ANDRIOL

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BRAND NAMES:
In the U.S.

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

BRAND NAMES:
In Canada

• Andriol
• Delatestryl
• Depo-Testosterone Cypionate
• Halotestin
• Malogen in Oil
• Metandren
• Scheinpharm Testone-Cyp

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
  • Capsules (Canada)

  Parenteral

• Testosterone
  • Injection (U.S. and Canada)

  Subcutaneous

• Testosterone
  • Implants (Pellets) (U.S.)

  Topical

• Testosterone
  • Gel
  • 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 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:
    • Adults5 milligrams (mg) one to four times a day.
  • For treatment of breast cancer in women:
    • Adults10 to 40 mg a day in divided doses.
  • For treatment of delayed sexual development in boys:
    • Children2.5 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:
    • Adults10 to 50 milligrams (mg) a day.
  • For treatment of breast cancer in women:
    • Adults50 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:
    • Children5 to 25 mg a day for four to six months.

  For testosterone

• For injection dosage form:
  • For androgen hormone replacement in men:
    • Adults25 to 50 milligrams (mg) injected into a muscle two or three times a week.
  • For treatment of breast cancer in women:
    • Adults50 to 100 mg injected into a muscle three times a week.
  • For treatment of delayed sexual development in boys:
    • ChildrenUp 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:
    • Adults150 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:
    • ChildrenUse 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)
    • Adults4 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.
    • ChildrenUse 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 older2.5 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 ageUse and dose must be determined by your doctor.

    When using the brand name Testoderm TTS patches (reservoir-type)

    • Adults5 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 ageUse and dose must be determined by your doctor.

  For testosterone cypionate or testosterone enanthate

• For injection dosage form:
  • For androgen hormone replacement in men:
    • Adults50 to 400 milligrams (mg) injected into a muscle every two to four weeks.
  • For treatment of breast cancer in women:
    • Adults200 to 400 mg injected into a muscle every two to four weeks.
  • For treatment of delayed sexual development in boys:
    • ChildrenUp 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:
    • Adults25 to 50 milligrams (mg) injected into a muscle two or three times a week.
  • For treatment of breast cancer in women:
    • Adults50 to 100 mg injected into a muscle three times a week.
  • For treatment of delayed sexual development in boys:
    • ChildrenUp 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:
    • Adults120 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 dayTake, 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 dayTake 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.

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.

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 cancerAndrogens 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 diseaseThese 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 prostateAndrogens can cause further enlargement of the prostate

• Heart or blood vessel diseaseAndrogens 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

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.

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

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 , 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)

For females with breast cancer or bedridden males or femalesin 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

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

Rare

For males or femalesmore 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

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.

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