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Testosterone Cypionate Injection, USP is a Schedule III (CIII), prescription-only, oil-based intramuscular solution indicated for testosterone replacement therapy (TRT) in males with primary or hypogonadotropic hypogonadism. Each mL of the 100 mg/mL formulation contains testosterone cypionate USP in cottonseed oil with benzyl benzoate and benzyl alcohol (preservative), supplied as a 10 mL multiple-dose vial (1,000 mg total) by Eugia US LLC (NDC 55150-276-01).

As an oil-soluble 17(β)-cyclopentylpropionate ester of testosterone, this formulation is absorbed slowly from the intramuscular lipid depot, supporting a clinically convenient dosing interval of every two to four weeks. It is not for intravenous use.

Key Benefits

• Indicated Testosterone Replacement: FDA-approved for primary hypogonadism (cryptorchidism, bilateral torsion, orchitis, orchidectomy) and hypogonadotropic hypogonadism (gonadotropin/LHRH deficiency, pituitary-hypothalamic injury).
• Extended-Release Pharmacokinetics: Intramuscular depot absorption yields an approximate 8-day half-life, enabling every 2–4 week dosing intervals.
• Multiple-Dose Vial Efficiency: 10 mL vial delivers 1,000 mg (100 mg/mL), supporting multi-patient or multi-dose clinical use.
• Supports Androgen-Dependent Physiology: Restores endogenous testosterone functions including maintenance of secondary sex characteristics, nitrogen balance, and erythropoiesis stimulation.
• USP-Grade Manufacturing: Produced under ANDA-approved (ANDA211817) standards by Eugia Pharma Specialities Limited; vial stopper is latex-free.

Dosage and Administration

• Route: Intramuscular use only — inject deep into the gluteal muscle. Not for intravenous administration.
• Confirm Diagnosis: Prior to initiation, verify hypogonadism with serum testosterone concentrations measured on at least two separate mornings, below the normal range.
• Adult Males (Hypogonadism Replacement): 50 mg to 400 mg administered every two to four weeks; adjust based on patient response and adverse reactions.
• Pediatric/Pubertal Induction: Dosage and titration individualized; monitor skeletal bone age every 6 months during androgen therapy.
• Visual Inspection: Inspect for particulate matter and discoloration before use. Warm and shake the vial to redissolve any crystals formed during cold storage.
• Storage: Store at 20°–25°C (68°–77°F); protect from light.

Why Choose Testosterone Cypionate Injection 100 mg/mL (10 mL Vial)?

• Flexible Multi-Dose Format: The 10 mL multiple-dose vial is optimized for clinical settings requiring individualized dosing across multiple administrations or patients.
• Proven Long-Acting Ester: The cypionate ester's ~8-day half-life reduces injection frequency compared to shorter-acting testosterone esters, supporting patient adherence.
• ANDA-Approved Generic: Bioequivalent formulation marketed under ANDA211817, providing a cost-effective TRT option without compromising USP-grade quality.

Warnings

• Cardiovascular and Thromboembolic Risk: Postmarketing reports include DVT, pulmonary embolism, myocardial infarction, and stroke. Testosterone can increase blood pressure; not recommended in patients with uncontrolled hypertension. Monitor cardiovascular status periodically.
• Contraindicated Populations: Do not use in patients with known hypersensitivity, breast or prostate carcinoma, serious cardiac/hepatic/renal disease, pregnancy, or women who are nursing. Not interchangeable with testosterone propionate.
• Abuse Potential and Hepatotoxicity: Classified as Schedule III controlled substance. High-dose or long-term androgen misuse is associated with hepatocellular carcinoma, peliosis hepatis, and serious psychiatric and cardiovascular adverse events. Monitor hematocrit, liver enzymes, and serum testosterone as clinically indicated.

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