Danazol

Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema. Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.

• Endometriosis
• 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 capsules (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
• Hereditary Angioedema
• The dosage requirements for continuous treatment of hereditary angioedema with danazol capsules 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. …

• Danazol capsules should not be administered to patients with: Undiagnosed abnormal genital bleeding
• Markedly impaired hepatic, renal, or cardiac function
• Pregnancy (see WARNINGS )
• Breast feeding
• Porphyria-Danazol capsules can induce ALA synthetase activity and hence porphyrin metabolism
• Androgen-dependent tumor
• Active thrombosis or thromboembolic disease and history of such events
• Hypersensitivity to danazol

PRECAUTIONS Because danazol capsules may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, or cardiac or renal dysfunction, polycythemia and hypertension require careful observation. Use with caution in patients with diabetes mellitus. Since hepatic dysfunction manifested by modest increases in serum transaminases levels has been reported in patients treated with danazol capsules, periodic liver function tests should be performed (see WARNINGS and ADVERSE REACTIONS ). Administration of danazol has been reported to cause exacerbation of the manifestations of acute intermittent porphyria (see CONTRAINDICATIONS ). …

The following events have been reported in association with the use of danazol capsules: Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare. Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.