国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)
Slayback Pharma LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
Testosterone Cypionate Injection is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration (2.2) ]. • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Admi
Testosterone Cypionate Injection is supplied as a sterile, clear colorless to pale yellow solution in single-dose vials as 200 mg/mL testosterone cypionate. Store at 15°C to 25°C (59°F to 77°F); excursions permitted to 2°C to 30°C (36°F to 86°F). Store product in carton to protect contents from light.
New Drug Application
TESTOSTERONE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION SLAYBACK PHARMA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TESTOSTERONE CYPIONATE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE CYPIONATE INJECTION. TESTOSTERONE CYPIONATE INJECTION FOR INTRAMUSCULAR USE, CIII INITIAL U.S. APPROVAL: PRIOR TO JAN 1, 1982 INDICATIONS AND USAGE Testosterone Cypionate Injection is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (1): (1) Limitations of Use: • Safety and efficacy of Testosterone Cypionate Injection in men with “age- related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established (1). • Safety and effectiveness in pediatric patients below the age of 12 years have not been established (8.4). (1) DOSAGE AND ADMINISTRATION • Injectable testosterone products may have different doses, strengths, or administration instructions and they are not substitutable on a milligram-per-milligram basis. Administer Testosterone Cypionate Injection by deep gluteal intramuscular injection only (2.1). • Prior to initiating Testosterone Cypionate Injection, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum concentrations are below the normal range (2.2). • Recommended dosage is 50 mg to 400 mg administered every two to four weeks as a deep intramuscular injection in the gluteal muscle. Individualize the dose and schedule based on the patient’s age, diagnosis, response to treatment, and the appearance of adverse reactions (2.3). (2) DOSAGE FORMS AND STRENGTHS Injection: 200 mg/mL in a single-dose vial (3) (3) CONTRAINDICATIONS • Known hypersensitivity to Testosterone Cypionate Injection or any of its components, skin manifestations and anaphylactoid 完全なドキュメントを読む