Indicated for the treatment of hypertension. AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy. AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

AVALIDE may be substituted for the titrated components.

The usual regimens of therapy with AVALIDE may be followed as long as the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so AVALIDE is not recommended.

AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion.

Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

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).

Sulfonamide or sulfonamide derivative drugs, such as hydrochlorothiazide, can cause an idiosyncratic reaction, resulting in transient myopia and acute angle closure glaucoma. Cases of acute angle-closure glaucoma have been reported with hydrochlorothiazide.

Initiation of antihypertensive therapy may cause symptomatic hypotension in patients with intravascular volume- or sodium-depletion, e.g., in patients treated vigorously with diuretics or in patients on dialysis. Such volume depletion should be corrected prior to administration of antihypertensive therapy.

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer.

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 used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction resulting in acute angle-closure glaucoma and elevated intraocular pressure with or without a noticeable acute myopic shift and/or choroidal effusions. Cases of acute angle-closure glaucoma have been reported with hydrochlorothiazide. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma may result in permanent vision loss.

Thiazides should be discontinued before carrying out tests for parathyroid function.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including irbesartan, may result in deterioration of renal function, including possible acute renal failure.

Co-administration of AVALIDE with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe.

In general, avoid combined use of RAS inhibitors.

Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan or thiazide diuretics.

Concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatremia.

Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Stagger the dosage of hydrochlorothiazide and the resin such that AVALIDE is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue AVALIDE as soon as possible.Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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• Use in patients under 18 years of age. GoToSource

• Prevention of post-coronary artery bypass graft atrial fibrillation. GoToSource

• Inhibition of  HBV-infection. GoToSource

• Aortic dilatation in marfan syndrome. GoToSource

• Erection recovery after nerve-sparing radical retropubic prostatectomy. GoToSource

• Diabetic nephropathy. GoToSource

Headache, dizziness, urinary tract infection, sinusitis and nasopharyngitis. GoToSource

Hypotension (low blood pressure) and renal dysfunction. GoToSource

Drug-induced lupus erythematosus (autoimmune disorder). GoToSource

Hyponatremia (low sodium level in the blood). GoToSource

Significant increase in total cholesterol. GoToSource

Hypercalcemia (high calcium level in blood). GoToSource

Increased risk of gout. GoToSource

Acute angle-closure glaucoma (sudden increase in eye pressure). GoToSource

Drug-induced acute pancreatitis (inflammation of pancreas). GoToSource

Non-melanoma skin cancer (basal cell skin cancer or squamous cell skin cancer). GoToSource

Lawsuits filed for cancer-causing impurity N-nitrosodiethylamine (NDEA).