TESTIM- testosterone gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

TESTOSTERONE

Sammensætning:

TESTOSTERONE 50 mg in 5 g

Indgivelsesvej:

TRANSDERMAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Testim® is indicated for testosterone 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. Testim® has not been clinically evaluated in males under 18 years of age. Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testim® is not indica

Produkt oversigt:

Testim® contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim® is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows: Storage Store at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Disposal Keep out of the reach of children. Used Testim® tubes should be discarded in household trash in a manner that prevents accidental exposure of children or pets; contents flammable. RX Only Manufactured for: Auxilium Pharmaceuticals, Inc. Malvern, PA 19355 USA By: DPT Laboratories, Ltd. San Antonio, TX 78215 Issued: September 2009 PL-0705-001.b 129092 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Autorisation status:

New Drug Application

Indlægsseddel

Physicians Total Care, Inc.
----------
Medication Guide
TESTIM® (těs TIM) 1%, CIII
(testosterone gel)
Read the Medication Guide that comes with TESTIM 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
doctor about your medical condition or your treatment.
What is the most important information I should know about TESTIM?
1.
Early signs and symptoms of puberty have happened in young children
who were accidentally
exposed to testosterone through contact with men using TESTIM.
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
2.
TESTIM can transfer from your body to others. Women and children
should avoid contact with
the unwashed or unclothed area where TESTIM has been applied to your
skin.
Stop using TESTIM and call your doctor right away if you see any signs
and symptoms in a child
or a woman that may have occurred through accidental exposure to
TESTIM.
Signs and symptoms of exposure to Testim 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 TESTIM in women may include:
•
changes in body hair
•
a large increase in acne
To lower the risk of transfer of TESTIM from your body to others, you
should follow these important
instructions:
•
Apply TESTIM only to the areas of your shoulders and upper arms that
will be covered by a short
sleeve T-shirt.
•
Wash your hands right away with soap and water after applying TESTIM.
•
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.
•
If you expect to have skin-to-skin contact with another person, first
wash the application area well
with soap and water.
•
If a woman or child makes contact

Produktets egenskaber

TESTIM - TESTOSTERONE GEL
PHYSICIANS TOTAL CARE, INC.
----------
TESTIM 1% (TESTOSTERONE GEL) CIII
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
VIRILIZATION HAS BEEN REPORTED IN CHILDREN WHO WERE SECONDARILY
EXPOSED TO TESTOSTERONE
GEL.
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN
USING TESTOSTERONE GEL.
HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO
RECOMMENDED
INSTRUCTIONS FOR USE.
(SEE WARNINGS, POTENTIAL FOR SECONDARY EXPOSURE TO TESTOSTERONE)
DESCRIPTION
Testim (testosterone gel) is a clear to translucent hydroalcoholic
topical gel containing 1%
testosterone. Testim provides continuous transdermal delivery of
testosterone for 24 hours,
following a single application to intact, clean, dry skin of the
shoulders and upper arms.
One 5 g or two 5 g tubes of Testim contains 50 mg or 100 mg of
testosterone, respectively, to be
applied daily to the skin’s surface. Approximately 10% of the
applied testosterone dose is absorbed
across skin of average permeability during a 24-hour period.
The active pharmacological ingredient in Testim is testosterone.
Testosterone USP is a white to practically white crystalline powder
chemically described as 17-β
hydroxyandrost-4-en-3-one. Inactive ingredients in Testim are purified
water, pentadecalactone,
carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol,
ethanol (74%), and tromethamine.
CLINICAL PHARMACOLOGY
Testim 1% (testosterone gel) delivers physiologic amounts of
testosterone, producing circulating
testosterone levels that approximate normal levels (e.g., 300 – 1000
ng/dL) seen in healthy men.
TESTOSTERONE – GENERAL ANDROGEN EFFECTS:
Testosterone and dihydrotestosterone (DHT), endogenous androgens, are
responsible for normal
®
®
®
®
®
®
®
growth and development of the male sex organs and for maintenance of
secondary sex characteristics.
These effects include the growth and maturation of the prostate,
seminal vesicles, penis, and scrotum;
the development of male hair distribution, such as fa