TESTOSTERONE gel

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Prasco Laboratories

INN (International Nazwa):

TESTOSTERONE

Skład:

TESTOSTERONE 50 mg in 5 g

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

New Drug Application Authorized Generic

Charakterystyka produktu

TESTOSTERONE- TESTOSTERONE GEL
PRASCO LABORATORIES
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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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 11/2016
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 co