TEKAMLO Rx

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TEKAMLO

Hypertension
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Generic Name and Formulations:

Aliskiren, amlodipine; 150mg/5mg, 150mg/10mg, 300mg/5mg, 300mg/10mg; tabs.

Select therapeutic use:

Indications for TEKAMLO:

Hypertension.

Adult:

Give once daily, consistently with regard to meals. Initial therapy: One 150mg/5mg tab daily. Add-on: switch when BP is not controlled with aliskiren or any DHP CCB alone. Replacement therapy: switch from previously-titrated components. Titrate at 2 to 4-week intervals (slow titration in hepatic impairment or heart failure); max one 300mg/10mg tab daily. Concomitant simvastatin: see Interactions.

Children:

Not established.

Contraindications:

Concomitant ARBs or ACEIs in diabetes.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting or start under close supervision. Severe obstructive coronary disease; increased risk of angina or MI with CCB upon dose initiation or change. Discontinue if angioedema or laryngeal edema occurs (have SC epinephrine available). Moderate renal impairment (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. Elderly. Neonates. Pregnancy: avoid. Nursing mothers: not recommended.

Interactions:

Avoid concomitant cyclosporine, itraconazole. Caution with NSAIDs, K+supplements, K+ sparing diuretics, K+ containing salt substitutes; may cause hyperkalemia. May be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted. 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. Amlodipine potentiates simvastatin; limit simvastatin dose to max 20mg daily. Amlodipine potentiated by CYP3A4 inhibitors; monitor and adjust dose. Caution with CYP3A4 inducers.

Pharmacological Class:

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

Adverse Reactions:

Peripheral edema; diarrhea, cough, rash, hyperuricemia; rare: angioedema, hypotension.

Generic Availability:

NO

How Supplied:

Tabs—30, 90

TEKAMLO 300mg/10mg tablets (Qty:30)

appx. price $179.00