VOGELXO- testosterone gel VOGELXO- testosterone gel, metered

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

Testosterone (UNII: 3XMK78S47O) (Testosterone - UNII:3XMK78S47O)

Հասանելի է:

Upsher-Smith Laboratories, LLC

INN (Միջազգային անվանումը):

Testosterone

Կազմը:

Testosterone 50 mg in 5 g

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Vogelxo 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 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 levels 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 levels but have gonadotropins in the normal or low range. Limitations of Use: - Safety and efficacy of Vogelxo in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - Safety and effic

Ապրանքի ամփոփագիր:

Vogelxo is supplied in unit-dose tubes in cartons of 30 and unit-dose packets in cartons of 30. Each tube or packet contains 50 mg testosterone in 5 g of gel. Vogelxo is also supplied in a metered-dose pump that delivers 12.5 mg of testosterone per complete pump actuation. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations. Each pump actuation delivers 1.25 g of gel. The metered-dose pump is supplied in cartons of 2. Vogelxo is available as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Used Vogelxo tubes, packets or pumps should be discarded in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions (5.2)] . Contents are flammable [see Warnings and Precautions (5.16)] .

Լիազորման կարգավիճակը:

New Drug Application

Տեղեկատվական թերթիկ

VOGELXO- TESTOSTERONE GEL, METERED
Upsher-Smith Laboratories, LLC
----------
MEDICATION GUIDE
VOGELXO® (VOH-JELKS-OH) CIII
(TESTOSTERONE) GEL, FOR TOPICAL USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
What is the most important information I should know about Vogelxo?
1.
Vogelxo 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 Vogelxo 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 Vogelxo.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with Vogelxo 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
Vogelxo may include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using Vogelxo 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 Vogelxo.
2.
To lower the risk of transfer of Vogelxo from your body to others,
follow these important instructions:
•
Apply Vogelxo only to the areas of your shoulders and upper arms that
will be covered by a
short sleeve t-shirt.
•
Wash your hands right away with soap and water after applying Vogelxo.
•
After the gel 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
well with soap and water.
•
If a chil

Ապրանքի հատկությունները

VOGELXO- TESTOSTERONE GEL
VOGELXO- TESTOSTERONE GEL, METERED
UPSHER-SMITH LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VOGELXO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VOGELXO.
VOGELXO (TESTOSTERONE) GEL, 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
TESTOSTERONE GEL. (5.2, 6.2)
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN
USING TESTOSTERONE GEL. (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
Contraindications (4)
04/2020
INDICATIONS AND USAGE
Vogelxo is an androgen indicated for testosterone 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 Vogelxo in men with age-related hypogonadism
have not been established (1)
Safety and efficacy of Vogelxo in males less than 18 years old have
not been established (8.4)
Topical testosterone products may have different doses, strengths, or
application instructions that may
result in different systemic exposure (1, 12.3)
DOSAGE AND ADMINISTRATION
Prior to initiating Vogelxo, 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).
Recommended starting dose for adult males: 50 mg of testosterone (one
tube or one packet or 4
pump actuations) applied topically once daily at approximately the
same time each day. (2.1)
Apply to clean, dry, intact skin of the shoulders and/or upper arms.
Do not apply Vogelxo t