Description
Androgens (AN-droe-jens) are male hormones. Some
androgens are naturally produced in the body and are necessary for the normal
sexual development of males.
Androgens are used for several reasons, such as:
-
to replace the hormone when the body is unable to produce enough
on its own.
-
to stimulate the beginning of puberty in certain boys who are late
starting puberty naturally.
-
to treat certain types of breast cancer in females.
In addition, some of these medicines may be used for other conditions as
determined by your doctor.
Androgens are available only with your doctor's prescription, in the following
dosage forms:
Oral
-
Fluoxymesterone
-
Tablets (U.S. and Canada)
-
Methyltestosterone
-
Capsules (U.S.)
-
Tablets (U.S. and Canada)
-
Testosterone
Parenteral
-
Testosterone
-
Injection (U.S. and Canada)
Subcutaneous
-
Testosterone
-
Implants (Pellets) (U.S.)
Topical
-
Testosterone
-
Gel
-
Ointment
-
Transdermal systems (skin patches) (U.S.)
Before Using This Medicine
In deciding to use a medicine,
the risks of taking the medicine must be weighed against the good it will
do. This is a decision you and your doctor will make. For androgens, the following
should be considered:
Allergies--Tell your doctor if you have ever had any unusual or
allergic reaction to androgens. Also tell your health care professional if
you are allergic to any other substances, such as foods, preservatives, or
dyes.
Pregnancy--Androgens are not recommended during pregnancy. When
given to pregnant women, the medicine has caused male features to develop
in female babies.
Breast-feeding--Use is not recommended in nursing mothers, since
androgens may pass into the breast milk and may cause unwanted effects in
the nursing baby, such as premature (too early) sexual development in males
and development of male features in female babies.
Children--Androgens may cause children to stop growing. In
addition, androgens may make male children develop too fast sexually and may
cause male-like changes in female children.
Older adults--When older male patients are treated with androgens,
they may have an increased risk of enlarged prostate (a male gland) or their
existing prostate cancer may get worse. For these reasons, a prostate examination
and a blood test to check for prostate cancer is often done before androgens
are prescribed for men over 50 years of age. These examinations may be repeated
during treatment.
Other medicines--Although certain medicines should not be used
together at all, in other cases two different medicines may be used together
even if an interaction might occur. In these cases, your doctor may want to
change the dose, or other precautions may be necessary. When you are taking
androgens, it is especially important that your health care professional know
if you are taking any of the following:
-
Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
-
Amiodarone (e.g., Cordarone) or
-
Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g.,
Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
-
Anti-infectives by mouth or by injection (medicines for infection)
or
-
Antithyroid agents (medicines for overactive thyroid) or
-
Carbamazepine (e.g., Tegretol) or
-
Carmustine (e.g., BiCNU) or
-
Chloroquine (e.g., Aralen) or
-
Dantrolene (e.g., Dantrium) or
-
Daunorubicin (e.g., Cerubidine) or
-
Disulfiram (e.g., Antabuse) or
-
Divalproex (e.g., Depakote) or
-
Estrogens (female hormones) or
-
Etretinate (e.g., Tegison) or
-
Gold salts (medicines for arthritis) or
-
Hydroxychloroquine (e.g., Plaquenil) or
-
Mercaptopurine (e.g., Purinethol) or
-
Methotrexate (e.g., Mexate) or
-
Methyldopa (e.g., Aldomet) or
-
Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
-
Oral contraceptives (birth control pills) containing estrogen or
-
Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,
Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil],
perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine
[e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],
trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine
[e.g., Temaril]) or
-
Phenytoin (e.g., Dilantin) or
-
Plicamycin (e.g., Mithracin) or
-
Valproic acid (e.g., Depakene)--Use of these medicines with
androgens may increase the chance of liver problems. Your doctor may want
you to have extra blood tests that check your liver while you are taking any
of these medicines with an androgen
-
Anticoagulants (blood thinners)--Androgens can increase the
effect of these medicines and possibly cause excessive bleeding
Other medical problems--The presence of other medical
problems may affect the use of androgens. Make sure you tell your doctor if
you have any other medical problems, especially:
-
Breast cancer (in males) or
-
Prostate cancer--Androgens can cause growth of these tumors
-
Breast cancer (in females)--Androgens may cause high calcium
levels in the blood to become worse
-
Diabetes mellitus (sugar diabetes)--Androgens can increase or
decrease blood sugar levels. Careful monitoring of blood glucose should be
done
-
Edema (swelling of face, hands, feet, or lower legs) or
-
Kidney disease or
-
Liver disease--These conditions can be worsened by the fluid
retention (keeping too much water in the body) that can be caused by androgens.
