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RANZOLONT 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 (HoFH) as an adjunct to diet and other…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage range is 5-80 mg/day of simvastatin 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.
1). Hypercholesterolaemia The patient should be placed on a standard cholesterol-lowering diet, and should continue on this diet during treatment with Simvastatin Tablets. 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 starting dosage is Simvastatin Tablets 40 mg/day in the evening.
, LDL apheresis) in these patients or if such treatments are unavailable. 5). Cardiovascular prevention The usual dose of Simvastatin Tablets 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 Tablets are 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 Tablets should not exceed 10 mg/day. 5). Renal impairment No modification of dosage should be necessary in patients with moderate renal impairment.
In patients with severe renal impairment (creatinine clearance < 30 ml/min), dosages above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously. Elderly No dosage adjustment is necessary. Paediatric population 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.
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). 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 40 mg/day of Simvastatin Tablets (n = 10,269) or placebo (n = 10,267), the safety profiles were comparable between patients treated with Simvastatin Tablets 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 Tablets 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). 5). Very rare: muscle rupture Not known: tendinopathy, sometimes complicated by rupture, immune-mediated necrotizing myopathy (IMNM)** ** There have been very rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, during or after treatment with some statins.
4).
Reproductive system and breast disorders:
Very rare: gynecomastia Not known: erectile dysfunction Immune system disorders: Very rare: anaphylaxis 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.
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. 5). 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). 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 Tablets should only be used in patients with severe hypercholesterolaemia 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). 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.
Reduced function of transport proteins Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin acid and increase the risk of myopathy and rhabdomyolysis. g. 521T>C genotype. 521T>C) coding for a less active OATP1B1 protein have an increased systemic exposure of simvastatin acid and increased risk of myopathy.
The risk of high dose (80 mg) simvastatin related myopathy is about 1% in general, without genetic testing. 5%. 2). Where available, genotyping for the presence of the C allele should be considered as part of the benefit-risk assessment prior to prescribing 80 mg simvastatin for individual patients and high doses avoided in those found to carry the CC genotype.
1. • Active liver disease or unexplained persistent elevations of serum transaminases. 6). g. g. 5). 5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1). Adjustments should be made at intervals of 4 weeks or more. The experience of Simvastatin Tablets in pre-pubertal children is limited. Method of administration Simvastatin Tablets are for oral administration. Simvastatin Tablets can be administered as a single dose in the evening.
4). Increases in HbA1c and fasting serum glucose levels have been reported with statins, including Simvastatin Tablets. g. 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). 6 mmol/L, BMI > 30kg/m2, raised triglycerides, history of hypertension).
Paediatric population 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 Tablets was generally similar to that of the group treated with placebo.
The long-term effects on physical, intellectual, and sexual maturation are unknown. 1). 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.
Healthcare professionals are asked to report any suspected adverse […]
However, absence of this gene upon genotyping does not exclude that myopathy can still occur. 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.
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 […]