IRBEZYD 300 Irbesartan 300mg Film-Coated Tablet 1's
RXDRUG-DR-XY40950-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Irbesartan is indicated for the treatment of essential hypertension; treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.
Dosage/Direction for Use
Hypertension, initially 150 mg once daily, increased if necessary to 300 mg once daily. Renal disease on hypertensive type 2 diabetes mellitus, initially 150 mg once daily, increased according to response to 300 mg once daily (in haemodialysis or in elderly over 75 years, initial dose of 75 mg once daily may be used).
Overdosage
Experience 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 Irbesartan (Irbezyd) tablets. 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. Irbesartan is not removed by haemodialysis.
Administration
May be taken with or without food.
Contraindications
It is contraindicated in the following conditions: Hypersensitivity to any of the components of this product, Congestive heart failure, Pregnancy, Lactation, Dehydration.
Special Precautions
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 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 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 other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in nonblacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
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 (Irbezyd) tablets.
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 drugs that affect the renin angiotensin-aldosterone system. While this is not documented with Irbesartan (Irbezyd) tablets, a similar effect should be anticipated with angiotensin II receptor antagonists.
Renal impairment and kidney transplantation: When Irbesartan (Irbezyd) tablets 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 Irbezyd (Irbesartan Tablets) 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 women and non-white subjects.
Hyperkalaemia: As with other drugs that affect the renin angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan (Irbezyd) tablets, 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.
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 Irbesartan (Irbezyd) tablets is not recommended.
Use in Pregnancy: The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Because of the possibility that irbesartan may have a similar effect on the fetus, it should not be used during pregnancy.
Use in Lactation: Irbesartan should be avoided in nursing mothers.
Use in Children: Irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available.
As observed for angiotensin converting enzyme inhibitors, Irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in nonblacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
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 (Irbezyd) tablets.
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 drugs that affect the renin angiotensin-aldosterone system. While this is not documented with Irbesartan (Irbezyd) tablets, a similar effect should be anticipated with angiotensin II receptor antagonists.
Renal impairment and kidney transplantation: When Irbesartan (Irbezyd) tablets 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 Irbezyd (Irbesartan Tablets) 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 women and non-white subjects.
Hyperkalaemia: As with other drugs that affect the renin angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan (Irbezyd) tablets, 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.
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 Irbesartan (Irbezyd) tablets is not recommended.
Use in Pregnancy: The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Because of the possibility that irbesartan may have a similar effect on the fetus, it should not be used during pregnancy.
Use in Lactation: Irbesartan should be avoided in nursing mothers.
Use in Children: Irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available.
Use In Pregnancy & Lactation
Use in Pregnancy: The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Because of the possibility that irbesartan may have a similar effect on the fetus, it should not be used during pregnancy.
Use in Lactation: Irbesartan should be avoided in nursing mothers.
Use in Lactation: Irbesartan should be avoided in nursing mothers.
Adverse Reactions
Nervous system disorders: Common: dizziness.
Cardiac disorders: Uncommon: tachycardia.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough.
Gastrointestinal disorders: Common: nausea/vomiting. Uncommon: diarrhoea, dyspepsia/heartburn.
Reproductive system and breast disorders: Uncommon: sexual dysfunction.
General disorders and administration site conditions: Common: fatigue. Uncommon: chest pain.
Nervous system disorders: Common: orthostatic dizziness.
Vascular disorders: Common: orthostatic hypotension. Uncommon: flushing.
Musculoskeletal, connective tissue and bone disorders: Common: musculoskeletal pain.
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps.
Immune system disorders: As with other angiotensinII receptor antagonists, rare cases of hypersensitivity reactions such as rash, urticaria, angioedema.
Metabolism and nutrition disorders: Hyperkalaemia.
Nervous system disorders: Headache.
Ear and labyrinth disorders: Tinnitus.
Gastrointestinal disorders: Dysgeusia.
Hepato-biliary disorders: Hepatitis, abnormal liver function.
Renal and urinary disorders: Impaired renal function including cases of renal failure in patients at risk.
Skin and subcutaneous tissue disorders: Leukocytoclastic vasculitis.
