Loading…
APO-ROSUVASTATIN is a brand name for Rosuvastatin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 05/2023
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 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 ...........................................................................
5 1 INDICATIONS ......................................................................................................................... 1 Pediatrics ......................................................................................................................
2 Geriatrics ...................................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................
6 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration ............................................................................................................. 5 Missed Dose .................................................................................................................
9 5 OVERDOSAGE ............................................................................................................... 9
).
Lipoprotein(a):
In some patients, the beneficial effect of lowered total cholesterol and LDL-C levels may be partly blunted by a concomitant increase in the Lipoprotein(a) [Lp(a)] concentrations. Present knowledge suggests the importance of high Lp(a) levels as an emerging risk factor for coronary heart disease.
It is thus desirable to maintain and reinforce lifestyle changes in high risk patients placed on rosuvastatin therapy.
Genetic Polymorphism:
In patients with SLCO1B1 (OATP1B1) and/or ABCG2 (BCRP) genetic polymorphisms there is a risk of increased rosuvastatin exposure (see
3 Pediatrics 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 ...........................................................................
5 1 INDICATIONS ......................................................................................................................... 1 Pediatrics ......................................................................................................................
2 Geriatrics ...................................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................
6 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration ............................................................................................................. 5 Missed Dose .................................................................................................................
9 5 OVERDOSAGE ............................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 9 7 WARNINGS AND PRECAUTIONS ..................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rosuvastatin in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
1 Special Populations .................................................................................................... 1 Pregnant Women .......................................................................................................
2 Breast-feeding ............................................................................................................ 3 Pediatrics ....................................................................................................................
4 Geriatrics .................................................................................................................... 16 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview ....................................................................................... 2 Clinical Trial Adverse Reactions .................................................................................
1 Clinical Trial Adverse Reactions – Pediatrics .............................................................. 3 Less Common Clinical Trial Adverse Reactions (< 1%) ............................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .......................................................................................................
5 Post-Market Adverse Reactions ................................................................................. 22 9 DRUG INTERACTIONS ..................................................................................................
1 Serious 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 ............................................................................. 34 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action .................................................................................................
2 Pharmacodynamics .................................................................................................... 3 Pharmacokinetics .......................................................................................................
35 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 37 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 37 PART II: SCIENTIFIC INFORMATION ......................................................................................
38 13 PHARMACEUTICAL INFORMATION .............................................................................. 38 14 CLINICAL TRIALS..........................................................................................................
1 Clinical Trial by Indication […]