"The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure."...
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.
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.
Manufactured for: Atlanta, GA 30328. Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 USA. Revised: Apr 2015
Last reviewed on RxList: 4/21/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional BiDil Information
BiDil - User Reviews
BiDil User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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