TESTOSTERONE CYPIONATE injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Proficient Rx LP

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) 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 event

Podsumowanie produktu:

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 71205-289-01 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, no 8, 8A e 8B - Fervença, - 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: October 2018 PIN300-WES/11

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION
PROFICIENT RX LP
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TESTOSTERONE CYPIONATE INJECTION, USP
RX Only CIII
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; 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 termination of linear
growth, brought about by fusion of the epiphyseal growth centers. In
chil