Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide

Contraindicated in patients with diabetes. Avoid in patients with renal impairment (GFR <60 ml/min). Dual RAS blockade increases risks of hypotension, hyperkalemia, and acute renal failure.

May lead to increased risk of renal impairment, loss of antihypertensive effect, and deterioration of renal function including possible acute renal failure.

Amlodipine increases exposure to cyclosporine, requiring monitoring.

Increases serum lithium concentrations and may cause lithium toxicity.

COX-2 inhibitors may result in deterioration of renal function including acute renal failure in elderly, volume-depleted, or renal-compromised patients. May attenuate antihypertensive effect.

NSAIDs may lead to increased risk of renal impairment and loss of antihypertensive effect. In elderly, volume-depleted, or renal-compromised patients, may result in deterioration of renal function including acute renal failure.

Amlodipine increases exposure to tacrolimus, requiring monitoring.

Amlodipine ( 7.2 ): Limit simvastatin to 20 mg daily when coadministered. Increased amlodipine exposure when coadministered with CYP3A inhibitors Hydrochlorothiazide ( 7.3 ): Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. Closely monitor blood pressure, renal function and electrolytes in patients on olmesartan medoxomil, amlodipine and hydrochlorothiazide and other agents that affect the RAS.

Reduces absorption of hydrochlorothiazide, decreasing its therapeutic effect.

Reduces systemic exposure and peak plasma concentration of olmesartan. Administer olmesartan at least 4 hours before colesevelam hydrochloride.

Reduces absorption of hydrochlorothiazide, decreasing its therapeutic effect.

Increased amlodipine exposure when coadministered with CYP3A inhibitors Hydrochlorothiazide ( 7.3 ): Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. Closely monitor blood pressure, renal function and electrolytes in patients on olmesartan medoxomil, amlodipine and hydrochlorothiazide and other agents that affect the RAS. Do not co-administer aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide in patients with diabetes [See Contraindications (4) ].

7 DRUG INTERACTIONS Olmesartan medoxomil ( 7.1 ): Nonsteroidal anti-inflammatory drugs (NSAIDS): May lead to increased risk of renal impairment and loss of antihypertensive effect. Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. 7.1 Drug Interactions with Olmesartan Medoxomil Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure.

Limit simvastatin to 20 mg daily when coadministered with amlodipine.

Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Use with Colesevelam Hydrochloride: Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.