TESTOSTERONE solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Prasco Laboratories

DCI (Dénomination commune internationale):

TESTOSTERONE

Composition:

TESTOSTERONE 30 mg in 1.5 mL

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

TESTOSTERONE - TESTOSTERONE SOLUTION
PRASCO LABORATORIES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTOSTERONE TOPICAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE TOPICAL
SOLUTION.
TESTOSTERONE TOPICAL SOLUTION, 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 TOPICAL TESTOSTERONE
PRODUCTS (5.2)
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN USING TESTOSTERONE
TOPICAL SOLUTION (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)
10/2016
INDICATIONS AND USAGE
Testosterone topical solution is 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 solution in men with
“age-related hypogonadism” have not been established.
(1)
Safety and efficacy of testosterone topical solution in males <18
years old have not been established. (8.4)
DOSAGE AND ADMINISTRATION
Prior to initiating testosterone topical solution, 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 testosterone topical solution dose is 60 mg of testosterone
(1 pump actuation of 30 mg of testosterone to each
axilla), applied once daily, at the same time each morning. (2.1)
Apply to clean, dry intact skin of the axilla, not to any other parts
of the body including the abdomen or genitals (2.2)
Dose adjustment: The do