TESTOSTERONE solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Cipla USA Inc.

Начин на приложение:

TOPICAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 referre

Каталог на резюме:

Testosterone topical solution 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. NDC: 69097-363-44 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.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Cipla USA Inc.
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MEDICATION GUIDE
Testosterone (tes-TOS-te-rone) Topical Solution
for topical use CIII
What is the most important information I should know about
testosterone topical solution?
1. Testosterone topical solution 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 topical solution 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 topical solution.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with testosterone topical
solution 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 topical solution may
include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using testosterone topical solution 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 topical solution:
2. To lower the risk of transfer of testosterone topical solution from
your body to others, follow these
important instructions:
•
Apply testosterone topical solution only to your armpits.
•
Wash your hands right away with soap and water after applying
testosterone topical solution.
•
After the solution 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

Данни за продукта

TESTOSTERONE- TESTOSTERONE SOLUTION
CIPLA USA INC.
----------
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 _[SEE WARNINGS AND PRECAUTIONS (5.2)]_ .
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN USING
TESTOSTERONE TOPICAL SOLUTION _[SEE DOSAGE AND ADMINISTRATION (2.2)
AND WARNINGS AND PRECAUTIONS (5.2)]_ .
HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO
RECOMMENDED INSTRUCTIONS FOR USE
_[SEE DOSAGE AND ADMINISTRATION (2.2), WARNINGS AND PRECAUTIONS (5.2)
AND PATIENT COUNSELING INFORMATION (17)]_ .
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 7/2017
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 test