DANAZOL (Systemic)

Some commonly used brand names are:

In the U.S.?

• Danocrine

In Canada?

• Cyclomen

Generic name product may be available in the U.S.

Category

• Angioedema, hereditary, prophylactic
• Gonadotropin inhibitor

Description

Danazol (DA-na-zole) may be used for a number of different medicalproblems. These include treatment of:

• Pain and/or infertility due to endometriosis;
• A tendency for females to develop cysts in the breasts (fibrocysticbreast disease); or
• Hereditary angioedema, which causes swelling of the face, arms, legs,throat, windpipe, bowels, or sexual organs.

Danazol may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Oral
• Capsules (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For danazol, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to danazol, androgens (male hormones), or anabolic steroids.Also tell your health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Danazol is not recommended for use during pregnancy,since it may cause a female baby to develop certain male characteristics.

Breast-feeding?Breast-feeding is not recommended while you aretaking this medicine because it may cause unwanted effects in the baby.

Children?Danazol may cause male-like changes in female childrenand cause premature sexual development in male children. It may also slowor stop growth in any child.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of danazol in the elderly with use in other age groups, danazolhas effects similar to androgens (male hormones). Androgens used in oldermales may increase the risk of developing prostate enlargement or cancer.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingdanazol, it is especially important that your health care professional knowif you are taking any of the following:

• Anticoagulants (blood thinners)?Danazol may increase the effectsof these medicines and possibly increase the risk of severe bleeding
• Tacrolimus (e.g., Prograf)?Danazol may increase the effectsof tacrolimus by increasing the amount of that medicine in the body

Other medical problems?The presence of other medicalproblems may affect the use of danazol. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Blood clotting disorders or
• Severe liver disease or
• Tumor caused by too much male hormones or
• Tumor on the genitals or
• Unusual bleeding from the vagina?Danazol should not be usedwhen these conditions exist

• Porphyria?This condition may be made worse

• Type 2 diabetes mellitus?Danazol may increase bloodglucose (sugar) levels

• Epilepsy or
• Heart disease or
• Kidney disease or
• Migraine headaches?These conditions can be made worse by thefluid retention (keeping too much body water) that can be caused by danazol

Proper Use of This Medicine

In orderfor danazol to help you, it must be taken regularly forthe full time of treatment as ordered by your doctor.

Dosing?The dose of danazol will be different for differentpatients. Follow your doctor's orders or the directionson the label. The following information includes only the average dosesof danazol. If your dose is different, do not changeit unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problems for which you are taking danazol.

• For capsules dosage form:
  • Adults and teenagers:
    • For treatment of endometriosis: 100 to 400 milligrams (mg) two timesa day for at least three to six months, and possibly for nine months.
    • For treatment of fibrocystic breast disease: 50 to 200 mg two timesa day for six months or until signs of the disease go away, whichever comesfirst.
    • For prevention of attacks of hereditary angioedema: 200 mg two orthree times a day. The dose may be lowered, depending upon your condition.
  • Children: Dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Yourdoctor should check your progress at regular visits to make sure that thismedicine does not cause unwanted effects.

Contact your doctor if you are a female and have alarger clitoris (sexual organ), deepening of your voice, or unnatural hairgrowth after taking danazol. Your doctor may advise you to stop takingthe medicine so these effects do not get worse.

For patients with diabetes:

• This medicine may affect blood glucose (sugar) levels. If you noticea change in the results of your blood or urine glucose test or if you haveany questions about this, check with your doctor.

Danazol may cause your skin to be more sensitive to sunlight than it isnormally. Exposure to sunlight, even for brief periods of time, may causea skin rash, itching, redness, or other discoloration of the skin, or a severesunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF)of a least 15. Some patients may require a product with a higher SPF number,especially if they have a fair complexion. If you have questions about this,check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check withyour doctor.

If you are taking danazol for endometriosisor fibrocystic breast disease:

• During the time you are taking danazol, your menstrual period maynot be regular or you may not have a menstrual period at all. This is to beexpected when you are taking this medicine. If regular menstruation does notbegin within 60 to 90 days after you stop taking this medicine, check withyour doctor.
• During the time you are taking danazol, you should use birth controlmethods that do not contain hormones. If you have any questions about this,check with your health care professional.
• If you suspect that you may have become pregnant,stop taking this medicine and check with your doctor. Continued useof danazol during pregnancy may cause male-like changes in female babies.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

For both females and males

Less common

Acne; dark-colored urine; increased oiliness of hair or skin; muscle cramps or spasms; swelling of feet or lowerlegs; unusual tiredness or weakness; weight gain (rapid)

Rare

Bleeding gums; bloating, pain or tendernessof abdomen or stomach; blood in urine; burning, numbness, pain, or tingling in all fingers except thesmallest finger; changes in vision; chest pain; chills; complete or partial numbness or weakness on one side of body; cough; coughing up blood; diarrhea; difficulty in speaking; difficulty in swallowing; dischargefrom nipple; eye pain; fast heartbeat; fever; headache; hives or other skin rash; joint pain; light-colored stools; loss of appetite (continuing); lossof muscle coordination; more frequent nosebleeds; muscle aches; nausea; purple- or red-colored, or other spots on body or inside themouth or nose; restlessness; shortness of breath; sore throat; sweating; tingling, numbness, or weakness in legs,which may move upward to arms, trunk, or face; unusualbruising or bleeding; unusual tiredness, weakness,or general feeling of illness; vomiting; yellow eyes or skin

For females only

More common

Decrease in breast size; irregular menstrualperiods; weight gain

Rare

Enlarged clitoris; hoarseness or deepeningof voice; unnatural hair growth

For males only

Rare

Changes in semen; decrease in size oftesticles

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

For both females and males

Less common

Flushing or redness of skin; mood ormental changes; nervousness

Rare

Increased sensitivity of skin to sunlight

For females only

Less common

Burning, dryness, or itching of vagina; vaginal bleeding

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

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses may not be included in productlabeling, danazol is used in certain patients with the following medical conditions:

• Gynecomastia (excess breast development in males)
• Menorrhagia (excessively long menstrual periods)
• Precocious puberty in females (premature sexual development)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.