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AMTURNIDE
Hypertension
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Drug Name:

AMTURNIDE Rx

Generic Name and Formulations:
Aliskiren hemifumarate/amlodipine besylate/hydrochlorothiazide (HCTZ); 150/5/12.5mg; 300/5/12.5mg; 300/5/25mg; 300/10/12.5mg; 300/10/25mg; tabs.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for AMTURNIDE:

Hypertension. Not for initial therapy.

Adult:

Take once daily. Titrate at 2-week intervals; max one 300/10/25mg tab daily. Replacement: may substitute for individually titrated components. Add-on/switch: if not adequately controlled on any two of the following: aliskiren, dihydropyridine CCB, thiazide diuretics. May switch with a lower dose of any component that causes dose-limiting ADRs. ≥75yrs or severe hepatic impairment: initially amlodipine 2.5mg/day (not available). Concomitant simvastatin: see Interactions.

Children:

Not established.

Contraindications:

Concomitant ARBs or ACEIs in diabetes. Anuria. Sulfonamide allergy.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting or start under close supervision. Severe aortic stenosis. Severe obstructive coronary disease: increased risk of angina or MI with CCB dose change. Discontinue if angioedema or laryngeal edema occurs (have SC epinephrine available). Moderate renal dysfunction (CrCl <60mL/min): avoid concomitant ARBs or ACEIs. Monitor BP, electrolytes, and renal function periodically. Consider withholding or discontinuing if significant renal dysfunction develops. Renal artery stenosis. Severe HF. Post-MI. Diabetes. Hepatic impairment. Asthma. SLE. Gout. Acute myopia. Secondary angle-closure glaucoma. Elderly. Neonates. Pregnancy: avoid. Nursing mothers: not recommended.

Interactions:

Aliskiren: concomitant cyclosporine, itraconazole: avoid. Caution with ACEIs, ARBs, NSAIDs, K+ sparing diuretics, K+ containing salt substitutes; may cause hyperkalemia. Dual inhibition of the renin-angiotensin system with ARBs or ACEIs may increase risk of hypotension, hyperkalemia, renal function changes. Concomitant furosemide; monitor. Decreased absorption with high fat meals. HCTZ: concomitant lithium (risk of toxicity): monitor; potentiates antihypertensives, possibly non-depolarizing muscle relaxants; orthostatic hypotension with alcohol, other CNS depressants; may need to adjust antidiabetic agents; decreased absorption by cholestyramine, colestipol resins (separate dosing by at least 4hrs). Both Aliskiren + HCTZ: may be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted. Amlodipine potentiates simvastatin; limit simvastatin dose to max 20mg daily.

Pharmacological Class:

Direct renin inhibitor + dihydropyridine (DHP) calcium channel blocker (CCB) + diuretic (thiazide).

Adverse Reactions:

Peripheral edema, dizziness, headache, nasopharyngitis; rare: angioedema, hypotension.

Generic Availability:

NO

How Supplied:

Tabs—30, 90

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