Also, liver disease can prevent the body from removing the medicine from the
bloodstream as fast as it normally would. This could increase the chance of
side effects occurring
-
Enlarged prostate--Androgens can cause further enlargement of
the prostate
-
Heart or blood vessel disease--Androgens can make these conditions
worse because androgens may increase blood cholesterol levels. Also, androgens
can cause fluid retention (keeping too much water in the body), which also
can worsen heart or blood vessel disease
Proper Use of This Medicine
Take this medicine only as directed.
Do not take more of it and do not take it more often than your doctor ordered
. Doing so may increase the chance of side effects.
There are two types of testosterone skin patches. The matrix-type is applied
to skin of the scrotum. The reservoir-type is never applied to the skin of
the scrotum. It is applied to other parts of the body. Be sure you know which
type you are using so that you will apply it properly. These skin patches
come with patient directions. Read them carefully before using the patch.
For patients taking fluoxymesterone
or methyltestosterone
:
-
Take this medicine with food to lessen possible stomach upset, unless
otherwise directed by your doctor.
For patients using the matrix-type skin patch of testosterone
(Testoderm or Testoderm with Adhesives)
:
-
You must apply the patch to the scrotum because the medicine easily
passes into your body at this area. Other areas of your skin are too thick
for the medicine to work properly.
-
Wash and dry your hands thoroughly before and after handling the
patch.
-
Before applying the patch:
-
Clean and dry your scrotum.
-
You should also dry-shave this area once a week by using a shaver
only (no soap or water). To dry-shave, stretch the skin of your scrotum with
your fingers. Use short gentle strokes with no pressure on the razor to remove
the hair. Do not use shaving cream or hair-removing creams (e.g., Nair).
-
You may sit with your legs apart or stand while applying the patch.
-
To apply the patch:
-
Open the wrapper containing the patch at the point shown on the package.
-
Carefully remove the patch from its protective plastic liner by peeling
the patch from the liner starting at the corner.
-
Warm your scrotum for a few seconds before applying the patch to
achieve the best results. Stretch the skin of your scrotum gently to remove
the folds by pulling the penis up and to the side. Another way is to pull
your scrotum down. Use your first and middle fingers to stretch the skin of
your scrotum.
-
Place the shiny side of the patch onto the warm stretched skin of
your scrotum.
-
Press the shiny side of the patch firmly in place with the palm of
your hand for about 10 seconds. Make sure there is good contact, especially
around the edges. The patch should stick to your scrotum and show the natural
wrinkles of your scrotum.
-
Put on comfortable, close-fitting briefs (underwear) after applying
the patch.
-
If a patch becomes loose or falls off, you may reapply it or discard
it and apply a new patch.
-
To remove the skin patch:
-
Gently peel the patch from the skin.
-
You may reuse the patch after removing it for swimming, bathing,
showering, or sexual activity. First, remove the patch and place the shiny
(sticky) side up on a counter. Before you reapply the patch, be sure the skin
on your scrotum is dry. Then, follow the directions to reapply the patch.
-
When the wearing period is over, fold the patch in half with the
sticky sides together. Place the folded, used patch in its protective pouch
or in aluminum foil. Be sure to throw it away out of the reach of children
and pets.
For patients using the reservoir-type skin patch of
testosterone (Androderm or Testoderm TTS)
:
-
Apply the patch called Androderm
to the
abdomen, back, thighs, or arms. Apply the patch called Testoderm TTS
to the back, arms, or upper buttocks. Do not apply these patches to the scrotum
.
-
Do not apply the patch to areas of the body that seem bony, such
as the top of the shoulders or near the elbows, or to areas that may have
to support your body while sleeping or sitting, such as the hips or shoulder
blades. Apply each new patch to a different place. Do not reapply a patch
to the same area of skin for 7 days.
-
Wash and dry your hands thoroughly before and after handling the
patch.
-
Before applying the patch, clean and dry the application site.
-
To apply the patch:
-
Open the wrapper containing the patch at the point shown on the package.
-
Carefully remove the patch from its protective plastic liner by peeling
the patch from the liner, starting at the corner.
