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AVALIDE- irbesartan and hydrochlorothiazide tabletAVALIDE- irbesartan and hydrochlorothiazide tablet, film coated


  1. Patient Information
  2. Relabeling Of "additional Barcode Label" By:

Patient Information 

Enter section text here

17.1 Pregnancy

Female patients of childbearing age should be told that use of drugs like AVALIDE during the second or third trimesters of pregnancy can cause serious problems in the fetus and infant including: low blood pressure, poor development of skull bones, kidney failure, and death. These effects have not occurred with drug exposure limited to the first trimester. Women using AVALIDE who become pregnant should notify their physician as soon as possible.

17.2 Symptomatic Hypotension

Patients using AVALIDE should be told that they may feel lightheaded, especially during the first days of use. Patients should inform their physician if they feel lightheaded or faint. If fainting occurs, the patient should stop using AVALIDE and contact the prescribing doctor.

Patients using AVALIDE should be told that getting dehydrated can lower their blood pressure too much and lead to lightheadedness and possible fainting. Dehydration may occur with excessive sweating, diarrhea, or vomiting and with not drinking enough liquids.


Manufactured by:
Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA

Distributed by:
Bristol-Myers Squibb Sanofi-Synthelabo Partnership
New York, New York 10016

1243926A1
Rev November 2008



Relabeling Of "additional Barcode Label" By: 

Physicians Total Care, Inc.
Tulsa, OK 74146



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