TESTIM- testosterone gel

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Endo Pharmaceuticals Inc.

INN (Tên quốc tế):

TESTOSTERONE

Thành phần:

TESTOSTERONE 50 mg in 5 g

Tuyến hành chính:

TRANSDERMAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

TESTIM is indicated for testosterone 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 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 TESTIM in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been esta

Tóm tắt sản phẩm:

TESTIM is supplied in unit-dose tubes in cartons of 30.  Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows: Store at 20°C to 25°C (68°F - 77°F). Excursions permitted to 15°C to 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Discard used TESTIM tubes 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)].

Tình trạng ủy quyền:

New Drug Application

Tờ rơi thông tin

Endo Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Testim® (TĔS tim)
(testosterone gel) for topical use, CIII
What is the most important information I should know about Testim?
1. Testim 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
Testim 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 Testim.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with Testim 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
Testim may include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using Testim 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 placed Testim.
2. To lower the risk of transfer of Testim from your body to others,
follow these important instructions:
•
Apply Testim 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 Testim.
•
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 child or woman touches the area where you have applied Testim,
that area on the child or woman
should be washed well with soap and water right

Đặc tính sản phẩm

TESTIM- TESTOSTERONE GEL
ENDO PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTIM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTIM .
TESTIM (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) 11/2020
INDICATIONS AND USAGE
TESTIM 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 (1)
Limitations of Use:
Safety and efficacy of TESTIM in men with “age-related
hypogonadism” have not been established. (1)
Safety and efficacy of TESTIM 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 TESTIM, 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) applied topically once
daily. (2.1)
Apply to clean, dry, intact skin of the shoulders and/or upper arms.
Do NOT apply TESTIM to the genitals
or abdomen. (2.1, 2.2)
If morning pre-dose serum testosterone concentration is below normal
range, increase dose to 100
mg. (2.1)