Each Lipitor 40 mg film-coated tablet contains 109.00 mg lactose monohydrate and 0.00016 mg benzoic acid.
Posology:
The patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue on this diet during treatment with Lipitor.
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.
Method of administration:
Lipitor is for oral administration. Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Contraindications
Lipitor is contraindicated in patients:
– with hypersensitivity to the active substance or to any of the excipients.
– 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:
-Hepatic impairment: Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve. Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, reduction of dose or withdrawal of Lipitor is recommended.
-Lipitor should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
-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.
-Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. A CK level should be measured before starting statin treatment in the following situations:
– Renal impairment
– Hypothyroidism
– Personal or familial history of hereditary muscular disorders
– Previous history of muscular toxicity with a statin or fibrate
– Previous history of liver disease and/or where substantial quantities of alcohol are consumed
– In elderly (age > 70 years), the necessity of such measurement should be considered, according to the presence of other predisposing factors for rhabdomyolysis
-Lipitor contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pregnancy:
Lipitor is contraindicated during pregnancy.
Breast-feeding:
Atorvastatin is contraindicated during breast-feeding.
Side Effects:
-Infections and infestations:
Common: nasopharyngitis, Blood and lymphatic system disorders
-Immune system disorders: Common: allergic reactions.
-Metabolism and nutrition disorders: Common: hyperglycaemia. Uncommon: hypoglycaemia, weight gain, anorexia.
