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AG-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: AG-Irbesartan (irbesartan) is indicated for the treatment of: • essential hypertension. AG-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 AG-Irbesartan (irbesartan) may need to be adjusted.
2 Recommended Dose and Dosage Adjustment Essential Hypertension The recommended initial dose of AG-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 AG-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 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.
Product Monograph AG-Irbesartan Page 6 of 40 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, AG-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 AG-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, AG-Irbesartan should be administered with caution and the blood pressure monitored closely.
The recommended starting dose of AG-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.
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 > 4100 patients with essential hypertension including approximately 1300 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; Product Monograph AG-Irbesartan Page 12 of 40 Hematologic: anemia, lymphocytopenia, thrombocytopenia; 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. 0 mg/dL). 2%). 0%.
Cardiovascular Hypotension - Volume Depleted Patients Occasionally, symptomatic hypotension has occurred after administration of irbesartan, in some cases after the first dose. It is more likely to occur in patients who are volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.
In these patients, because of the potential fall in BP, therapy should be started under close medical supervision (see DOSAGE AND ADMINISTRATION). Similar considerations apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in BP could result in myocardial infarction or cerebrovascular accident.
73m2). Therefore, Product Monograph AG-Irbesartan Page 8 of 40 the use of AG-Irbesartan in combination with aliskiren-containing drugs is contraindicated in these patients (see CONTRAINDICATIONS). The use of AG-Irbesartan in combination with of ACE inhibitors is contraindicated in patients with diabetic nephropathy (see CONTRAINDICATIONS).
Further, co-administration of ARBs, including irbesartan, with other agents blocking the RAS, such as ACE inhibitors or aliskiren-containing drugs, is generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure, and hyperkalemia.
Lithium Increases in serum lithium concentrations and lithium toxicity (including fatal outcome) have been reported with concomitant use of irbesartan and lithium (see DRUG INTERACTIONS). Therefore, this combination is not recommended.
Serum lithium levels should be monitored carefully in patients receiving irbesartan and lithium if the combination is necessary. Valvular Stenosis There is concern on theoretical grounds that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction.
AG-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 AG- Irbesartan tablets) • Pregnant women (see WARNINGS AND PRECAUTIONS, Special Populations).
• Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations). Product Monograph AG-Irbesartan Page 5 of 40
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Administration AG-Irbesartan may be administered with or without food. 5 Missed Dose Patients should be instructed to take AG-Irbesartan at the next scheduled dose and not take two doses at the same time if they miss a dose.
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. 16g/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, […]
Driving and Operating Machinery The effect of irbesartan on the ability to drive and use of machinery has not been studied, but based on its pharmacodynamic properties, AG-Irbesartan is unlikely to affect this ability. When driving vehicles or operating machinery, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Endocrine and Metabolism AG-Irbesartan may induce hypoglycemia, particularly in patients treated for diabetes. Therefore, dose adjustment of antidiabetic treatment such as repaglinide or insulin may be required (see ADVERSE REACTIONS).
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 Product Monograph AG-Irbesartan Page 9 of 40 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 CONTRAINDICATIONS and DRUG INTERACTIONS). The use of ARBs including AG-Irbesartan in combination with an ACEI is contraindicated in patients with diabetic nephropathy due to risk of hyperkalemia, hypotension and renal impairment (see CONTRAINDICATIONS and DRUG INTERACTIONS).
Use of AG-Irbesartan should include appropriate assessment of renal function. In hypertensive type 2 diabetic patients with proteinuria (≥900 mg/day), a population which has a high risk of renal artery stenosis, no patient treated with irbesartan in IDNT had an early acute rise in serum creatinine attributable to renal artery disease (see CLINICAL PHARMACOLOGY).
Skin The use of AG-Irbesartan in patients with psoriasis or a history of psoriasis should be carefully weighed as it may exacerbate psoriasis. 1 Pregnant Women Drugs that act directly on the renin-angiotensin-aldosterone system (RAAS) can cause fetal and neonatal morbidity and death when administered to pregnant women.
When pregnancy is detected, AG-Irbesartan (irbesartan) should be discontinued as soon as possible. The use of ARBs is contraindicated during pregnancy. Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors (another class of therapeutic products interfering with the RAAS) during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Given the current evidence available on the risk with ARBs, similar risks may exist for this class of drugs. Patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
When pregnancy is diagnosed, treatment with angiotensin II antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started. The use of ARBs during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification, retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia).
Product Monograph AG-Irbesartan Page 10 of […]