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NANDOVAR XL is a brand name for Fluvastatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Dyslipidaemia Treatment of adults with 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. Secondary prevention in coronary heart disease Secondary prevention of major adverse…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Dyslipidaemia Prior to initiating treatment with Lescol XL, patients should be placed on a standard cholesterol-lowering diet, which should be continued during treatment. Starting and maintenance doses should be individualized according to the baseline LDL-C levels and the treatment goal to be accomplished.
The recommended dosing range is 20 to 80 mg/day. For patients requiring LDL-C reduction to a goal of < 25% a starting dose of 20 mg fluvastatin may be used in the evening. For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg fluvastatin in the evening.
The dose may be uptitrated to 80 mg daily, administered as a single dose (one Lescol XL 80 mg prolonged release tablet) at any time of the day or as one 40 mg dose of fluvastatin given twice daily (one dose in the morning and one dose in the evening).
The maximum lipid-lowering effect with a given dose is achieved within 4 weeks. Dose adjustments should be made at intervals of 4 weeks or more. Secondary prevention in coronary heart disease In patients with coronary heart disease after percutaneous coronary interventions, the appropriate daily dose is 80 mg.
Lescol XL is efficacious in monotherapy. When Lescol XL is used in combination with cholestyramine or other resins, it should be administered at least 4 hours after the resin to avoid significant interaction due to binding of the drug to the resin.
5). Paediatric population Children and adolescents with heterozygous familial hypercholesterolaemia Prior to initiating treatment with fluvastatin in children and adolescents aged 9 years and older with heterozygous familial hypercholesterolaemia, the patient should be placed on a standard cholesterol-lowering diet, and continued during treatment.
The recommended starting dose is 20 mg fluvastatin. Dose adjustments should be made at 6-week intervals. Doses should be individualised according to baseline LDL- C levels and the recommended goal of therapy to be accomplished. The maximum daily dose administered is 80 mg either as fluvastatin 40 mg twice daily or as one Lescol XL 80 mg prolonged-release tablet once daily.
The use of fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents has not been investigated. Lescol XL has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia.
The most commonly reported adverse reactions are mild gastrointestinal symptoms, insomnia and headache. Adverse drug reactions (Table 1) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent first.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category, using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
g. 4) Reproductive system and breast disorders Not known* Erectile dysfunction Investigations Common Blood creatine phosphokinase increased, blood transaminases increased * Based on post-marketing experience with Lescol (fluvastatin) via spontaneous case reports and literature cases.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. 6 mmol/L, BMI>30kg/m2, raised triglycerides, history of hypertension) • Tendinopathy, sometimes complicated by tendon rupture.
Paediatric population Children and adolescents with heterozygous familial hypercholesterolaemia The safety profile of fluvastatin in children and adolescents with heterozygous familial hypercholesterolaemia assessed in 114 patients aged 9 to17 years treated in two open-label non-comparative clinical trials was similar to the one observed in adults.
In both clinical trials no effect was observed on growth and sexual maturation. The ability of the trials to detect any effect of treatment in this area was however low. Laboratory findings Biochemical abnormalities of liver function have been associated with HMG- CoA reductase inhibitors and other lipid-lowering agents.
Liver function Post marketing cases of fatal and non-fatal hepatic failures have been reported with some statins including Lescol XL. g. nausea, vomiting, loss of appetite, jaundice, impaired brain function, easy bruising or bleeding), and treatment discontinuation should be considered.
As with other lipid-lowering agents, it is recommended that liver function tests be performed before the initiation of treatment and at 12 weeks following initiation of treatment or elevation in dose and periodically thereafter in all patients.
Should an increase in aspartate aminotransferase or alanine aminotransferase exceed 3 times the upper limit of normal and persist, therapy should be discontinued. In very rare cases, possibly drug-related hepatitis was observed that resolved upon discontinuation of treatment.
Caution should be exercised when Lescol XL is administered to patients with a history of liver disease or heavy alcohol ingestion. Skeletal muscle Myopathy has rarely been reported with fluvastatin. Myositis and rhabdomyolysis have been reported very rarely.
In patients with unexplained diffuse myalgias, muscle tenderness or muscle weakness, and/or marked elevation of creatine kinase (CK) values, myopathy, myositis or rhabdomyolysis have to be considered. Patients should therefore be advised to promptly report unexplained muscle pain, muscle tenderness or muscle weakness, particularly if accompanied by malaise or fever.
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.
Interaction with Fusidic acid Lescol XL must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
1. 8). 6).
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Renal Impairment Lescol XL is cleared by the liver, with less than 6% of the administered dose excreted into the urine. The pharmacokinetics of fluvastatin remain unchanged in patients with mild to severe renal insufficiency. 5 mL/sec or 30 mL/min), these doses should be initiated with caution.
2). Elderly population No dose adjustments are necessary in this population. Method of administration Lescol XL tablets can be taken with or without meals and should be swallowed whole with a glass of water.
9% on twice daily fluvastatin capsules 40 mg. The majority of patients with these abnormal biochemical findings were asymptomatic. 0%). 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
5). The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of fusidic acid. , for the treatment of severe infections, the need for co-administration of Lescol XL and fusidic acid should only be considered on a case by case basis and under close medical supervision.
Creatine kinase measurement There is no current evidence to require routine monitoring of plasma total CK or other muscle enzyme levels in asymptomatic patients on statins. If CK has to be measured it should not be done following strenuous exercise or in the presence of any plausible alternative cause of CK increase as this makes the value interpretation difficult.
Before treatment As with all other statins physicians should prescribe fluvastatin with caution in patients with pre-disposing factors for rhabdomyolysis and its complications. A creatine kinase level should be measured before starting fluvastatin treatment in the following situations: • Renal impairment • Hypothyroidism • Personal or familial history of hereditary muscular disorders • Previous history of muscular toxicity with a statin or fibrate • Alcohol abuse • Sepsis • Hypotension • Excessive exercise of muscle • Major surgery • Severe metabolic, endocrine or electrolyte disorders • In elderly (age > 70 years), the necessity of such measurement should be considered, according to the presence of other predisposing factors for rhabdomyolysis.
In such situations, the risk of treatment should be considered in relation to the possible benefit and clinical monitoring is recommended. If CK levels are significantly elevated at baseline (> 5xULN), levels should be re-measured within 5 to 7 days later to confirm the results.
If CK levels are still significantly elevated (> 5xULN) at baseline, treatment should not be started. Whilst on treatment If muscular symptoms like pain, weakness or cramps occur in patients receiving fluvastatin, their CK levels should be measured.
Treatment should be stopped if these levels are found to be significantly elevated (> 5xULN). If muscular symptoms are severe and cause daily discomfort, even if CK levels are elevated to ≤ 5xULN, treatment discontinuation should be considered.
Should the symptoms resolve and CK levels return to normal, then re-introduction of fluvastatin or another statin may be considered at the lowest dose and under close monitoring. The risk of myopathy has been reported to be increased in patients receiving immunosuppressive agents (including ciclosporin), fibrates, nicotinic acid or erythromycin together with other HMG-CoA reductase inhibitors.
Isolated cases of myopathy have been reported post-marketing for concomitant administration of fluvastatin with ciclosporin and fluvastatin with colchicines. 5). 8). Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever).
If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued. Diabetes Mellitus Some evidence suggests that statins as a class raise blood glucose and in some patients, at high risk of future diabetes, may produce […]