TESTOSTERONE gel

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Actavis Pharma, Inc.

Droga podania:

TRANSDERMAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Testosterone gel 1% is indicated for testosterone 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 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% in men with “age-related hypogonadism” (also referred to as “late-onset hypogon

Podsumowanie produktu:

Testosterone Gel 1% is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:  Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Discard used Testosterone Gel 1% tubes in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions (5.2)] . Contents are flammable [see Warnings and Precautions (5.16)] .

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

Actavis Pharma, Inc.
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MEDICATION GUIDE
Testosterone (tes tos' ter one) Gel 1%, CIII
for topical use
What is the most important information I should know about
testosterone gel 1%?
1.
Testosterone gel 1% 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%
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%.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with testosterone gel 1% 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%
may include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using testosterone gel 1% 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 placed
testosterone gel 1%.
2.
To lower the risk of transfer of testosterone gel 1% from your body to
others, follow these important instructions:
•
Apply testosterone gel 1% only to the areas of 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%.
•
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

Charakterystyka produktu

TESTOSTERONE- TESTOSTERONE GEL
ACTAVIS PHARMA, INC.
----------
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 1%, 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% is an androgen indicated for testosterone
replacement therapy in males for
conditions associated with a deficiency or absence of endogenous
testosterone:
Primary Hypogonadism (Congenital or Acquired) (1)
Hypogonadotropic Hypogonadism (1)
Limitations of Use:
Safety and efficacy of testosterone gel 1% in men with “age-related
hypogonadism” have not been
established. (1)
Safety and efficacy of testosterone gel 1% in males less than 18 years
old have not been established.
(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
Prior to initiating testosterone gel 1%, 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)
Recommended starting dose for adult males: 50 mg of testosterone (one
tube) applied topically once
daily. (2.1)
Apply to clean, dry, intact skin of the shoulders and/or upper arms.
Do NOT apply testosterone gel 1%
to the genitals or abdomen. (2.1, 2.2)
If morning pre-dose serum testosterone concentration is below normal
range, i