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TEVA 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 lipid…
Verbatim from this product's MHRA label. Tap a section to expand.
The dosage range is 5-80 mg/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 80 mg/day given as a single dose in the evening.
4). 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 10-20 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 20-40 mg/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 dosage is simvastatin 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg, and an evening dose of 40 mg.
, LDL apheresis) in these patients or if such treatments are unavailable. Cardiovascular prevention The usual dose of simvastatin is 20 to 40 mg/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. In patients taking ciclosporin, danazol, gemfibrozil or other fibrates (except fenofibrate) concomitantly with simvastatin, the dose of simvastatin should not exceed 10 mg/day.
In patients taking amiodarone or verapamil concomitantly with simvastatin, the dose of simvastatin should not exceed 20 mg/day. 5). 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 <30 mL/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 10 mg 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 categorised as “rare”.
1) involving 20,536 patients treated with 40 mg/day of simvastatin (n=10,269) or placebo (n=10,267), the safety profiles were comparable between patients treated with simvastatin 40 mg 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 40 mg. 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). 02 %, respectively). Reproductive system and breast disorders Uncommon: sexual dysfunction 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.
6 mmol/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.
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 80 mg/day, respectively. In these trials, patients were carefully monitored and some interacting medicinal products were excluded.
02 % for patients on 20 mg/day. Approximately half of these myopathy cases occurred during the first year of treatment. 1 %. ) 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 (>5x 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.
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 > 70 years) PL 00289/0526 Version 02 − 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.
g. g. 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 10-40 mg/day; the maximum recommended dose is 40 mg/day.
1). Adjustments should be made at intervals of 4 weeks or more. The experience of simvastatin in pre-pubertal children is limited. PL 00289/0526 Version 02
The long-term effects on physical, intellectual, and sexual maturation are unknown. No sufficient data are currently available after one year of treatment. ). PL 00289/0526 Version 02
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 (>5x ULN), treatment should be stopped.
If muscular symptoms are severe and cause daily discomfort, even if CK levels are <5x 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.
A higher rate of myopathy has been observed in patients titrated to the 80 mg dose. 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.
g. 2). 5). 5). 5). g. 5). If treatment with itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with simvastatin must be suspended during the course of treatment. 5). Concomitant intake of grapefruit juice and simvastatin should be avoided.
The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with ciclosporin, danazol or gemfibrozil. The combined use of simvastatin with gemfibrozil should be avoided, unless the benefits are likely to outweigh the increased risks of this drug combination.
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