danazol (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 50mg
  • 100mg
  • 200mg

Endometriosis

Mild: 200-400 mg/day PO divided BID

Moderate-to-severe: 800 mg/day PO divided BID

Titrate downward to dose sufficient to maintain amenorrhea

Therapy typically continued for 6 months; may continue up to 9 months

Fibrocystic Breast Disease

100-400 mg/day PO divided BID

Maintenance therapy continued for 3-6 months

Hereditary Angioedema

200 mg PO BID/TID initially, THEN

Decrease dose by 50% at intervals of at least 1-3 months

If attack occurs, increase dose by increments up to 200 mg/day

Safety & efficacy not established

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Interactions

Interaction Checker

and danazol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Intracranial hypertension

            Increased blood pressure

            Thromboembolism

            Anxiety

            Depression

            Dizziness

            Urticaria

            Androgenic Effects (common)

            • Mild hirsutism
            • Decreased breast size
            • Voice changes
            • Sore throat, acne
            • Increased oiliness of skin or hair
            • Hair loss

            Menstrual irregularities (common)

            Gastroenteritis

            Nausea

            Vomiting

            Elevated LFTs

            Joint pain

            Muscle spasm

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            Warnings

            Black Box Warnings

            Contraindicated in pregnancy

            Thromboembolism, thrombophlebitic, and thrombotic events, including life-threatening or fatal strokes, have been reported

            Peliosis hepatitis and benign hepatic adenoma have been observed with long-term use

            Benign intracranial hypertension (pseudotumor cerebri) has been reported

            Contraindications

            Pregnancy, breastfeeding

            Porphyria

            Undiagnosed abnormal genital bleeding

            Severe liver/renal/cardiac disease,

            Hypersensitivity

            Cautions

            Breast cancer

            Epilepsy

            Migraine

            Cardiac dysfunction

            Renal impairment

            Preliminary epidemiological evidence suggests that the use of danazol might increase the baseline risk of ovarian cancer in patients being treated for endometriosis

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: enters breast milk/contraindicated

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Half-Life: 4.5 hr

            Peak Plasma Time: 2 hr

            Bioavailability: well absorbed

            Metabolism: extensively in the liver to 2-hydroxymethyl ethisterone

            Metabolites: 2-hydroxymethyl ethisterone (activity unknown)

            Excretion: mainly in urine, small amount in feces

            Mechanism of Action

            Suppresses pituitary-ovarian axis by inhibition of pituitary gonadotropin output

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.