TESTOSTERONE gel TESTOSTERONE gel, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Testosterone (UNII: 3XMK78S47O) (Testosterone - UNII:3XMK78S47O)

Available from:

Upsher-Smith Laboratories, LLC

INN (International Name):

Testosterone

Composition:

Testosterone 50 mg in 5 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Testosterone gel 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 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 levels 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 levels but have gonadotropins in the normal or low range. Limitations of Use: - Safety and efficacy of testosterone gel in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.

Product summary:

Testosterone gel is supplied in unit-dose tubes in cartons of 30 and unit-dose packets in cartons of 30. Each tube or packet contains 50 mg testosterone in 5 g of gel. Testosterone gel is also supplied in a metered-dose pump that delivers 12.5 mg of testosterone per complete pump actuation. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations. Each pump actuation delivers 1.25 g of gel. The metered-dose pump is supplied in cartons of 2. Testosterone gel is available as follows: 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 tubes, packets or pumps should be discarded in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions (5.2)] . Contents are flammable [see Warnings and Precautions (5.16)] .

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

TESTOSTERONE- TESTOSTERONE GEL, METERED
Upsher-Smith Laboratories, LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised 5/2020
MEDICATION GUIDE
Testosterone (tes-TOS-te-rōn) Gel, CIII
for topical use
What is the most important information I should know about
testosterone gel?
1.
Testosterone gel 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 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.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with Testosterone
gel 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 may
include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using testosterone gel 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.
2.
To lower the risk of transfer of testosterone gel from your body to
others, follow these important
instructions:
•
Apply testosterone gel only to the areas of 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.
•
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 ski

Summary of Product characteristics

TESTOSTERONE- TESTOSTERONE GEL
TESTOSTERONE- TESTOSTERONE GEL, METERED
UPSHER-SMITH LABORATORIES, LLC
----------
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)
RECENT MAJOR CHANGES
Contraindications (4)
05/2020
INDICATIONS AND USAGE
Testosterone gel is an androgen indicated for testosterone 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 in men with age-related
hypogonadism have not been
established (1)
Safety and efficacy of testosterone gel 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
Prior to initiating testosterone gel, 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).
Recommended starting dose for adult males: 50 mg of testosterone (one
tube or one packet or 4
pump actuations) applied topically once daily at approximately the
same time each day. (2.1)
Apply to clean, dry, intact skin of t