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ANDRO GEL
ANDRO GEL ONLINE
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 |
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| Anticoagulants (blood thinners)—Androgens can increase the
effect of these medicines and possibly cause excessive
bleeding |
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. |
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| 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. |
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| 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. |
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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. |
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| 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. |
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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. |
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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. |
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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. |
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| 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. |
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| For treatment of delayed sexual development in boys:
| Children—Use and dose must be determined by your
doctor. |
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| 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. |
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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 for
twenty-four hours a day.
| Children up to 15 years of age—Use and dose must
be determined by your doctor. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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Precautions While Using This Medicine
Your doctor should check your progress at regular visits to
make sure this medicine does not cause unwanted effects.
For patients with diabetes mellitus (sugar diabetes) :
| This medicine may affect blood sugar levels. If you notice a
change in the results of your blood or urine sugar tests or if
you have any questions, check with your doctor. |
For patients using the brand name Testoderm patches
(matrix-type):
| In some cases, this medicine can pass from you to your
sexual partner. Tell your doctor if your female sex partner
has a great increase in acne. Also, tell your doctor if her
hair begins to grow in odd places like her upper lip, chest,
or back. This will not occur if you are using the
reservoir-type skin patch because it is not applied to the
scrotum and because it has a protective liner. |
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:
| Less common
| For males or females
| Dizziness; frequent or continuing headache ;
lack or loss of strength; nausea; overall
body flushing, redness, or itching of skin;
rapid weight gain; rapidly changing moods, such
as depersonalization, dysphoria, euphoria, depression,
paranoia, and quick to react or overreact emotionally;
swelling of feet or lower legs; unusual bleeding
; unusual tiredness; vomiting ;
yellow skin or eyes (occurring with fluoxymesterone or
methyltestosterone more often than with testosterone) |
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| For females with breast cancer or bedridden males or
females—in addition to the side effects listed above
| Confusion or mental depression; constipation ;
increased thirst; increased urge to urinate or
increased amount of urine |
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| For males only
| Black, tarry stools; burning sensation or
hardening or thickening of skin under patch;
chills; continuing pain at site of implants;
difficulty in urinating; itching, skin redness,
or rash under patch, severe (less likely with
nonscrotal patch); pain in scrotum or groin;
vomiting of blood or material that looks like coffee
grounds |
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| Rare
| For males or females—more likely with oral
androgens or long-term or high doses of androgens
| Abdominal or stomach pain, continuing; bad
breath odor, continuing; black, tarry or
light-colored stools or dark urine; fever;
hives; loss of appetite, continuing; mood
or mental changes; purple or red spots on body
or inside the mouth or nose; sore throat ;
swelling, pain, or tenderness of abdomen;
vomiting of blood |
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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 |
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| For males only
| Decrease in testicle size; infection, pain,
redness, swelling, sores, or other skin irritation
underneath patch |
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Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
Additional Information
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