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Testosterone Enanthate Injection, USP is a sterile, oil-based intramuscular solution providing 200 mg/mL of testosterone enanthate in sesame oil with chlorobutanol as a preservative. It is an androgen indicated for testosterone replacement therapy in males with primary or hypogonadotropic hypogonadism, and secondarily for palliation of inoperable metastatic mammary carcinoma in select female patients.

Available as a 5 mL multiple-dose vial (1,000 mg per vial), this Schedule CIII controlled substance is manufactured under USP standards and distributed by Hikma Pharmaceuticals USA Inc. It is for intramuscular use only and requires a valid prescription.

Key Benefits

• Androgen Replacement Therapy: Indicated for primary hypogonadism (cryptorchidism, orchidectomy, bilateral torsion) and hypogonadotropic hypogonadism due to LHRH deficiency or pituitary-hypothalamic injury.
• Extended-Release Pharmacokinetics: Oil-based ester formulation absorbs slowly from the lipid phase, allowing dosing intervals of 2 to 4 weeks.
• Support of Secondary Male Characteristics: Maintains muscle mass, bone density, male hair distribution, and other androgen-dependent physiological functions.
• Multiple-Dose Vial Efficiency: Each 5 mL vial delivers up to 1,000 mg at 200 mg/mL, supporting multi-patient or multi-cycle clinical use.
• USP-Grade Sterile Manufacturing: Colorless to pale yellow sterile solution produced to United States Pharmacopeia standards.

Dosage and Administration

For intramuscular use only. Inject slowly and deeply into the gluteal muscle; avoid intravascular injection. Confirm diagnosis of hypogonadism with morning serum testosterone measurements on at least two separate days prior to initiating therapy.

• Male Hypogonadism (Replacement Therapy): 50 to 400 mg every 2 to 4 weeks. Total doses above 400 mg per month are generally not required.
• Delayed Puberty in Males: 50 to 200 mg every 2 to 4 weeks for a limited duration (typically 4 to 6 months); dosage adjusted based on chronological and skeletal age.
• Palliation of Inoperable Metastatic Mammary Cancer (Women): 200 to 400 mg every 2 to 4 weeks.
• Visual Inspection: Inspect for particulate matter and discoloration prior to administration. A wet needle or syringe may cause cloudiness but does not affect potency.

Why Choose Testosterone Enanthate Injection, USP?

• Clinically Established Dosing Intervals: Bi-weekly to monthly administration reduces injection frequency compared to shorter-acting testosterone formulations.
• Versatile Vial Format: The 5 mL multi-dose vial (NDC 0143-9750-01) provides flexibility for clinical settings managing multiple patients.
• Stable Storage: Store at controlled room temperature 20°C to 25°C (68°F to 77°F); warming and rotating the vial redissolves any crystals formed during cold storage.

Warnings

• Cardiovascular and Thromboembolic Risk: Postmarketing reports include DVT, pulmonary embolism, myocardial infarction, and stroke. Monitor blood pressure periodically; not recommended for use in patients with uncontrolled hypertension.
• Hepatotoxicity: Prolonged high-dose use has been associated with peliosis hepatis, cholestatic hepatitis with jaundice, and hepatocellular carcinoma. Discontinue immediately if liver function tests become abnormal.
• Abuse Potential and Contraindications: Testosterone enanthate is a Schedule CIII controlled substance with documented abuse risk. Contraindicated in men with known or suspected breast or prostate carcinoma, and in women who are or may become pregnant (androgens cause fetal virilization).

Disclaimer: This product description was generated by AI and is intended for informational purposes only. Please consult the latest package insert.