isosorbide dinitrate/hydralazine (Rx)

Brand and Other Names:BiDil
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

isosorbide dinitrate/hydralazine

tablet

  • 20mg/37.5mg

Heart Failure

1 tab PO q8hr; titrate dose to effect; not to exceed 2 tab PO q8hr

Heart failure in self-identified African Americans as Adjunct Therapy

1 tab PO q8hr; titrate dose to effect; not to exceed 2 tab PO q8hr

Safety and efficacy not established

Heart failure

1 tab PO q8hr; titrate dose to effect; not to exceed 2 tab PO q8hr

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Interactions

Interaction Checker

and isosorbide dinitrate/hydralazine

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

            Isosorbide Dinatrate

            • Flushing
            • Hypotension/orthostatic hypotension
            • Lightheadedness
            • Palpitations
            • Rebound hypertension (uncommon)
            • Syncope
            • Unstable angina tachyarrhythmia
            • Dizziness
            • Headache
            • Restlessness
            • Weakness
            • Nausea
            • Methemoglobinemia (infrequent)

            Hydralazine

            • Hypotension
            • Palpitations
            • Tachycardia
            • Headache
            • Neuropathy
            • Anorexia
            • Diarrhea
            • Nausea
            • Vomiting
            • Agranulocytosis
            • Leukopenia
            • Hepatotoxicity
            • Chest pain
            • Dyspnea
            • Nasal congestion
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            Warnings

            Contraindications

            Allergy to organic nitrates

            Concomitant use with PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, or vardenafil)

            Concomitant use with soluble guanylate cyclase (sGC) stimulators (eg, riociguat)

            Concomitant use can cause severe hypotension, syncope, or myocardial ischemia

            Cautions

            Hydralazine may cause symptomatic lupus erythematosus syndromes; consider discontinuation if clinically appropriate

            May aggravate myocardial ischemia and angina

            Peripheral neuritis may be treated with pyridoxine

            Symptomatic hypotension may occur

            Paradoxical bradycardia may occur

            Use caution in pulmonary hypertension

            Caution in patients with coronary artery disease or tachycardia

            Caution in in suspected right ventricular infarction or acute MI

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            Pregnancy & Lactation

            Pregnancy

            There are no data on use in pregnant women, and insufficient data on its components (hydralazine and isosorbide dinitrate) to assess a drug-associated risk of major birth defects or miscarriage with first trimester use; available published data on hydralazine use in pregnancy during second and third trimesters have not shown association with adverse pregnancy-related outcomes

            Pregnant women with heart failure are at increased risk for preterm birth; clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth

            Animal data

            • Hydralazine hydrochloride is teratogenic in mice at 66 mg/kg and possibly in rabbits at 33 mg/kg (2 and 3 times maximum recommended human dose (MRHD) on a body surface area basis)
            • Isosorbide dinitrate has been shown to cause a dose-related increase in embryo-toxicity (excess mummified pups) in rabbits at 70 mg/kg (12 times the MRHD on a body surface area basis)

            Lactation

            There are no data on presence of drug in human or animal milk, effects on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            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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            Formulary

            FormularyPatient Discounts

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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.