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ALTITUDEAliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpointswas a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney diseasecardiovascular diseaseor bothThe study was terminated early because of an increased risk of adverse outcomesCardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interesthyperkalaemiahypotension and renal dysfunctionwere more frequently reported in the aliskiren group than in the placebo group.

The dose should be individualised according to patient profile and blood pressure responsesee section 4.4

Fetal toxicity may developdiscontinue if pregnancy is detectedRenal impairmentDialysisesphigh-flux membraneSalt/volume depletionHypertrophic cardiomyopathySevere CHFIschemic heart diseaseCerebrovascular diseaseHyponatremiaRenal artery stenosisSurgeryMonitor BPelectrolytesrenal and liver functionMonitor serum potassium in diabeticsDiscontinue if angioedema or laryngeal edemajaundice or marked elevations of liver enzymes occurBlack patients may have higher rate of angioedema than non-Black patientsElderlyNeonatesPregnancymonitorNursing mothersnot recommended.

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Zestril may be used as monotherapy or in combination with other classes of antihypertensive therapysee sections 4.34.44.5 and 5.1

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Be sure to mention angiotensin-converting enzyme ace inhibitors such as benazepril lotensin , captopril capoten , enalapril vasotec , fosinopril monopril , lisinopril prinivil, zestril , moexipril univasc , perindopril, aceon , quinapril accupril , ramipril altace , and trandolapril mavik , lithium eskalith, lithobid , nonsteroidal anti-inflammatory medications nsaids such as ibuprofen advil, motrin and naproxen aleve, naprosyn , medications for diabetes, or high blood pressure, other diuretics, and potassium supplements.

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Initial dose2.5 to 5 mg orally once a day Maintenance doseDosage should be increased as tolerated Maximum dose40 mg orally once a day.

If you have diabetesdo not use Zestril together with any medication that contains aliskirensuch as Tekturna or Tekamlo

Following oral administration of lisinoprilpeak serum concentrations occur within about 7 hoursalthough there was a trend to a small delay in time taken to reach peak serum concentrations in acute myocardial infarction patientsBased on urinary recoverythe mean extent of absorption of lisinopril is approximately 25with interpatient variability of 6-60over the dose range studied5-80 mgThe absolute bioavailability is reduced approximately 16in patients with heart failureLisinopril absorption is not affected by the presence of food.

If you are allergic to lisinopril or any of the other ingredients of this medicinelisted in section 6if you have ever had an allergic reaction to another ACE inhibitor medicineThe allergic reaction may have caused swelling of the handsfeetanklesfacelipstongue or throatIt may also have made it difficult to swallow or breatheangioedemaif a member of your family has had severe allergic reactionsangioedemato an ACE inhibitor or you have had severe allergic reactionsangioedemawithout a known causeif you are more than 3 months pregnantIt is also better to avoid Zestril in early pregnancysee Pregnancy sectionif you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If you are allergic to lisinopril or any of the other ingredients of this medicinelisted in section 6if you have ever had an allergic reaction to another ACE inhibitor medicineThe allergic reaction may have caused swelling of the handsfeetanklesfacelipstongue or throatIt may also have made it difficult to swallow or breatheangioedemaif a member of your family has had severe allergic reactionsangioedemato an ACE inhibitor or you have had severe allergic reactionsangioedemawithout a known causeif you are more than 3 months pregnantIt is also better to avoid Zestril in early pregnancysee Pregnancy sectionif you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

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