TESTOSTERONE CYPIONATE injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Cipla USA Inc.

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency, or absence of endogenous testosterone. - Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. - Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - Known hypersensitivity to the drug - Males with carcinoma of the breast - Males with known or suspected carcinoma of the prostate gland - Women who are pregnant (see PRECAUTIONS, Pregnancy ) - Patients with serious cardiac, hepatic or renal disease (see WARNINGS ) Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Abuse Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dependence Behaviors Associated with Addiction Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: - Taking greater dosages than prescribed - Continued drug use despite medical and social problems due to drug use - Spending significant time to obtain the drug when supplies of the drug are interrupted - Giving a higher priority to drug use than other obligations - Having difficulty in discontinuing the drug despite desires and attempts to do so - Experiencing withdrawal symptoms upon abrupt discontinuation of use Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

Ringkasan produk:

Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular administration available as: 1 mL Vial, Cartons of 1 vial                                      NDC 69097-802-32 10 mL Multiple Dose Vials, Cartons of 1 vial           NDC 69097-802-37 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059 Revised: February 2021

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
CIPLA USA INC.
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TESTOSTERONE CYPIONATE INJECTION, USP
CIII RX Only
DESCRIPTION
Testosterone Cypionate Injection, USP for intramuscular injection,
contains Testosterone
Cypionate, USP which is the oil-soluble 17 (beta)-
cyclopentylpropionate ester of the
androgenic hormone testosterone.
Testosterone Cypionate, USP is a white or creamy white crystalline
powder, odorless or
nearly so and stable in air. It is insoluble in water, freely soluble
in alcohol, chloroform,
dioxane, ether, and soluble in vegetable oils.
The chemical name for Testosterone Cypionate, USP is
androst-4-en-3-one,17-(3-
cyclopentyl-1- oxopropoxy)-, (17β)-. Its molecular formula is C
H
O , and the
molecular weight 412.61.
The structural formula is represented below:
Testosterone Cypionate Injection, USP is available in one strength,
200 mg/mL
Testosterone Cypionate, USP.
Each mL of the 200 mg/mL solution contains:
Testosterone Cypionate, USP
200 mg
Benzyl Benzoate, USP
0.2 mL
Cottonseed Oil, USP
560 mg
Benzyl Alcohol, USP (as preservative)
9.45 mg
CLINICAL PHARMACOLOGY
Endogenous androgens are responsible for normal growth and development
of the male
sex organs and for maintenance of secondary sex characteristics. These
effects include
growth and maturation of the prostate, seminal vesicles, penis, and
scrotum;
27
40
3
growth and maturation of the prostate, seminal vesicles, penis, and
scrotum;
development of male hair distribution, such as beard, pubic, chest,
and axillary hair;
laryngeal enlargement, vocal cord thickening, and alterations in body
musculature and
fat distribution. Drugs in this class also cause retention of
nitrogen, sodium, potassium,
and phosphorus, and decreased urinary excretion of calcium. Androgens
have been
reported to increase protein anabolism and decrease protein
catabolism. Nitrogen
balance is improved only when there is sufficient intake of calories
and protein.
Androgens are responsible for the growth spurt of adolescence and for
eventual
t