Bezartan Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Irbesartan

Indications/Uses

Essential HTN. Diabetic nephropathy in patients w/ type 2 diabetes & HTN.

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Dosage/Direction for Use

Initial & maintenance dose: 150 mg once daily, may be increased to 300 mg or other anti-hypertensives can be added. Hypertensive type 2 diabetic patient Initially 150 mg once daily, titrated up to 300 mg once daily. Elderly >75 yr & haemodialysis patient Initially 75 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Concomitant use w/ aliskiren-containing drugs in patients w/ DM or renal impairment. 2nd & 3rd trimesters of pregnancy.

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Warnings

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Special Precautions

Not recommended in primary aldosteronism & dual blockade of the renin-angiotensin-aldosterone system. Bilateral renal artery stenosis or artery stenosis to single functioning kidney; hyperkalaemia; aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy; ischaemic cardiopathy or CV disease. Correct vol &/or Na depletion prior to initiation. Periodic monitoring of serum K & creatinine levels, electrolytes & BP. Not recommended in combination w/ ACE inhibitors; lithium. Black patients. May affect ability to drive & use machines. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended during 1st trimester of pregnancy & lactation. Childn 0-18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hyperkalaemia. Dizziness, orthostatic dizziness; orthostatic hypotension; nausea/vomiting; musculoskeletal pain; fatigue; significantly increased plasma creatine kinase.

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Drug Interactions

Increased hypotensive effects w/ diuretics & other antihypertensives. Higher frequency of adverse events w/ ACE inhibitors or aliskiren. Increased serum K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes. Reversible increased serum lithium conc & toxicity. Attenuated antihypertensive effect w/ NSAIDs eg, selective COX-2 inhibitors, ASA & non-selective NSAIDs.

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Storage

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Action

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MIMS Class

Angiotensin II Antagonists

ATC Classification

C09CA04 - irbesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.

Regulatory Classification

Presentation/Packing

Form

Bezartan FC tab 150 mg

Packing/Price

30's

Form

Bezartan FC tab 300 mg

Packing/Price

30's

Bezartan

irbesartan

Manufacturer:

Duopharma Manufacturing (Bangi)

Distributor:

Duopharma Marketing