Danazol

{{DrugProjectFormSinglePage |authorTag={{ |aOrAn=a |hasBlackBoxWarning=Yes |adverseReactions= |blackBoxWarningTitle=ConditionName: |blackBoxWarningBody=ConditionName:

• Content

|fdaLIADAdult======Endometriosis=====

• Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management.

• Dosing Information

• 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

• 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 capsules are 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.

• Dosing Information

• 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.

Hereditary Angioedema

• Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.

• Dosing Information

• 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.

|offLabelAdultGuideSupport=* There is limited information regarding Off-Label Guideline-Supported Use of Danazol in adult patients.

|offLabelAdultNoGuideSupport=* There is limited information regarding Off-Label Non–Guideline-Supported Use of Danazol in adult patients.

|fdaLIADPed=* There is limited information regarding FDA-Labeled Use of Danazol in pediatric patients.

|offLabelPedGuideSupport=* There is limited information regarding Off-Label Guideline-Supported Use of Danazol in pediatric patients.

|offLabelPedNoGuideSupport=* There is limited information regarding Off-Label Non–Guideline-Supported Use of Danazol in pediatric patients.

|contraindications=* Condition1

|warnings=* Description

Precautions

• Description

|clinicalTrials=There is limited information regarding Clinical Trial Experience of Danazol in the drug label.

Miscellaneous

|postmarketing=There is limited information regarding Postmarketing Experience of Danazol in the drug label.

Miscellaneous

|drugInteractions=* Drug

• Description

|useInPregnancyFDA=* Pregnancy Category |useInPregnancyAUS=* Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Danazol in women who are pregnant. |useInLaborDelivery=There is no FDA guidance on use of Danazol during labor and delivery. |useInNursing=There is no FDA guidance on the use of Danazol with respect to nursing mothers. |useInPed=There is no FDA guidance on the use of Danazol with respect to pediatric patients. |useInGeri=There is no FDA guidance on the use of Danazol with respect to geriatric patients. |useInGender=There is no FDA guidance on the use of Danazol with respect to specific gender populations. |useInRace=There is no FDA guidance on the use of Danazol with respect to specific racial populations. |useInRenalImpair=There is no FDA guidance on the use of Danazol in patients with renal impairment. |useInHepaticImpair=There is no FDA guidance on the use of Danazol in patients with hepatic impairment. |useInReproPotential=There is no FDA guidance on the use of Danazol in women of reproductive potentials and males. |useInImmunocomp=There is no FDA guidance one the use of Danazol in patients who are immunocompromised.

|administration=* Oral

• Intravenous

|monitoring=There is limited information regarding Monitoring of Danazol in the drug label.

• Description

|IVCompat=There is limited information regarding IV Compatibility of Danazol in the drug label.

|overdose====Acute Overdose===

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Danazol in the drug label.

|drugBox= |mechAction=*

|structure=*

File:Danazol01.png

This image is provided by the National Library of Medicine.

|PD=There is limited information regarding Pharmacodynamics of Danazol in the drug label.

|PK=There is limited information regarding Pharmacokinetics of Danazol in the drug label.

|nonClinToxic=There is limited information regarding Nonclinical Toxicology of Danazol in the drug label.

|clinicalStudies=There is limited information regarding Clinical Studies of Danazol in the drug label.

|howSupplied=* |packLabel= |fdaPatientInfo=There is limited information regarding Patient Counseling Information of Danazol in the drug label.

|alcohol=* Alcohol-Danazol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

|brandNames=* ®

|lookAlike=* A® — B®

|drugShortage= }} {{#subobject:

 |Page Name=Danazol
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Danazol
 |Label Name=Danazol11.png

}}

{{#subobject:

 |Label Page=Danazol
 |Label Name=Danazol11.png

}}