Loading…
JAMP-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: JAMP-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…
Verbatim from this product's HC label. Tap a section to expand.
). Many of the patients who have developed rhabdomyolysis on therapy with simvastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients merit closer monitoring.
24% for Chinese patients (n=5468). While the only Asian population assessed in this clinical trial was Chinese, caution should be used when prescribing simvastatin to Asian patients and the lowest dose necessary should be employed. 4 Drug-Drug Interactions).
The risk of myopathy/rhabdomyolysis is increased by concomitant use of simvastatin with the following drugs: Contraindicated Drugs Potent inhibitors of CYP3A4: for example, the antifungal azoles (itraconazole, ketoconazole, posaconazole and voriconazole), the antibiotics (erythromycin, clarithromycin and telithromycin), the HIV protease inhibitors, HCV protease inhibitors (boceprevir, telaprevir), the antidepressant nefazodone (not marketed in Canada), or drugs containing cobicistat.
4 Drug- Drug interactions and Pharmacokinetics). 4 Drug-Drug interactions and Pharmacokinetics). 4 Drug-Drug interactions).
Daptomycin:
Both daptomycin and HMG-CoA reductase inhibitors are independently associated with skeletal muscle effects. Reports of myopathy and/or rhabdomyolysis have been observed with simvastatin coadministered with daptomycin. Ophthalmologic Current long-term data from clinical studies do not indicate an adverse effect of simvastatin on the human lens.
Renal Simvastatin Tablets do not undergo significant renal excretion, modification of dosage should not be necessary in patients with moderate renal insufficiency (see Musculoskeletal). Higher dosages required for some patients with severe hypercholesterolemia are associated with increased plasma levels of simvastatin.
Reproductive Health:
Female and Male Potential Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). JAMP-Simvastatin should be administered to women of childbearing age only when such patients are highly unlikely to JAMP-Simvastatin (Simvastatin Tablets) Page 15 of 62 conceive and have been informed of the possible harm.
, Musculoskeletal 11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 5 4. 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 5 Missed Dose ...........................................................................................................
8 5. 8 6. 8 7. 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 ........................................................................... 3 Clinical Trial Adverse Reactions – Pediatrics ........................................................
JAMP-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). 4. 1 Dosing Considerations Patients should be placed on a standard cholesterol-lowering diet before receiving JAMP- Simvastatin and should continue this diet during treatment with JAMP-Simvastatin.
If appropriate, a program of weight control and physical exercise should be implemented. Prior to initiating therapy with JAMP-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 JAMP-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 JAMP-Simvastatin is discouraged (see Musculoskeletal). Therefore, 80 mg/day of JAMP-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 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 JAMP-Simvastatin should be switched to alternative LDL-C-lowering treatments with lower risks of muscle toxicity.
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.
1 Pregnant Women. • Fertility See Reproductive and Developmental Toxicology. Skin In few instances eosinophilia and skin eruptions appear to be associated with simvastatin treatment. 1 Pregnant Women JAMP-Simvastatin is contraindicated during pregnancy (see Reproductive and Developmental Toxicology).
Safety in pregnant women has not been established. No controlled clinical trials with simvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received.
However, in an analysis of approximately 200 prospectively followed pregnancies exposed during the first trimester to Simvastatin Tablets or another closely related HMG-CoA reductase inhibitor, the incidence of congenital anomalies was comparable to that seen in the general population.
5-fold or greater increase in congenital anomalies over the background incidence. Although there is no evidence that the incidence of congenital anomalies in offspring of patients taking Simvastatin Tablets or another closely related HMG-CoA reductase inhibitor differs from that observed in the general population, maternal treatment with JAMP-Simvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis.
Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering drugs during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolemia. For these reasons, JAMP-Simvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.
Treatment with JAMP- Simvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant (see 2 CONTRAINDICATIONS). 2 Breast-feeding It is not known whether simvastatin or its metabolites are excreted in human milk.
Because many drugs are excreted in human milk and because of the potential for serious adverse JAMP-Simvastatin (Simvastatin Tablets) Page 16 of 62 reactions, women taking JAMP-Simvastatin should not nurse (see 2 CONTRAINDICATIONS).
3 Pediatrics Safety and effectiveness of simvastatin in patients 10-<18 years of age with heterozygous familial hypercholesterolemia have been evaluated in a controlled clinical trial in adolescent boys and in […]
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................... 5 Post-Market Adverse Reactions ..........................................................................
18 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 ............................................................................................... 30 11. STORAGE, STABILITY AND DISPOSAL ......................................................................... 32 12.
SPECIAL HANDLING INSTRUCTIONS .......................................................................... 32 PART II: SCIENTIFIC INFORMATION ...................................................................................... 33 13 PHARMACEUTICAL INFORMATION ............................................................................
33 14 CLINICAL TRIALS ........................................................................................................ 1 Clinical Trials by Indication .................................................................................
2 Comparative Bioavailability Studies ................................................................. 48 15 MICROBIOLOGY......................................................................................................... 49 16 NON-CLINICAL TOXICOLOGY ......................................................................................
49 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 54 PATIENT MEDICATION INFORMATION ................................................................................. 55 JAMP-Simvastatin (Simvastatin Tablets) Page 4 of 62 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS JAMP-Simvastatin (Simvastatin Tablets) is indicated in adults as an adjunct to diet for: • […]
JAMP-Simvastatin (Simvastatin Tablets) Page 6 of 62 - Patients currently tolerating 80 mg/day of JAMP-Simvastatin who need an interacting drug that is either contraindicated or associated with an increase of plasma level of Simvastatin Tablets 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.
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 -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 JAMP-Simvastatin.
Adjustments of dosage, if required, should be made as specified above. • Homozygous familial hypercholesterolemia (HoFH) In HoFH patients taking lomitapide concomitantly with JAMP-Simvastatin, the dose of JAMP- Simvastatin should not exceed 20 mg/day.
4 Drug- Drug Interactions). • Dosage in Pediatric Patients (10- <18 years of age) with Heterozygous Familial Hypercholesterolemia The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10–40 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). • Geriatric (> 65 years of age) No dosage adjustment is necessary for the elderly. 4 Geriatric and 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 JAMP-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).
JAMP-Simvastatin should be started at 5 mg/day of simvastatin and be closely monitored. Dosages above 10 mg/day should be […]