Valugan

HTN, as monotherapy or w/ other antihypertensive agents to lower BP. Reduces risk of fatal & non-fatal CV events, primarily stroke & MI. Initial therapy in patients likely to need multiple antihypertensive agents to achieve BP goals.

Individualized dosage & may be increased after at least 2 wk. Effective dose: Telmisartan 20-80 mg once daily, amlodipine 2.5-10 mg. Max: 80 mg/10 mg once daily. Replacement therapy for separate tab Same component doses once daily. Add-on therapy when HTN is not adequately controlled on antihypertensive monotherapy Patient treated w/ amlodipine 10 mg who experiences any dose-limiting adverse reactions eg, edema 40 mg/5 mg once daily. Initial therapy Initially 40 mg/5 mg once daily. Patient requiring larger BP reduction May be started on 80 mg/5 mg once daily. Patient ≥75 yr, & patient w/ hepatic impairment Initiate amlodipine at 2.5 mg. Slowly titrate dose. Patient w/ severe renal impairment Slowly titrate dose.

May be taken with or without food.

Hypersensitivity. Co-administration of aliskiren in patients w/ diabetes.

Worsening angina & MI can develop after starting or increasing dose particularly in patients w/ severe obstructive CAD. Closely monitor BP, renal function & electrolytes in concomitant use w/ other agents that affect the renin-angiotensin-aldosterone system (RAAS). Correct intravascular vol- or salt-depletion before initiating therapy. Avoid concomitant use of aliskiren in patients w/ renal impairment (GFR <60 mL/min/1.73 m²). Initial therapy w/ telmisartan & amlodipine tab is not recommended in patients ≥75 yr or w/ hepatic impairment. Discontinue therapy as soon as possible when pregnancy is detected. Safety & effectiveness in ped patients have not been established. Telmisartan: Symptomatic hypotension may occur after initiation of therapy in patients w/ activated renin-angiotensin system eg, vol- or salt-depleted patient. Hyperkalemia may occur, particularly in patients w/ advanced renal impairment, heart failure, on renal replacement, or on K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that increase K levels. Dual blockade of the RAAS w/ ARBs, ACE inhibitors or aliskiren is associated w/ increased risk of hypotension, hyperkalemia, & changes in renal function (including acute renal failure). Reduced clearance in patients w/ biliary obstructive disorders or hepatic insufficiency. Anticipate changes in renal function in susceptible individuals. Use during 2nd & 3rd trimesters of pregnancy reduces fetal renal function & increases fetal & neonatal morbidity & death. Amlodipine: Possible symptomatic hypotension particularly in patients w/ severe aortic stenosis. Closely monitor patients w/ heart failure. Recommended to discontinue nursing while amlodipine is administered.

Peripheral edema, dizziness, & back pain. Edema (other than peripheral edema), hypotension, & syncope. Headache, fatigue, nausea, abdominal pain. Telmisartan: URTI, sinusitis, diarrhea, pharyngitis. Flu-like symptoms, dyspepsia, myalgia, UTI, pain, coughing, HTN, chest pain. Amlodipine: Flushing, palpitations. Somnolence.

Telmisartan: Increased in digoxin peak plasma conc & trough conc. Reversible increases in serum lithium conc & toxicity. May result in deterioration of renal function, including possible acute renal failure, w/ NSAIDs (including selective COX-2 inhibitors) in patients who are elderly, vol-depleted, or w/ compromised renal function. Antihypertensive effect may be attenuated by NSAIDs (including selective COX-2 inhibitors). Increased exposure to ramipril & ramiprilat; possibly additive pharmacodynamic effects w/ ramipril. Possible inhibition of metabolism of drugs metabolized by CYP2C19. Amlodipine: Increased exposure to simvastatin. May increase systemic exposure of cyclosporine or tacrolimus. Increased systemic exposure w/ diltiazem (CYP3A4 inhibitor). Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) may increase plasma conc of amlodipine. Monitor patients for adequate clinical effect when co-administered w/ CYP3A4 inducers.

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.

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