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ZOCOR 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: ZOCOR® (simvastatin) 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 of 40)…
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 ZOCOR® does 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). ZOCOR® should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the possible harm.
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 ZOCOR® is contraindicated during pregnancy (see Reproductive and Developmental Toxicology).
). The 5 mg dosage is provided for information purposes only. Although simvastatin tablets 5 mg are available in the marketplace, ZOCOR® is no longer marketed in the 5 mg strength in Canada. • Hepatic Impairment ZOCOR® is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels (see 2 CONTRAINDICATIONS and Hepatic/Biliary/Pancreatic).
• Drug discontinuation If the patient becomes pregnant while taking ZOCOR®, the drug should be discontinued immediately and the patient appraised of the potential harm to the fetus. If hypersensitivity is suspected, ZOCOR® should be discontinued.
If the transaminase levels show evidence of progression, particularly if they rise to three times the ULN and are persistent, the drug should be discontinued. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of ZOCOR®; if such a condition should develop during therapy, the drug should be discontinued.
If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with ZOCOR®, promptly interrupt therapy. If an alternate etiology is not found, do not restart ZOCOR®. ZOCOR® therapy should be immediately discontinued if markedly elevated CK levels are measured or myopathy is diagnosed or suspected.
, sepsis, hypotension, major surgery, trauma, severe metabolic endocrine and electrolyte disorders, or uncontrolled seizures). 4 Drug-Drug Interactions) Therapy with simvastatin should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.
4 Administration ZOCOR® is for oral administration. ZOCOR®can be administered as a single dose in the evening with a meal. 5 Missed Dose If a tablet is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose: only the prescribed dose should be taken at the appointed time.
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 ZOCOR® and should continue this diet during treatment with ZOCOR®.
If appropriate, a program of weight control and physical exercise should be implemented. Prior to initiating therapy with ZOCOR®, 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 ZOCOR® 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 ZOCOR® is discouraged (see Musculoskeletal). Therefore, 80 mg/day of ZOCOR® 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 ZOCOR® 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.
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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 ZOCOR® (simvastatin) Page 15 of 62 during the first trimester to ZOCOR® 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 ZOCOR® or another closely related HMG-CoA reductase inhibitor differs from that observed in the general population, maternal treatment with ZOCOR® 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, ZOCOR® should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.
Treatment with ZOCOR® 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 reactions, women taking ZOCOR® 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 girls who were at least one-year post-menarche.
Patients treated with simvastatin had an adverse experience profile generally similar to that of patients treated with placebo. Doses greater […]
A double dose should not be taken. 5. 6 g. All patients recovered without sequelae. Should an overdose occur, institute symptomatic and supportive measures as required. For management of a suspected drug overdose, contact your regional poison control centre.
6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging ZOCOR®, 10 mg tablets, are peach, oval-shaped biconvex, film coated tablets, engraved MSD 735 on one side and plain on the other.
Available in blister packages of 28 tablets. ZOCOR®, 20 mg tablets, are tan, oval-shaped biconvex, film coated tablets, engraved MSD 740 on one side and plain on the other. Available in blister packages of 28 tablets. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral tablet 10 mg, 20 mg and 40 mg ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide.
ZOCOR® (simvastatin) Page 9 of 62 ZOCOR®, 40 mg tablets, are brick red, oval-shaped biconvex, film coated tablets, engraved MSD 749 on one side and plain on the other. Available in blister packages of 28 tablets. ZOCOR® 10 mg and 20 mg tablets contain yellow ferric oxide and red ferric oxide.
ZOCOR® 40 mg tablets contain red ferric oxide. 7. WARNINGS AND PRECAUTIONS General The patient should be advised to inform health professionals of the prior use of ZOCOR® or any other lipid-lowering agent. In primary prevention intervention the effects of simvastatin-induced changes in lipoprotein levels, including reduction of serum cholesterol, on cardiovascular morbidity or mortality or total mortality have not been established.
Carcinogenesis and Mutagenesis See Carcinogenicity Driving and Operating Machinery “Zocor has no or negligible influence on the ability to drive and use machines. However, dizziness has been reported in post market adverse effects for ZOCOR.
” Endocrine and Metabolism HMG-CoA reductase inhibitors interfere with cholesterol synthesis and as such might theoretically blunt adrenal and/or gonadal steroid production. Clinical studies with simvastatin and other HMG-CoA reductase inhibitors have suggested that these agents do not reduce plasma cortisol concentration or impair adrenal reserve and do not reduce basal plasma testosterone concentration.
However, the effects of HMG-CoA reductase inhibitors on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the pituitary-gonadal axis in premenopausal women are unknown. Patients treated with simvastatin who develop clinical evidence of endocrine dysfunction should be evaluated appropriately.
4 Drug-Drug Interactions). Increases in fasting glucose and HbA1c levels have been reported with inhibitors of HMG-CoA reductase as a class. For some patients, at high risk of diabetes mellitus, hyperglycemia was sufficient to shift them to the diabetes status.
The benefit of treatment continues to outweigh the small increased risk. Periodic monitoring of these patients is recommended. […]
- Patients currently tolerating 80 mg/day of ZOCOR® who need an interacting drug that is either ZOCOR® (simvastatin) Page 6 of 62 contraindicated or associated with an increase of plasma level of ZOCOR® 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 simvastatin.
The 5 mg dosage is provided for information purposes only. Although simvastatin tablets 5 mg are available in the marketplace, ZOCOR® is no longer marketed in the 5 mg strength in Canada. Adjustments of dosage, if required, should be made as specified above.
• Homozygous familial hypercholesterolemia (HoFH) In HoFH patients taking lomitapide concomitantly with ZOCOR®, the dose of ZOCOR® 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). ZOCOR® (simvastatin) Page 7 of 62 Higher dosages required for some patients with severe hypercholesterolemia are associated with increased plasma levels of simvastatin. 4 Drug-Drug Interactions). • Renal Impairment Because ZOCOR® 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). ZOCOR should be started at 5mg/day of simvastatin and be closely monitored. Dosages above 10 mg/day should be […]