Danazol

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Generic Name: Danazol Brand Name(s): Danazol.

Uses

What is Danazol used for?

Danazol is commonly used in women to treat pelvic pain and infertility due to a certain uterus disorder (endometriosis) and also to treat breast pain/tenderness/nodules due to a certain breast condition (fibrocystic breast disease). It is also used in both men and women to prevent swelling of the abdomen/arms/legs/face/airway due to a certain congenital disease (hereditary angioedema).

Danazol is an androgen similar to testosterone. For the treatment of endometriosis and fibrocystic breast disease, it works by decreasing the amount of hormones made by the ovaries. These hormones usually make the conditions worse. For the treatment of angioedema, danazol helps to increase the amount of a certain protein in your body’s defense system (immune system).

How should I take Danazol?

Take this medication by mouth, usually twice daily or as directed by your doctor. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition does not improve or if it worsens.

How do I store Danazol?

Danazol is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Danazol in the bathroom or the freezer. There may be different brands of Danazol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Danazol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Danazol?

Before taking danazol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease (such as coronary artery disease, stroke), high blood pressure (hypertension), diabetes, high cholesterol levels, breast cancer, liver disease, kidney disease, seizures, migraine headaches, unusual vaginal bleeding, certain blood disorders (porphyria, polycythemia), prostate cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may affect the sperm. Consult your doctor for more details.

This medication must not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Danazol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Danazol. This Danazol is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Danazol?

Weight gain, acne, flushing, sweating, voice changes (hoarseness, change in pitch), abnormal growth of body hair (in women), vaginal dryness/irritation, or decreased breast size may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: swelling hands/ankles/feet, menstrual changes (such as spotting, missed periods), mental/mood changes (such as nervousness, mood swings).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Danazol?

Some products that may interact with this drug include: “blood thinners” (such as warfarin), certain “statin” cholesterol medications (lovastatin, simvastatin).

This medication may interfere with certain laboratory tests (including blood levels of male hormones such as testosterone), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Danazol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Danazol?

Danazol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Danazol?

Danazol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Danazol.

What is the dose of Danazol for an adult?

Usual Adult Dose for Endometriosis

Mild Disease:

-Initial dose: 200 to 400 mg orally per day, given in 2 divided doses

-Maintenance dose: Gradual downward titrations should be performed to maintain amenorrhea.

-Duration of therapy: Up to 9 months

Moderate to Severe Disease or Patients Infertile due to Endometriosis:

-Initial dose: 800 mg orally per day, given in 2 divided doses

-Maintenance dose: Gradual downward titrations should be performed to maintain amenorrhea.

-Duration of therapy: Up to 9 months

Comments:

-Treatment should begin during menstruation, OR appropriate pregnancy tests should be performed prior to starting treatment ensure that the patient is not pregnant while on treatment.

-Treatment should continue uninterrupted 3 to 6 months, but may continue for up to 9 months.

-Treatment may be reinstituted if symptoms recur.

Use: Treatment of endometriosis amenable to hormonal management

Usual Adult Dose for Fibrocystic Breast Disease

100 to 400 mg orally per day, given in 2 divided doses

Comments:

-Most patients may be treated with simple measures (e.g., padded brassieres, analgesics). Patients requiring treatment with this drug may have symptoms of severe pain and tenderness.

-Patients should be advised that treatment is not innocuous; hormone level alterations and symptom recurrence are very common after discontinuation of treatment.

-This drug is usually effective in decreasing symptoms of fibrocystic breast disease (e.g., nodularity, pain, tenderness); pain and tenderness are typically eliminated in 2 to 3 months, and nodularity is usually eliminated after 4 to 6 months of uninterrupted treatment.

-Approximately 50% of patients will have symptom recurrence within 1 year; treatment may be reinstated in this patient population if necessary.

Use: Treatment of symptomatic fibrocystic breast disease by suppression of ovarian function

Usual Adult Dose for Angioedema

Initial dose: 200 mg orally 2 to 3 times a day

-After a favorable initial response, continuing doses should be determined by decreasing the dose by 50% or less at intervals of 1 to 3 months (or longer).

-If an attack occurs, the daily dose may be increased by 200 mg.

Comment: Patients should be monitored closely during dose adjustments, especially in patients with airway involvement.

Use: Prevention of all types of angioedema (e.g., cutaneous, abdominal, laryngeal) in male and female patients

Renal Dose Adjustments

Renal dysfunction: Data not available

Marked renal dysfunction: Contraindicated

Liver Dose Adjustments

Liver dysfunction: Frequent monitoring recommended.

Marked liver dysfunction: Contraindicated

Other Comments

Administration advice:

-Non-hormonal contraceptive devices should be used during treatment.

Storage requirements:

-Protect from light.

General:

-Ovulation and cyclic bleeding usually resume within 60 to 90 days after discontinuation of treatment.

-This drug may be used in conjunction with surgery or in patients not responding to other treatments (as sole therapy) for the treatment of endometriosis.

Monitoring:

-Hematologic: Periodic hematologic tests

-Hepatic: Periodic liver function tests; hepatic ultrasonography (for patients receiving repeated treatment courses or on long-term treatment)

-Respiratory: Change in voice

Patient advice:

-Patients, especially professional singers, should be told to immediately report any change in voice during or after treatment.

-Patients should be told to use non-hormonal methods of contraception during treatment.

-Patients of childbearing potential should be apprised of the potential harm to the fetus.

-Female patients should discontinue treatment and should speak to a healthcare provider immediately if pregnancy occurs.

What is the dose of Danazol for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Danazol available?

Danazol is available in the following dosage forms and strengths:

  • Capsule

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Danazol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 19, 2018 | Last Modified: January 19, 2018

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