(1) Irbesartan and Irbesartan and Hydrochlorothiazide Tablets can cause injury and death to the developing fetus and therefore should be discontinued if pregnancy occurs. They should also not be used in people who are allergic to any component of the product or to other sulfonamide-derived drugs. Other precautions for both products include: excessive reductions in blood pressure, decreased renal function, and potassium and electrolyte abnormalities. Reports of exacerbation or activation of systemic lupus erythematosus, drug interactions with lithium, visual changes and metabolic disturbances and impaired liver function have been associated with Irbesartan and Hydrochlorothiazide Tablets. If any of these conditions occur or are suspected, medical attention should be sought. SOURCE Mylan Inc.