Loading…
PRO-SIMVASTATIN is a brand name for Simvastatin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PRO-SIMVASTATIN (simvastatin tablets) is indicated in adults as an adjunct to diet for: Reduction of risk of total mortality, myocardial infarction and ischemic stroke in patients with high risk of coronary events (because of existing Coronary Heart Disease (CHD), occlusive arterial disease, or diabetic over the age…
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 before receiving PRO- SIMVASTATIN and should continue this diet during treatment with PRO-SIMVASTATIN. If appropriate, a program of weight control and physical exercise should be implemented.
Prior to initiating therapy with PRO-SIMVASTATIN, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed. After establishing that the elevation in plasma lipids represents a primary disorder not due to underlying conditions such as poorly controlled diabetes mellitus, hypothyroidism, the nephrotic syndrome, liver disease, or dysproteinaemias, it should ideally be determined that patients for whom treatment with SIMVASTATIN is being considered have an elevated LDL-C level as the cause for an elevated total serum cholesterol.
The usual dosage is 5 to 40 mg/day. Due to the increased risk of myopathy/rhabdomyolysis, particularly during the first year of treatment, the use of 80 mg/day of PRO-SIMVASTATIN is discouraged (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).
Therefore, 80 mg/day of SIMVASTATIN should be restricted to patients who have been taking this dosage chronically with no evidence of muscle toxicity or to patients at high risk for cardiovascular complications who do not tolerate other statins and in PRO-SIMVASTATIN (Simvastatin Tablets) Page 6 of 60 whom the benefits are expected to outweigh the potential risks.
In other patients, consider alternative treatment strategies as follows: - Patients unable to achieve their LDL-C goal with the 40-mg dose of PRO-SIMVASTATIN should be switched to alternative LDL-C-lowering treatments with lower risks of muscle toxicity.
- Patients currently tolerating 80 mg/day of PRO-SIMVASTATIN who need an interacting drug that is either contraindicated or associated with an increase of plasma level of PRO- SIMVASTATIN should be switched to an alternative statin with less potential for a drug-drug interaction.
2 Recommended Dose and Dosage Adjustment Prevention of Cardiovascular Disease in patients at high risk of coronary events, with or without hyperlipidemia, because of existing Coronary Heart Disease (CHD) or other occlusive arterial disease, or being over the age of 40 years with a diagnosis of diabetes: The recommended starting dose is 40 mg/day given as a single dose in the evening.
1 Adverse Reaction Overview Based on experience in a total of over 2300 patients, of whom more than 1200 were treated for one year and over 230 for 2 years or more, simvastatin tablets are generally well tolerated and adverse reactions are usually mild and transient.
5 Post-Market Adverse Reactions). 2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In pre-marketing controlled clinical studies, 1% of patients were withdrawn due to adverse experiences attributable to simvastatin tablets.
8 *Considered possibly, probably, or definitely drug related as assessed by the investigators. 4 years of the study.
Ophthalmologic:
See 7 WARNINGS AND PRECAUTIONS. 3 Pediatrics; 10 CLINICAL PHARMACOLOGY). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Marked persistent increases of serum transaminases (ALT, AST) have been noted.
Note that ALT may emanate from muscle, therefore ALT rising with CK may indicate myopathy (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Monitoring and Laboratory Tests and 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).
PRO-SIMVASTATIN (Simvastatin Tablets) Page 19 of 60 About 5% of patients had elevations of creatine phosphokinase (CK) levels three or more times the normal value on one or more occasions. This was attributable to the noncardiac fraction of CK.
, Musculoskeletal 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 .............................................................................................................. 5 2 CONTRAINDICATIONS ................................................................................................
5 4 DOSAGE AND ADMINISTRATION ................................................................................ 1 Dosing Considerations ......................................................................................... 2 Recommended Dose and Dosage Adjustment ....................................................
4 Administration ..................................................................................................... 5 Missed Dose .........................................................................................................
8 5 OVERDOSAGE ............................................................................................................ 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 9 7 WARNINGS AND PRECAUTIONS .................................................................................
Simvastatin is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnant and breast-feeding women. 4 Drug-Drug Interactions). 4 Drug-Drug Interactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Simvastatin 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.
Drug therapy can be initiated simultaneously with diet and exercise. Slowing progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions in hypercholesterolemic patients with coronary heart disease: The recommended dosage is 5 to 40 mg/day usually given as a single dose in the evening.
Hyperlipidemia The recommended starting dose is 10 mg/day given as a single dose in the evening. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg/day given as a single dose in the evening. Patients with mild to moderate hypercholesterolemia can be treated with a starting dose of 5 mg of PRO-SIMVASTATIN.
Adjustments of dosage, if required, should be made as specified above. Homozygous familial hypercholesterolemia (HoFH) In HoFH patients taking lomitapide concomitantly with PRO-SIMVASTATIN, the dose of PRO- SIMVASTATIN should not exceed 20 mg/day.
