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. USP DI® Volume II, Advice for the Patient.

ANDROGENS (Systemic)

Table Of Contents:
Brand Names
Category
Description
Before Using This Medicine
Proper Use of This Medicine
Precautions While Using This Medicine
Side Effects of This Medicine
Additional Information

Some commonly used brand names are:

In the U.S.—

  • Androderm 3
  • Android 2
  • Android-F 1
  • Andro L.A. 200 3
  • Andronate 100 3
  • Andronate 200 3
  • Andropository 200 3
  • Andryl 200 3
  • Delatest 3
  • Delatestryl 3
  • Depotest 3
  • Depo-Testosterone 3
  • Everone 200 3
  • Halotestin 1
  • ORETON Methyl 2
  • T-Cypionate 3
  • Testamone 100 3
  • Testaqua 3
  • Testex 3
  • Testoderm 3
  • Testoderm with Adhesives 3
  • Testopel Pellets 3
  • Testred 2
  • Testred Cypionate 200 3
  • Testrin-P.A. 3
  • Virilon 2
  • Virilon IM 3

In Canada—

  • Delatestryl 3
  • Depo-Testosterone Cypionate 3
  • Halotestin 1
  • Malogen in Oil 3
  • Metandren 2

Note:

For quick reference, the following androgens are numbered to match the corresponding brand names.

This information applies to the following medicines
1. Fluoxymesterone (floo-ox-i-MES-te-rone)
2. Methyltestosterone (meth-il-tes-TOS-te-rone)
3. Testosterone (tes-TOS-te-rone)
‡ Generic name product may be available in the U.S.

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)
    Parenteral
  • Testosterone
    • Injection (U.S. and Canada)
    Subcutaneous
  • Testosterone
    • Implants (Pellets) (U.S.)
    Topical
  • Testosterone
    • Ointment
    • Transdermal systems (skin patches) (U.S.)

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 the abdomen, back, thighs, or upper arms. 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):

  • 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):

  • Apply the patch to the abdomen, back, thighs, or arms. Men over 65 years of age should not apply it to the back because the medicine is not absorbed as well at that location. Do not apply the patch 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 (patches):
    • For androgen hormone replacement in men:
        When using the brand name Testoderm patches (matrix-type)
      • Adults—4 or 6 mg (one patch) applied to your scrotum once a day. 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. The patch(es) should be worn at least twenty-two of the twenty-four hours in a day. Do not apply to your back if you are older than 65 years of age.
      • Children up to 15 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 (mg) injected into a muscle once a month for four to six months.

Missed dose—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.

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:

      More common

        For females only

          Acne or oily skin; decreased breast size; irregular menstrual cycles; hoarseness or deepening of voice; increase in size of female genitals; increase in unnatural hair growth or male pattern baldness

          Note:

          These symptoms may occur in females whose male sexual partner uses a scrotal patch.

        For males only

          Blistering of skin under patch (especially when the nonscrotal patch is applied to bony areas of the skin); breast soreness or enlargement; frequent or continuing erection of penis lasting up to 4 hours or painful penile erections lasting longer than 4 hours; frequent urge to urinate; itching or redness of skin under patch (less likely with nonscrotal patch) or at site of implants, mild to severe

        For prepubertal boys only

          Acne; early growth of pubic hair; enlargement of penis; frequent or continuing erections

    Less common

      For males or females

        Dizziness; frequent or continuing headache; nausea; overall body flushing, redness, or itching of skin; rapid weight gain; 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)

      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

      For males only

        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

    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; purple or red spots on body or inside the mouth or nose; sore throat; swelling, pain, or tenderness of abdomen; vomiting of blood

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 both males and females

        Acne, mild; diarrhea; increase in pubic hair growth; infection, pain, redness, or other irritation at site of injection; decrease or increase in sexual desire or drive; stomach pain; trouble in sleeping

      For males only

        Decrease in testicle size

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/19/97

Note: The information contained herein has been devised without reference to cultural, dietary, societal, language, prescribing or dispensing conditions (including those imposed by law), other than those of the United States, which might affect the information provided. Information is for your personal use only and may not be sold or redistributed.

Copyright ® 2001 Micromedex, Inc. All rights reserved. USPDI® and Advice for the Patient? are registered trademarks USP used under license to Micromedex, Inc. Patient Education Leaflets is a trademark of Micromedex, Inc.

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