• Danazant indications
• Uses of Danazant in details
• Danazant description
• Danazant dosage
• Danazant interactions
• Danazant side effects
• Danazant contraindications

What is Danazant?

Danazant is used to treat a number of different medical problems. These include:

• Endometriosis.
• Fibrocystic breast disease (cysts in the breasts).
• Hereditary angioedema (swelling of the different parts of the body, such as abdomen or stomach, arms, legs, throat, skin, or sexual organs.

Danazant is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses may not be included in product labeling, Danazant is used in certain patients with the following medical conditions:

• Gynecomastia (breast development in males).
• Menorrhagia (abnormally heavy and prolonged menstrual periods).
• Precocious puberty in females (a condition that causes early puberty in girls).

Danazant indications

Endometriosis

Danazant Capsules USP are 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. Danazant Capsules USP 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.

Hereditary Angioedema

Danazant Capsules USP are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.

How should I use Danazant?

Use Danazant as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Danazant by mouth with or without food.
• If you are being treated for endometriosis or fibrocystic breast disease, you should begin treatment during menstruation.
• Endometriosis patients - You must take Danazant consistently for 3 to 6 months. It may be necessary to take Danazant for 9 months.
• If you miss a dose of Danazant, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Danazant.

Uses of Danazant in details

Use: Labeled Indications

Endometriosis: Treatment of endometriosis amenable to hormonal management.

Hereditary angioedema (HAE), prophylaxis: Prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.

Guideline recommendations:Danazant may be considered for short-term pre-procedural and long-term HAE prophylaxis as an alternative to CI inhibitor (human). Danazant is not recommended for treatment of acute HAE attacks (WAO/EAACI [Maurer 2018]).

Off Label Uses

Cyclic breast pain (mastalgia) associated with benign breast disorders

Data from a meta-analysis, which included five randomized controlled studies, support the use of Danazant in the treatment of cyclic breast pain (breast pain associated with the menstrual cycle) in females with benign breast disease (malignancy excluded). When compared to placebo, Danazant significantly decreased breast pain and improved quality of life; however, significant side effects were observed in the majority of women.

Danazant description

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. Danazant has been used in the treatment of endometriosis and some benign breast disorders. [PubChem]

Danazant dosage

Danazant Dosage

Generic name: Danazant

Dosage form: capsule

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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 Danazant. 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 Danazant 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 Danazant. A nonhormonal method of contraception is recommended when Danazant 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 Danazant. 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

The dosage requirements for continuous treatment of hereditary angioedema with Danazant 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.

More about Danazant (Danazant)

• Side Effects
• During Pregnancy
• Dosage Information
• Drug Images
• Drug Interactions
• Support Group
• En Espanol
• 2 Reviews - Add your own review/rating

Consumer resources

• Danazant
• Danazant (Advanced Reading)

Professional resources

• Danazant (FDA)
• Danazant (AHFS Monograph)

Related treatment guides

• Angioedema
• Endometriosis
• Evan's Syndrome
• Fibrocystic Breast Disease

Danazant interactions

See also:
What other drugs will affect Danazant?

Prolongation of prothrombin time occurs in patients stabilized on warfarin.

Therapy with Danazant may cause an increase in carbamazepine levels in patients taking both drugs.

Danazant can cause insulin resistance. Caution should be exercised when used with antidiabetic drugs.

Danazant may raise the plasma levels of cyclosporin and tacrolimus, leading to an increase of the renal toxicity of these drugs. Monitoring of systemic concentrations of these drugs and appropriate dose adjustments may be needed when used concomitantly with Danazant.

Danazant can increase the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism.

The risk of myopathy and rhabdomyolysis is increased by concomitant administration of Danazant with statins such as simvastatin, atorvastatin and lovastatin. Caution should be exercised if used concomitantly. Consult the product labeling for statin drugs for specific information on dose restrictions in presence of Danazant.

Laboratory Tests

Danazant treatment may interfere with laboratory determinations of testosterone, androstenedione and dehydroepiandrosterone. Other metabolic events include a reduction in thyroid binding globulin and T, but without disturbance of thyroid stimulating hormone or of free thyroxin index.

Danazant side effects

See also:
What are the possible side effects of Danazant?

