Rotaqor®. Each coated tablet contains 10/ 20/ 40/ 80 mg of atorvastatin. Excipient(s) with known effects: Lactose monohydrate. Indications. Hypercholesterolemia, prevention of cardiovascular disease. Posology. The dose must be customized according to the baseline LDL-c levels, the therapy goal and the patient's response. The maximum initial dose is 10 mg once a day. The dose adjustment should be performed at intervals of 4 weeks or more. The maximum dose is 80 mg once a day. Primary hypercholesterolemia and combined hyperlipidemia. Most of the patients are controlled with 10 mg once per day. Heterozygous familial hypercholesterolemia. Patients should start with a 10 mg dose per day of Rotaqor®. The doses should be individualized and adjusted every 4 weeks, at 40 mg per day. Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg Rotaqor® once daily. Homozygous familial hypercholesterolemia. The dose of Rotaqor® in patients with homozygous familial hypercholesterolemia is 10 to 80 mg per day. Rotaqor® should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable. Prevention of cardiovascular disease. In the primary prevention trials the dose was 10 mg/day. Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines. It does not require dosage adjustment in renal failure. El uso en pediatría solo se debe realizar por médicos con experiencia en el tratamiento de la hiperlipidemia pediátrica y los pacientes deben ser re-evaluados de forma periódica para verificar su progreso. For patients of 10 years old, the recommended starting dose of Rotaqor® is 10 mg per day, with adjustments of up to 20 mg per day. 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 hypercholesterolaemia aged 10 years and above, the recommended starting dose of Rotaqor® is 10 mg per day. The dose may be increased to 80 mg 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 daily is supported by study data in adults and by limited clinical data from studies in children with heterozygous familial hypercholesterolaemia. Contraindications. In patients with known hypersensitivity to the active substance or to any of the excipients of this medication, with active hepatic disease or unexplained persistent increases of serum transaminases that exceed more than 3 times the upper limit of the normal range, during pregnancy, breastfeeding, and childbearing potential women who are not using the appropriate contraceptive measures; patients taking antivirals for the treatment of hepatitis C glecaprevir/pibrentasvir. Precautions on the usage. Tests of the liver function must be performed before starting the treatment, and periodically thereafter. Rotaqor® should be used with caution in patients who consume excessive amounts of alcohol and/or have a history of hepatic disease. Patients who previously suffered hemorrhagic stroke or lacunar infarct, the potential risk of hemorrhagic stroke should be carefully considered before starting the treatment. The prescription of atorvastatin in patients with factors that may predispose them to rhabdomyolysis, should be used with caution. The risk of developing rhabdomyolysis increases when Rotaqor® is concomitantly administered with certain medications that may increase the plasma concentrations of Rotaqor®, as potent inhibitors of CYP3A4, or transport proteins (i.e., cyclosporine, telithromycin, clarithromycin, delavirdine, estiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, and anti-HIV protease inhibitors; including the ritonavir, lopinavir, atazanavir, indinavir, duranavir, tipranavir/ritonavir, etc.). The risk of myopathy can also increase with the concomitant usage of gemfibrozil and other fibric acid by-products, antivirals for the treatment of hepatitis C (HCV) (boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin or ezetimibe. If possible, alternative therapies should be considered (that do not interact) instead of these medications. Very rare cases have been reported of necrotizing myopathy mediated by the immune system (IMNM) during or after treatment with statins. Exceptional cases of interstitial lung disease with some statins have been reported, especially with long term therapy. Adverse Events. Nasopharyngitis, allergic reaction, hyperglycemia, headache, pharyngolaryngeal pain, epistaxis, constipation, flatulence, dyspepsia, nausea, diarrhea, myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain, abnormal hepatic function evidence, increase in blood creatinine kinase. CDS V07 April 2019.