TESTOSTERONE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

TESTOSTERONE

Composition:

TESTOSTERONE 10 mg in 1 g

Administration route:

TOPICAL

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 non-aerosol, metered-dose pumps that deliver 12.5 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% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, USP, respectively. Keep testosterone gel out of the reach of children. Storage Store at 20° to 25°C (68° to 77°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
Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Testosterone (tes tosʹ 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:
Behavior problems:
Women
Signs and symptoms in women when they come in direct contact with
testosterone gel 1% may include:
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
applied
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 areas of your shoulders, 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 the
application area well with soap and water.
•
If a child or woman touches the area where you have applied
testosterone gel
1%, that area on the child or woman should be washed well with soap
and
water right away.
What is testosterone gel 1%?
Testosterone gel 1% is a prescription medic

Summary of Product characteristics

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, 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 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
actuations, two 25 mg packets, or one 50 mg
packet), applied once dail