TESTOSTERONE gel, metered

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Testosterone (UNII: 3XMK78S47O) (Testosterone - UNII:3XMK78S47O)

Saatavilla:

Dr. Reddy's Laboratories, Inc.

Antoreitti:

TRANSDERMAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 “lat

Tuoteyhteenveto:

Testosterone gel 1.62% is supplied in non-aerosol, metered-dose pumps that deliver 20.25 mg of testosterone 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. Store at controlled room temperature 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

TESTOSTERONE- TESTOSTERONE GEL, METERED
DR. REDDY'S LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTOSTERONE GEL 1.62% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE GEL
1.62%.
TESTOSTERONE GEL 1.62% FOR TOPICAL USE CIII
INITIAL U.S. APPROVAL: 1953
WARNING: SECONDARY EXPOSURE TOTESTOSTERONE
_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), applie