Atorvastatin

Atorvastatin: May be taken with or without food. Avoid excessive consumption (>1 L/day) of grapefruit juice.

Active liver disease or unexplained persistent serum transaminase elevation. Pregnancy and lactation. Concomitant use with glecaprevir/pibrentasvir combination, systemic fusidic acid or within 7 days of stopping fusidic acid treatment, telaprevir, ciclosporin, and tipranavir/ritonavir combination.

Patient with predisposing factors for rhabdomyolysis (e.g. hypothyroidism, personal or family history of hereditary muscular disorders, history of muscular toxicity with statin or fibrate), history of liver disease, recent stroke or TIA. Patients who consume large quantities of alcoholic beverages. Patient taking clarithromycin, itraconazole, fosamprenavir, ritonavir (plus darunavir, fosamprenavir, or saquinavir), elbasvir/grazoprevir combination, letermovir, boceprevir and nelfinavir. Patient with known SLCO1B1 gene polymorphism. Renal impairment. Children and elderly. Monitoring Parameters Obtain lipid profile (fasting or non-fasting) before treatment initiation; fasting lipid profile during treatment. Monitor LFTs at baseline and periodically thereafter. May perform baseline creatine phosphokinase measurement for those at risk for myopathy. Assess for signs and symptoms of myopathy or rhabdomyolysis; new-onset diabetes mellitus.

Significant: Myalgia, myositis, myopathy; increased serum transaminase, serum creatine kinase, HbA_1c and fasting blood sugar levels. Rarely, immune-mediated necrotising myopathy (IMNM), interstitial lung disease, worsen or precipitate myasthenia gravis. Gastrointestinal disorders: Diarrhoea, constipation, flatulence, dyspepsia, nausea. General disorders and administration site conditions: Malaise, asthenia, fatigue, pyrexia. Hepatobiliary disorders: Hepatitis. Immune system disorders: Allergic reactions. Investigations: Abnormal LFT. Musculoskeletal and connective tissue disorders: Arthralgia, muscle spasms, back pain, joint swelling, pain in extremity. Nervous system disorders: Headache, dizziness, paraesthesia, hypoaesthesia, amnesia. Psychiatric disorders: Insomnia, nightmares. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, pharyngolaryngeal pain, epistaxis. Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, alopecia.
Potentially Fatal: Rhabdomyolysis (with or without acute renal failure secondary to myoglobinuria), hepatic failure.

May increase the risk of myopathy and rhabdomyolysis with moderate or potent CYP3A4 inhibitors (e.g. clarithromycin, erythromycin, ketoconazole, voriconazole, itraconazole, posaconazole, diltiazem, verapamil, certain antivirals for hepatitis C, HIV protease inhibitors), transport protein inhibitors (e.g. letermovir), gemfibrozil or other fibric acid derivatives, niacin, ezetimibe, and colchicine. Decreased plasma concentrations with CYP3A4 inducers (e.g. efavirenz, rifampicin), Al- and Mg-containing antacid, colestipol. May increase the plasma concentration of digoxin, norethisterone and ethinylestradiol.

Dyslipidaemic Agents

C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.