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SIMVASTATIN is a brand name for Simvastatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate Treatment of homozygous familial hypercholesterolaemia as an adjunct to diet and other…
Verbatim from this product's MHRA label. Tap a section to expand.
The dosage range is 5-80mg/day given orally as a single dose in the evening. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80mg/day given as a single dose in the evening. 1)..
Hypercholesterolaemia The patient should be placed on a standard cholesterol-lowering diet, and should continue on this diet during treatment with simvastatin. The usual starting dose is 10-20mg/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 20-40mg/day given as a single dose in the evening. Adjustments of dosage, if required, should be made as specified above. Homozygous familial hypercholesterolaemia Based on the results of a controlled clinical study, the recommended starting dosage is simvastatin 40mg/day in the evening.
, LDL apheresis) in these patients or if such treatments are unavailable. Cardiovascular prevention The usual dose of simvastatin is 20 to 40mg/day given as a single dose in the evening in patients at high risk of coronary heart disease (CHD, with or without hyperlipidaemia).
Drug therapy can be initiated simultaneously with diet and exercise. Adjustments of dosage, if required, should be made as specified above. Concomitant therapy Simvastatin is effective alone or in combination with bile acid sequestrants.
Dosing should occur either > 2 hours before or > 4 hours after administration of a bile acid sequestrant. 3) or fenofibrate, the dose of simvastatin should not exceed 10mg/day. In patients taking amiodarone, amlodipine, verapamil, or diltiazem concomitantly with simvastatin, the dose of simvastatin should not exceed 20mg/day.
) Dosage in renal insufficiency No modification of dosage should be necessary in patients with moderate renal insufficiency. In patients with severe renal insufficiency (creatinine clearance < 30ml/min), dosages above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.
Use in the elderly No dosage adjustment is necessary. Use in children and adolescents (10-17 years of age) For children and adolescents (boys Tanner Stage II and above and girls who are at least one year post-menarche, 10-17 years of age) with heterozygous familial hypercholesterolaemia, the recommended usual starting dose is 10mg once a day in the evening.
1). For HPS, only serious adverse events were recorded as well as myalgia, increases in serum transaminases and CK. For 4S, all the adverse events listed below were recorded. If the incidence rates on simvastatin were less than or similar to that of placebo in these trials, and there were similar reasonably causally related spontaneous report events, these adverse events are categorized as “rare”.
1) involving 20,536 patients treated with 40mg/day of simvastatin (n = 10,269) or placebo (n = 10,267), the safety profiles were comparable between patients treated with simvastatin 40mg and patients treated with placebo over the mean 5 years of the study.
1 % in patients treated with placebo). 1 % in patients treated with simvastatin 40mg. 09 % (n = 9) of patients treated with placebo.
The frequencies of adverse events are ranked according to the following:
Very common (> 1/10), Common (> 1/100, < 1/10), Uncommon (≥ 1/1000, < 1/100), Rare (> 1/10,000, < 1/1000), Very Rare (< 1/10,000), not known (cannot be estimated from the available data). 5).
Reproductive system and breast disorders:
Not known: erectile dysfunction General disorders and administration site conditions: Rare: asthenia An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, ESR increased, arthritis and arthralgia, urticaria, photosensitivity, fever, flushing, dyspnoea and malaise.
4). Increases in HbA1c and fasting serum glucose levels have been reported with statins, including simvastatin. , memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use, including simvastatin. 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).
Myopathy/Rhabdomyolysis Simvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN).
Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and very rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma.
As with other HMG-CoA reductase inhibitors, the risk of myopathy/rhabdomyolysis is dose related. 61% at 20, 40 and 80mg/day, respectively. In these trials, patients were carefully monitored and some interacting medicinal products were excluded.
02% for patients on 20mg/day. Approximately half of these myopathy cases occurred during the first year of treatment. 1%. ) The risk of myopathy is greater in patients on simvastatin 80 mg compared with other statin-based therapies with similar LDL-C-lowering efficacy.
Therefore, the 80-mg dose of simvastatin should only be used in patients with severe hypercholesterolemia and at high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks.
5). Creatine Kinase measurement Creatine Kinase (CK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CK increase as this makes value interpretation difficult. If CK levels are significantly elevated at baseline (> 5 x ULN), levels should be re-measured within 5 to 7 days later to confirm the results.
Before the treatment All patients starting therapy with simvastatin, or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness.
g. g. 5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Children and adolescents should be placed on a standard cholesterol-lowering diet before simvastatin treatment initiation; this diet should be continued during simvastatin treatment. The recommended dosing range is 10-40mg/day; the maximum recommended dose is 40mg/day.
1). Adjustments should be made at intervals of 4 weeks or more. The experience of simvastatin in pre-pubertal children is limited. With simvastatin 80mg tablets, dosages of 80mg and 40mg (=half tablet) can be achieved. To achieve lower dosages, tablets of 5, 10 or 20mg are commercially available.
The following additional adverse events have been reported with some statins: • Sleep disturbances, including nightmares • Sexual dysfunction. 6mmol/L, BMI>30kg/m2, raised triglycerides, history of hypertension). Children and adolescents (10-17 years of age) In a 48-week study involving children and adolescents (boys Tanner Stage II and above and girls who were at least one year post-menarche) 10-17 years of age with heterozygous familial hypercholesterolaemia (n = 175), the safety and tolerability profile of the group treated with simvastatin was generally similar to that of the group treated with placebo.
The long-term effects on physical, intellectual, and sexual maturation are unknown. No sufficient data are currently available after one year of treatment. ) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis. In order to establish a reference baseline value, a CK level should be measured before starting a treatment in the following situations: • Elderly (age ≥65 years) • Female gender • Renal impairment • Uncontrolled hypothyroidism • Personal or familial history of hereditary muscular disorders • Previous history of muscular toxicity with a statin or fibrate • Alcohol abuse.
In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended. If a patient has previously experienced a muscle disorder on a fibrate or a statin, treatment with a different member of the class should only be initiated with caution.
If CK levels are significantly elevated at baseline (> 5 x ULN), treatment should not be started. Whilst on treatment If muscle pain, weakness or cramps occur whilst a patient is receiving treatment with a statin, their CK levels should be measured.
If these levels are found, in the absence of strenuous exercise, to be significantly elevated (> 5 x ULN), treatment should be stopped. If muscular symptoms are severe and cause daily discomfort, even if CK levels are < 5 x ULN, treatment discontinuation may be considered.
If myopathy is suspected for any other reason, treatment should be discontinued. If symptoms resolve and CK levels return to normal, then re-introduction of the statin or introduction of an alternative statin may be considered at the lowest dose and with close monitoring.
1). Periodic CK measurements are recommended as they may be useful to identify subclinical cases of myopathy. However, there is no assurance that such monitoring will prevent myopathy. Therapy with simvastatin should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.
There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins. IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
Reduced function of transport proteins Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis. 521T>C genotype. 521T>C) coding for a less active OATP1B1 protein have an increased systemic exposure of simvastatin and increased risk of myopathy.
The risk of high dose (80 mg) simvastatin related myopathy is about 1 % in general, without genetic testing. 5 %. 3 % in […]