TESTOSTERONE- testosterone cypionate injection, solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)

MAH:

Slayback Pharma LLC

administration_route:

INTRAMUSCULAR

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

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.

authorization_status:

New Drug Application

SPC

TESTOSTERONE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION
SLAYBACK PHARMA LLC
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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