Generic Name and Formulations:
Isosorbide dinitrate 20mg, hydralazine HCl 37.5mg; scored tabs.
Arbor Pharmaceuticals, LLC
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.
Not established in NYHA Class IV HF.
Initially 1 tab 3 times daily, may reduce to ½ tab 3 times daily if not tolerated; titrate as tolerated after 3–5 days. Max 2 tabs 3 times daily.
Allergy to organic nitrates. Concomitant PDE5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil), or riociguat.
Correct volume/salt depletion prior to initiation. Hypotension. Hypertrophic cardiomyopathy. Discontinue if syncope occurs. Give pyridoxine if peripheral neuritis occurs. Hepatic impairment. Elderly. Pregnancy (Cat.C). Nursing mothers.
See Contraindications. Severe hypotension with PDE5 inhibitors or riociguat.
Vasodilators (nitrate + direct-acting).
Headache (usually transient), dizziness, asthenia, nausea, vomiting, hypotension, sinusitis, tachycardia, paresthesia, amblyopia; SLE.
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