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Dosage/Direction for Use
Oral Hypertension Adult: Monotherapy or in combination with other antihypertensive agents: 150 mg once daily, may be increased to 300 mg once daily if needed. Elderly: >75 years Initially, 75 mg once daily. Renal impairment: Patients undergoing haemodialysis: Initially, 75 mg once daily. Oral Diabetic nephropathy in type 2 diabetes mellitus Adult: Initially, 150 mg once daily, may increase to 300 mg once daily if needed. Special Populations: Patient with intravascular volume or salt depletion: Initially, 75 mg once daily. |
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Administration
May be taken with or without food.
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Contraindications
Pregnancy. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2).
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Special Precautions
Patient with volume or salt depletion, unstented unilateral or bilateral renal artery stenosis, significant aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, heart failure, diabetes mellitus, ascites due to cirrhosis or refractory ascites, idiopathic or hereditary angioedema, history of angioedema associated with ACE inhibitor therapy. Patient undergoing surgery. Not recommended in patients with primary aldosteronism. Black patients. Renal impairment. Elderly. Lactation. Patient Counselling This drug may cause dizziness or weariness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood pressure, electrolytes (e.g. serum K levels), serum creatinine, BUN, and urinalysis. Assess for signs of angioedema.
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Adverse Reactions
Significant: Symptomatic hypotension (particularly in patients with salt or volume depletion), renal function deterioration and/or increased serum creatinine, hyperkalaemia, hypoglycaemia (particularly in diabetic patients). Rarely, angioedema.
Blood and lymphatic system disorders: Anaemia, thrombocytopenia.
Cardiac disorders: Tachycardia, chest pain.
Ear and labyrinth disorders: Tinnitus, vertigo.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia.
General disorders and administration site conditions: Fatigue.
Hepatobiliary disorders: Jaundice, hepatitis.
Immune system disorders: Hypersensitivity reactions (e.g. anaphylaxis, anaphylactic shock).
Investigations: Increased plasma creatine kinase, increased liver enzymes.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, arthralgia, muscle cramps.
Nervous system disorders: Dizziness, headache, orthostatic dizziness.
Skin and subcutaneous tissue disorders: Urticaria, rash.
Vascular disorders: Orthostatic hypotension, flushing.
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Overdosage
Symptoms: Hypotension, tachycardia, bradycardia. Management: Symptomatic and supportive treatment. May consider administering activated charcoal, inducing emesis, or performing gastric lavage.
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Drug Interactions
May increase the serum concentrations and toxicity of lithium. Enhanced hypotensive effect with other antihypertensive agents. Serum K levels may be increased with K-sparing diuretics, K supplements, K-containing salt substitutes, or other drugs that may elevate serum K levels (e.g. heparin). NSAIDs (including selective COX-2 inhibitors) may reduce the antihypertensive effect of irbesartan, and may increase the risk of worsened renal function (including acute renal failure). May increase the serum concentration of repaglinide.
Potentially Fatal: Increased risk of hypotension, hyperkalaemia, and reduced renal function (including acute renal failure) with aliskiren or ACE inhibitors. |
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Lab Interference
May result in false-negative aldosterone/renin ratio (ARR).
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Action
Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by selectively binding to angiotensin II receptor type 1 (AT1) receptors.
Onset: 1-2 hours. Duration: >24 hours. Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Bioavailability: 60-80%. Time to peak plasma concentration: 1.5-2 hours. Distribution: Volume of distribution: 53-93 L. Plasma protein binding: Approx 96%. Metabolism: Metabolised in the liver via glucuronide conjugation and oxidation; oxidation is primarily mediated by CYP2C9 isoenzyme. Excretion: Mainly via faeces (80%); urine (approx 20%; <2% as unchanged drug). Terminal elimination half-life: Approx 11-15 hours. |
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Storage
Oral: Store between 15-30°C.
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CIMS Class
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ATC Classification
C09CA04 - irbesartan ; Belongs to the class of angiotensin II antagonists. Used in the treatment of cardiovascular disease.
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