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Testosterone Cypionate Injection, USP (CIII) is a Schedule III controlled, oil-soluble androgenic hormone ester formulated for deep intramuscular (IM) injection. Distributed by Xiromed LLC, it is indicated exclusively for testosterone replacement therapy (TRT) in adult males with confirmed hypogonadism due to primary or hypogonadotropic causes.

Available in two concentrations—100 mg/mL and 200 mg/mL—this USP-grade solution provides a slow-release pharmacokinetic profile with an intramuscular half-life of approximately eight days, supporting dosing intervals of every two to four weeks.

Key Benefits

• Indicated for Primary and Hypogonadotropic Hypogonadism: Clinically indicated for testosterone deficiency resulting from testicular failure (cryptorchidism, bilateral torsion, orchitis, orchidectomy) or gonadotropin/LHRH deficiency from tumors, trauma, or radiation.
• Extended-Release Dosing: Oil-soluble cypionate ester absorbed slowly from the lipid phase after IM injection; effective dosing interval of 2–4 weeks reduces administration burden.
• Dual-Concentration Availability: Supplied as 100 mg/mL (10 mL multiple-dose vial) and 200 mg/mL (1 mL single-dose and 10 mL multiple-dose vials) to support individualized dosing.
• USP-Grade Sterile Formulation: Manufactured under stringent pharmaceutical controls; each vial is visually inspectable for particulate matter and discoloration prior to use.
• Supports Androgen-Dependent Physiologic Functions: Restores testosterone levels to maintain secondary male sex characteristics, muscle mass, bone density, and nitrogen balance in deficient patients.

Dosage and Administration

• Route: Intramuscular use only. Administer deep into the gluteal muscle. Not for intravenous use.
• Diagnosis Confirmation: Prior to initiation, confirm hypogonadism with serum testosterone levels measured on at least two separate mornings, both below the normal range.
• Adult Hypogonadal Males: 50–400 mg administered every 2 to 4 weeks; dosage individualized based on patient response and adverse reaction profile.
• Pediatric Hypogonadism: Dosage and titration individualized; bone age (wrist/hand) must be monitored every 6 months during androgen therapy in children.
• Pre-Administration Inspection: Inspect visually for particulates and discoloration. If crystals are present due to cold storage, warm and shake the vial to redissolve before use.
• Storage: Store at 20°–25°C (68°–77°F); protect from light.

Why Choose Testosterone Cypionate Injection, USP?

• Flexible Vial Formats: Available in single-dose (1 mL) and multiple-dose (10 mL) vials at both 100 mg/mL and 200 mg/mL, allowing prescribers to match format to clinical need and patient population.
• Predictable Pharmacokinetics: Approximately 8-day intramuscular half-life enables stable androgen exposure with biweekly to monthly dosing schedules.
• Established TRT Option: Approved under ANDA215351; widely utilized in clinical practice for long-term management of confirmed hypogonadism when endogenous testosterone production is absent or insufficient.

Warnings

• Cardiovascular and Thromboembolic Risk: Postmarketing reports include DVT, pulmonary embolism, myocardial infarction, and stroke. Monitor blood pressure periodically; not recommended in patients with uncontrolled hypertension. Discontinue if venous thromboembolic event is suspected.
• Abuse Potential (Schedule III): Testosterone has documented abuse potential, particularly at supratherapeutic doses. Abuse can result in serious cardiovascular events, psychiatric adverse reactions, and physical dependence with withdrawal symptoms lasting weeks to months.
• Contraindicated Populations: Contraindicated in males with known or suspected breast or prostate carcinoma, pregnant women, patients with serious cardiac/hepatic/renal disease, and individuals with known hypersensitivity to testosterone cypionate or any formulation component.

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