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:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Testosterone Gel, 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Limitations of use: Risk Summary Testosterone Gel, 1.62% is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see Contraindications (4) and Clinical Pharmacology (12.1)] . Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone dur

Product summary:

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.  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 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TESTOSTERONE- TESTOSTERONE GEL
Bryant Ranch Prepack
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MEDICATION GUIDE
Testosterone (tes-TOS-te-rone)
Gel, 1.62%
for topical use
CIII
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
w

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,
1.62% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TESTOSTERONE GEL,
1.62%.
TESTOSTERONE GEL, FOR TOPICAL USE CIII
INITIAL U.S. APPROVAL: 1953
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
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: (1)
•
•
Limitations of use: (1)
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
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).
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
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 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