-
Place the shiny side of the patch onto the skin.
-
Press the shiny side of the patch firmly in place with the palm of
your hand for about 10 seconds. Be sure there is good contact, especially
around the edges.
-
If a patch becomes loose or falls off, you may reapply it or discard
it and apply a new patch.
-
To remove the skin patch:
-
Gently peel the patch from the skin.
-
You do not need to remove this patch for swimming, bathing, showering,
or sexual activity.
-
When the wearing period is over, fold the patch in half with the
sticky sides together. Place the folded, used patch in its protective pouch
or in aluminum foil. Be sure to throw it away out of the reach of children
and pets.
Dosing--The dose of
these medicines will be different for different patients. Follow your doctor's orders or the directions on the label
. The following
information includes only the average doses of these medicines. If your dose is different, do not change it
unless your doctor tells
you to do so.
The number of capsules or tablets that you take depends on the strength
of the medicine. Also, the number of doses you take each
day, the time between doses, and the length of time you take the medicine
depend on the medical problem for which you are taking the androgen
.
For fluoxymesterone
-
For oral
dosage form (tablets):
-
For androgen hormone replacement in men:
-
Adults--5 milligrams (mg) one to four times a day.
-
For treatment of breast cancer in women:
-
Adults--10 to 40 mg a day in divided doses.
-
For treatment of delayed sexual development in boys:
-
Children--2.5 to 10 mg a day for four to six months.
For methyltestosterone
-
For oral
dosage forms (capsules or tablets):
-
For androgen hormone replacement in men:
-
Adults--10 to 50 milligrams (mg) a day.
-
For treatment of breast cancer in women:
-
Adults--50 mg one to four times a day. Your doctor may decrease
your dose to 50 mg two times a day after two to four weeks.
-
For treatment of delayed sexual development in boys:
-
Children--5 to 25 mg a day for four to six months.
For testosterone
-
For injection
dosage form:
-
For androgen hormone replacement in men:
-
Adults--25 to 50 milligrams (mg) injected into a muscle two
or three times a week.
-
For treatment of breast cancer in women:
-
Adults--50 to 100 mg injected into a muscle three times a week.
-
For treatment of delayed sexual development in boys:
-
Children--Up to 100 mg injected into a muscle once a month for
four to six months.
-
For subcutaneous
dosage form (implants):
-
For androgen hormone replacement in men:
-
Adults--150 to 450 milligram (mg) (two to six implants) inserted
into the skin every three to six months.
-
For treatment of delayed sexual development in boys:
-
Children--Use and dose must be determined by your doctor.
-
For topical
dosage forms :
-
For androgen hormone replacement in men:
When using the brand name AndroGel 1% testosterone gel
-
The recommended starting dose is one 5 gram packet applied once daily
(preferably in the morning) to clean, dry , intact skin of the shoulders and
upper arms and/or abdomen. Allow the application sites to dry prior to dressing
and wash hands with soap and water after application.
When using the brand name Testoderm or Testoderm with Adhesives patches
(matrix-type)
-
Adults--4 or 6 mg (one patch) applied to your scrotum once a
day at about 8 a.m. The patch should be worn at least twenty-two of the twenty-four
hours in a day.
-
Children--Use and dose must be determined by your doctor.
When using the brand name Androderm patches (reservoir-type)
-
Adults and teenagers 15 years of age and older--2.5 to 7.5 mg
(one to three patches) applied to the abdomen, back, thighs, or upper arms
once a day at about 10 p.m. The patch(es) should be worn at least twenty-two
of the twenty-four hours in a day.
-
Children up to 15 years of age--Use and dose must be determined
by your doctor.
When using the brand name Testoderm TTS patches (reservoir-type)
-
Adults--5 mg (one patch) applied to the back, arms, or upper
buttocks once a day at about 8 a.m. Your doctor may increase your dose if
necessary. The patch should be worn at least twenty-two of the twenty-four
hours in a day.
-
Children up to 18 years of age--Use and dose must be determined
by your doctor.
For testosterone cypionate or testosterone enanthate
-
For injection
dosage form:
-
For androgen hormone replacement in men:
-
Adults--50 to 400 milligrams (mg) injected into a muscle every
two to four weeks.
-
For treatment of breast cancer in women:
-
Adults--200 to 400 mg injected into a muscle every two to four
weeks.
