a condition characterized by insufficient production of testosterone in the body. It is used in adult males to replace or supplement endogenous testosterone levels when deficiency is confirmed by clinical features and biochemical tests.
Dosage and Administration: The dosage of Testosterone Undecanoate Injection depends on the severity of testosterone deficiency and individual patient response. It is administered by deep intramuscular injection, typically into the gluteal muscle. The recommended initial dose is usually 750 mg, followed by subsequent maintenance doses every 10 to 14 weeks.
Dosage Forms and Strengths: Testosterone Undecanoate Injection is available as a clear, colorless solution in vials or ampules. Each milliliter of solution contains a specified amount of testosterone undecanoate, typically ranging from 250 mg to 1000 mg per mL.
Contraindications: Testosterone Undecanoate Injection is contraindicated in patients with hypersensitivity to testosterone or any of the components of the formulation. It should not be used in males with breast or prostate cancer, and in females, especially during pregnancy or breastfeeding.
Warnings and Precautions: Before initiating therapy with Testosterone Undecanoate Injection, healthcare providers should evaluate patients for the presence of prostate cancer, breast cancer, cardiovascular disease, hepatic impairment, renal impairment, and other conditions that may be exacerbated by testosterone therapy. Patients should be monitored regularly for signs of virilization, fluid retention, and other adverse effects.
Adverse Reactions/Side Effects: Common adverse reactions associated with Testosterone Undecanoate Injection include injection site pain, erythema, swelling, and irritation. Other potential side effects may include acne, oily skin, hair loss, gynecomastia, changes in libido, mood swings, and alterations in lipid profiles.
Drug Interactions: Testosterone Undecanoate Injection may interact with other medications, including anticoagulants, corticosteroids, insulin, and certain antidiabetic agents. Healthcare providers should carefully monitor patients receiving concomitant therapy for potential drug interactions.
Use In Specific Populations Description: Testosterone Undecanoate Injection is not recommended for use in children, pregnant women, or nursing mothers due to potential adverse effects on fetal development or infant health. It should be used with caution in elderly patients and those with pre-existing medical conditions.
How Supplied/Storage and Handling: Testosterone Undecanoate Injection is supplied as a solution in vials or ampules. It should be stored at controlled room temperature, protected from light and moisture. Unused portions should be discarded according to local regulations for biohazardous waste disposal.