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LIPITOR is a brand name for Atorvastatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypercholesterolaemia Lipitor 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The patient should be placed on a standard cholesterol-lowering diet before receiving {(Invented) name} and should continue on this diet during treatment with {(Invented) name}. 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 once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once a day. Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia The majority of patients are controlled with {(Invented) name} 10 mg 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. Heterozygous familial hypercholesterolaemia Patients should be started with {(Invented) name} 10 mg daily.
Doses should be individualised and adjusted every 4 weeks to 40 mg daily. 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 atorvastatin once daily. 1). 1). 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.
4). 2). 3). 5). 5). Elderly Efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population. Paediatric population Hypercholesterolaemia 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.
1). 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. 1). 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. 2 but no recommendation on a posology can be made. Other pharmaceutical forms/strengths may be more appropriate for this population. Method of administration {(Invented) name} is for oral administration.
In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lipitor vs. 0% of the patients on placebo. Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for Lipitor.
Estimated frequencies of reactions are ranked according to the following convention: common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Infections and infestations Common: nasopharyngitis. Blood and lymphatic system disorders Rare: thrombocytopenia. Immune system disorders Common: allergic reactions. Very rare: anaphylaxis. Metabolism and nutrition disorders Common: hyperglycaemia.
Uncommon: hypoglycaemia, weight gain, anorexia. Psychiatric disorders Uncommon: nightmare, insomnia. Nervous system disorders Common: headache. Uncommon: dizziness, paraesthesia, hypoesthesia, dysgeusia, amnesia. Rare: peripheral neuropathy.
Not known: myasthenia gravis. Eye disorders Uncommon: vision blurred. Rare: visual disturbance. Not known: ocular myasthenia. Ear and labyrinth disorders Uncommon: tinnitus. Very rare: hearing loss. Respiratory, thoracic and mediastinal disorders Common: pharyngolaryngeal pain, epistaxis.
Gastrointestinal disorders Common: constipation, flatulence, dyspepsia, nausea, diarrhoea. Uncommon: vomiting, abdominal pain upper and lower, eructation, pancreatitis. Hepatobiliary disorders Uncommon: hepatitis. Rare: cholestasis. Very rare: hepatic failure.
Skin and subcutaneous tissue disorders Uncommon: urticaria, skin rash, pruritus, alopecia. Rare: angioneurotic oedema, dermatitis bullous including erythema multiforme, Stevens- Johnson syndrome, toxic epidermal necrolysis, and lichenoid drug reactions.
Hepatic impairment 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.
Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve. 8). Lipitor should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) In a post-hoc analysis of stroke subtypes in patients without coronary heart disease (CHD) who had a recent stroke or transient ischemic attack (TIA) there was a higher incidence of haemorrhagic stroke in patients initiated on atorvastatin 80 mg compared to placebo.
The increased risk was particularly noted in patients with prior haemorrhagic stroke or lacunar infarct at study entry. 1). Skeletal muscle effects 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, a potentially life-threatening condition characterised by markedly elevated creatine kinase (CK) levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.
There have been very rare reports of an immune mediated necrotizing myopathy (IMNM) during or after treatment with some statins. IMNM is clinically characterised by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment, positive anti-HMG CoA reductase antibody and improvement with immunosuppressive agents.
Before the treatment Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. 2) In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
6) − treated with the hepatitis C antivirals glecaprevir/pibrentasvir
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Musculoskeletal and connective tissue disorders Common: myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain. Uncommon: neck pain, muscle fatigue. Rare: myopathy, myositis, rhabdomyolysis, muscle rupture, tendonopathy, sometimes complicated by rupture.
Very rare: lupus-like syndrome. 4). Reproductive system and breast disorders Very rare: gynecomastia. Vascular disorders Rare: vasculitis. General disorders and administration site conditions Uncommon: malaise, asthenia, chest pain, peripheral oedema, fatigue, pyrexia.
Investigations Common: liver function test abnormal, blood creatine kinase increased. Uncommon: white blood cells urine positive. As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving Lipitor.
These changes were usually mild, transient, and did not require interruption of treatment. 8% patients on Lipitor. These elevations were dose related and were reversible in all patients. 5% of patients on Lipitor, similar to other HMG-CoA reductase inhibitors in clinical trials.
4). Paediatric population Paediatric patients aged from 10 to 17 years of age treated with atorvastatin had an adverse experience profile generally similar to that of patients treated with placebo, the most common adverse experiences observed in both groups, regardless of causality assessment, were infections.
No clinically significant effect on growth and sexual maturation was observed in a 3-year study based on the assessment of overall maturation and development, assessment of Tanner Stage, and measurement of height and weight. The safety and tolerability profile in paediatric patients was similar to the known safety profile of atorvastatin in adult patients.
The clinical safety database includes safety data for 520 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 121 patients were in the age range of 6 to 9, and 392 patients were in the age range of 10 to 17.
Based on the data available, the frequency, type and severity of adverse reactions in children is similar to adults. The following adverse events have been reported with some statins: • Sexual dysfunction. • Depression. 4). 6 mmol/L, BMI>30kg/m2, raised triglycerides, history of hypertension).
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 CK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started. 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 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results. Whilst on treatment − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
− If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CK levels should be measured. If these levels are found to be significantly elevated (> 5 times ULN), treatment should be stopped. − If muscular symptoms are severe and cause daily discomfort, even if the CK levels are elevated to ≤ 5 x ULN, treatment discontinuation should be considered.
− If symptoms resolve and CK levels return to normal, then re-introduction of atorvastatin or introduction of an alternative statin may be considered at the lowest dose and with close monitoring. − Atorvastatin must be discontinued if clinically significant elevation of CK levels (> 10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected.
g. ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, letermovir and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc).
g. boceprevir, telaprevir, elbasvir/grazoprevir, ledipasvir/sofosbuvir), erythromycin, niacin, or ezetimibe. If possible, alternative (non- interacting) therapies should be considered instead of these medicinal products. In cases where co-administration of these medicinal products with atorvastatin is necessary, the benefit and the risk of concurrent treatment should be carefully considered.
When patients are receiving medicinal products that increase the plasma concentration of atorvastatin, a lower maximum dose of atorvastatin is recommended. 5). The risk of myopathy and/or rhabdomyolysis may be increased by concomitant […]