Indicated for the treatment of hypertension, to lower blood pressure: in patients not adequately controlled with monotherapy; as initial therapy in patients likely to need multiple drugs to help achieve blood pressure goals.

Edarbyclor may be administered with other antihypertensive agents as needed.

Do not co-administer aliskiren-containing products with Edarbyclor in patients with diabetes.

Edarbyclor is contraindicated in patients with anuria.

Chlorthalidone may precipitate azotemia.

In patients with an activated renin-angiotensin system, such as volume- or salt depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Edarbyclor. Such patients are probably not good candidates to start therapy with more than one drug; therefore, correct volume prior to administration of Edarbyclor.

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported.

In patients with renal disease, chlorthalidone may precipitate azotemia.

Safety and effectiveness of Edarbyclor in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) have not been established.

Thiazide diuretics can cause hyponatremia and hypokalemia. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Co-administration of digitalis may exacerbate the adverse effects of hypokalemia.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

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

The antihypertensive effect of Edarbyclor may be attenuated by NSAIDs, including selective COX-2 inhibitors.

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.  Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

Lithium renal clearance is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity. Consider monitoring lithium levels when using Edarbyclor.

Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists.

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 Edarbyclor as soon as possible.

Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia.

It is not known if azilsartan is excreted in human milk, but azilsartan is excreted at low concentrations in the milk of lactating rats and thiazide-like diuretics like chlorthalidone are excreted in human milk.

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• Dosage greater than 40/25 mg per day. GoToSource

• Use in patients under the age of 18. GoToSource

Fetal toxicity, azotemia (high levels of nitrogen-containing compounds in blood) and gout (type of arthritis caused by excess uric acid in bloodstream). GoToSource    

Hyperuricemia (high level of uric acid in the blood). GoToSource

Hyponatremia (low blood sodium level). GoToSource

Hyperglycemia (high blood sugar). GoToSource

Hypotension (low blood pressure) and hypokalemia (low blood potassium level). GoToSource

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