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Hypotension: Telmisartan: In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of therapy with Telmisartan + Amlodipine tablets. Either correct this condition prior to administration of Telmisartan + Amlodipine tablets, or start treatment under close medical supervision with a reduced dose.
If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
Amlodipine: Since the vasodilation induced by amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, observe patients with severe aortic stenosis closely when administering amlodipine, as one should with any vasodilator.
Hyperkalemia: Telmisartan: Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at risk.
Patients with Impaired Hepatic Function: Telmisartan: As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Initiate telmisartan at low doses and titrate slowly in these patients.
Amlodipine: Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (1/2) is 56 hours in patients with impaired hepatic impairment have decreased clearance of amlodipine, start amlodipine or add amlodipine at 2.5 mg in patients with hepatic impairment. The lowest dose of Telmisartan + Amlodipine is 40/5 mg; therefore, initial therapy with Telmisartan + Amlodipine tablets is not recommended in hepatically impaired patients.
Renal Function Impairment: Telmisartan: As a consequence of inhibiting the renin-angiotensin aldosterone system, anticipate changes in renal function in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal dysfunction), treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with telmisartan.
In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen were observed. There has been no long term use of telmisartan in patients with unilateral or bilateral renal artery stenosis, but anticipate an effect similar to that seen with ACE inhibitors.
Dual Blockade of the Renin-Angiotensin-Aldosterone System: Telmisartan: As a consequence of inhibiting the renin-angiotensin aldosterone system, changes in renal function (including acute renal failure) have been reported. Dual blockade of the renin angiotensin-aldosterone system (e.g., by adding an ACE inhibitor to an angiotensin II receptor antagonist) should include close monitoring of renal function.
Risk of Myocardial Infarction or Increased Angina: Amlodipine: Uncommonly, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.
Heart Failure: Amlodipine: Closely monitor patients with heart failure. There was no overall adverse effect on survival or cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure).
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