Cardiac disorders: Uncommon: tachycardia.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough.
Gastrointestinal disorders: Common: nausea/vomiting. Uncommon: diarrhoea, dyspepsia/heartburn.
Reproductive system and breast disorders: Uncommon: sexual dysfunction.
General disorders and administration site conditions: Common: fatigue. Uncommon: chest pain.
Nervous system disorders: Common: orthostatic dizziness.
Vascular disorders: Common: orthostatic hypotension. Uncommon: flushing.
Musculoskeletal, connective tissue and bone disorders: Common: musculoskeletal pain.
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps.
Immune system disorders: As with other angiotensinII receptor antagonists, rare cases of hypersensitivity reactions such as rash, urticaria, angioedema.
Metabolism and nutrition disorders: Hyperkalaemia.
Nervous system disorders: Headache.
Ear and labyrinth disorders: Tinnitus.
Gastrointestinal disorders: Dysgeusia.
Hepato-biliary disorders: Hepatitis, abnormal liver function.
Renal and urinary disorders: Impaired renal function including cases of renal failure in patients at risk.
Skin and subcutaneous tissue disorders: Leukocytoclastic vasculitis.
Drug Interactions
Diuretics and other antihypertensive agents: Other antihypertensive agents may increase the hypotensive effects of Irbesartan; however Irbesartan (Irbezyd) tablets 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 (Irbezyd) tablets.
Potassium supplements and potassium-sparing diuretics: Based on 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 so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Nonsteroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with nonsteroidal anti-inflammatory drugs (i.e. selective COX2 inhibitors, acetylsalicylic acid > 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.
Potassium supplements and potassium-sparing diuretics: Based on 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 so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Nonsteroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with nonsteroidal anti-inflammatory drugs (i.e. selective COX2 inhibitors, acetylsalicylic acid > 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.
Storage
Store at temperature not exceeding 30˚C.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Irbesartan is a nonpeptide angiotensin II antagonist that selectively blocks the binding of angiotensin II to the AT1 receptor. In the renin-angiotensin system, angiotensin I is converted by angiotensin-converting enzyme (ACE) to form angiotensin II. Angiotensin II stimulates the adrenal cortex to synthesize and secrete aldosterone, which decreases the excretion of sodium and increases the excretion of potassium. Angiotensin II also acts as a vasoconstrictor in vascular smooth muscle. Irbesartan, by blocking the binding of angiotensin II to the AT1 receptor, promotes vasodilation and decreases the effects of aldosterone. The negative feedback regulation of angiotensin II on renin secretion also is inhibited, but the resulting rise in plasma renin concentrations and consequent rise in angiotensin II plasma concentrations do not counteract the blood pressure lowering effect that occurs.
Pharmacokinetics: Irbesartan is rapidly absorbed from the gastrointestinal tract with an oral bioavailability of 60 to 80%. It undergoes some metabolism in the liver to inactive metabolites. Peak plasma concentrations of Irbesartan occur 1.5 to 2 hours after an oral dose. Irbesartan is about 90% bound to plasma proteins. It is excreted as unchanged drug and metabolites in the bile and in urine; after oral or intravenous administration approximately 20% of the dose is excreted in the urine, with less than 2% as unchanged drug. The terminal elimination half-life is about 11 to 15 hours.
Pharmacokinetics: Irbesartan is rapidly absorbed from the gastrointestinal tract with an oral bioavailability of 60 to 80%. It undergoes some metabolism in the liver to inactive metabolites. Peak plasma concentrations of Irbesartan occur 1.5 to 2 hours after an oral dose. Irbesartan is about 90% bound to plasma proteins. It is excreted as unchanged drug and metabolites in the bile and in urine; after oral or intravenous administration approximately 20% of the dose is excreted in the urine, with less than 2% as unchanged drug. The terminal elimination half-life is about 11 to 15 hours.
MedsGo Class
Angiotensin II Antagonists
Features
Brand
IRBEZYD 300
Full Details
Dosage Strength
300mg
Drug Ingredients
- Irbesartan
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Irbesartan
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY40950
Drug Classification
Prescription Drug (RX)
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