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Isosorbide and Hydralazine tablets
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  • FDA PI

Isosorbide and Hydralazine tablets

Generic name: isosorbide dinitrate and hydralazine hydrochloride
Dosage form: tablet, film coated
Drug class:Miscellaneous antihypertensive combinations

Medically reviewed by Drugs.com. Last updated on Apr 1, 2022.

Indications and Usage for Isosorbide and Hydralazine tablets

Treatment of Heart Failure in Self-identified Black Patients

Isosorbide dinitrate and hydralazine hydrochloride tablets are indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status.

Limitations of Use

There is little experience in patients with NYHA class IV heart failure.

Isosorbide and Hydralazine tablets Dosage and Administration

Isosorbide dinitrate and hydralazine hydrochloride tablets should be initiated at a dose of one isosorbide dinitrate and hydralazine hydrochloride tablet, three times a day. Titrate to a maximum of two tablets three times daily, if tolerated.

Although titration of isosorbide dinitrate and hydralazine hydrochloride tablets can be rapid (3-5 days), some patients may experience side effects and may take longer to reach their maximum tolerated dose. The dosage may be decreased to as little as one-half isosorbide dinitrate and hydralazine hydrochloride tablet three times a day if intolerable side effects occur. Efforts should be made to titrate up as soon as side effects subside.

Dosage Forms and Strengths

The isosorbide dinitrate and hydralazine hydrochloride tablets (20 mg isosorbide dinitrate and 37.5 mg hydralazine hydrochloride) are orange, biconvex, approximately 8 mm in diameter, scored, film-coated, and debossed with "20" on one side over the score and "N" on the other side.

Contraindications

Isosorbide dinitrate and hydralazine hydrochloride tablets are contraind...