TESTOSTERONE gel

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Aleor Dermaceuticals Limited

Calea de administrare:

TRANSDERMAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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 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 should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Aleor Dermaceuticals Limited
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MEDICATION GUIDE
Testosterone (tes-TOS-te-rone) Gel, 1.62% CIII
for topical use
1. What is the most important information I should know about
testosterone gel, 1.62%?
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

Caracteristicilor produsului

TESTOSTERONE - TESTOSTERONE GEL
ALEOR DERMACEUTICALS LIMITED
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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 da