TESTOSTERONE gel, metered

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Actavis Pharma, Inc.

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Testosterone topical gel is indicated for replacement therapy in 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, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [FSH] and 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 serum testosterone concentrations but have gonadotropins in the normal or low range.     Limitations of Use - Safety and efficacy of testosterone topical gel in men with “age-related hypogonadism” (also referred to as “

Povzetek izdelek:

Testosterone Topical Gel is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone, USP per complete pump actuation. The metered dose pump is capable of dispensing 120 metered pump actuations. One (1) pump actuation dispenses 0.5 g of gel. Testosterone Topical Gel is available in packages of 1 canister (NDC 0591-2363-60). Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Do Not Freeze. Used Testosterone Topical Gel canisters should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Actavis Pharma, Inc.
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MEDICATION GUIDE
Testosterone (tes tos' ter one) CIII
Topical Gel
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 front and inside area of your
thighs that will be covered by clothing.
•
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
testostero

Lastnosti izdelka

TESTOSTERONE- TESTOSTERONE GEL, METERED
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)
RECENT MAJOR CHANGES
Contraindications (4) 03/2020
INDICATIONS AND USAGE
Testosterone topical gel is an androgen 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 topical gel in men with
“age-related hypogonadism” have not been
established. (1)
Safety and efficacy of testosterone topical gel in males less than 18
years old have not been
established. (8.4)
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)
Starting dose of testosterone gel is 40 mg of testosterone (4 pump
actuations) applied topically once
daily in the morning. (2.1)
Apply to clean, dry, intact skin of the thighs. Do not apply
testosterone gel to the genitals or other parts
of the body. (2.2)
Dose adjustment: testosterone gel can be dose adjusted between a
minimum of 10 mg of testosterone
(1 pump actuation) and a maximum of 70 mg o