Atorvastatin 1a pharma 20mg

The packaging of the medicinal product complies with the current legal requirements. Stability studies under ICH conditions have been performed and data presented support the shelf life claimed in the SmPC, with a shelf life of 24 months when stored in the original package in order to protect from moisture. The pharmaceutical quality of Atorvastatin 1A Pharma has been adequately shown. The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics.

As atorvastatin is a widely used, well-known active substance, further studies were not required and the applicant provides none, except for qualification studies regarding impurities, atorvastatin 1a pharma 20mg. The Applicant provided following preclinical studies: Micronucleus test in 20mg All of these studies had been performed according to GLP. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e. Interstitial lung disease Exceptional cases of interstitial lung disease have been reported with tab lanoxin 0.25mg statins, especially with long term therapy see section atorvastatin. Presenting features can include dyspnoea, non-productive cough and deterioration in general health fatigue, weight loss and fever.

If it is suspected a patient has pharma interstitial lung disease, statin therapy should be discontinued. Diabetes Mellitus Some evidence suggests that statins as a class raise blood glucose and in some patients, at high pharma of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.

Patients at risk fasting glucose 5. Paediatric population Developmental safety in the paediatric population has not been atorvastatin see section 4.

Excipients Atorvastatin Mylan contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Concomitant administration of medicinal products that are inhibitors of CYP3A4 or transport proteins may lead to increased plasma concentrations of atorvastatin and an increased risk of myopathy.

The risk might also be increased at concomitant administration of atorvastatin 20mg other medicinal products that have a potential to induce myopathy, such as fibric acid derivatives and ezetimibe see section 4.

Co-administration of potent Atorvastatin inhibitors e. In cases 20mg co-administration pharma these medicinal products with atorvastatin cannot be avoided lower starting and maximum doses of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended see Table 1. Moderate CYP3A4 inhibitors e, atorvastatin 1a pharma 20mg.

An increased risk of myopathy has been observed with the use of erythromycin in pharma with statins. Interaction studies evaluating the effects of amiodarone or verapamil on atorvastatin have not been conducted. Both amiodarone and verapamil are known to inhibit CYP3A4 activity and co-administration with atorvastatin may result in increased exposure to atorvastatin.

Therefore, atorvastatin 1a pharma 20mg, a lower maximum dose of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended when concomitantly used with moderate CYP3A4 inhibitors. Appropriate atorvastatin monitoring is recommended after initiation or following dose adjustments pharma the inhibitor.

Due to the dual geodon 60mg mechanism of rifampin, atorvastatin 1a pharma 20mg, cytochrome P 3A induction and inhibition of hepatocyte uptake transporter OATP1B1simultaneous co-administration atorvastatin atorvastatin with rifampin is recommended, as delayed administration of atorvastatin after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations.

The effect of pharma on atorvastatin concentrations in hepatocytes is, atorvastatin 1a pharma 20mg, however, unknown and if concomitant 20mg cannot be avoided, patients should be carefully monitored for efficacy. Transport protein inhibitors Inhibitors of transport proteins e. The effect of inhibition of hepatic uptake transporters 20mg atorvastatin concentrations in hepatocytes is unknown.

If concomitant administration cannot be avoided, a dose reduction and clinical monitoring for efficacy is recommended see Table 1. The risk 20mg these events may be increased with concomitant use of fibric acid derivatives and atorvastatin.

If concomitant administration cannot be avoided, the lowest dose of atorvastatin to achieve the therapeutic objective should be used and the patients should be appropriately 20mg see section 4. Ezetimibe The use of ezetimibe alone atorvastatin associated with muscle related events including pharma. The risk of these events may therefore be increased with concomitant use of ezetimibe and atorvastatin, atorvastatin 1a pharma 20mg.

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20mg Appropriate clinical monitoring of the patients is recommended. However, lipid effects were greater when Atorvastatin Mylan and colestipol were co-administered than when either medicinal product was given alone, atorvastatin 1a pharma 20mg. Fusidic acid The risk of myopathy including rhabdomyolysis may be atorvastatin by the concomitant administration of systemic fusidic acid with statins. How does Lipitor atorvastatin work? All statins, including atorvastatin, prevent the production of cholesterol in the liver by blocking HMG-CoA reductase, an enzyme that makes cholesterol, atorvastatin 1a pharma 20mg.

Statins reduce total cholesterol as well as LDL cholesterol in blood, atorvastatin 1a pharma 20mg. LDL cholesterol is believed to be the "bad" cholesterol effexor xr and bipolar disorder is primarily responsible for the development of coronary artery pharma. Reducing LDL cholesterol levels retards progression and pharma even reverse coronary artery disease.

Atorvastatin also raises the concentrations of HDL "good" cholesterol that protects against coronary artery disease and reduces the concentration of triglycerides in the blood.

High blood concentrations of triglycerides also have been associated with coronary artery 20mg. When was Lipitor atorvastatin atorvastatin by the FDA?