INDICATIONS AND USAGE:
Danazol is indicated for the treatment of endometriosis amenable to hormonal management.
Fibrocystic Breast Disease:
Most cases of symptomatic fibrocystic breast disease may be treated by simple measures (e.g., padded brassieres and analgesics).
In infrequent patients, symptoms of pain and tenderness may be severe enough to warrant treatment by suppression of ovarian function. Danazol is usually effective in decreasing nodularity, pain, and tenderness. It should be stressed to the patient that this treatment is not innocuous in that it involves considerable alterations of hormone levels and that recurrence of symptoms is very common after cessation of therapy.
Danazol is indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
DOSAGE AND ADMINISTRATION:
In moderate to severe disease, or in patients infertile due to endometriosis, a starting dose of 800 mg given in two divided doses is recommended. Amenorrhea and rapid response to painful symptoms is best achieved at this dosage level. Gradual downward titration to a dose sufficient to maintain amenorrhea may be considered depending upon patient response. For mild cases, an initial daily dose of 200 mg to 400 mg given in two divided doses is recommended and may be adjusted depending on patient response. Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with danazol. (See CONTRAINDICATIONS and WARNINGS.) It is essential that therapy continue uninterrupted for 3 to 6 months but may be extended to 9 months if necessary. After termination of therapy, if symptoms recur, treatment can be reinstituted.
Fibrocystic Breast Disease:
The total daily dosage of danazol for fibrocystic breast disease ranges from 100 mg to 400 mg given in two divided doses depending upon patient response. Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with danazol. A nonhormonal method of contraception is recommended when danazol is administered at this dose, since ovulation may not be suppressed.
In most instances, breast pain and tenderness are significantly relieved by the first month and eliminated in 2 to 3 months. Usually elimination of nodularity requires 4 to 6 months of uninterrupted therapy. Regular menstrual patterns, irregular menstrual patterns, and amenorrhea each occur in approximately one-third of patients treated with 100 mg of danazol. Irregular menstrual patterns and amenorrhea are observed more frequently with higher doses. Clinical studies have demonstrated that 50% of patients may show evidence of recurrence of symptoms within one year. In this event, treatment may be reinstated.
The dosage requirements for continuous treatment of hereditary angioedema with danazol should be individualized on the basis of the clinical response of the patient. It is recommended that the patient be started on 200 mg, two or three times a day. After a favorable initial response is obtained in terms of prevention of episodes of edematous attacks, the proper continuing dosage should be determined by decreasing the dosage by 50% or less at intervals of one to three months or longer if frequency of attacks prior to treatment dictates. If an attack occurs, the daily dosage may be increased by up to 200 mg. During the dose adjusting phase, close monitoring of the patient's response is indicated, particularly if the patient has a history of airway involvement.
Danazol Capsules, USP are available as:
|50 mg:||Yellow opaque cap/white opaque body capsule. Imprinted with black ink stylized barr 633. Available in bottles of:|
|100 NDC 0555-0633-02|
|100 mg:||Yellow opaque cap/yellow clear body capsule. Imprinted with black ink stylized b arr 634. Available in bottles of:|
|100 NDC 0555-0634-02|
|200 mg:||Orange opaque cap/orange clear body capsule. Imprinted with black ink stylized b arr 635. Available in bottles of:|
|60 NDC 0555-0635-09|
|100 NDC 0555-0635-02|
|500 NDC 0555-0635-04|
Dispense with a child-resistant closure in a well-closed container as defined in the USP.
Store at controlled room temperature 15°-30°C (59°-86°F).
BARR LABORATORIES, INC.
POMONA, NY 10970
BR-633, 634, 635