ANDROGEL- testosterone gel

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

testosterone (UNII: 3XMK78S47O) (testosterone - UNII:3XMK78S47O)

थमां उपलब्ध:

Physicians Total Care, Inc.

INN (इंटरनेशनल नाम):

testosterone

रचना:

testosterone 10 mg in 1 g

प्रशासन का मार्ग:

TRANSDERMAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

AndroGel, an androgen, 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 (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 levels but have gonadotropins in the normal or low range. AndroGel should not be used in any of the following patients: - Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.1), Adverse Reactions (6.1), and

उत्पाद समीक्षा:

AndroGel is supplied in non-aerosol, metered-dose pumps. The pump is composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g AndroGel Pump in the twin package is capable of dispensing 75 g or 60 metered 1.25 g doses. AndroGel 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. Keep AndroGel out of the reach of children. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Disposal Used AndroGel pumps or used AndroGel packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

ANDROGEL - TESTOSTERONE GEL
Physicians Total Care, Inc.
----------
Medication Guide
AndroGel® (AN DROW JEL) CIII
(testosterone gel) 1%
Read the Medication Guide that comes with AndroGel before you start
taking 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 AndroGel?
1. Early signs and symptoms of puberty have happened in young children
who were accidentally exposed
to testosterone through contact with men using AndroGel.
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
AndroGel can transfer from your body to others.
2. Women and children should avoid contact with the unwashed or
unclothed area where AndroGel has
been applied to your skin.
Stop using AndroGel 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
AndroGel.
Signs and symptoms of exposure to AndroGel 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 AndroGel in women may include:
•
changes in body hair
•
a large increase in acne
To lower the risk of transfer of AndroGel from your body to others,
you should follow these important
instructions:
•
Apply AndroGel 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
AndroGel.
•
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.
�

उत्पाद विशेषताएं

ANDROGEL - TESTOSTERONE GEL
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANDROGEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ANDROGEL.
ANDRO GEL (TESTOSTERONE GEL) 1% 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 TESTOSTERONE GEL (5.2, 6.2).
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN USING TESTOSTERONE
GEL (5.2).
HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO
RECOMMENDED INSTRUCTIONS FOR USE
(5.2).
RECENT MAJOR CHANGES
BOXED WARNING 9/2009
WARNINGS AND PRECAUTIONS (5.2) 9/2009
INDICATIONS AND USAGE
AndroGel 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) (1.1)
Hypogonadotropic Hypogonadism (Congenital or Acquired) (1.1)
DOSAGE AND ADMINISTRATION
Recommended starting dose: 5 g for adult males, applied topically once
daily (2.1).
Apply to clean, dry, intact skin of shoulders and upper arms and/or
abdomen. Do NOT apply AndroGel to the genitals
(2.1).
Dose adjustment for adult males: If serum testosterone level is below
the normal range, adjust dose from 5 g to 7.5 g
and from 7.5 g to 10 g (2.3).
DOSAGE FORMS AND STRENGTHS
AndroGel (testosterone gel) 1% for topical use is available as:
2 x 75 g pumps (each pump dispenses 60 metered 1.25 g doses) (3)
2.5 g packet or 5 g packet (3)
CONTRAINDICATIONS
Men with carcinoma of the breast or known or suspected prostate cancer
(4, 5.1).
Pregnant or breast feeding women. Testosterone may cause fetal harm
(4).
WARNINGS AND PRECAUTIONS
Patients with benign prostatic hyperplasia (BPH) treated with
androgens are at an increased risk for worsening of signs
and symptoms of BPH (5.1).
Secondary exposure to testosterone in children and women can occur
with us