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

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 include menstrual disturbances in the form of spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with Danazant, 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 Danazant of 400 mg or more. It is recommended that patients receiving Danazant be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, and hepatic adenoma have been reported.

Abnormalities in laboratory tests may occur during therapy with Danazant 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 Danazant 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; 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; other: increased insulin requirements in diabetic patients, change in libido, elevation in blood pressure, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.

Danazant contraindications

See also:
What is the most important information I should know about Danazant?

You should not use this medication if you are allergic to Danazant, or if you have porphyria, a history of stroke or blood clot, or severe problems with your heart, liver, or kidney. You also should not take Danazant if you are pregnant or breast-feeding, if you have breast or uterine cancer, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

Danazant can harm an unborn baby or cause vaginal birth defects in a newborn female infant. Do not use if you are pregnant.

You may need to have a negative pregnancy test before starting this treatment.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment with Danazant.

Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.

Call your doctor at once if you have a serious side effect such as sudden numbness or weakness, problems with vision or speech, chest pain, sudden cough, or wheezing, swelling, rapid weight gain, feeling short of breath, ringing in your ears, dizziness, nausea, pain behind your eyes, stomach pain and loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Active ingredient matches for Danazant:

Danazol in Ireland, Hong Kong.

List of Danazant substitutes (brand and generic names)	Sort by popularity
Unit description / dosage (Manufacturer)	Price, USD
Danatrol (Belgium, France, Greece, Italy, Luxembourg, Netherlands, Portugal, Spain, Switzerland, Tunisia)
Capsule; Oral; Danazol 200 mg (Sanofi synthelabo)
Danazol (Argentina, Brazil, Malaysia, Mexico, Philippines, Singapore, Taiwan, Thailand)
Capsule; Oral; Danazol 100 mg
Capsule; Oral; Danazol 200 mg
Capsule; Oral; Danazol 50 mg
Danazol powder	$ 21.42
Danazol 200 mg capsule	$ 5.20
Danocrine 200 mg capsule	$ 4.53
Danazol 100 mg capsule	$ 2.92
Cyclomen 200 mg Capsule	$ 2.31
Danazol 50 mg capsule	$ 1.95
Cyclomen 100 mg Capsule	$ 1.45
Cyclomen 50 mg Capsule	$ 0.98
Danazol / Astar 200 mg x 1000's
Danazol / Swiss 200 mg x 100's
Danazol / Tai Yu 200 mg x 1000's
Danazol / Sinton 200 mg x 1000's
Danazol capsule 100 mg/1 (Teva Pharmaceuticals Usa, Inc. (US))
Danazol capsule 200 mg/1 (American Health Packaging (US))
Danazol capsule 50 mg/1 (Lannett Company, Inc. (US))
Danazol 100
Danazol 200
Danazol American Generics (Colombia)
Danazol Astar (Taiwan)
Danazol Central Procurement (Malta)
Danazol Eipico (Egypt)
Danazol Hualian (China)
Danazol Jelfa (Poland)
Danazol Merck (Colombia)
Danazol Polfarmex (Poland)
Danazol Swiss Pharm (Taiwan)
Danazol Tai Yu (Taiwan)
Danazol Youngpoong (South Korea)
Danazol-New Hualian (China)
Danazol-shifa 200
Danocrine (Hong Kong, Indonesia)
Capsule; Oral; Danazol 100 mg (Sanofi Group Indonesia)
Capsule; Oral; Danazol 200 mg (Sanofi Group Indonesia)
Capsule; Oral; Danazol 50 mg (Sanofi Group Indonesia)
Danocrine 200 mg x 100's (Sanofi Group Indonesia)
Danocrine 200 mg x 10's (Sanofi Group Indonesia)	$ 108.39
100 capsule in 1 bottle (Sanofi Group Indonesia)
60 capsule in 1 bottle (Sanofi Group Indonesia)
Danodiol (Kenya, Sudan, Zimbabwe)
See 287 substitutes for Danazant

References

1. DailyMed. "DANAZOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "danazol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "danazol". http://www.drugbank.ca/drugs/DB01406 (accessed September 17, 2018).

Reviews

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Information checked by Dr. Sachin Kumar, MD Pharmacology