TESTOSTERONE solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Padagis Israel Pharmaceuticals Ltd

INN:

TESTOSTERONE

composition:

TESTOSTERONE 30 mg in 1.5 mL

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Testosterone Topical Solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Limitations of use: Pregnancy Category X [see Contraindications (4) ] — Testosterone Topical Solution is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a female fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Although it is not known how much testosterone transfers into human milk, Testosterone Topical Solution is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Testosterone and other androgens may adversely affect lactation. [See Contraindications (4) ]. Safety and efficacy of Testosterone Topical Solution has not been establis

leaflet_short:

Testosterone Topical Solution USP, 30 mg/1.5 mL 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 pump 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 45802-610 -01 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

PIL

TESTOSTERONE- TESTOSTERONE SOLUTION
Padagis Israel Pharmaceuticals Ltd
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MEDICATION GUIDE
TESTOSTERONE (tes-TOS-te-rone)
topical solution USP, 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

SPC

TESTOSTERONE- TESTOSTERONE SOLUTION
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
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._
•
•
•
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN
USING TESTOSTERONE TOPICAL SOLUTION, 30 MG/1.5 ML (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, 30 mg/1.5 mL is indicated for
replacement therapy in males for conditions
associated with a deficiency or absence of endogenous testosterone:
•
•
Limitations of use:
•
•
DOSAGE AND ADMINISTRATION
Prior to initiating Testosterone Topical Solution, 30 mg/1.5 mL,
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).
•
•
•
•
•
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, 30 MG/1.5 ML (2.2, 5.2)
HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO
RECOMMENDED
INSTRUCTIONS FOR USE (2.2, 5.2, 17)
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Safety and efficacy of Testosterone Topical Solution, 30 mg/1.5 mL in
men with “age-related
hypogonadism” have not been established. (1)
Safety and efficacy of Testosterone Topical Solution, 30 mg/1.5 mL in
males <18 years old have not
been established. (8.4)
St