-
For treatment of delayed sexual development in boys:
-
Children--Up to 100 mg injected into a muscle once a month for
four to six months.
For testosterone propionate
-
For injection
dosage form:
-
For androgen hormone replacement in men:
-
Adults--25 to 50 milligrams (mg) injected into a muscle two
or three times a week.
-
For treatment of breast cancer in women:
-
Adults--50 to 100 mg injected into a muscle three times a week.
-
For treatment of delayed sexual development in boys:
-
Children--Up to 100 milligrams injected into a muscle once a
month for four to six months.
For testosterone undecanoate
-
For oral
dosage form (capsules):
-
For androgen hormone replacement in men:
-
Adults--120 to 160 milligrams (mg) divided into two doses a
day taken with meals for two to three weeks. Then dose is reduced to 40 to
120 mg a day, taken with meals, and divided into 2 doses a day when possible.
Missed dose--For oral dosage forms: If you miss a dose of this
medicine and your dosing schedule is:
-
One dose a day--Take, use, or apply the missed dose as soon
as possible. However, if you do not remember it until the next day, skip the
missed dose and go back to your regular dosing schedule. Do not double doses.
-
More than one dose a day--Take or use the missed dose as soon
as possible. However, if it is almost time for your next dose, skip the missed
dose and go back to your regular dosing schedule. Do not double doses.
For topical dosage forms (patches): If you miss a dose of this medicine
or your patch falls off within 12 hours after applying it and cannot be reapplied,
skip the rest of the dose and go back to your regular dosing schedule. Do
not double doses.
If you have any questions about this, check with your doctor.
Storage--To store this medicine:
-
Keep out of the reach of children.
-
Store away from heat and direct light.
-
Do not store in the bathroom, near the kitchen sink, or in other
damp places. Heat or moisture may cause the medicine to break down.
-
Keep the injection form of this medicine from freezing.
-
Do not keep outdated medicine or medicine no longer needed. Be sure
that any discarded medicine is out of the reach of children.
Side Effects of This Medicine
Discuss these possible effects with your doctor:
-
Tumors of the liver, liver cancer, or peliosis hepatis (a form of
liver disease) have occurred during long-term, high-dose therapy with androgens.
Although these effects are rare, they can be very serious and may cause death.
-
Androgens can stimulate existing prostate cancer in men who already
have it but have not yet been diagnosed. Also, the prostate (a male gland)
may become enlarged. Enlargement of the prostate does not mean that cancer
will develop. If enlargement occurs and you have difficulty in urinating,
it is a good idea to be checked by your doctor.
-
When androgens are used in women, especially in high doses, male-like
changes may occur, such as hoarseness or deepening of the voice, unnatural
hair growth, or unusual hair loss. Most of these changes will go away if the
medicine is stopped as soon as the changes are noticed. However, some changes,
such as voice changes or enlarged clitoris, may not go away.
-
When androgens are used in high doses in males, they interfere with
the production of sperm. This effect is usually temporary and only happens
during the time you are taking the medicine. However, discuss this possible
effect with your doctor if you are planning on having children.
Along
with its needed effects, a medicine may cause some unwanted effects. Although
not all of these side effects appear very often, when they do occur they may
require medical attention. Check with your doctor as soon as possible if any
of the following side effects occur:
Other side
effects may occur that usually do not need medical attention. These side effects
may go away during treatment as your body adjusts to the medicine. However,
check with your doctor if any of the following side effects continue or are
bothersome:
Less common
For males and females
Acne, mild; diarrhea; hair loss or thinning of hair; increase in pubic
hair growth; infection, pain, redness, or other irritation
at site of injection; decrease or increase in sexual
desire or drive; nervousness; stomach pain; trouble in sleeping
For males only
Decrease in testicle size; infection,
pain, redness, swelling, sores, or other skin irritation underneath patch
Other
side effects not listed above may also occur in some patients. If you notice
any other effects, check with your doctor.
Additional Information
Once a medicine has been approved
for marketing for a certain use, experience may show that it is also useful
for other medical problems. Although these uses are not included in product
labeling, androgens are used in certain patients with the following medical
conditions:
-
Anemias (blood problems)
-
Delayed growth spurt
-
Development of male features in transsexuals
-
Microphallus (underdevelopment of the penis)
-
Lichen sclerosus (a skin problem of the vulva)
Other than the above information, there is no additional information relating
to proper use, precautions, or side effects for these uses.
