ANDROGEL- testosterone gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Rebel Distributors Corp.

INN (International Name):

TESTOSTERONE

Sammensetning:

TESTOSTERONE 10 mg in 1 g

Administreringsrute:

TRANSDERMAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

1.1 Testosterone Replacement Therapy 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 Precaution

Produkt oppsummering:

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.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Rebel Distributors Corp.
----------
Manufactured By:
Laboratoires Besins International
Montrouge, France
For:
Unimed Pharmaceuticals, LLC
A Solvay Pharmaceuticals, Inc. Company
Marietta, GA 30062-2224
Repackaged by:
Rebel Distributors Corp.
Thousand Oaks, CA 91320
U.S. Patent No. 6,503, 894
© 2007 Solvay Pharmaceuticals, Inc.
Revised: December 2007
500122/500127 Rev Dec 2007(1)
Revised: 9/2010
Document Id: 77215d87-ad22-4169-bd5f-a453f10b21ef
Set id: 77215d87-ad22-4169-bd5f-a453f10b21ef
Version: 1
Effective Time: 20100908
Rebel Distributors Corp.

Preparatomtale

ANDROGEL- TESTOSTERONE GEL
REBEL DISTRIBUTORS CORP.
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ANDROGEL
1 INDICATIONS AND USAGE
1.1 Testosterone Replacement Therapy
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.
DOSAGE AND ADMINISTRATION
2.1 General Dosing
The recommended starting dose of AndroGel is 5 g once daily
(preferably in the morning) to clean, dry,
intact skin of the shoulders and upper arms and/or abdomen. AndroGel
must not be applied to the
genitals. AndroGel is supplied as either a pump or in individual
packets. After applying the gel, the
application site should be allowed to dry for a few minutes prior to
dressing. Avoid fire, flames or
smoking until the gel has dried since alcohol based products,
including AndroGel, are flammable.
Hands should be washed with soap and water after AndroGel has been
applied. _[see Warnings and_
_Precautions (5.2, 5.10)]._
2.2 Administration
Multi-Dose Pump
Patients should be instructed to prime the pump before using it for
the first time by fully depressing the
pump mechanism (actuation) 3 times and discard this portion of the
product to assure precise dose
delivery. After the priming procedure, patients should completely
depress the pump one time (actuation)
for every 1.25 g (AndroGel Pump) of product required to achieve the
daily prescribed dosage.