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DANAZOL

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 danazol 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 danazol. If your dose is different, do not change it 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 time allowed between doses, and the length of time you take the medicine depend on 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 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

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.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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 danazol, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic 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 are taking this medicine because it may cause unwanted effects in the baby.

Children 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.

Older adults 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.

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 danazol, it is especially important that your health care professional know if you are taking any of the following:

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

• 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 used when these conditions exist

• Porphyria This condition may be made worse

• Diabetes mellitus (sugar diabetes) Danazol may increase blood glucose (sugar) levels

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