TESTOSTERONE gel

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Par Pharmaceutical, Inc.

给药途径:

TRANSDERMAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Testosterone gel is indicated for testosterone 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 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 in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”

產品總結:

Testosterone gel is supplied in unit-dose tubes in cartons of 30.  Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows: Store at 20°C to 25°C (68°F - 77°F). Excursions permitted to 15°C to 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Discard used testosterone gel tubes 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)].

授权状态:

New Drug Application Authorized Generic

资料单张

Par Pharmaceutical, Inc.
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Medication Guide
Testosterone Gel
for topical use, CIII
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 placed 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 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
t

产品特点

TESTOSTERONE- TESTOSTERONE GEL
PAR PHARMACEUTICAL, INC.
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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 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 (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) applied topically once daily. (2.1)
Apply to clean, dry, intact skin of the shoulders and/or upper arms.
Do NOT apply testosterone gel to the genitals or
abdomen. (2.1, 2.2)
If morning pre-dose serum testosterone concentration is below normal
range, increase dose to