NATESTO- testosterone gel

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

testosterone (UNII: 3XMK78S47O) (testosterone - UNII:3XMK78S47O)

Dostępny od:

Aytu BioScience, Inc.

INN (International Nazwa):

testosterone

Skład:

testosterone 5.5 mg

Droga podania:

NASAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Natesto 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 Natesto in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not b

Podsumowanie produktu:

Natesto (testosterone) nasal gel is available as a metered dose pump containing 11 grams of gel dispensed as 60 metered pump actuations. One pump actuation delivers 5.5 mg of testosterone in 0.122 grams of gel. Keep Natesto out of reach of children. Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used Natesto dispensers should be discarded in household trash in a manner that prevents accidental exposure of children or pets.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

NATESTO- TESTOSTERONE GEL
AYTU BIOSCIENCE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NATESTO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NATESTO.
NATESTO (TESTOSTERONE) NASAL GEL CIII INITIAL U.S. APPROVAL: 1953
RECENT MAJOR CHANGES
Warnings and Precautions (5.7)
10/2016
INDICATIONS AND USAGE
Natesto 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 Natesto in men with “age-related
hypogonadism” have not been established (1).
Safety and efficacy of Natesto in males less than 18 years old have
not been established. (1, 8.4)
DOSAGE AND ADMINISTRATION
Prior to initiating Natesto, 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).
The recommended dose of Natesto is 11 mg of testosterone (2 pump
actuations, one per nostril), applied intranasally
three times daily. (2.1)
Serum total testosterone concentrations should be checked
periodically, starting as soon as one month after initiating
treatment with Natesto. If total testosterone concentrations
consistently exceed 1050 ng/dL, therapy with Natesto
should be discontinued. If total testosterone concentrations are
consistently below 300 ng/dL, an alternative treatment
should be considered. (2.1)
Not recommended for use with nasally administered drugs other than
sympathomimetic decongestants (e.g.,
oxymetazoline). (2.3, 7.4, 12.3).
DOSAGE FORMS AND STRENGTHS
Natesto nasal gel is available as a metered-dose pump. One pump
actuation delivers 5.5 mg of testosterone. (3)
CONTRAINDICATIONS
Men with carcinoma of the breast or known or suspected prostate cancer
(4, 5.3)
Pregnant or breast-feeding