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COVERSYL PLUS is a brand name for Indapamide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: COVERSYL® PLUS LD (perindopril erbumine / indapamide) is indicated for the initial treatment of mild to moderate essential hypertension. COVERSYL® PLUS and COVERSYL® PLUS HD (perindopril erbumine / indapamide) are indicated in the treatment of mild to moderate essential hypertension in patients for whom combination…
Verbatim from this product's HC label. Tap a section to expand.
). The safety and efficacy of COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD in renovascular hypertension and in congestive heart failure have not been established and therefore, their use in this condition is not recommended.
1 Pediatrics (<18 years of age) The safety and effectiveness of COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD in children have not been established. Its use in this age group, therefore, is not recommended. 2 Geriatrics (> 65 years of age) Although the blood pressure response and safety profile of COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD in patients >65 years old were comparable to those of the younger adult patients, greater sensitivity of some elderly patients cannot be ruled out.
73m2). COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD (perindopril erbumine / indapamide) are contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see the
). Treatment of progressive angioedema should be aggressive. Failing a rapid response to medical therapy, mechanical methods to secure an airway should be undertaken before massive oedema complicates oral or nasal intubation. Patients who respond to medical treatment should be observed carefully for a possible rebound phenomenon.
The onset of angioedema associated with the use of ACE inhibitors may be delayed for COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD (perindopril erbumine / indapamide) Product Monograph Page 9 of 65 weeks or months. Patients may have multiple episodes of angioedema with long symptom-free intervals.
Angioedema may occur with or without urticaria. The incidence of angioedema during ACE inhibitor therapy has been reported to be higher in black than in non-black patients. There are reports that switching a patient to another ACE inhibitor could be followed by a recurrence of angioedema.
Because of the potential severity of this rare event, another ACE inhibitor should not be used in patients with a history of angioedema (see 2 CONTRAINDICATIONS). Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see 2 CONTRAINDICATIONS).
g. g. g. swelling of the airways or tongue, with or without respiratory impairment). Caution should be used when initiating ACE inhibitor therapy in patients already taking a mTOR, DPP-IV or NEP inhibitor or vice versa (see
, General). Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women). Nursing women (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Breast-feeding).
73m2). Patients with hypokalemia. Patients with severe hepatic impairment. Patients with hepatic encephalopathy. Combination with anti-arrhythmic agents causing torsade de pointes (see 9 DRUG INTERACTIONS – Drug-Drug Interactions).
Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the total lactase deficiency as COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD contain lactose (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance).
Combination with sacubitril/valsartan due to an increased risk of angioedema. 73m2) (see 7 WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) and Renal, and 9 DRUG INTERACTIONS, Drug-Drug Interactions, Dual Blockade of the Renin-Angiotensin-System (RAS) with ACE inhibitors, ARBs or aliskiren-containing drugs).
Patients with extracorporeal treatments leading to contact of blood with negatively charged surfaces (see 9 DRUG INTERACTIONS), Patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney (see 7 WARNINGS AND PRECAUTIONS, Renal).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions When used in pregnancy, angiotensin converting enzyme (ACE) inhibitors can cause injury or even death of the developing fetus. When pregnancy is detected, COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD should be discontinued as soon as possible.
1 Dosing Considerations Dosage of COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD (perindopril erbumine / indapamide) must be individualized and adjustment is required in the elderly, and in case of renal impairment. COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD (perindopril erbumine / indapamide) Product Monograph Page 6 of 65 COVERSYL® PLUS / COVERSYL® PLUS HD are not for initial therapy and the dose should be determined by titration of the individual components.
10/2022 7 WARNING AND PRECAUTIONS 10/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES................................................ Error!
Bookmark not defined. 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 ................................................................................................. 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Indapamide in Canada.
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2 Recommended Dose and Dosage Adjustment Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation and salt restriction. The dosage of other antihypertensive agents being used with COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD may need to be adjusted.
The presence of food in the gastrointestinal tract reduces the bioavailability of perindoprilat. Pediatrics (<18 years) Health Canada has not authorized an indication for pediatric use. 4 Administration COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD should be taken once daily, preferably in the morning before a meal (see 9 DRUG INTERACTIONS – Drug-Food Interactions).
COVERSYL® PLUS LD: 1 tablet per day as a single dose. In case of uncontrolled blood pressure, the dose may be increased to 2 tablets of COVERSYL® PLUS LD as a single dose or 1 tablet of COVERSYL® PLUS.
COVERSYL® PLUS or COVERSYL® PLUS HD:
Once the patient has been successfully titrated with the individual components, 1 tablet per day of COVERSYL® PLUS or COVERSYL® PLUS HD may be substituted if the titrated doses and dosing schedule can be achieved by the fixed combination (see 1 INDICATIONS and 7 WARNINGS AND PRECAUTIONS).
The elderly Treatment should be initiated after considering blood pressure response and renal function. 73m2) (see 2 CONTRAINDICATIONS). 73m2) (see 2 CONTRAINDICATIONS). Treatment with COVERSYL® PLUS LD / COVERSYL® PLUS should start with the adequate dosage of the combination of the individual components.
Caution should be exercised especially in the elderly patients as greater sensitivity in the elderly cannot be ruled out. 73m2, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium levels.
5 Missed Dose If a dose is missed, a double dose should not be taken; the patient should just carry on with the next dose at the normal time. COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD (perindopril erbumine / indapamide) Product Monograph Page 7 of 65 5 OVERDOSAGE The most likely adverse event in case of COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD overdose is hypotension with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, polyuria or oliguria which may progress to anuria.
Electrolytes and water disturbances may occur. The first measure is to rapidly eliminate ingested COVERSYL® PLUS LD / COVERSYL® PLUS / COVERSYL® PLUS HD by gastric lavage and/or administration of activated charcoal. Fluid and electrolyte balance should then be restored.
If marked hypotension is produced, place the patient in a supine position with the head lower than the rest of the body. 9% sodium chloride or use any other method of volume expansion. Perindoprilat, the active form of perindopril, can be dialysed (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics).
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – […]