Eprosartan

As with ACE inhibitors, concomitant use of Angiotensin II Receptor Blockers and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.

Concomitant use of losartan with the NSAID indometacin led to a decrease in efficacy of the angiotensin II receptor blocker; a class effect cannot be excluded.

No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min). Caution is recommended for use in patients with creatinine clearance <30 ml/min or in patients undergoing dialysis.

When eprosartan is used in patients with mild to moderate hepatic impairment, special care should be exercised due to the fact that there is limited experience in this patient population.

Elevated serum potassium levels have been observed in placebo controlled clinical trials. Experience from other drugs affecting the renin-angiotensin-aldosterone system indicate that concomitant use of potassium sparing diuretics, potassium supplements, salt replacing agents containing potassium or other drugs which may elevate serum potassium levels (e.g. heparin) may cause an increase in serum potassium.

Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent.

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. While this is not documented with eprosartan, the possibility of a similar effect cannot be excluded and careful monitoring of serum lithium levels is recommended during concomitant use.

Treatment with eprosartan is not recommended for these patients.

Symptomatic hypotension may occur in patients with severe volume depletion and/or salt depletion (e.g. high dose diuretic therapy). These conditions should be corrected before commencing therapy.

During treatment with other drugs affecting the renin-angiotensin-aldosterone system, hyperkalaemia may occur, especially in patients with impaired renal function and/or cardiac failure. Regular monitoring for serum potassium levels is recommended in risk patients.

Based on experience with the use of other medicinal products which affect the renin-angiotensin-aldosterone system concomitant administration with potassium-sparing diuretics, potassium-supplements, salt replacing preparations containing potassium or other drug which may elevate potassium levels (e.g. heparin) may lead to increased serum potassium levels and should therefore be administered cautiously with eprosartan.

There is limited experience of treatment of patients with coronary heart disease.

As with all vasodilators caution should be exercised in patients with aortic and mitral valve stenosis or hypertrophic cardiomyopathy.

The use of AIIRAs is not recommended during the first trimester of pregnancy. The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy.

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Blockers, similar risks may exist for this class of drugs. Unless continued Angiotensin II Receptor Blocker therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with Angiotensin II Receptor Blockers should be stopped immediately and, if appropriate, alternative therapy should be started.

Exposure to Angiotensin II Receptor Blocker therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

Should exposure to Angiotensin II Receptor Blockers have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken Angiotensin II Receptor Blockers should be closely observed for hypotension.

Because no information is available regarding the use of eprosartan during breast-feeding, eprosartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

No studies on the effects on the ability to drive and use machines has been performed. Based on its pharmacodynamic properties, eprosartan is unlikely to affect this ability. When driving vehicles or operating machines, it should be taken into account, that occasionally dizziness or weariness may occur during treatment of hypertension.