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Irbes 150 mgTreatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.Theropeutic ClassAngiotensin-ll receptor blockerPharmacologyIrbes 150 mg is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.Dosage & Administration of Irbes 150 mgAdult: The usual recommended initial and maintenance dose is Irbes 150 mg 150 mg once daily, with?or without food. Irbes 150 mg at a dose of 150 mg once daily generally provides a better 24 hour?blood pressure control than 75 mg. However, initiation of therapy with Irbes 150 mg 75 mg could?be considered, particularly in haemodialysed patients and in the elderly over 75 years.?In patients insufficiently controlled with Irbes 150 mg 150 mg once daily, the dose of Irbes 150 mg?can be increased to Irbes 150 mg 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an?additive effect with Irbes 150 mg.?In hypertensive type 2 diabetic patients, therapy should be initiated at Irbes 150 mg 150 mg?once daily and titrated up to Irbes 150 mg 300 mg once daily as the preferred maintenance dose?for treatment of renal disease.?The demonstration of renal benefit of Irbes 150 mg in hypertensive type 2 diabetic patients is based?on studies where Irbes 150 mg was used in addition to other antihypertensive agents, as needed, to?reach target blood pressure.?Elderly: although consideration should be given to initiating therapy with Irbes 150 mg 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderlyPaediatric: Irbes 150 mg is not recommended for use in children and adolescents due to?insufficient data on safety and efficacy.Dosage of Irbes 150 mgAdult: The usual recommended initial and maintenance dose is Irbes 150 mg 150 mg once daily, with?or without food. Irbes 150 mg at a dose of 150 mg once daily generally provides a better 24 hour?blood pressure control than 75 mg. However, initiation of therapy with Irbes 150 mg 75 mg could?be considered, particularly in haemodialysed patients and in the elderly over 75 years.?In patients insufficiently controlled with Irbes 150 mg 150 mg once daily, the dose of Irbes 150 mg?can be increased to Irbes 150 mg 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an?additive effect with Irbes 150 mg.?In hypertensive type 2 diabetic patients, therapy should be initiated at Irbes 150 mg 150 mg?once daily and titrated up to Irbes 150 mg 300 mg once daily as the preferred maintenance dose?for treatment of renal disease.?The demonstration of renal benefit of Irbes 150 mg in hypertensive type 2 diabetic patients is based?on studies where Irbes 150 mg was used in addition to other antihypertensive agents, as needed, to?reach target blood pressure.?Elderly: although consideration should be given to initiating therapy with Irbes 150 mg 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderlyPaediatric: Irbes 150 mg is not recommended for use in children and adolescents due to?insufficient data on safety and efficacy.Interaction of Irbes 150 mgDiuretics and other antihypertensive?agents: prior treatment with high dose diuretics may result in volume depletion and?a risk of hypotension when initiating therapy with Irbes 150 mg.Potassium?supplements and potassium-sparing diuretics: based on experience with the use of?other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing?diuretics, potassium supplements, salt substitutes containing potassium or?other drugs that may increase serum potassium levels (e.g. heparin) may lead to?increases in serum potassium and is, therefore, not recommended.Lithium:?reversible increases in serum lithium concentrations and toxicity have been reported?during concomitant administration of lithium with angiotensin converting enzyme?inhibitors. Similar effects have been very rarely reported with Irbes 150 mg so far.?Therefore, this combination is not recommended. If the combination proves?necessary, careful monitoring of serum lithium levels is recommended.Non-steroidal?anti-inflammatory drugs: When angiotensin II antagonists are administered?simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2?inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of?the antihypertensive effect may occur. Additional information on Irbes 150 mg?interactions: In clinical studies, the pharmacokinetic of Irbes 150 mg is not affected by?hydrochlorothiazide. Irbes 150 mg is mainly metabolised by CYP2C9 and to a lesser?extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic?interactions were observed when Irbes 150 mg was coadministered with warfarin, a?drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin?on the pharmacokinetic of Irbes 150 mg have not been evaluated. The pharmacokinetic?of digoxin was not altered by coadministration of Irbes 150 mg.ContraindicationsConcomitant use with aliskiren in patients with diabetes and renal impairment (GFR <60 ml/min). Pregnancy.Side Effects of Irbes 150 mgDiarrhoea, fatigue, dyspepsia or heartburn, dizziness, orthostatic hypotension, nausea, vomiting, musculoskeletal pain, thrombocytopaenia, hyperkalaemia, elevated serum creatinine.Pregnancy & LactationPregnancy: Irbes 150 mg is contraindicated in the second and third trimesters of?pregnancy. In the second and third trimesters, substances that act directly on the?renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull?hypoplasia and even foetal death. As precautionary measure, Irbes 150 mg should?preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If?pregnancy is diagnosed, Irbes 150 mg should be discontinued as soon as possible, skull?and renal function should be checked with echography if, inadvertently, the?treatment was taken for a long period.Lactation: Irbes 150 mg is contraindicated during lactation. It is not known whether?Irbes 150 mg is excreted in human milk. Irbes 150 mg is excreted in the milk of lactating?rats. Precautions: Intravascular volume depletion: symptomatic hypotension,?especially after the first dose, may occur in patients who are volume and/or sodium?depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbes 150 mg.Precautions & WarningsPatients with unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.Overdose Effects of Irbes 150 mgExperience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no?toxicity. The most likely manifestations of overdosage are expected to be?hypotension and tachycardia; bradycardia might also occur from overdose. No?specific information is available on the treatment of overdosage with Irbes 150 mg. The?patient should be closely monitored, and the treatment should be symptomatic and?supportive. Suggested measures include induction of emesis and/or gastric lavage.?Activated charcoal may be useful in the treatment of overdosage. Irbes 150 mg is not?removed by haemodialysis.Storage ConditionsStore in a cool and dry place, protected from light.Use In Special PopulationsRenal impairment: no dosage adjustment is necessary in patients with impaired renal function. A?lower starting dose of Irbes 150 mg 75 mg should be considered for patients undergoing?haemodialysis.?Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to?administration of Irbes 150 mg.?Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate?hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.Hypertensive patients with?type 2 diabetes and renal disease: the effects of Irbes 150 mg both on renal and?cardiovascular events were not uniform across all subgroups, in an analysis carried?out in the study with patients with advanced renal disease. In particular, they?appeared less favourable in women and non-white subjects.Hyperkalaemia: as with?other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may?occur during the treatment with Irbes 150 mg, especially in the presence of renal?impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.?Close monitoring of serum potassium in patients at risk is recommended.Aortic and?mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other?vasodilators, special caution is indicated in patients suffering from aortic or mitral?stenosis, or obstructive hypertrophic cardiomyopathy.Primary aldosteronism:?patients with primary aldosteronism generally will not respond to anti-hypertensive?drugs acting through inhibition of the renin-angiotensin system. Therefore, the use?of Irbes 150 mg is not recommended.General: in patients whose vascular tone and?renal function depend predominantly on the activity of the renin-angiotensinaldosterone?system (e.g. patients with severe congestive heart failure or underlying?renal disease, including renal artery stenosis), treatment with angiotensin converting?enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has?been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal?failure. As with any anti-hypertensive agent, excessive blood pressure decrease in?patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result?in a myocardial infarction or stroke.Drug ClassesAngiotensin-ll receptor blockerMode Of ActionIrbes 150 mg is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.PregnancyPregnancy: Irbes 150 mg is contraindicated in the second and third trimesters of?pregnancy. In the second and third trimesters, substances that act directly on the?renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull?hypoplasia and even foetal death. As precautionary measure, Irbes 150 mg should?preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If?pregnancy is diagnosed, Irbes 150 mg should be discontinued as soon as possible, skull?and renal function should be checked with echography if, inadvertently, the?treatment was taken for a long period.Lactation: Irbes 150 mg is contraindicated during lactation. It is not known whether?Irbes 150 mg is excreted in human milk. Irbes 150 mg is excreted in the milk of lactating?rats. Precautions: Intravascular volume depletion: symptomatic hypotension,?especially after the first dose, may occur in patients who are volume and/or sodium?depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbes 150 mg.Pediatric UsesRenal impairment: no dosage adjustment is necessary in patients with impaired renal function. A?lower starting dose of Irbes 150 mg 75 mg should be considered for patients undergoing?haemodialysis.?Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to?administration of Irbes 150 mg.?Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate?hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.Hypertensive patients with?type 2 diabetes and renal disease: the effects of Irbes 150 mg both on renal and?cardiovascular events were not uniform across all subgroups, in an analysis carried?out in the study with patients with advanced renal disease. In particular, they?appeared less favourable in women and non-white subjects.Hyperkalaemia: as with?other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may?occur during the treatment with Irbes 150 mg, especially in the presence of renal?impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.?Close monitoring of serum potassium in patients at risk is recommended.Aortic and?mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other?vasodilators, special caution is indicated in patients suffering from aortic or mitral?stenosis, or obstructive hypertrophic cardiomyopathy.Primary aldosteronism:?patients with primary aldosteronism generally will not respond to anti-hypertensive?drugs acting through inhibition of the renin-angiotensin system. Therefore, the use?of Irbes 150 mg is not recommended.General: in patients whose vascular tone and?renal function depend predominantly on the activity of the renin-angiotensinaldosterone?system (e.g. patients with severe congestive heart failure or underlying?renal disease, including renal artery stenosis), treatment with angiotensin converting?enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has?been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal?failure. As with any anti-hypertensive agent, excessive blood pressure decrease in?patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result?in a myocardial infarction or stroke.