TESTOSTERONE ENANTHATE injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

TESTOSTERONE ENANTHATE (UNII: 7Z6522T8N9) (TESTOSTERONE - UNII:3XMK78S47O)

Dostupné s:

Eugia US LLC

Podání:

INTRAMUSCULAR

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Males Testosterone enanthate injection is indicated for replacement therapy in conditions associated with a 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. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. Safety and efficacy of testosterone enanthate injection in men with age-related hypogonadism have not been established. Delayed puberty – Testosterone enanthate injection may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers (see WARNINGS ). Females Metastatic mammary cancer – Testosterone enanthate injection may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field. Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate and in women who are or may become pregnant. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus and is most likely to occur in the female fetus when the drugs are given in the first trimester. If the patient becomes pregnant while taking androgens, she should be apprised of the potential hazard to the fetus. This preparation is also contraindicated in patients with a history of hypersensitivity to any of its components. Testosterone enanthate injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. 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 of 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. 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.

Přehled produktů:

Testosterone enanthate injection, USP is a clear, colorless to pale yellow color oily solution and is supplied as follows: 1,000 mg per 5 mL (200 mg/mL) 5 mL multiple-dose vial                                                          NDC 55150-336-01 packaged individually STORAGE Testosterone enanthate injection, USP should be stored at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Warming and rotating the vial between the palms of the hands will redissolve any crystals that may have formed during storage at low temperatures. For Prescription Use Only The vial stopper is not made with natural rubber latex. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Medical Inquiries: 1-866-850-2876   Revised: February 2024

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

TESTOSTERONE ENANTHATE - TESTOSTERONE ENANTHATE INJECTION, SOLUTION
EUGIA US LLC
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TESTOSTERONE ENANTHATE INJECTION, USP CIII
RX ONLY
MULTIPLE DOSE VIAL
DESCRIPTION
Testosterone enanthate injection, USP provides testosterone enanthate,
a derivative of
the primary endogenous androgen testosterone, for intramuscular
administration. In
their active form, androgens have a 17-beta-hydroxy group.
Esterification of the 17-
beta-hydroxy group increases the duration of action of testosterone;
hydrolysis to free
testosterone occurs _in vivo_. Each mL of sterile, clear colorless to
pale yellow color oily
solution provides 200 mg testosterone enanthate, USP in sesame oil
with 5 mg
chlorobutanol (chloral derivative) as a preservative.
Testosterone enanthate is designated chemically as androst-4-en-3-one,
17-[(1-
oxoheptyl)-oxy]-, (17β)-. Structural formula:
CLINICAL PHARMACOLOGY
Endogenous androgens are responsible for the normal growth and
development of the
male sex organs and for maintenance of secondary sex characteristics.
These effects
include growth and maturation of prostate, seminal vesicles, penis,
and scrotum;
development of male hair distribution, such as beard, pubic, chest,
and axillary hair;
laryngeal enlargement; vocal cord thickening; alterations in body
musculature; and fat
distribution.
Androgens 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
the eventual
termination of linear growth which is brought about by fusion of the
epiphyseal growth
centers. In children, exogenous androgens accelerate linear growth
rates but may
cause a disproportionate advancement in bone maturation. Use over long
periods may
result in fusion of the epiphyseal growth centers and termination of
the growth proc