Danazol (Page 3 of 3)

Geriatric Use

Clinical studies of danazol did not include sufficient numbers of subjects aged 65 and over to determine the safety and effectiveness of danazol in elderly patients.

ADVERSE REACTIONS

The following events have been reported in association with the use of danazol:

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. Although cyclical bleeding and ovulation usually return within 60 to 90 days after discontinuation of therapy with danazol, persistent amenorrhea has occasionally been reported.

Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.

Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of danazol of 400 mg or more. It is recommended that patients receiving danazol be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, hepatic adenoma, hepatocellular injury, hepatocellular jaundice and hepatic failure have been reported (see WARNINGS and PRECAUTIONS).

Abnormalities in laboratory tests may occur during therapy with danazol including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.

The following reactions have been reported, a causal relationship to the administration of danazol has neither been confirmed nor refuted; allergic: urticaria, pruritus and rarely, nasal congestion; CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain-Barre syndrome; gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis and splenic peliosis; musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention; genitourinary: hematuria, prolonged posttherapy amenorrhea; hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted. Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme; other: increased insulin requirements in diabetic patients, change in libido, myocardial infarction, palpitation, tachycardia, elevation in blood pressure, interstitial pneumonitis, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Danazol capsules, USP are available as follows:

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) capsules.
100 mg:	Yellow opaque cap/yellow clear body capsule. Imprinted with black ink stylized barr 634. Available in bottles of 100 (NDC 0555-0634-02) capsules.
200 mg:	Orange opaque cap/orange clear body capsule. Imprinted with black ink stylized barr 635. Available in bottles of 60 (NDC 0555-0635-09) and 100 (NDC 0555-0635-02) capsules.

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep this and all medications out of the reach of children.

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Rev. D 10/2022

Package/Label Display Panel

NDC 0555-0633-02

Danazol

Capsules, USP

50 mg

Rx only

100 Capsules

Package/Label Display Panel

NDC 0555-0634-02

Danazol

Capsules, USP

100 mg

Rx only

100 Capsules

Package/Label Display Panel

NDC 0555-0635-09

Danazol

Capsules, USP

200 mg

Rx only

60 Capsules

DANAZOL danazol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-0633 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DANAZOL (DANAZOL) DANAZOL 50 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE D&C YELLOW NO. 10 D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SHELLAC PROPYLENE GLYCOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE FD&C YELLOW NO. 6

Product Characteristics Color yellow, white Score no score Shape CAPSULE Size 16mm Flavor Imprint Code barr;633 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0555-0633-02 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074582 06/25/1998

DANAZOL danazol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-0634 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DANAZOL (DANAZOL) DANAZOL 100 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE D&C YELLOW NO. 10 D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SHELLAC PROPYLENE GLYCOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE FD&C YELLOW NO. 6

Product Characteristics Color yellow Score no score Shape CAPSULE Size 16mm Flavor Imprint Code barr;634 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0555-0634-02 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074582 06/25/1998

DANAZOL danazol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-0635 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DANAZOL (DANAZOL) DANAZOL 200 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE D&C YELLOW NO. 10 D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SHELLAC PROPYLENE GLYCOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE D&C RED NO. 28

Product Characteristics Color orange Score no score Shape CAPSULE Size 19mm Flavor Imprint Code barr;635 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0555-0635-09 60 CAPSULE in 1 BOTTLE None 2 NDC:0555-0635-02 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074582 08/09/1996

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2022 Teva Pharmaceuticals USA, Inc.