Monograph Details
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Cardiovascular System
> CHF and arrhythmias
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BIDIL |
| Manufacturer |
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NitroMed Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Vasodilators (nitrate + direct-acting). |
| Generic Name |
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Isosorbide dinitrate 20mg, hydralazine HCl 37.5mg; scored tabs. |
| Indications |
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Heart failure (HF) in black patients, as adjunct to standard treatment, to improve survival, prolong time to hospitalization for HF, and improve patient-reported functional status. |
| Children |
Not recommended. |
| Adults |
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Initially 1 tab 3 times daily, may reduce to 1/2 tab 3 times daily if not tolerated; titrate as tolerated after 3–5 days. Max 2 tabs 3 times daily. |
| Contraindications |
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Concomitant PDE5 inhibitors (eg, sildenafil). |
| Precautions |
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Discontinue if syncope occurs. Recent MI. Give pyridoxine if peripheral neuritis occurs. Hypertrophic cardiomyopathy. Hypovolemia. Hypotension. Hepatic impairment. Elderly. Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
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See Contraindications. Severe hypotension with PDE5 inhibitors (eg, sildenafil, vardenafil, tadalafil). Caution with MAOIs, alcohol, other antihypertensives (monitor with potent antihypertensives). |
| Adverse Reactions |
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Headache (usually transient), dizziness, orthostatic hypotension, sinusitis, GI upset, tachycardia, paresthesia, amblyopia. |
| How Supplied |
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Tabs—180 |
| Additional Resources |
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• Related Prescribing Note |
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