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AURO-VALSARTAN is a brand name for Valsartan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Auro-Valsartan (valsartan tablets) is indicated for: • Hypertension o For the treatment of mild to moderate essential hypertension. o Auro-Valsartan may be administered alone, or concomitantly with thiazide diuretics. o The safety and efficacy of concurrent treatment with valsartan and angiotensin converting enzyme…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Hepatic Impairment: No initial dosage adjustment is required in patients with mild to moderate liver disease. 3 Pharmacokinetics, and 7 WARNINGS AND PRECAUTIONS - Hepatic/Biliary/Pancreatic). • Renal Impairment: No initial dosage adjustment is required for patients with renal impairment including those patients requiring hemodialysis.
3 Pharmacokinetics, and 7 WARNINGS AND PRECAUTIONS - Renal). 4 Geriatrics). • Concomitant Diuretic Therapy: In patients receiving diuretics, valsartan therapy should be initiated with caution, since these patients may be volume-depleted and thus more likely to experience hypotension following initiation of additional anti-hypertensive therapy.
Whenever possible, all diuretics should be discontinued two to three days prior to the Auro-Valsartan Product Monograph Page 6 of 44 administration of valsartan to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS - Hypotension, and 9 DRUG INTERACTIONS - Diuretics).
If this is not possible because of the patient’s condition, valsartan should be administered with caution and the blood pressure monitored closely. Thereafter, the dosage should be adjusted according to the individual response of the patient.
2 Recommended Dose and Dosage Adjustment • Hypertension Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation, salt restriction, and other pertinent clinical factors (see 7 WARNINGS AND PRECAUTIONS- Hypotension).
The dosage of antihypertensive agents used with valsartan may need to be adjusted. The recommended initial dose of Auro-Valsartan is 80 mg once daily. The antihypertensive effect is present within 2 weeks and maximal reduction is usually attained within 4 weeks following initiation of therapy.
In patients whose blood pressure is not adequately controlled, the daily dose may be increased to a maximum of 320 mg or a thiazide diuretic added. It is not recommended to prescribe the maximum dose of 320 mg without prior up- titration.
3 Pharmacokinetics). • Following Myocardial Infarction Valsartan may be initiated as early as 12 hours after a myocardial infarction in clinically stable patients. In order to diminish the risk of hypotension, the recommended starting dose is 20 mg twice daily.
Post-Market Findings). Patients with a known hypersensitivity (anaphylaxis) or angioedema to ARBs should not be treated with Auro-Valsartan (see 8 ADVERSE REACTIONS, Post-Market Findings). Auro-Valsartan Product Monograph Page 9 of 44 Cardiovascular Hypotension Occasionally, symptomatic hypotension has occurred after administration of valsartan, 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 blood pressure, therapy should be started under close medical supervision.
Similar considerations apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in myocardial infarction or cerebrovascular accident. Caution should be exercised when initiating therapy after acute myocardial infarction.
Patients with heart failure or those in the early post-myocardial infarction period that are given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy is usually not necessary if patients are well screened prior to instituting treatment and found to be clinically stable.
If symptomatic hypotension does occur, consideration should be given to dosage reduction (see 4 DOSAGE AND ADMINISTRATION - Following Myocardial Infarction). In patients treated following myocardial infarction, the recommended regimen of valsartan has been observed to result in a greater incidence of hypotension as a serious adverse event than the conventional dosage regimen of captopril in this indication (see 8 ADVERSE REACTIONS - Following Myocardial Infarction).
In patients with heart failure, a greater incidence of hypotension has been reported. Monitoring and dose adjustment should be considered. Valvular Stenosis There is concern on theoretical grounds that patients with aortic stenosis might be at a particular risk of decreased coronary perfusion, because they do not develop as much afterload reduction.
1 Serious Drug Interactions 11/2023 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 (< 18 years of age) ...........................................................................................
2 Geriatrics (> 65 years of age) ........................................................................................... 4 2 CONTRAINDICATIONS .........................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................... 5 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations .....................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................. 5 Missed Dose .....................................................................................................................
7 5 OVERDOSAGE...................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................................... 7 7 WARNINGS AND PRECAUTIONS ..........................................................................................
