Testosterone Cypionate Injection Solution
Testonex-C is a sterile intramuscular injection containing testosterone cypionate 200 mg/mL, formulated in an ethyl oleate–based oil solution. Testosterone cypionate is a long-acting ester of testosterone designed for sustained release following intramuscular administration.
Formulation Characteristics
- Long-acting testosterone ester
- Ethyl oleate–based oil solution
- Sterile injectable formulation for intramuscular use
- Designed for stable and prolonged testosterone release
Composition
- Active substance: Testosterone Cypionate — 200 mg per 1 mL
- Excipients: Benzyl alcohol, benzyl benzoate, ethyl oleate
Indications
- Testosterone replacement therapy in male hypogonadism confirmed by clinical and biochemical testing
- Supportive hormone therapy for female-to-male transgender patients under medical supervision
Pharmacological Overview
Testosterone cypionate is a depot ester of testosterone. After intramuscular administration, it is gradually hydrolyzed to free testosterone, resulting in prolonged androgenic activity. Testosterone is metabolized primarily in the liver and excreted mainly via the urine as conjugated metabolites.
Dosage and Directions for Use
For testosterone replacement therapy in hypogonadal males, a typical dose is 200 mg administered every seven days.
Maximum recommended dose: 800 mg per month.
If a dose is missed, it should be administered as soon as possible. If it is close to the time of the next scheduled dose, the missed dose should be skipped. Do not double doses.
Contraindications
- Use in women, including pregnancy and breastfeeding
- Known or suspected carcinoma of the prostate or male breast
- Hypersensitivity to testosterone or any component of the formulation
- Pediatric use
Warning: This product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions in neonates and premature infants.
Side Effects and Special Precautions
Prolonged testosterone therapy may lead to feminizing effects such as mastalgia or gynecomastia, particularly in patients with hepatic impairment. Exogenous testosterone administration suppresses endogenous testosterone production through feedback inhibition of pituitary luteinizing hormone (LH). At high doses, suppression of spermatogenesis may occur due to inhibition of follicle-stimulating hormone (FSH).
Testosterone therapy may result in either increased or decreased libido. Serum testosterone levels and clinical response should be monitored regularly during treatment.
Known Symptoms of Overdose
Symptoms of testosterone overdose are not well defined. There is no specific antidote. Treatment should be symptomatic and supportive.
Storage and Stability
Store at room temperature between 15 °C and 30 °C. Protect from light. Keep out of reach of children.
Oil-based testosterone solutions may develop crystal formation if stored at temperatures below the recommended range. If crystallization occurs, gently warming and shaking the vial may re-dissolve the crystals.
Crystallization has not been shown to affect the efficacy, quality, or safety of the product when properly re-dissolved.
Special Handling Instructions
All used needles, syringes, and injection materials must be disposed of in accordance with local environmental and medical waste regulations. Disposable syringes and needles should be discarded immediately after use in designated puncture-proof containers.