PENDO-IRBESARTAN-HCTZ

pendo-IRBESARTAN-HCTZ is contraindicated in:  Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.

 Patients who are hypersensitive to other sulphonamide-derived drugs, because of the hydrochlorothiazide component.  Patients with anuria. 73m2) (see WARNINGS AND PRECAUTIONS, Renal - Renal Impairment, and DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) with ARBs, ACE inhibitors or aliskiren containing drugs).

 Combination with angiotensin converting enzyme (ACE) inhibitors in patients with diabetic nephropathy (see WARNINGS AND PRECAUTIONS, Renal - Renal Impairment, and DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) with ARBs, ACE inhibitors or aliskiren-containing drugs).

 Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (due to lactose component of the pendo-IRBESARTAN-HCTZ tablets). WARNINGS AND PRECAUTIONS Serious Warnings and Precautions When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury and even death of the developing fetus.

When pregnancy is detected, pendo-IRBESARTAN-HCTZ should be discontinued as soon as possible (see WARNINGS AND PRECAUTIONS – Special Populations). General The effect of irbesartan on the ability to drive and use machinery has not been studied, but based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability.

When driving vehicles or operating machinery, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension. Cardiovascular Hypotension Occasionally, symptomatic hypotension has occurred after administration of irbesartan, in some cases after the first dose.

It is more likely to occur in patients who are volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. In these patients, because of the potential fall in blood pressure, therapy should be started under close medical supervision (see DOSAGE AND ADMINISTRATION).

Similar considerations apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in myocardial infarction or pendo-IRBESARTAN-HCTZ Product Monograph Page 5 of 42 cerebrovascular accident.

Valvular Stenosis There is concern on theoretical grounds that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction.

73m2). Therefore, the use of pendo-IRBESARTAN-HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see CONTRAINDICATIONS). The use of pendo-IRBESARTAN-HCTZ in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy (see CONTRAINDICATIONS).

Further, co-administration of ARBs, including the irbesartan component of pendo-IRBESARTAN- HCTZ, with other agents blocking the RAS, such as ACE inhibitors or aliskiren-containing drugs, is generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure, and hyperkalemia.

Endocrine and Metabolism Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalemia, hyponatremia and hypochloremic alkalosis). Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

Calcium excretion is decreased by thiazides which may cause intermittent and slight elevation of serum calcium. , vitamin D therapy) is prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly. Marked hypercalcemia suggests the possibility of hyperparathyroidism.

Thiazides should be discontinued before carrying out tests for parathyroid function. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia. Hyperuricemia may occur, and an acute attack of gout may be precipitated in certain patients receiving thiazide therapy.

Insulin requirements in diabetic patients may be altered and latent diabetes mellitus may become manifest during thiazide diuretic therapy. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.

pendo-IRBESARTAN-HCTZ Product Monograph Page 6 of 42 Thiazides may decrease serum PBI levels without signs of thyroid disturbance. Hepatic/Biliary/Pancreatic Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations in fluid and electrolyte balance may precipitate hepatic coma.

Immune Hypersensitivity Reaction Sensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma. Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or […]