Telmisartan - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Avoid fetal or neonatal exposure Hypotension: Correct any volume or salt depletion before initiating therapy.

Observe for signs and symptoms of hypotension.

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis Titrate slowly in patients with hepatic or severe renal impairment Heart failure: Monitor for worsening Avoid concomitant use with an ACE inhibitor Myocardial infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of telmisartan and amlodipine tablets, particularly in patients with severe obstructive coronary artery disease .

5.1 Fetal Toxicity Pregnancy Category D Telmisartan Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.

Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible [see Use in Specific Populations ] .

5.2 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 and amlodipine tablets.

Either correct this condition prior to administration of telmisartan and 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 Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.

Because of the gradual onset of action, acute hypotension is unlikely.

5.3 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.

5.4 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 [see Dosage and Administration , Use in Specific Populations , and Clinical Pharmacology ] .

Amlodipine Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function.

Since patients with 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 and amlodipine tablet is 40/5 mg; therefore, initial therapy with telmisartan and amlodipine tablet is not recommended in hepatically impaired patients [see Use in Specific Populations ] .

5.5 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 [see Clinical Pharmacology ] .

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.