AXIRON- testosterone solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Physicians Total Care, Inc.

INN (Међународно име):

TESTOSTERONE

Састав:

TESTOSTERONE 30 mg in 1.5 mL

Пут администрације:

TOPICAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

AXIRON is an androgen indicated for replacement therapy in 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 (FSH, LH) above the normal range. - Hypogonadotropic hypogonadism (congenital or acquired): idiopathic 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. Important limitations of use — Safety and efficacy of AXIRON in males <18 years old have not been established [see Use in Specific Populations (8.4)] . - AXIRON is contraindicated in

Резиме производа:

AXIRON (testosterone) topical solution 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. Neither the bottle nor the applicator cup contains latex. NDC 54868-6406-0 Keep AXIRON out of reach of children. Store 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 AXIRON bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.

Статус ауторизације:

New Drug Application

Информативни летак

AXIRON - TESTOSTERONE SOLUTION
Physicians Total Care, Inc.
----------
Medication Guide
AXIRON® (AXE-e-RON) CIII
(testosterone) topical solution
Read this Medication Guide before you start using AXIRON and each time
you get a refill. There may be
new information. This information does not take the place of talking
with your healthcare provider about
your medical condition or treatment.
What is the most important information I should know about AXIRON?
AXIRON can transfer from your body to others. This can happen if other
people come into contact with
the area where the AXIRON was applied.
Signs of puberty that are not expected (for example, pubic hair) have
happened in young children who
were accidentally exposed to testosterone through skin to skin contact
with men using topical testosterone
products like AXIRON.
•
Women and children should avoid contact with the unwashed or unclothed
area where AXIRON
has been applied. If a woman or child makes contact with the
application area, the contact area on
the woman or child should be washed well with soap and water right
away.
•
To lower the risk of transfer of AXIRON from your body to others, you
should follow these
important instructions:
•
Apply AXIRON only to your armpits.
•
Wash your hands right away with soap and water after applying AXIRON.
•
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 another person to have direct skin-to-skin contact with
your armpits, first
wash the application area well with soap and water.
Stop using AXIRON 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
AXIRON:
Signs and symptoms in children may include:
•
enlarged penis or clitoris
•
early development of pubic hair
•
increased erections or sex drive
•
aggressive behavior
Signs and symptoms in women may include:
•
changes in body ha

Карактеристике производа

AXIRON - TESTOSTERONE SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AXIRON SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AXIRON.
AXIRON (TESTOSTERONE) TOPICAL SOLUTION, FOR TOPICAL USE CIII
INITIAL U.S. APPROVAL: 1953
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
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 AXIRON (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
AXIRON is an androgen indicated for 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)
Important limitations of use: Safety and efficacy of AXIRON in males
<18 years old have not been established (8.4)
DOSAGE AND ADMINISTRATION
Starting AXIRON dose is 60 mg of testosterone (1 pump actuation of 30
mg of testosterone to each axilla), applied
once daily, at the same time each morning. (2.1)
Apply to clean, dry intact skin of the axilla, not to any other parts
of the body including the abdomen or genitals (2.2)
Dose adjustment: The dose of testosterone may be decreased from 60 mg
(2 pump actuations) to 30 mg (1 pump
actuation) or increased from 60 mg to 90 mg (3 pump actuations) or
from 90 mg to 120 mg (4 pump actuations) based
on the serum testosterone concentration from a single blood draw 2 –
8 hours after applying AXIRON and at least 14
days after starting treatment or following dose adjustment. (2.2)
Patients should wash hands immediately with soap and water after
applying AXIRON and cover the application site with
clothing after the solution has dried. Wash the application site
thoroughly with soap and water prior to any