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RIVA-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: , 1.1 Pediatrics 10/2022 1 INDICATIONS, 1.2 Geriatrics 10/2022 7 WARNINGS AND PRECAUTIONS 10/2022 8 ADVERSE REACTIONS, 8.2 Clinical Trial Adverse Reactions 10/2022 8 ADVERSE REACTIONS, 8.5 Post-Market Adverse Reactions 10/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES…
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 RIVA-IRBESARTAN may need to be adjusted.
2 Recommended Dose and Dosage Adjustment Essential Hypertension The recommended initial dose of RIVA-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 RIVA-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. Geriatric No initial dosage adjustment is required in the elderly (see ACTION AND 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 ACTION AND 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 ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Population and Conditions). Concomitant Diuretic Therapy In patients receiving diuretics, RIVA-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 RIVA-IRBESARTAN to reduce the likelihood of hypotension (see WARNINGS AND PRECAUTIONS, Cardiovascular, and DRUG INTERACTIONS). If this is not possible because of the RIVA-IRBESARTAN Page 6 of 33 patient’s condition, RIVA-IRBESARTAN should be administered with caution and the blood pressure monitored closely.
The recommended starting dose of RIVA-IRBESARTAN is 75 mg once daily in hypovolemic patients (see WARNING AND PRECAUTIONS, Cardiovascular). Thereafter, the dosage should be adjusted according to the individual response of the patient.
5 Post-Market Adverse Reactions 10/2022 TABLE OF CONTENTS 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.............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations .................................................................................................
RIVA-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.
) • 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 RIVA-IRBESARTAN tablets).
• Pregnant women (see WARNINGS AND PRECAUTIONS, Special Populations). • Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations). RIVA-IRBESARTAN Page 5 of 33
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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4 Administration RIVA-IRBESARTAN may be administered with or without food. 5 Missed Dose Patients should be instructed to take RIVA-IRBESARTAN at the next scheduled dose and not take two doses at the same time if they miss a dose.
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 Interaction ...........................................................................................
13 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 .................................................................. 2 Comparative Bioavailability Studies ..................................................................... 24 15 MICROBIOLOGY .......................................................................................................
25 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 25 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 28 PATIENT MEDICATION INFORMATION ..................................................................................
29 RIVA-IRBESARTAN Page 4 of 33 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS RIVA-IRBESARTAN is indicated for the treatment of: • essential hypertension. RIVA-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 Populations).
2 Geriatrics Geriatrics (> 65 years of age): In clinical studies, no overall differences in safety or efficacy were observed between patients > 65 years of age and younger patients (see WARNINGS AND PRECAUTIONS, Special Populations).
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