Danazol (Oral Route)

These include treatment of:

• Pain and/or infertility due to endometriosis;


• A tendency for females to develop cysts in the breasts (fibrocystic breast 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.

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 may not be included in product labeling, 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)

This product is available in the following dosage forms:

• Capsule

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Danazol may cause male-like changes in female children and cause premature sexual development in male children. It may also slow or stop growth in any child.

Geriatric

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

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione


• Bupropion


• Dicumarol


• Lovastatin


• Phenprocoumon


• Simvastatin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine


• Cyclosporine


• Tacrolimus


• Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you 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 vaginaa€”Danazol should not be used when these conditions exist

• Porphyriaa€”This condition may be made worse

• Type 2 diabetes mellitusa€”Danazol may increase blood glucose (sugar) levels

• Epilepsy or


• Heart disease or


• Kidney disease or


• Migraine headachesa€”These conditions can be made worse by the fluid retention (keeping too much body water) that can be caused by danazol

Proper Use

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

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For capsules dosage form:
  
  
  
  • Adults and teenagers:
    
    
    
    • For treatment of endometriosis: 100 to 400 milligrams (mg) two times a day for at least three to six months, and possibly for nine months.
    
    
    • For treatment of fibrocystic breast disease: 50 to 200 mg two times a day for six months or until signs of the disease go away, whichever comes first.
    
    
    • For prevention of attacks of hereditary angioedema: 200 mg two or three 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 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

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

For patients with diabetes:

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

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

• Stay out of direct sunlight, especially between the hours of 10:00 a.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 protect your lips.


• Do not use a sunlamp or tanning bed or booth.

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

If you are taking danazol for endometriosis or fibrocystic breast disease:

• During the time you are taking danazol, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when you are taking this medicine. If regular menstruation does not begin within 60 to 90 days after you stop taking this medicine, check with your doctor .


• During the time you are taking danazol, you should use birth control methods 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 use of danazol during pregnancy may cause male-like changes in female babies.

Side Effects

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 may need medical attention .

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

For both females and malesLess common

• Acne


• Dark-colored urine


• Increased oiliness of hair or skin


• Muscle cramps or spasms


• Swelling of feet or lower legs


• Unusual tiredness or weakness


• Weight gain (rapid)

Rare

• Bleeding gums


• Bloating, pain or tenderness of abdomen or stomach


• Blood in urine


• Burning, numbness, pain, or tingling in all fingers except the smallest 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


• Discharge from nipple


• Eye pain


• Fast heartbeat


• Fever


• Headache


• Hives or other skin rash


• Joint pain


• Light-colored stools


• Loss of appetite (continuing)


• Loss of muscle coordination


• More frequent nosebleeds


• Muscle aches


• Nausea


• Purple- or red-colored, or other spots on body or inside the mouth or nose


• Restlessness


• Shortness of breath


• Sore throat


• Sweating


• Tingling, numbness, or weakness in legs, which may move upward to arms, trunk, or face


• Unusual bruising or bleeding


• Unusual tiredness, weakness, or general feeling of illness


• Vomiting


• Yellow eyes or skin

For females onlyMore common

• Decrease in breast size


• Irregular menstrual periods


• Weight gain

Rare

• Enlarged clitoris


• Hoarseness or deepening of voice


• Unnatural hair growth

For males onlyRare

• Changes in semen


• Decrease in size of testicles

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For both females and malesLess common

• Flushing or redness of skin


• Mood or mental changes


• Nervousness

Rare

• Increased sensitivity of skin to sunlight

For females onlyLess common

• Burning, dryness, or itching of vagina


• Vaginal bleeding

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.