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U.S. Department of Health and Human Services

Safety

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Avalide (irbesartan/hydrochlorothiazide) tablets

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

 

June 2014

Summary View

WARNINGS AND PRECAUTIONS

the following section was deleted:

5.5  Lithium Interaction

Hydrochlorothiazide

  • Lithium generally should not be given with thiazides. [See Drug Interactions (7).]

DRUG INTERACTIONS

the following language was added/deleted:

Irbesartan

  • No significant drug-drug pharmacokinetic (or pharmacodynamic) interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin, and nifedipine [see Clinical Pharmacology (12.3)].
  • Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan or thiazide diuretics. Monitor lithium levels in patients receiving Avapro and lithium.

Dual Blockade of the Renin-Angiotensin System (RAS)

the following text was added as the second paragraph:

  • In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors.

 

May 2014

Summary View

7 DRUG INTERACTIONS

Dual Blockade of the Renin-Angiotensin System (RAS)

  • ...text was added as the second paragraph...In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors.
  • Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan or thiazide diuretics. Monitor lithium levels in patients receiving Avapro and lithium. 

 

October 2012

Summary View 

CONTRAINDICATIONS

Do not co-administer aliskiren with Avalide in patients with diabetes
 

DRUG INTERACTIONS

Dual Blockade of the Renin-Angiotensin System (RAS):
  • Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on Avalide and other agents that affect the RAS.
  • Do not co-administer aliskiren with Avalide in patients with diabetes. Avoid use of aliskiren with Avalide in patients with renal impairment (GFR <60 ml/min).

 

February 2012 

Summary View

 

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.