AndroGel is a hormone replacement product
for men suffering from hypogonadism, a low level of the male
hormone testosterone. This condition is marked by symptoms
such as impotence and decreased interest in sex, lowered mood,
fatigue, and decreases in bone density and lean body mass.
Testosterone replacement therapy helps correct these problems.
AndroGel, applied daily to the skin, provides an especially
convenient way of taking the hormone, which was previously
administered only by injection or skin patch. |
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AndroGel® is the first-ever
testosterone replacement gel to be approved by the FDA for
replacement therapy in men for conditions associated with
low testosterone. Low testosterone, also known as hypogonadism,
affects approximately four to five million American men. The
condition is linked to diminished interest in sex, impotence,
reduced lean body mass, decreased bone density, lowered mood
and increased fatigue. Androgens are contraindicated in men
with carcinoma of the breast, or known or suspected carcinoma
of the prostate. AndroGel® has not been clinically evaluated
in males under 18 years of age. AndroGel® is not indicated
for use in women, has not been evaluated in women, and must
not be used in women. Pregnant women should avoid skin contact
with AndroGel® application sites in men. Testosterone
may cause fetal harm. Please see full prescribing information.
General Information
AndroGel is a hydroalcoholic gel to be applied to the clean,
dry skin of the shoulders, upper arms and/or abdomen. The
gel is absorbed through the skin and delivers testosterone
to the patient for approximately 24 hours. This product
is indicated for men with primary hypogonadism or hypogonadotropic
hypogonadism which results from insufficient secretion of
testosterone and is characterized by low serum testosterone
concentrations.
Two types of hypogonadism for which this
drug is indicated:
1. Primary hypogonadism: testicular failure; characterized
by low serum testosterone levels and gonadotropins (FSH, LH)
above the normal range
2. Hypogonadotropic hypogonadism: idiopathic gonadotropin
or LHRH deficiency or pituitary-hypothalamic injury from tumors,
trauma, or radiation; characterized by low serum testosterone
levels, but with gonadotropins in the normal or low range
In addition to supplying sufficient amounts of testosterone,
AndroGel, like other drugs in its class, may promote retention
of nitrogen, sodium, potassium, phosphorus, and decreased
urinary excretion of calcium. Furthermore, it may increase
protein anabolism and decrease protein catabolism. This class
of drugs (androgens) may also stimulate the production of
red blood cells.
Hypogonadism affects approximately 4 to 5 million American
men.
Symptoms of hypogonadism include:
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Impotence
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Decreased sexual desire
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Fatigue and loss of energy
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Mood depression
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Regression of secondary sexual characteristics
(growth and maturation of prostate, seminal vesicles,
penis, and scrotum; the development of male hair distribution,
including facial, pubic, chest, axillary hair; laryngeal
enlargement; vocal chord thickening; alterations in body
musculature; fat distribution)
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Osteoporosis
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