Aprovasc

Essential HTN in patients whose BP is not adequately controlled on irbesartan or amlodipine monotherapy.

Individualized dosage. 1 tab daily. Max: 300 mg/10 mg daily.

May be taken with or without food.

Hypersensitivity to irbesartan, amlodipine or dihydropyridines. Shock (including cardiogenic shock). Obstruction of left ventricular outflow tract eg, clinically significant aortic stenosis. Unstable angina (excluding Prinzmetal's angina). Hemodynamically unstable heart failure following acute MI. Severe hypotension. Not to be co-administered w/ aliskiren-containing medications in patients w/ diabetes or moderate to severe renal impairment (GFR <60 mL/min/1.73 m²); ACE inhibitors in patients w/ diabetic nephropathy. Pregnancy & lactation.

Correct vol- & Na-depletion prior to initiating therapy. Hypertensive crisis. Not recommended in dual blockade of the renin-angiotensin-aldosterone system in combination w/ ACE inhibitors. Patients whose renal function depends on the renin-angiotensin aldosterone system activity eg, hypertensive patients w/ stenosis of the renal artery of 1 or both kidneys or w/ severe CHF. May reduce renal clearance of lithium. May affect ability to drive & use machines. Hepatic insufficiency. Childn. Irbesartan: Hypoglycemia particularly in patients w/ diabetes. Amlodipine: Patients w/ heart failure.

Peripheral edema, edema; palpitations; dizziness, headache, somnolence; orthostatic hypotension; gingival swelling; proteinuria; nausea/vomiting; fatigue. Irbesartan: Vertigo; upper abdominal pain, tongue disorder. Amlodipine: Drowsiness; visual disturbances (including diplopia); flushing; dyspnea; abdominal pain, dyspepsia, altered bowel habits (including diarrhea & constipation); asthenia; glossodynia; cough; contact dermatitis; hot flush.

Irbesartan: Increased C_max & AUC of repaglinide. Increased serum K w/ K-sparing diuretics, K supplements or K-containing salt substitutes or other medications that may increase kalaemia. Attenuated antihypertensive effect w/ NSAIDs including COX-2 inhibitors. Increased serum conc & toxicity of lithium. Amlodipine: Increased bioavailability resulting in increased BP-lowering effects w/ grapefruit or grapefruit juice. Exposure may be increased w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem. May cause variations in plasma conc w/ CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Risk of hyperkalemia w/ dantrolene infusion. Additive BP-reducing effects w/ other medicinal products w/ antihypertensive properties. Increased risk of blood tacrolimus levels. Increase in min conc of cyclosporine. May increase exposure of molecular target of rapamycin (mTOR) inhibitors eg, sirolimus, temsirolimus, everolimus; simvastatin.

Angiotensin II Antagonists / Calcium Antagonists

C09DB05 - irbesartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

Rx