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Atorvastatin Oral Suspension Abbreviated Prescribing Information

Abbreviated Prescribing Information: Atorvastatin 4mg /ml Oral Suspension Consult Summary of Product Characteristics before prescribing. Presentation: Oral Suspension. White to brownish white Suspension, each 1 ml contains 4 mg of Atorvastatin (as 4.14 mg atorvastatin calcium trihydrate). Therapeutic Indications: For hypercholesterolaemia Atorvastatin Oral Suspension is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and Iib of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin Oral Suspension is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Posology and Method of Administration: The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin Oral Suspension and should continue this diet during treatment with Atorvastatin Oral Suspension. The dose should be individualised according to baseline LDL-C levels, the goal of therapy and patient response. The usual starting dose is 10 mg (2.5 ml) once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum dose is 80 mg (20 ml) once a day. For primary hypercholesterolaemia and combined (mixed) hyperlipidaemia the majority of patients are controlled with Atorvastatin Oral Suspension 10 mg (2.5 ml) once a day. A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks. The response is maintained during chronic therapy. For heterozygous familial hypercholesterolaemia patients should be started with Atorvastatin Oral Suspension 10 mg (2.5 ml) daily. Doses should be individualised and adjusted every 4 weeks to 40 mg (10 ml) daily. Thereafter, either the dose may be increased to a maximum of 80 mg (20 ml) daily or a bile acid sequestrant may be combined with 40 mg (10 ml) atorvastatin once daily. For homozygous familial hypercholesterolaemia. Only limited data are available. The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg (2.5 to 20 ml) daily. Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. Paediatric population: Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress. For patients with Heterozygous Familial Hypercholesterolemia aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg (2.5 ml) per day. The dose may be increased to 80 mg (20 ml) daily, according to the response and tolerability. Doses should be individualised according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more. The dose titration to 80 mg (20 ml) daily is supported by study data in adults and by limited clinical data from studies in children with Heterozygous Familial Hypercholesterolemia. There are limited safety and efficacy data available in children with Heterozygous Familial Hypercholesterolemia between 6 to 10 years of age derived from open-label studies. Atorvastatin is not indicated in the treatment of patients below the age of 10 years. Currently available data are described in the SmPC but no recommendation on posology can be made. Other pharmaceutical forms/strengths may be more appropriate for this population. Contra-indications: Atorvastatin Oral Suspension is contraindicated in patients: with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC; with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal; during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures; treated with the hepatitis C antivirals glecaprevir/pibrentasvir. Special Warnings and Precautions for use: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed. Atorvastatin Oral Suspension should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. The potential risk of hemorrhagic stroke should be carefully considered before initiating treatment particularly in patients with prior hemorrhagic stroke or lacunar infarct. Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis and subsequently to renal failure. Special care should be exercised for immune-mediated necrotizing myopathy during or after treatment as it is reported for some statins. Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. Creatine Kinase (CK) level should be measured before starting statin treatment and if CK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started. Given the increased risk of rhabdomyolysis, care should be taken when giving atorvastatin in combination with other medications including potent inhibitors of CYP3A4 or transport proteins. The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, antivirals for the treatment of hepatitis C (HCV). Atorvastatin 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. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. No clinically significant effect on growth and sexual maturation was observed in paediatric population in a 3- year study. Patients at risk of diabetes mellitus (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically. If myasthenia gravis or ocular myasthenia develops or worsens, atorvastatin oral suspension should be stopped using. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. The common adverse reactions are nasopharyngitis, allergic reactions, hyperglycaemia, headache, pharyngolaryngeal pain, epistaxis, constipation, flatulence, dyspepsia, nausea, diarrhoea, myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain, liver function test abnormal, and blood creatine kinase increased. Refer the SmPC for details of other adverse reactions.Pack Size and NHS Price: 150ml – £216.00. Marketing Authorisation Number: PL 00427/0256 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [August-2023]

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400