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 1.62% 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-

Podsumowanie produktu:

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. Testosterone gel 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° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Used testosterone gel 1.62% pumps or used testosterone gel 1.62% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

Actavis Pharma, Inc.
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MEDICATION GUIDE
Testosterone (tes tosʹ ter one) Gel 1.62% CIII
for topical use
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 well with soap a

Charakterystyka produktu

TESTOSTERONE- TESTOSTERONE GEL
ACTAVIS PHARMA, INC.
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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 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
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 or a single 40.5
mg packet), applied