TEKAMLO Rx

Indications for TEKAMLO:

Hypertension.

Adult Dose for TEKAMLO:

Give once daily, consistently with regard to meals. Initial therapy: One 150mg/5mg tablet 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 tablet daily. Concomitant simvastatin: see Interactions.

Children's Dose for TEKAMLO:

Not recommended.

Pharmacological Class:

Renin inhibitor + dihydropyridine (DHP) calcium channel blocker (CCB).

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. Moderate renal dysfunction (CrCl <60mL/min): avoid concomitant with ARBs or ACEIs. Impaired renal function: monitor serum creatinine periodically. Renal artery stenosis. Heart failure. Severe hepatic impairment. Monitor for hyperkalemia. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:

Concomitant cyclosporine, itraconazole: not recommended. Caution with ACEIs, ARBs, 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. Decreased absorption with high fat meals. Amlodipine potentiates simvastatin; limit simvastatin dose to max 20mg daily.

Adverse Reactions:

Peripheral edema; diarrhea, cough, rash, hyperuricemia; rare: angioedema (discontinue if occurs, do not restart), hypotension.

How Supplied:

Tabs—30, 90