TESTOSTERONE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Testosterone Gel 1% 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% in men with “age-related hypogonadism” (also referred to as “late-onset

Product summary:

Testosterone Gel 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g gel contains 25 mg testosterone. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Disposal Used Testosterone Gel 1% pumps or used Testosterone Gel 1% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TESTOSTERONE- TESTOSTERONE GEL
Bryant Ranch Prepack
----------
MEDICATION GUIDE
TESTOSTERONE GEL 1% CIII
(tes-TOS-te-ron) 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 ifyou 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%.
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 areas of your shoulders, and upper
arms, or stomach area
(abdomen) 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 gel off the application area well or have showered.
•
If you expect to have skin-to-skin contact with another person, first
wash

Summary of Product characteristics

TESTOSTERONE- TESTOSTERONE GEL
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTOSTERONE GEL 1%
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TESTOSTERONE GEL 1%.
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).
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 10/2016
INDICATIONS AND USAGE
Testosterone Gel 1% 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% 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
DOSAGE AND ADMINISTRATION FOR TESTOSTERONE GEL 1% DIFFERS FROM
TESTOSTERONE GEL 1.62
%. FOR DOSAGE AND ADMINISTRATION OF TESTOSTERONE GEL 1.62% REFER TO
ITS FULL PRESCRIBING
INFORMATION. (2)
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)
Starting dose of Testosterone Gel 1% is 50 mg of testosterone (4 pump
a