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APO-PERINDOPRIL-INDAPAMIDE 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: APO-PERINDOPRIL-INDAPAMIDE 2 mg / 0.625 mg (perindopril erbumine / indapamide) is indicated for the initial treatment of mild to moderate essential hypertension. APO-PERINDOPRIL-INDAPAMIDE 4 mg / 1.25 mg and 8 mg / 2.5 mg (perindopril erbumine / indapamide) are indicated in the treatment of mild to moderate essential…
Verbatim from this product's HC label. Tap a section to expand.
). The safety and efficacy of perindopril erbumine / indapamide 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 perindopril erbumine / indapamide 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 perindopril erbumine / indapamide 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).
APO-PERINDOPRIL-INDAPAMIDE is contraindicated in:
APO-PERINDOPRIL-INDAPAMIDE (Perindopril Erbumine and Indapamide Tablets) Page 5 of 79 • 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 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
05/2023 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 ....................................................................................................
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 ..................................................................................................................
7 5 OVERDOSAGE ................................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................... 7 7 WARNINGS AND PRECAUTIONS .....................................................................................
05/2023 7 WARNINGS AND PRECAUTIONS 05/2023 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 ....................................................................................................
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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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1 Special Populations ..................................................................................................... 1 Pregnant Women ........................................................................................................
3 Pediatrics (<18 years of age) ....................................................................................... 4 Geriatrics (>65 years of age) .......................................................................................
5 Diabetic patients ......................................................................................................... 6 Patients with impaired liver function ..........................................................................
20 8 ADVERSE REACTIONS ................................................................................................... 1 Adverse Reaction Overview ........................................................................................
2 Clinical Trial Adverse Reactions ................................................................................... 3 Less Common Clinical Trial Adverse Reactions ........................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...........................................................................................................................
5 Post-Market Adverse Reactions .................................................................................. 26 9 DRUG INTERACTIONS ...................................................................................................
2 Drug Interactions Overview ........................................................................................ 3 Drug- Behavioural Interactions ...................................................................................
4 Drug-Drug Interactions ................................................................................................ 5 Drug-Food Interactions ...............................................................................................
6 Drug-Herb Interactions................................................................................................ 7 Drug-Laboratory Test Interactions ..............................................................................
39 10 CLINICAL PHARMACOLOGY .......................................................................................... 1 Mechanism of Action ..................................................................................................
2 Pharmacodynamics ..................................................................................................... 3 Pharmacokinetics ........................................................................................................
41 11 STORAGE, STABILITY AND DISPOSAL ............................................................................ 44 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 44 PART II: SCIENTIFIC INFORMATION .....................................................................................
45 13 PHARMACEUTICAL INFORMATION ............................................................................... 45 14 CLINICAL TRIALS ...........................................................................................................
1 Clinical Trials by Indication .......................................................................................... 2 Comparative Bioavailability Studies ............................................................................
53 15 MICROBIOLOGY […]