TESTOSTERONE gel

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

REMEDYREPACK INC.

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Testosterone gel 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 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 (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 testosterone gel in men with "age-related hypogonadism" (also referred to as "late-onset hypog

Podsumowanie produktu:

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.

Status autoryzacji:

New Drug Application

Ulotka dla pacjenta

TESTOSTERONE- TESTOSTERONE GEL
REMEDYREPACK 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 clothi

Charakterystyka produktu

TESTOSTERONE- TESTOSTERONE GEL
REMEDYREPACK 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._
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
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)
Primary Hypogonadism (Congenital or Acquired) (1)
Hypogonadotropic Hypogonadism (Congenital or Acquired) (1)
Limitations of use: (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)
DOSAGE AND ADMINISTRATION
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), applied once daily in the morning. (2.1)
Apply to clean, dry, intact skin of shoulders and upper arms and/or
abdomen. Do NOT apply testosterone gel to any