DANATROL

A synthetic steroid with antigonadotropic and anti-estrogenic activities that acts as an anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins.

It possesses some androgenic properties.

Danazol has been used in the treatment of endometriosis and some benign breast disorders.

For the treatment of endometriosis and fibrocystic breast disease (in patients unresponsive to simple measures).

Also used for the prophylactic treatment of all types of hereditary angioedema in males and females.

Danazol is a derivative of the synthetic steroid ethisterone, a modified testosterone.

It was approved by the

U.S. Food and Drug Administration (FDA) as the first drug to specifically treat endometriosis, but its role as a treatment for endometriosis has been largely replaced by the gonadotropin-releasing hormone (GnRH) agonists.

Danazol has antigonadotropic and anti-estrogenic activities.

Danazol acts as an anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins.

It possesses some androgenic properties.

Estrogen receptor Agonist Androgen receptor Agonist

Progesterone receptor Agonist + 2 more targets.

Hepatic, to principal metabolites, ethisterone and 17-hydroxymethylethisterone.

Hover over products below to view reaction partners Danazol 17-hydroxymethylethisterone Ethisterone.

Approximately 24 hours.

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Danazol capsules should not be administered to patients with: Undiagnosed abnormal genital bleeding.

Markedly impaired hepatic, renal, or cardiac function.

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.

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 to 6 months but may be extended to 9 months if necessary.

After termination of therapy, if symptoms recur, treatment can be reinstituted.

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. During the dose adjusting phase, close monitoring of the patient's response is indicated, particularly if the patient has a history of airway involvement.

USP, 50 mg are available as maize opaque/white opaque capsules imprinted with logo "LANNETT" on the cap and "1392" on the body and are supplied in: Bottles of 60 (NDC 62135-475-60) Danazol Capsules USP, 100 mg are available as maize opaque/maize opaque capsules imprinted with logo "LANNETT" on the cap and "1368" on the body and are supplied in: Bottles of 60 (NDC 62135-476-60) Danazol Capsules USP, 200 mg are available as orange opaque/orange opaque capsules imprinted with logo "LANNETT" on the cap and "1369" on the body and are supplied in: Bottles of 60 (NDC 62135-477-60) Store at 20° to 25°C (68° to 77°F) .

Dispense in a well-closed container with a child-resistant closure as defined in the USP.

Manufactured for

Congers, NY 10920 L71285 Rev. 02/2023.