TESTOSTERONE- testosterone gel

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Perrigo New York Inc

INN (Tarptautinis Pavadinimas):

TESTOSTERONE

Sudėtis:

TESTOSTERONE 12.5 mg in 1.25 g

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Testosterone gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Limitations of use: Pregnancy Category X [see Contraindications (4) ]: Testosterone gel 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, such as testosterone, 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 gel 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 gel in pediatric males less than 18 years old ha

Produkto santrauka:

16.1 How Supplied Testosterone gel is supplied in non-aerosol, metered-dose pumps that deliver 12.5 mg of testosterone per complete pump actuation. The pumps are composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g metered-dose Pump is capable of dispensing 75 g of gel or 60 metered pump actuations; each pump actuation dispenses 1.25 g of gel containing 12.5 mg of testosterone. NDC Number Package Size 45802-116 -02 2 x 75 g pumps (each pump dispenses 60 metered pump actuations with each pump actuation containing 12.5 mg of testosterone in 1.25 g of gel) Testosterone gel is also supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively. NDC Number Package Size 45802-116 -65 30 packets (25 mg of testosterone in 2.5 g of gel per packet) 45802-116 -39 30 packets (50 mg of testosterone in 5 g of gel per packet) 16.2 Storage and Handling Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] 16.3 Disposal Used testosterone gel pumps or used testosterone gel packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Autorizacija statusas:

New Drug Application

Pakuotės lapelis

TESTOSTERONE- TESTOSTERONE GEL
Perrigo New York Inc
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MEDICATION GUIDE
testosterone gel
Testosterone (tes-TOS-te-rone gel) CIII
Read this Medication Guide that comes with testosterone gel before you
start using it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
healthcare provider about your medical condition or your treatment.
What is the most important information I should know about
testosterone gel?
1. Early signs and symptoms of puberty have happened in young children
who were accidentally exposed to
testosterone through contact with men using testosterone gel.
Signs and symptoms of early puberty in a child may include:
•
enlarged penis or clitoris
•
early development of pubic hair
•
increased erections or sex drive
•
aggressive behavior
Testosterone gel can transfer from your body to others.
2. Women and children should avoid contact with the unwashed or
unclothed area where testosterone gel has
been applied to your skin.
Stop using testosterone gel and call your healthcare provider right
away if you see any signs and symptoms
in a child or a woman that may have occurred through accidental
exposure to testosterone gel.
Signs and symptoms of exposure to testosterone gel in children may
include:
•
enlarged penis or clitoris
•
early development of pubic hair
•
increased erections or sex drive
•
aggressive behavior
Signs and symptoms of exposure to testosterone gel in women may
include:
•
changes in body hair
•
a large increase in acne
To lower the risk of transfer of testosterone gel from your body to
others, you should follow these important
instructions:
•
Apply testosterone gel only to areas that will be covered by a short
sleeve T-shirt. These areas are your
shoulders and upper arms, or stomach area (abdomen), or shoulders,
upper arms and stomach area.
•
Wash your hands right away with soap and water after applying
testosterone gel.
•
After the gel has dried, cover the application area with clo

Prekės savybės

TESTOSTERONE- TESTOSTERONE GEL
PERRIGO NEW YORK INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTOSTERONE GEL SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE GEL.
TESTOSTERONE GEL, FOR TOPICAL USE, CIII
INITIAL U.S. APPROVAL: 1953
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 10/2016
INDICATIONS AND USAGE
Testosterone is an androgen indicated for replacement therapy in males
for conditions associated with a deficiency or
absence of endogenous testosterone: (1)
•
•
Limitations of use: (1)
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Testosterone gel for topical use is available as follows: (3)
•
•
•
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)
Primary Hypogonadism (Congenital or Acquired) (1)
Hypogonadotropic Hypogonadism (Congenital or Acquired) (1)
Safety and efficacy of testosterone gel in men with age-related
hypogonadism have not been established. (1)
Safety and efficacy of testosterone gel 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)
Prior to initiating testosterone gel, 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 dose of testosterone gel is 50 mg of testosterone (4 pump
actuations, two 25 mg packets, or one 50 mg
packet)