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Bidil (Hydralazine Hydrochloride / Isosorbide Dinitrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Treatment of Heart Failure in Self-identified Black Patients

BiDil is 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.

DOSAGE AND ADMINISTRATION

BiDil should be initiated at a dose of one BiDil Tablet, three times a day. Titrate to a maximum of two tablets three times daily, if tolerated.

Although titration of BiDil 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 BiDil 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 BiDil (20 mg isosorbide dinitrate and 37.5 mg hydralazine hydrochloride) tablets 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.

HOW SUPPLIED/STORAGE AND HANDLING

BiDil Tablets contain 20 mg of isosorbide dinitrate and 37.5 mg of hydralazine hydrochloride. They are biconvex, approximately 8 mm in diameter, scored, film-coated, orange tablets debossed "20" on one side over the score and " N " on the other side.

  • NDC 24338-010-18: Bottles of 180

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Keep bottles tightly closed.

Protect from light. Dispense in a light-resistant, tight container.

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