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Irbesartan 150


Composition :
Irbesartan 150 : Each tablet contains Irbesartan 150 mg

Pharmachology :
Irbesartan is expected to block all actions of angiotensin-II mediated by the AT receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors result in increases in plasma rennin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. Serum potassium levels are not significantly affected by Irbesartan alone at the recommended doses. Irbesartan does not inhibit ACE (Kininase-II, an enzyme wich generates angiotensin-II and also degrades bradykinin into inactive metabolites). Irbesartan does not require metabolic activation for its activity.

Indication :

  • Treatment of essential hypertension
  • To decrease micro- and macro-albuminurea in hypertension patients with nephropathic diabetic caused by NIDDM (Non-Insulin Dependent Diabetic Mellitus).

Dosage and Administration :
The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hours blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particulary in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan can be increased to 300 mg, or other antihypertensive agents can be added. In particular, the addition of a diuretic such as Hydrochlorotiazide has been shown to have an additive effect with Irbesartan.
In hypertensive type-2 diabetic patients, therapy should be initiated at 150 mg Irbesartan once daily and titrated up to 300 mg once daily as the preffered maintenance dose for treatment of renal disease.
The demonstration of renal benefit of Irbesartan in hypertensive type-2 diabetic patients is based on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure.

  • Renal impairment: No dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis.
  • Intravascular volume depletion: Volume and/or Sodium depletion should be corrected prior to administration of Irbesartan.
  • Hepatic impairment: No dosage adjustment is necessary in patients with impaired mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
  • Elderly patients: Although consideration should been given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
  • Children: Safety and efficacy of Irbesartan have not been established in children.

Contraindications :

  • Hypersensitivity to the any component of this product
  • Second and third trimesters of pregnancy
  • Woman in breast-feeding/lactation

Warnings and 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 Irbesartan.
  • Renovascular hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system. While this is not documented with Irbesartan, a similar effect should be anticipated with angiotensin-II receptor antagonists.
  • Renal impairment and kidney transplantation: When Irbesartan is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Irbesartan in patients with a recent kidney transplantation.
  • Hypertensive patients with type 2 diabetes and renal disease: The effects of Irbesartan 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 woman and non-white subjects.
  • Lithium: The combination of lithium and Irbesartan is not 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 antihypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
  • General: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with ACE 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 antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. As observed for angiotensin converting enzyme inhibitors, Irbesartan and the angiotensin antagonists are appereantly less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
  • Paediatric use: Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not appear to lower blood pressure effectively in pediatrics patients ages 6 to 16 years.

Drugs Interactions :

  • Diuretics and other antihypertensive agents: Other antihypertensive agents may increase the hypotensive effects of Irbesartan; however, Irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan.
  • Potassium supplements and potassium-sparing diuretics: Experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassium-sparing 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 Irbesartan. Therefore, this combination is not recommended (see Special Warning and Precautions). If combination proves necessary, careful monitoring of serum lithium levels is recommended.
  • NSAIDs: When angiotensin II antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetosal (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. As with ACE inhibitors, concomitant use of angiotensin II antagonists 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.
  • No significant drug interaction-drug pharmacokinetic (or pharmacodynamic) interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin.

Adverse Reactions :

  • Nervous system disorders: Headache, dizziness.
  • Cardiac disorders: Tachycardia.
  • Vascular disorders: Flushing, orthostatic hypotension.
  • Respiratory, thoracic and mediastinal disorders: Cough.
  • Gastrointestinal disorders: Nausea/vomiting, diarrhea, dyspepsia/heartburn.
  • Reproductive system and breast disorders: Sexual dysfunction.
  • General disorders and administration site conditions: Fatigue, chest pain.
  • Musculoskeletal, connective tissue and bone disorders: Musculoskeletal pain, myalgia, arthalgia.
  • Immune system disorders: Rash, urticaria, angioedema.
  • Metabolism and nutrition disorders: Hyperkalemia.
  • Ear and labyrinth disorders: Tinnitus.
  • Hepato-biliary disorders: Hepatitis, abnormal liver function.

Overdosage :
No data are available in regard to overdosage in humans.The most likely manifestations of overdose are hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodyalisis. 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 overdose.

Presentation :
Irbesartan 150 : Box, 3 strips @ 10 film coated tablets

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