TESTOSTERONE gel, metered

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Amneal Pharmaceuticals NY LLC

Пут администрације:

TOPICAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Testosterone gel 1.62% is indicated for replacement therapy in adult males for 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, orchiectomy, Klinefelter's syndrome, 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. - 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. Limitations of use: - Safety and efficacy of testosterone gel 1.62% in men with “age-related hypogonadism” (also referred to as “late-

Резиме производа:

Testosterone gel 1.62% is supplied as a clear, colorless gel, in non-aerosol, metered-dose pumps that deliver 20.25 mg of testosterone, USP per complete pump actuation. The pumps are composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations; each pump actuation dispenses 1.25 g of gel. 88 g pump (each pump dispenses 60 metered pump actuations with each pump actuation containing 20.25 mg of testosterone, USP in 1.25 g of gel) NDC   69238-1013-2 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Used testosterone gel 1.62% pumps should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Amneal Pharmaceuticals NY LLC
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MEDICATION GUIDE
Testosterone (tes tos’ ter one) Gel 1.62%, for topical use (CIII)
What is the most important information I should know about
testosterone gel 1.62%?
1. Testosterone gel 1.62% can transfer from your body to others
including, children and women. Children
and women should avoid contact with the unwashed or not covered
(unclothed) areas where testosterone
gel 1.62% has been applied to your skin. Early signs and symptoms of
puberty have occurred in young
children who have come in direct contact with testosterone by touching
areas where men have used
testosterone gel 1.62%.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with testosterone gel
1.62% may include:
Abnormal sexual changes:
•
enlarged penis or clitoris.
•
early growth of hair near the vagina or around the penis (pubic hair).
•
erections or acting out sexual urges (sex drive).
Behavior problems:
•
acting aggressively, behaving in an angry or violent way.
Women
Signs and symptoms in women when they come in direct contact with
testosterone gel 1.62% may
include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using testosterone gel 1.62% and call your healthcare provider
right away if you see any signs and
symptoms in a child or a woman that may have happened through
accidental touching of the area where
you have applied testosterone gel 1.62%.
2. To lower the risk of transfer of testosterone gel 1.62% from your
body to others, follow these important
instructions:
•
Apply testosterone gel 1.62% only to your shoulders and upper arms
that will be covered by a
short sleeve t-shirt.
•
Wash your hands right away with soap and water after applying
testosterone gel 1.62%.
•
After the gel has dried, cover the application area with clothing.
Keep the area covered until you
have washed the application area well or have showered.
•
If you expect to have skin-to-skin contact with another person, first
wash the application area wel

Карактеристике производа

TESTOSTERONE- TESTOSTERONE GEL, METERED
AMNEAL PHARMACEUTICALS NY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTOSTERONE GEL SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE GEL.
TESTOSTERONE GEL, FOR TOPICAL USE CIII
INITIAL U.S. APPROVAL: 1953
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
VIRILIZATION HAS BEEN REPORTED IN CHILDREN WHO WERE SECONDARILY
EXPOSED TO TESTOSTERONE GEL (5.2, 6.2).
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN USING TESTOSTERONE
GEL (2.2, 5.2).
HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO
RECOMMENDED INSTRUCTIONS FOR
USE (2.2, 5.2, 17).
INDICATIONS AND USAGE
Testosterone gel 1.62% is indicated for replacement therapy in males
for conditions associated with a deficiency or
absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Limitations of use:
Safety and efficacy of testosterone gel 1.62% in men with
“age-related hypogonadism” have not been established. (1)
Safety and efficacy of testosterone gel 1.62% in males less than 18
years old have not been established. (1, 8.4)
Topical testosterone products may have different doses, strengths, or
application instructions that may result in
different systemic exposure. (1, 12.3)
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION FOR TESTOSTERONE GEL 1.62% DIFFERS FROM
TESTOSTERONE GEL 1%. FOR DOSAGE AND
ADMINISTRATION OF TESTOSTERONE GEL 1% REFER TO ITS FULL PRESCRIBING
INFORMATION. (2)
Prior to initiating testosterone gel 1.62%, confirm the diagnosis of
hypogonadism by ensuring that serum testosterone
has been measured in the morning on at least two separate days and
that these concentrations are below the normal
range (2).
Starting dose of testosterone gel 1.62% is 40.5 mg of testosterone (2
pump actuations), applied topically once