• Auro-Valsartan is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). 2 Breast-feeding).
4 Drug-Drug Interactions, Dual Blockade of the Renin-Angiotensin-System (RAS) with ARBs, ACEIs, or aliskiren).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Thereafter, patients may be up titrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to dosage reduction.
Valsartan should be given with other standard post- myocardial infarction treatment, including thrombolytics, aspirin and statins, as indicated. Concomitant use of beta-blockers is to be encouraged with valsartan in this clinical setting, if indicated, since further substantial relative risk reduction may be expected with such use over that of valsartan alone.
• Heart Failure The recommended starting dose of Auro-Valsartan is 40 mg twice daily. Titration every two weeks to 80 mg and 160 mg twice daily should be done to the highest dose tolerated by the patient. Consideration should be given to reduce the dose of concomitant diuretics.
The maximum recommended dose is 160 mg twice daily. 5 Missed Dose Patients should try to take their dose at the same time each day, preferably in the morning. However, if they have forgotten to take the dose during the day, they should carry on with the next dose at the usual time.
They should not double doses.
73m2). Therefore, the use of Auro-Valsartan in combination with aliskiren-containing drugs is contraindicated in these patients. Co- administration of ARBs, including Auro-Valsartan, with other agents blocking the RAS such as ACEIs or aliskiren-containing drugs is not recommended in any patient, as adverse outcomes cannot be excluded.
Driving and Operating Machinery Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Auro-Valsartan Product Monograph Page 10 of 44 Hepatic/Biliary/Pancreatic On average, patients with mild to moderate chronic liver disease have twice the exposure to valsartan of healthy volunteers as measured by AUC and Cmax.
3 Pharmacokinetics). Renal As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function have been seen in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, 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. Following myocardial infarction, major renal dysfunction was observed to occur more frequently with valsartan than with captopril monotherapy (see 8 ADVERSE REACTIONS - Following Myocardial Infarction).
The role of modestly lower blood pressure that may occur with valsartan compared to captopril monotherapy is not known. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data). Patients exposed to potassium-sparing diuretics and/or potassium supplements were more likely to develop hyperkalemia.
Accordingly, their use should be carefully monitored or avoided (see
1 Special Populations ........................................................................................................ 1 Pregnant Women ........................................................................................................
2 Breast-feeding............................................................................................................. 3 Pediatrics (< 18 years of age) ......................................................................................
4 Geriatrics (> 65 years of age) ...................................................................................... 12 8 ADVERSE REACTIONS ........................................................................................................
2 Clinical Trial Adverse Reactions...................................................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .....................................................................................................................................
14 Auro-Valsartan Product Monograph Page 3 of 44 9 DRUG INTERACTIONS ........................................................................................................ 1 Serious Drug Interactions ...............................................................................................
4 Drug-Drug Interactions .................................................................................................. 5 Drug-Food Interactions ..................................................................................................
19 10 CLINICAL PHARMACOLOGY ............................................................................................. 1 Mechanism of Action ...................................................................................................
2 Pharmacodynamics ...................................................................................................... 3 Pharmacokinetics .........................................................................................................
20 11 STORAGE, STABILITY AND DISPOSAL ............................................................................... 21 12 SPECIAL HANDLING INSTRUCTIONS .................................................................................
22 PART II: SCIENTIFIC INFORMATION ...................................................................................... 23 13 PHARMACEUTICAL INFORMATION ......................................................................................
23 14 CLINICAL TRIALS ................................................................................................................... 1 Clinical Trials by Indication ...........................................................................................
2 Comparative Bioavailability Studies ............................................................................. 30 15 MICROBIOLOGY ...................................................................................................................
31 16 NON-CLINICAL TOXICOLOGY ................................................................................................ 31 17 SUPPORTING PRODUCT MONOGRAPHS .............................................................................
36 PATIENT MEDICATION INFORMATION ................................................................................. 37 Auro-Valsartan Product Monograph Page 4 of 44 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Auro-Valsartan (valsartan tablets) is indicated for: • Hypertension o For the treatment of mild to moderate essential hypertension.
o Auro-Valsartan may be administered alone, or concomitantly with thiazide diuretics. o The safety and efficacy of concurrent treatment with valsartan and angiotensin […]