Label Changes for:

Avalide (irbesartan/hydrochlorothiazide) tablets

February 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

 

WARNINGS AND PRECAUTIONS

Electrolyte and Metabolic Imbalances

Irbesartan-Hydrochlorothiazide

  • Based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium. Concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect.
  • Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically.
  • Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
  • Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
  • The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.
  • Thiazides may decrease urinary calcium excretion. Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.

 

ADVERSE REACTIONS

Post-Marketing Experience
  • Impaired renal function, including cases of renal failure in patients at risk, has been reported with irbesartan and Avalide.
  • Cases of increased CPK and rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

 

DRUG INTERACTIONS

  • NSAIDs: Can reduce diuretic, natriuretic, and antihypertensive effects of diuretics and increase risk for renal impairment
  • Carbamazine: Increased risk of hyponatremia.
  • Carbamazepine: concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatremia. Electrolytes should be monitored during concomitant use.

Cholestyramine and Colestipol Resins

  • Avalide should be taken at least one hour before or four hours after these medications.
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