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ENEBIUM is a brand name for Rosuvastatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of hypercholesterolaemia Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g.…
Verbatim from this product's MHRA label. Tap a section to expand.
Before treatment initiation the patient should be placed on a standard cholesterol lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines.
The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference. Enebium may be given at any time of day, with or without food. Treatment of hypercholesterolaemia The recommended start dose is 5 or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor.
The choice of start dose should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions (see below). 1). 4). Specialist supervision is recommended when the 40 mg dose is initiated.
1). Paediatric population Paediatric use should only be carried out by specialists. Children and adolescents 6 to 17 years of age (Tanner Stage <II-V) Heterozygous familial hypercholesterolaemia In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily.
• In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population. • In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily.
Safety and efficacy of doses greater than 20 mg have not been studied in this population. 4). Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment.
Homozygous familial hypercholesterolaemia In children 6 to 17 years of age with homozygous familial hypercholesterolaemia, the recommended maximum dose is 20 mg once daily. A starting dose of 5 to 10 mg once daily depending on age, weight and prior statin use is advised.
4). Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment. There is limited experience with doses other than 20 mg in this population.
The adverse reactions seen with rosuvastatin are generally mild and transient. In controlled clinical trials, less than 4% of rosuvastatin -treated patients were withdrawn due to adverse reactions. Tabulated list of adverse reactions Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for rosuvastatin.
Adverse reactions listed below are classified according to frequency and system organ class (SOC). The frequencies of adverse reactions are ranked according to the following convention: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Table 2. 6 mmol/L, BMI >30 kg/m2, raised triglycerides, history of hypertension). As with other HMG-CoA reductase inhibitors, the incidence of adverse drug reactions tends to be dose dependent.
Renal effects:
Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with rosuvastatin. Shifts in urine protein from none or trace to ++ or more were seen in <1% of patients at some time during treatment with 10 and 20 mg, and in approximately 3% of patients treated with 40 mg.
A minor increase in shift from none or trace to + was observed with the 20 mg dose. In most cases, proteinuria decreases or disappears spontaneously on continued therapy. Review of data from clinical trials and post- marketing experience to date has not identified a causal association between proteinuria and acute or progressive renal disease.
Haematuria has been observed in patients treated with rosuvastatin and clinical trial data show that the occurrence is low. g. myalgia, myopathy (including myositis) and, rarely, rhabdomyolysis with and without acute renal failure have been reported in rosuvastatin -treated patients with all doses and in particular with doses > 20 mg.
Renal Effects Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with higher doses of rosuvastatin, in particular 40 mg, where it was transient or intermittent in most cases.
8). The reporting rate for serious renal events in post- marketing use is higher at the 40 mg dose. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg. g. myalgia, myopathy and, rarely, rhabdomyolysis have been reported in Enebium-treated patients with all doses and in particular with doses > 20 mg.
Very rare cases of rhabdomyolysis have been reported with the use of ezetimibe in combination with HMG-CoA reductase inhibitors. 5) and caution should be exercised with their combined use. As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis associated with rosuvastatin in post-marketing use is higher at the 40 mg dose.
Creatine Kinase Measurement Creatine Kinase (CK) should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase which may confound interpretation of the result. If CK levels are significantly elevated at baseline (>5xULN) a confirmatory test should be carried out within 5 – 7 days.
If the repeat test confirms a baseline CK >5xULN, treatment should not be started. Before Treatment Enebium, as with other HMG-CoA reductase inhibitors, should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis.
2) • concomitant use of fibrates. In such patients the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended. If CK levels are significantly elevated at baseline (>5xULN) treatment should not be started.
Whilst on Treatment Patients should be asked to report inexplicable muscle pain, weakness or cramps immediately, particularly if associated with malaise or fever. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5xULN) or if muscular symptoms are severe and cause daily discomfort (even if CK levels are ≤ 5x ULN).
Enebium is contraindicated: - in patients with hypersensitivity to rosuvastatin or to any of the excipients. - in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN).
- in patients with severe renal impairment (creatinine clearance <30 ml/min). - in patients with myopathy. 5) - in patients receiving concomitant ciclosporin. The 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy / rhabdomyolysis.
Such factors include: - moderate renal impairment (creatinine clearance < 60 ml/min) - hypothyroidism - personal or family history of hereditary muscular disorders - previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate - alcohol abuse - situations where an increase in plasma levels may occur - Asian patients - concomitant use of fibrates.
2)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The 40 mg tablet is not suitable for use in paediatric patients. Children younger than 6 years The safety and efficacy of use in children younger than 6 years has not been studied. Therefore, Enebium is not recommended for use in children younger than 6 years.
4). No other dose adjustment is necessary in relation to age. Dosage in patients with renal insufficiency No dose adjustment is necessary in patients with mild to moderate renal impairment. The recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance <60 ml/min).
The 40 mg dose is contraindicated in patients with moderate renal impairment. 2). Dosage in patients with hepatic impairment There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below.
2). 4). There is no experience in subjects with Child- Pugh scores above 9. 3). 2). The recommended start dose is 5 mg for patients of Asian ancestry. The 40 mg dose is contraindicated in these patients. 421AA have been shown to be associated with an increase in rosuvastatin exposure.
2). 4). 3). g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Enebium is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these […]
A dose-related increase in CK levels has been observed in patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient. 4). A Cholesterol Treatment Trialists’ (CTT) Collaboration meta-analysis in 2022 assessed 19 double-blind trials of statin versus placebo (n=123,940) and four double-blind trials of a more intensive versus a less intensive statin regimen (n=30,724).
The meta-analysis demonstrated statin therapy caused a small relative increase (3%) in the number of first reports of mild muscle pain or weakness largely confined to the first year of treatment. The meta-analysis also demonstrated an increase in first episode of muscle pain or weakness symptoms being more likely for intensive statin regimens compared to moderate/less intense statin regimens.
Most (>90%) of all reports of muscle symptoms by participants allocated statin therapy were not due to the statin.
Liver effects:
As with other HMG-CoA reductase inhibitors, a dose-related increase in transaminases has been observed in a small number of patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient.
The following adverse events have been reported with some statins:
Sexual dysfunction. 4). The reporting rates for rhabdomyolysis, serious renal events and serious hepatic events (consisting mainly of increased hepatic transaminases) is higher at the 40 mg dose. 4). In other respects, the safety profile of rosuvastatin was similar in children and adolescents compared to adults.
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.
If symptoms resolve and CK levels return to normal, then consideration should be given to re- introducing Enebium or an alternative HMG-CoA reductase inhibitor at the lowest dose with close monitoring. Routine monitoring of CK levels in asymptomatic patients is not warranted.
There have been very rare reports of an immune-mediated necrotising myopathy (IMNM) during or after treatment with statins, including rosuvastatin. IMNM is clinically characterised by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
8). Enebium should be discontinued in case of aggravation of symptoms. Recurrences when the same or a different statin was (re-) administered have been reported. In clinical trials, there was no evidence of increased skeletal muscle effects in the small number of patients dosed with rosuvastatin and concomitant therapy.
However, an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics.
Gemfibrozil increases the risk of myopathy when given concomitantly with some HMG-CoA reductase inhibitors. Therefore, the combination of rosuvastatin and gemfibrozil is not recommended. The benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of such combinations.
8). Rosuvastatin 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.
5). Patients 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. g. for the treatment of severe infections, the need for co-administration of rosuvastatin and fusidic acid should only be considered on a case by case basis and under close medical supervision.
g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be […]