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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: IRBESARTAN (irbesartan) is indicated for the treatment of: • essential hypertension. 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 reduction of…
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 IRBESARTAN (irbesartan) may need to be adjusted.
2 Recommended Dose and Dosage Adjustment Essential Hypertension The recommended initial dose of 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 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. Geriatrics No initial dosage adjustment is required in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Population and Conditions; and WARNINGS AND PRECAUTIONS).
Renal Insufficiency No initial dosage adjustment is required in patients with renal impairment (see CLINICAL PHARMACOLOGY, 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.
Hepatic Insufficiency No initial dosage adjustment is required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, 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 WARNINGS AND PRECAUTIONS, Cardiovascular; and DRUG INTERACTIONS). If this is not possible because of the patient’s condition, IRBESARTAN (irbesartan) Page 6 of 35 IRBESARTAN should be administered with caution and the blood pressure monitored closely.
The recommended starting dose of IRBESARTAN is 75 mg once daily in hypovolemic patients (see WARNINGS AND PRECAUTIONS, Cardiovascular). Thereafter, the dosage should be adjusted according to the individual response of the patient. 4 Administration IRBESARTAN may be administered with or without food.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Irbesartan was evaluated for safety in > 4,100 patients with essential hypertension including approximately 1,300 patients treated for > 6 months and 400 patients for ≥ 1 year.
5% of patients given placebo. The following potentially serious adverse reactions have been reported rarely with irbesartan in controlled clinical trials: syncope, hypotension. 2% of patients receiving placebo. In addition, the following potentially important events occurred in < 1% of patients receiving irbesartan, regardless of drug relationship: Body as a Whole: fever; Cardiovascular: angina pectoris, arrhythmic/conduction disorder, cardio-respiratory arrest, flushing, heart failure, hypertension, hypertensive crisis, myocardial infarction; Dermatologic: dermatitis, ecchymosis, erythema, photosensitivity, pruritus, urticaria; Endocrine: gout, libido change, sexual dysfunction; Gastrointestinal: constipation, distension abdomen, flatulence, gastroenteritis, hepatitis; Hematologic: anemia, lymphocytopenia, thrombocytopenia; IRBESARTAN (irbesartan) Page 11 of 35 Musculoskeletal: arthritis, muscle cramp, muscle weakness, myalgia; Nervous System: cerebrovascular accident, depression, numbness, paresthesia, sleep disturbance, somnolence, transient ischemic attack, tremor, vertigo; Renal/Genitourinary: abnormal urination; Respiratory: dyspnea, epistaxis, pulmonary congestion, tracheobronchitis, wheezing; Special Senses: conjunctivitis, hearing abnormality, taste disturbance, visual disturbance.
08/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ......................................................................................................................... 1 Pediatrics .......................................................................................................................
2 Geriatrics........................................................................................................................ 4 2 CONTRAINDICATIONS .........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 1 Dosing Considerations ...................................................................................................
2 Recommended Dose and Dosage Adjustment .............................................................. 4 Administration ................................................................................................................
5 Missed Dose .................................................................................................................. 6 5 OVERDOSAGE ......................................................................................................................
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 DOSAGE FORMS STRENGTHS, COMPOSITION AND PACKAGING.
73m2) (see WARNINGS AND PRECAUTIONS, Cardiovascular and Renal; and DRUG INTERACTIONS). • Combination with Angiotensin-Converting Enzyme Inhibitors (ACEIs) in patients with diabetic nephropathy (see WARNINGS AND PRECAUTIONS, Cardiovascular and Renal; and DRUG INTERACTIONS).
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (due to the lactose component of IRBESARTAN tablets). • Pregnant women (see WARNINGS AND PRECAUTIONS, Special Populations).
• Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations). IRBESARTAN (irbesartan) Page 5 of 35
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Irbesartan in Canada.
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5 Missed Dose Patients should be instructed to take IRBESARTAN at the next scheduled dose and not take two doses at the same time if they miss a dose.
0 mg/dL). 2%). 2% vs. 0%. Laboratory Test Findings In controlled clinical trials of hypertension, clinically important differences in laboratory tests were rarely associated with irbesartan. 6%) in irbesartan treated subjects. 9% on placebo.
16 g/dL were observed in patients receiving irbesartan. No patients were discontinued due to anemia.
Hyperkalemia:
The laboratory test parameter profile was similar in clinical trials conducted in patients with hypertension, type 2 diabetes and renal disease compared to that of patients with hypertension only, with the exception of hyperkalemia.
4% of the patients in the irbesartan 300 mg group compared to 22% of the patients in the placebo group. 5% of the patients in the irbesartan group. 3% of the patients in the placebo group. 4% of the patients in the irbesartan and placebo groups, respectively.
3%, respectively, of patients receiving placebo. In […]
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 6 7 WARNINGS AND PRECAUTIONS ........................................................................................ 1 Special Populations .......................................................................................................
1 Pregnant Women ........................................................................................................ 2 Breast-feeding .............................................................................................................
3 Pediatrics .................................................................................................................... 4 Geriatrics .....................................................................................................................
9 8 ADVERSE REACTIONS ......................................................................................................... 2 Clinical Trial Adverse Reactions ....................................................................................
5 Post-Market Adverse Reactions .................................................................................. 12 9 DRUG INTERACTIONS ........................................................................................................
2 Drug Interactions Overview.......................................................................................... 4 Drug-Drug Interactions.................................................................................................
12 10 CLINICAL PHARMACOLOGY ............................................................................................. 1 Mechanism of Action....................................................................................................
2 Pharmacodynamics ..................................................................................................... 3 Pharmacokinetics.........................................................................................................
17 11 STORAGE, STABILITY AND DISPOSAL ............................................................................ 18 PART II: SCIENTIFIC INFORMATION .......................................................................................
19 13 PHARMACEUTICAL INFORMATION .................................................................................. 19 14 CLINICAL TRIALS ...............................................................................................................
1 Trial Design and Study Demographics ........................................................................ 3 Comparative Bioavailability Studies ............................................................................. 24 15 MICROBIOLOGY..................................................................................................................
25 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 25 17 SUPPORTING PRODUCT MONOGRAPHS ........................................................................ 30 PATIENT MEDICATION INFORMATION ..................................................................................
31 IRBESARTAN (irbesartan) Page 4 of 35 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS IRBESARTAN (irbesartan) is indicated for the treatment of: • essential hypertension. 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 reduction of microalbuminuria, and the occurrence of doubling of serum creatinine (see CLINICAL TRIALS).
1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of IRBESARTAN in patients < 18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use (see WARNINGS AND PRECAUTIONS, Special […]