4 Drug-Drug Interactions). Dosage in Pediatric Patients (10 to <18 years of age) with Heterozygous Familial Hypercholesterolemia PRO-SIMVASTATIN (Simvastatin Tablets) Page 7 of 60 The recommended usual starting dose is 10 mg once a day in the evening.
The recommended dosing range is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see 10 CLINICAL PHARMACOLOGY). Geriatrics (> 65 years of age) No dosage adjustment is necessary for the elderly.
4 Geriatric and 7 WARNINGS AND PRECAUTIONS, Musculoskeletal). Higher dosages required for some patients with severe hypercholesterolemia are associated with increased plasma levels of simvastatin. 4 Drug-Drug Interactions). Renal Impairment Because PRO-SIMVASTATIN does not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal insufficiency.
4 Drug-Drug Interactions). PRO- SIMAVASTIN should be started at 5 mg/day of simvastatin and be closely monitored. Dosages above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see 7 WARNINGS AND PRECAUTIONS).
Hepatic Impairment PRO-SIMVASTATIN is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Drug discontinuation If the patient becomes pregnant while taking PRO-SIMAVASTATIN, the drug should be discontinued immediately and the patient appraised of the potential harm to the foetus. If hypersensitivity is suspected, PRO-SIMAVASTATIN should be discontinued.
If the transaminase […]
4 Drug-Drug interactions). 5 Post-Market Adverse Reactions The following additional adverse reactions were reported either in uncontrolled clinical studies or in post-marketing experience with simvastatin tablets, regardless of causality assessment.
Endocrine disorders:
Increases in fasting glucose and HbA1c levels have been reported with simvastatin tablets. Diabetes mellitus has been reported with statins, including simvastatin tablets.
Eye disorders:
Ocular myasthenia Gastrointestinal: Vomiting Hematologic: Anemia Leukopenia Purpura Hepatic/Pancreatic: Hepatitis Fatal and non-fatal hepatic failure with liver transplant outcome have been reported, regardless of the dose.
Jaundice Pancreatitis Laboratory Tests:
Elevated alkaline phosphatase and γ-glutamyl transpeptidase. Increased HbA1c and fasting serum glucose levels.
Musculoskeletal:
Rhabdomyolysis Muscle Cramps Myalgia Myasthenia gravis There have been rare reports of immune-mediated necrotizing myopathy with statins (see 7 PRO-SIMVASTATIN (Simvastatin Tablets) Page 20 of 60 WARNINGS AND PRECAUTIONS, Musculoskeletal).
Neurologic:
Dizziness Paresthesia Peripheral Neuropathy Peripheral neuropathy with muscle weakness or sensory disturbance has been reported. , memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with simvastatin use, regardless of the dose.
These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Pulmonary:
Interstitial lung disease Psychiatric: Depression Insomnia Reproductive system and breast disorders: Erectile dysfunction Sensitivity: An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: Anaphylaxis Angioedema Arthralgia Arthritis Dermatomyositis Dyspnea Eosinophilia ESR increased Fever Flushing Lupus-like Syndrome Malaise Photosensitivity Polymyalgia Rheumatica Thrombocytopenia Urticaria Vasculitis Skin: Alopecia Erythema Multiforme including Stevens-Johnson syndrome Lichen planus [Sec.
5-slu-lichen-planus] PRO-SIMVASTATIN (Simvastatin Tablets) Page 21 of 60 Pruritus Rash Others: Although the […]
1 Special Populations ............................................................................................ 1 Pregnant Women ............................................................................................... 2 Breast-feeding ....................................................................................................
3 Pediatrics............................................................................................................ 4 Geriatrics ............................................................................................................
17 8 ADVERSE REACTIONS ............................................................................................... 1 Adverse Reaction Overview ............................................................................... 2 Clinical Trial Adverse Reactions .........................................................................
3 Clinical Trial Adverse Reactions – Pediatrics...................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other 06/2025 PRO-SIMVASTATIN (Simvastatin Tablets) Page 3 of 60 Quantitative Data...............................................................................................
5 Post-Market Adverse Reactions......................................................................... 19 9 DRUG INTERACTIONS .............................................................................................. 1 Serious Drug Interactions ..................................................................................
2 Drug Interactions Overview ............................................................................... 4 Drug-Drug Interactions ...................................................................................... 5 Drug-Food Interactions ......................................................................................
7 Drug-Laboratory Test Interactions..................................................................... 29 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action .........................................................................................
2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ............................................................................................... 31 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
33 12 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 33 PART II: SCIENTIFIC INFORMATION ..................................................................................... 34 13 PHARMACEUTICAL INFORMATION ...........................................................................
34 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indication ................................................................................
2 Comparative Bioavailability Studies .................................................................. 47 15 MICROBIOLOGY ....................................................................................................... 47 16 NON-CLINICAL TOXICOLOGY ....................................................................................
48 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 52 PATIENT MEDICATION INFORMATION ................................................................................ 53 PRO-SIMVASTATIN (Simvastatin Tablets) Page 4 of 60 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PRO-SIMVASTATIN (simvastatin tablets) is indicated in adults as an adjunct to diet for: Reduction of risk of total mortality, myocardial […]