Cardialta

HTN, alone or w/ other antihypertensive agents. Initial therapy in patients who are likely to need multiple drugs to achieve BP goals.

Individualized dosage. Max: 80/10 mg once daily. Replacement therapy Same component doses in 1 tab once daily. Add-on therapy Patient w/ HTN not adequately controlled on antihypertensive monotherapy or patient treated w/ amlodipine 10 mg who experiences any dose-limiting adverse reactions eg, edema May be switched to 40/5 mg once daily. Initial therapy 40/5 mg once daily. Patient requiring larger BP reduction May be started on 80/5 mg once daily. Patient w/ hepatic impairment or elderly ≥75 yr Initiate therapy w/ amlodipine 2.5 mg.

May be taken with or without food.

Hypersensitivity (eg, anaphylaxis or angioedema).

Discontinue use immediately when pregnancy is detected. In case of no appropriate alternative during pregnancy, apprise mother of potential risk to fetus, perform serial ultrasound exam to assess intra-amniotic environment & discontinue use if oligohydramnios are observed. Discontinue nursing during treatment. Closely observe infants w/ histories of in utero exposure to telmisartan + amlodipine for hypotension, oliguria & hyperkalemia. Initial therapy is not recommended in patients ≥75 yr or those w/ hepatic impairment. Telmisartan: Hyperkalemia may occur in patients particularly those w/ advanced renal impairment, heart failure, on renal replacement therapy, or on K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that increase K levels. Patients w/ biliary obstructive disorders or hepatic insufficiency. Oliguria &/or progressive azotemia & (rarely) w/ acute renal failure &/or death in patients whose renal function may depend on activity of the renin-angiotensin-aldosterone system eg, patients w/ severe CHF or renal dysfunction. Correct vol or salt depletion (eg, in patients treated w/ high doses of diuretics) prior to administration or start treatment under close medical supervision w/ reduced dose. Consider periodic determinations of serum electrolytes particularly in patients at risk of hyperkalemia. Anticipate increases in serum creatinine or BUN in patients w/ unilateral or bilateral renal artery stenosis. Closely monitor renal function in dual blockade of the renin-angiotensin-aldosterone system eg, by adding ACE inhibitor. Amlodipine: Uncommonly, reports of patients particularly w/ severe obstructive CAD developing increased frequency, duration or severity of angina or acute MI on starting therapy or at time of dose increase. Closely observe patients w/ severe aortic stenosis during administration. Closely monitor patients w/ heart failure.

Peripheral edema, dizziness, back pain. Edema (other than peripheral edema), hypotension, syncope.

Telmisartan: Median increases in digoxin peak plasma & trough conc. Reversible increases in serum lithium conc & toxicity. May result in deterioration of renal function, including possible acute renal failure w/ NSAIDs in patients who are elderly, vol-depleted (including those on diuretics), or w/ compromised renal function. Antihypertensive effect may be attenuated by NSAIDs including selective COX-2 inhibitors. Increased steady-state C_max & AUC of ramipril & ramiprilat. Decreased C_max & AUC w/ ramipril. Amlodipine: Increased exposure to simvastatin.

Angiotensin II Antagonists / Calcium Antagonists

C09DB04 - telmisartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

Rx