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BIDIL- hydralazine hydrochloride and isosorbide dinitrate tablet, film coated


Patient Information

Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

Headache

Inform patients that headaches often accompany treatment with BiDil, especially during initiation of treatment. Advise patients to consult a physician to adjust the dose of BiDil if headache continues with repeated dosing.

Hypotension

Warn patients about lightheadedness on standing.

Advise patients that inadequate fluid intake or excessive fluid loss from perspiration, diarrhea or vomiting may lead to an excessive fall in blood pressure and cause lightheadedness or even syncope. If syncope does occur, advise patients to discontinue BiDil and notify their prescribing physician as soon as possible.

Phosphodiesterase-5 Inhibitors

Advise patients to inform their physicians if they are taking, or planning to take, sildenafil, vardenafil, or tadalafil. Bidil should not be taken concomitantly with phosphodiesterase-5 inhibitors.

Worsening Ischemic Heart Disease

Advise patients to inform their physicians of any worsening of symptoms of myocardial ischemia, especially those with hypertrophic cardiomyopathy.

Systemic Lupus Erythematosus-like Symptoms

Advise patients if symptoms suggestive of systemic lupus erythematosus such as arthralgia, fever, chest pain, prolonged malaise occur to notify their prescribing physician.

Peripheral Neuritis

Advise patients if symptoms of peripheral neuritis paresthesia, numbness, and tingling occur to notify the prescribing physician.

Manufactured for:
Arbor Pharmaceuticals, LLC
Atlanta, GA 30328

Manufactured by:
Kremers Urban Pharmaceuticals Inc.,
a subsidiary of Lannett Company, Inc.
Seymour, IN 47274, USA

BiDil is a registered trademark of Arbor Pharmaceuticals, LLC
2019
U.S. Patent number 6,784,177; 6,465,463
All rights reserved

BDL-PI-04



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