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PHARMA-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.
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).
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 co-administered with daptomycin. Ophthalmologic Current long-term data from clinical studies do not indicate an adverse effect of simvastatin on the human lens.
Renal pharma-SIMVASTATIN 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). pharma-SIMVASTATIN 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. pharma-SIMVASTATIN (Simvastatin Tablets) Page 16 of 59 Skin In few instances eosinophilia and skin eruptions appear to be associated with simvastatin treatment.
1 Pregnant Women pharma-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 or another closely related HMG-CoA reductase inhibitor, the incidence of congenital anomalies was comparable to that seen in the general population.
). • Hepatic Impairment pharma-SIMVASTATIN 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 pharma-SIMVASTATIN, the drug should be discontinued immediately and the patient appraised of the potential harm to the fetus. If hypersensitivity is suspected, pharma-SIMVASTATIN 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 pharma-SIMVASTATIN; 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 pharma-SIMVASTATIN, promptly interrupt therapy. If an alternate etiology is not found, do not restart pharma-SIMVASTATIN.
pharma-SIMVASTATIN 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 pharma-SIMVASTATIN is for oral administration.
pharma-SIMVASTATIN 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.
pharma-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 pharma- SIMVASTATIN and should continue this diet during treatment with pharma-SIMVASTATIN.
If appropriate, a program of weight control and physical exercise should be implemented. Prior to initiating therapy with pharma-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 pharma-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 pharma-SIMVASTATIN is discouraged (see Musculoskeletal). Therefore, 80 mg/day of pharma-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 pharma-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.
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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 or another closely related HMG-CoA reductase inhibitor differs from that observed in the general population, maternal treatment with pharma-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, pharma-SIMVASTATIN should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.
Treatment with pharma-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 reactions, women taking pharma-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 pharma-SIMVASTATIN (Simvastatin Tablets) Page 17 of 59 boys and […]
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.
pharma-SIMVASTATIN (Simvastatin Tablets) Page 9 of 59 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet/ 5 mg, 10 mg, 20 mg, 40 mg and 80 mg Ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, talc, and titanium dioxide.
Tablets 5 mg, 10 mg, 20 mg, 40mg and 80mg contain yellow ferric oxide. Tablets 10 mg, 20 mg, 40 mg and 80 mg also contain red ferric oxide. pharma-SIMVASTATIN tablets, 5 mg is buff colored, shield shaped, biconvex, film coated tablets, engraved with ‘5’ on one face and engraved with ‘S’ on the other.
Dispensed in Blisters of 30’s (3x10’s) and HDPE bottles of 100’s. pharma-SIMVASTATIN, 10 mg is peach colored, shield shaped, biconvex, film coated tablets, engraved with ‘10’ on one face and engraved with ‘S’ on the other. Dispensed in HDPE bottles of 100’s and 500’s.
pharma-SIMVASTATIN, 20 mg is tan colored, shield shaped, biconvex, film coated tablets, engraved with ‘20’ on one face and engraved with ‘S’ on the other. Dispensed in HDPE bottles of 100’s and 500’s. pharma-SIMVASTATIN, 40 mg is brick red colored, shield shaped, biconvex, film coated tablets, engraved with ‘40’ on one face and engraved with ‘S’ on the other.
Dispensed in HDPE bottles of 100’s. pharma-SIMVASTATIN, 80 mg is brick red colored, caplet shaped, deep biconvex, film coated tablets, engraved with ‘80’ on one face and engraved with ‘S’ on the other. Dispensed in Blisters of 30’s (3x10’s) and HDPE bottles of 100’s.
pharma-SIMVASTATIN (Simvastatin Tablets) Page 10 of 59 7. WARNINGS AND PRECAUTIONS General The patient should be advised to inform health professionals of the prior use of pharma- SIMVASTATIN 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 pharma-SIMVASTATIN has no or negligible influence on the ability to drive and use machines. However, dizziness has been reported in post market adverse effects for Simvastatin.
Patients should avoid driving or using machines if feeling dizzy. 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.
Caution should be […]
pharma-SIMVASTATIN (Simvastatin Tablets) Page 6 of 59 - Patients currently tolerating 80 mg/day of pharma-SIMVASTATIN who need an interacting drug that is either contraindicated or associated with an increase of plasma level of pharma-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.
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.
• Homozygous familial hypercholesterolemia (HoFH) In HoFH patients taking lomitapide concomitantly with pharma-SIMVASTATIN, the dose of pharma-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) pharma-SIMVASTATIN (Simvastatin Tablets) Page 7 of 59 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 pharma-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). pharma- SIMVASTATIN should be started at 5mg/day of simvastatin and be closely monitored. Dosages above 10 mg/day should be carefully considered and, if deemed necessary, […]