TESTOPEL- testosterone pellet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

ENDO USA, Inc.

INN (Nama Antarabangsa):

TESTOSTERONE

Komposisi:

TESTOSTERONE 75 mg

Laluan pentadbiran:

SUBCUTANEOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy. b. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex 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 TESTOPEL® (testosterone pellets) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. c. Androgens 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 taken every 6 months to assess the effect of treatment on epiphyseal centers (see WARNINGS). Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate. If administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. The 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 these drugs she should be apprised of the potential hazard to the fetus. Controlled Substance TESTOPEL® 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 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. 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 pellets each containing 75mg testosterone. One pellet per vial in boxes of 10 (NDC: 66887-004-10) and 100 (NDC: 66887-004-20). Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Rx Only Manufactured for: Endo USA Malvern, PA 19355 © 2024 Endo, Inc. or one of its affiliates. Revised 03/2024

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

TESTOPEL- TESTOSTERONE PELLET
ENDO USA, INC.
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TESTOPEL
(TESTOSTERONE PELLETS)
C-III
DESCRIPTION
TESTOPEL (testosterone pellets) are cylindrically shaped pellets 3.2mm
(1/8 inch) in
diameter and approximately 9mm in length. Each sterile pellet weighs
approximately
78mg (75mg testosterone) and is ready for implantation.
Androgens are steroids that develop and maintain primary and secondary
male sex
characteristics. Testosterone is a member of this class.
Structural formula for testosterone follows:
INGREDIENTS
Each TESTOPEL (testosterone pellets) for subcutaneous implantation
contains 75mg
testosterone. In addition each pellet contains the following inactive
ingredients: stearic
acid NF 0.97mg and polyvinylpyrrolidone USP 2mg.
TESTOPEL (testosterone pellets) consist of crystalline testosterone.
When implanted
subcutaneously, the pellets slowly release the hormone for a long
acting androgenic
effect.
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 the growth and maturation of prostate, seminal vesicles, penis
and scrotum; the
development of male hair distribution such as beard, pubic, chest and
axillary hair,
laryngeal enlargements, vocal cord thickening, alterations in body
musculature and fat
®
®
®
®
distribution. Drugs in this class can also cause retention of
nitrogen, sodium, potassium,
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 the 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
ma