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Testosterone Cypionate Injection, USP (CIII) is a sterile, oil-based intramuscular solution containing testosterone cypionate—the 17ß-cyclopentylpropionate ester of testosterone. Available in 100 mg/mL and 200 mg/mL concentrations, it is indicated exclusively for androgen replacement therapy in males with confirmed hypogonadism due to testicular or hypothalamic-pituitary failure.

This Schedule III controlled substance is distributed by Hospira, Inc., a Pfizer subsidiary, and is formulated in cottonseed oil with benzyl benzoate and benzyl alcohol as a preservative. For intramuscular use only. Rx only.

Key Benefits

• Clinically Indicated Hormone Replacement: Treats primary hypogonadism (cryptorchidism, orchitis, orchidectomy) and hypogonadotropic hypogonadism (gonadotropin/LHRH deficiency, pituitary-hypothalamic injury).
• Extended-Release Pharmacokinetics: Oil-soluble ester formulation yields a half-life of approximately 8 days IM, enabling dosing every 2–4 weeks for stable androgen levels.
• Dual-Strength Availability: Supplied as 100 mg/mL (10 mL multi-dose vial) and 200 mg/mL (1 mL single-dose and 10 mL multi-dose vials) to support individualized dosing regimens.
• Supports Secondary Male Characteristics: Restores androgen-dependent physiological functions including muscle protein anabolism, bone density maintenance, and male hair distribution.
• Trusted Clinical Formulation: Manufactured under ANDA085635 with USP-grade excipients; produced and labeled by Pharmacia & Upjohn Company LLC.

Dosage and Administration

• Route: Intramuscular (IM) use only—deep gluteal muscle injection. Not for intravenous use.
• Hypogonadal Replacement (Adult Males): 50–400 mg administered every 2 to 4 weeks, adjusted based on patient response and serum testosterone levels.
• Diagnosis Confirmation Required: Serum testosterone must be measured on at least two separate mornings and confirmed below normal range prior to initiating therapy.
• Visual Inspection: Inspect for particulate matter and discoloration before administration. Warm and shake vial to redissolve any crystals formed during low-temperature storage.
• Pediatric Use: Safety and effectiveness not established in patients under 12 years of age.

Why Choose Testosterone Cypionate Injection?

• Long-Acting Convenience: Biweekly to monthly dosing intervals reduce administration burden compared to shorter-acting androgens. Not interchangeable with testosterone propionate due to differences in duration of action.
• Flexible Vial Options: Single-dose (1 mL) and multi-dose (10 mL) formats available at both 100 mg/mL and 200 mg/mL to accommodate varied clinical and institutional settings.
• Proven Androgen Replacement: Widely prescribed for primary and hypogonadotropic hypogonadism with individualized dosing supported by established clinical protocols.

Warnings

• Cardiovascular and Thromboembolic Risk: Postmarketing reports include DVT and pulmonary embolism. Testosterone may increase blood pressure over time. Not recommended in patients with uncontrolled hypertension. Monitor cardiovascular status periodically.
• Contraindications: Do not use in males with known or suspected breast or prostate carcinoma, patients with serious cardiac, hepatic, or renal disease, patients with known hypersensitivity to the drug, or in pregnant women (teratogenic; causes female fetal virilization).
• Abuse Potential and Hepatotoxicity: Schedule III controlled substance. Abuse at supratherapeutic doses can cause cardiac arrest, hepatocellular carcinoma, and serious psychiatric events. Long-term high-dose androgen use has been associated with hepatic adenomas and peliosis hepatis.

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