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M-IRBESARTAN is a brand name for Irbesartan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: M-IRBESARTAN (Irbesartan Tablets USP) is indicated for the treatment of: essential hypertension. M-IRBESARTAN may be used alone or concomitantly with thiazide diuretics. hypertensive patients with type 2 diabetes mellitus and renal disease to reduce the rate of progression of nephropathy as measured by the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure (BP) elevation, salt restriction, and other pertinent clinical factors. The dosage of other antihypertensive agents used with M-IRBESARTAN (irbesartan) may need to be adjusted.
2 Recommended Dose and Dosage Adjustment Essential Hypertension The recommended initial dose of M-IRBESARTAN is 150 mg once daily. In patients whose BP is not adequately controlled, the daily dose may be increased to 300 mg. Essential Hypertension with Type 2 Diabetic Renal Disease The recommended initial dose of M-IRBESARTAN is 150 mg once daily.
In patients whose BP is not adequately controlled, the daily dose may be increased to 300 mg once daily, the preferred maintenance dose. 3 Pharmacokinetics, Special Population and Conditions and 7 WARNINGS AND PRECAUTIONS). 3 Pharmacokinetics, Special Population and Conditions).
However, due to the apparent greater sensitivity of hemodialysis patients, an initial dose of 75 mg is recommended in this group of patients. 3 Pharmacokinetics, Special Population and Conditions). Concomitant Diuretic Therapy In patients receiving diuretics, irbesartan therapy should be initiated with caution, since these patients may be volume-depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.
Whenever possible, all diuretics should be discontinued 2-3 days prior to the administration of irbesartan to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and 9 DRUG PrM-IRBESARTAN Product Monograph Page 6 of 35 INTERACTIONS).
If this is not possible because of the patient’s condition, irbesartan should be administered with caution and the blood pressure monitored closely. The recommended starting dose of M-IRBESARTAN is 75 mg once daily in hypovolemic patients (see 7 WARNING AND PRECAUTIONS, Cardiovascular).
Thereafter, the dosage should be adjusted according to the individual response of the patient. 4 Administration M-IRBESARTAN may be administered with or without food. 5 Missed Dose Patients should be instructed to take M-IRBESARTAN at the next scheduled dose and not take two doses at the same time if they miss a dose.
). Renal Renal Impairment As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), changes in renal function have been seen in susceptible individuals. In patients whose renal function may depend on the activity of the RAAS, such as patients with bilateral renal artery stenosis, unilateral renal artery stenosis to a solitary kidney, or severe congestive heart failure, treatment with agents that inhibit this system has been associated with oliguria, progressive azotemia, and rarely, acute renal failure and/or death.
In susceptible patients, concomitant diuretic use may further increase risk. 73m2) (see 2 CONTRAINDICATIONS and
1 Special Populations). 1 Special Populations). 2 CONTRAINDICATIONS M-IRBESARTAN (irbesartan) is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 73m2) (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular and Renal, and 9 DRUG INTERACTIONS). Combination with Angiotensin-Converting Enzyme Inhibitors (ACEIs) in patients with diabetic nephropathy (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular and Renal, and 9 DRUG INTERACTIONS).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (due to the lactose component of M- IRBESARTAN tablets). 1 Special Populations). 1 Special Populations).
PrM-IRBESARTAN Product Monograph Page 5 of 35 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury or even death of the developing fetus.
1 Special Populations). 1 Dosing Considerations Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure (BP) elevation, salt restriction, and other pertinent clinical factors.
The dosage of other antihypertensive agents used with M-IRBESARTAN (irbesartan) may need to be adjusted. 2 Recommended Dose and Dosage Adjustment Essential Hypertension The recommended initial dose of M-IRBESARTAN is 150 mg once daily.
In patients whose BP is not adequately controlled, the daily dose may be increased to 300 mg. Essential Hypertension with Type 2 Diabetic Renal Disease The recommended initial dose of M-IRBESARTAN is 150 mg once daily. In patients whose BP is not adequately controlled, the daily dose may be increased to 300 mg once daily, the preferred maintenance dose.
M-IRBESARTAN (irbesartan) is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
73m2) (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular and Renal, and 9 DRUG INTERACTIONS). Combination with Angiotensin-Converting Enzyme Inhibitors (ACEIs) in patients with diabetic nephropathy (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular and Renal, and 9 DRUG INTERACTIONS).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (due to the lactose component of M- IRBESARTAN tablets). 1 Special Populations). 1 Special Populations).
PrM-IRBESARTAN Product Monograph Page 5 of 35
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Pharmacokinetics, Special Population and Conditions and 7 WARNINGS AND PRECAUTIONS). 3 Pharmacokinetics, Special Population and Conditions). However, due to the apparent greater sensitivity of hemodialysis patients, an initial dose of 75 mg is recommended in this group of patients.
3 Pharmacokinetics, Special Population and Conditions). Concomitant Diuretic Therapy In patients receiving diuretics, irbesartan therapy should be initiated with caution, since these patients may be volume-depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.
Whenever possible, all diuretics should be discontinued 2-3 days prior to the administration of irbesartan to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and 9 DRUG PrM-IRBESARTAN Product Monograph Page 6 of 35 INTERACTIONS).
If this is not possible because of the patient’s condition, irbesartan should be administered with caution and the blood pressure monitored closely. The recommended starting dose of M-IRBESARTAN is 75 mg once daily in hypovolemic patients (see 7 WARNING AND PRECAUTIONS, Cardiovascular).
Thereafter, the dosage should be adjusted according to the individual response of the patient. 4 Administration M-IRBESARTAN may be administered with or without food. 5 Missed Dose Patients should be instructed to take M-IRBESARTAN at the next scheduled dose and not take two doses at the same time if they miss a dose.
5 OVERDOSAGE Few cases of overdosage with irbesartan have been reported, with no complaints and no significant clinical sequelae. Reported overdoses ranged from 600 - 900 mg daily. Durations of overdosing ranged from 2 - 3 weeks up to 30 days and over.
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 hypotension and tachycardia; bradycardia might also occur. No specific information is available on the treatment of overdosage with irbesartan.
The patient should be closely monitored, and the treatment should be supportive and relieve symptoms. 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 hemodialysis. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet, 75 mg, 150 mg and 300 mg calcium stearate, lactose monohydrate, microcrystalline cellulose, poloxamer 188, pregelatinized starch and sodium starch glycolate.
M-IRBESARTAN (irbesartan) 75 mg tablets are white to off-white, oval shaped, biconvex uncoated tablets, debossed with ‘RI 21’ on one side and plain on the other. PrM-IRBESARTAN Product Monograph Page 7 of 35 M-IRBESARTAN (irbesartan) 150 mg tablets are white to […]