TESTOSTERONE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aleor Dermaceuticals Limited

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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): 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 (FSH, 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 topical solution in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been estab

Product summary:

Testosterone topical solution USP is available as a metered-dose pump containing 110 mL of solution. The pump is capable of dispensing 90 mL of solution in 60 metered pump actuations. One actuation delivers 30 mg of testosterone in 1.5 mL of solution. Each metered-dose pump is supplied with an applicator. The bottle and the applicator cup are not made with natural rubber latex. Keep testosterone topical solution out of reach of children. Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aleor Dermaceuticals Limited
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Revised: 12/2021
Document Id: f37d0249-0de6-4657-bf15-fbf63ccd27b5
34391-3
Set id: 9fe3a833-d9eb-4559-9b9e-1379ec4487a0
Version: 2
Effective Time: 20211208
Aleor Dermaceuticals Limited

Summary of Product characteristics

TESTOSTERONE - TESTOSTERONE SOLUTION
ALEOR DERMACEUTICALS LIMITED
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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)
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 dose of testosterone may be decreased from 60 mg
(2 pump