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AG-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: AG-Rosuvastatin (rosuvastatin calcium) is indicated in adults as an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of elevated total cholesterol (Total-C), LDL-C, ApoB, the Total-C/HDL-C ratio and triglycerides (TG) and for increasing HDL- C; in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients should be placed on a standard cholesterol-lowering diet (at least equivalent to the Adult Treatment Panel III (ATP III TLC diet)) before receiving AG-Rosuvastatin (rosuvastatin calcium) and should continue on this diet during treatment with AG- Rosuvastatin.
If appropriate, a program of weight control and physical exercise should be implemented. Prior to initiating therapy with AG-Rosuvastatin, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed.
2 Recommended Dose and Dosage Adjustment Hypercholesterolemia The dose range of AG-Rosuvastatin in adults is 5 to 40 mg orally once a day. The recommended starting dose of AG-Rosuvastatin in most adult patients is 10 mg orally once daily.
The majority of adult patients are controlled at the 10 mg dose. If necessary, dose adjustment can be made at 2-4 week intervals. The maximum response is usually achieved within 2-4 weeks and is maintained during chronic therapy. Initiation of therapy with AG-Rosuvastatin 5 mg once daily may be considered for adult patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy (see Musculoskeletal).
Adult patients who are switched to AG-Rosuvastatin from treatment with another HMG- CoA reductase inhibitor should be started on 10 mg even if they were on a high dose of the previous HMG-CoA reductase inhibitor. A switch dose of 20 mg may be considered for patients with severe hypercholesterolemia.
For adult patients with severe hypercholesterolemia (including those with familial hypercholesterolemia), a 20 mg start dose may be considered. These patients should be carefully followed. A dose of 40 mg once daily should only be used in adult patients with severe hypercholesterolemia who do not achieve the desired effect on 20 mg and have no predisposing factors for myopathy/rhabdomyolysis (see 2 CONTRAINDICATIONS).
Consultation with a specialist is recommended when initiating AG-Rosuvastatin 40 mg AG-Rosuvastatin (Rosuvastatin Calcium Tablets) Page 6 of 50 dose. The dosage of AG-Rosuvastatin should be individualized according to baseline LDL-C, total C/HDL-C ratio and/or TG levels to achieve the recommended desired lipid values at the lowest possible dose.
Prevention of Major Cardiovascular Events A dose of 20 mg once daily has been found to reduce the risk of major cardiovascular events (see 14 CLINICAL TRIALS).
).
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.
AG-Rosuvastatin (Rosuvastatin Calcium Tablets) Page 10 of 50 Genetic Polymorphism:
In patients with SLCO1B1 (OATP1B1) and/or ABCG2 (BCRP) genetic polymorphisms there is a risk of increased rosuvastatin exposure (see
2 Breast-feeding 10/2024 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 .....................................................................................................................
2 Geriatrics ...................................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................
4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration .............................................................................................................. 5 Missed Dose ................................................................................................................
7 5 OVERDOSAGE ..................................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 8 7 WARNINGS AND PRECAUTIONS .......................................................................................
2 Breast-feeding 10/2024 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 .....................................................................................................................
2 Geriatrics ...................................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................
4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration .............................................................................................................. 5 Missed Dose ................................................................................................................
7 5 OVERDOSAGE ..................................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 8 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.
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Dosing Considerations in Special Populations • Patients with Hepatic Impairment:
The usual dose range applies in patients with mild to moderate hepatic impairment. Increased systemic exposure has been observed in patients with severe hepatic impairment and, therefore, in these patients the dose of AG-Rosuvastatin should not exceed 20 mg once daily (see 2 CONTRAINDICATIONS and Hepatic/Biliary/Pancreatic).
• Patients with Renal Impairment: The usual dose range applies in patients with mild to moderate renal impairment. Increased systemic exposure to rosuvastatin has been observed in patients with severe renal impairment. 73 m2) the starting dose of AG-Rosuvastatin should be 5 mg and not exceed 10 mg once daily (see 2 CONTRAINDICATIONS and Renal).
• Ethnic Origin: The initial dose of AG-Rosuvastatin, in Asian patients, should be 5 mg once daily. The potential for increases in systemic exposure must be considered when making treatment decisions. 1 Special Populations, Ethnic Origin).
• Pediatrics (10 – <18 years of age): In pediatric patients with heterozygous familial hypercholesterolemia the recommended starting dose of AG-Rosuvastatin is 5 mg taken orally once daily. The AG-Rosuvastatin dose should be individualized according to baseline LDL-C levels and the recommended goal of therapy.
The maximum daily dose in this patient population is 10 mg. The safety and efficacy of rosuvastatin calcium doses greater than 20 mg have not been studied in this population. Treatment experience with rosuvastatin calcium in pediatric patients (aged 8 years and above) with homozygous familial hypercholesterolemia is limited to 8 patients.
3 Pediatrics). 4 Geriatrics). 421CC. 421AA genotype, a maximum once daily dose of 20 mg of AG-Rosuvastatin is recommended (see 7 WARNINGS AND PRECAUTIONS, 9 DRUG INTERACTIONS, and Special Populations and Conditions). g. OATP1B1 and BCRP).
The risk of myopathy (including rhabdomyolysis) is increased when AG-Rosuvastatin is administered concomitantly with certain medicines that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (see Table 4).
Whenever possible, alternative medications should be considered, and if necessary, consider temporarily discontinuing AG-Rosuvastatin therapy. In situations where coadministration of these medicines with AG-Rosuvastatin is unavoidable, the benefit and the risk of concurrent treatment and AG-Rosuvastatin dosing adjustments should be carefully considered (see 7 WARNINGS AND PRECAUTIONS and Special Populations and Conditions).
• Drug discontinuation AG-Rosuvastatin should be discontinued as soon as pregnancy is recognized. However, the ongoing therapeutic need and the benefit risk in individual patients with very high risk of cardiovascular […]
1 Special Populations ....................................................................................................... 1 Pregnant Women .......................................................................................................
2 Breast-feeding ............................................................................................................ 3 Pediatrics ...................................................................................................................
4 Geriatrics .................................................................................................................... 13 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 ................................................................................. 19 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 ............................................................................. 29 10 CLINICAL PHARMACOLOGY ............................................................................................
1 Mechanism of Action .................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 30 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
31 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 31 PART II: SCIENTIFIC INFORMATION ...........................................................................................
32 13 PHARMACEUTICAL INFORMATION ................................................................................. 32 14 CLINICAL TRIALS ..............................................................................................................
1 Clinical Trial by Indication […]
1 Special Populations ....................................................................................................... 1 Pregnant Women .......................................................................................................
2 Breast-feeding ............................................................................................................ 3 Pediatrics ...................................................................................................................
4 Geriatrics .................................................................................................................... 13 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 ................................................................................. 19 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 ............................................................................. 29 10 CLINICAL PHARMACOLOGY ............................................................................................
1 Mechanism of Action .................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 30 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
31 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 31 PART II: SCIENTIFIC INFORMATION ...........................................................................................
32 13 PHARMACEUTICAL INFORMATION ................................................................................. 32 14 CLINICAL TRIALS […]