TESTOSTERONE gel

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Strides Pharma Science Limited

Manustamisviis:

TRANSDERMAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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-

Toote kokkuvõte:

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, respectively.                    NDC 64380-151-02         30 packets (a unit dose packet containing 25 mg of testosterone provided in 2.5 g of gel)                                                                                                                                  NDC 64380-152-02         30 packets (a unit dose packet containing 50 mg of testosterone provided in 5 g of gel) 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% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Strides Pharma Science Limited
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MEDICATION GUIDE
TESTOSTERONE GEL 1% CIII
(tes-TOS-te-rōn) 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 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 are

Toote omadused

TESTOSTERONE - TESTOSTERONE GEL
STRIDES PHARMA SCIENCE LIMITED
----------
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)
INDICATIONS AND USAGE
Testosterone Gel 1% is indicated for replacement therapy in males for
conditions associated with a
deficiency or absence of endogenous testosterone: (1)
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of use: (1)
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 (two 25
mg packets, or one 50 mg
packet), applied onc