ANDROGEL- testosterone gel

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

testosterone (UNII: 3XMK78S47O) (testosterone - UNII:3XMK78S47O)

Pieejams no:

AbbVie Inc.

SNN (starptautisko nepatentēto nosaukumu):

testosterone

Kompozīcija:

testosterone 16.2 mg in 1 g

Ievadīšanas:

TRANSDERMAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

AndroGel 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 AndroGel 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadi

Produktu pārskats:

AndroGel 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. AndroGel 1.62% is also supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 1.25 g or 2.5 g gel contains 20.25 mg or 40.5 mg testosterone, respectively. Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature]. Used AndroGel 1.62% pumps or used AndroGel 1.62% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Autorizācija statuss:

New Drug Application

Lietošanas instrukcija

AbbVie Inc.
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MEDICATION GUIDE
ANDROGEL® (AN DROW JEL) CIII
(testosterone gel) 1.62% for topical use
What is the most important information I should know about ANDROGEL
1.62%?
•
1. ANDROGEL 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 ANDROGEL 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 ANDROGEL 1.62%.
•
Children
•
Signs and symptoms of early puberty in a child when they come in
direct contact with
ANDROGEL 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
ANDROGEL
1.62% may include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using ANDROGEL 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 ANDROGEL 1.62%.
2. To lower the risk of transfer of ANDROGEL 1.62% from your body to
others, follow these
important instructions:
•
Apply ANDROGEL 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 ANDROGEL
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 well with soap and water.
•
If a child or woman touches the area where you h

Produkta apraksts

ANDROGEL- TESTOSTERONE GEL
ABBVIE INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANDROGEL 1.62% SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ANDROGEL 1.62%.
ANDRO GEL (TESTOSTERONE GEL) 1.62% 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
AndroGel 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 AndroGel 1.62% in men with “age-related
hypogonadism” have not been established. (1)
Safety and efficacy of AndroGel 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 ANDROGEL 1.62% DIFFERS FROM ANDROGEL 1%.
FOR DOSAGE AND ADMINISTRATION
OF ANDROGEL 1% REFER TO ITS FULL PRESCRIBING INFORMATION. (2)
Prior to initiating AndroGel 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 AndroGel 1.62% is 40.5 mg of testosterone (2 pump
actuations or a single 40.5 mg packet), applied
topically once daily in the morning. (2.1)
Apply to clean, dry, intact