For patients with prior hemorrhagic stroke or lacunar infarct, the balance of risks and benefits of atorvastatin 80 mg is uncertain, and the potential risk of hemorrhagic stroke should be carefully considered before initiating treatment see section 5.
Before the treatment 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: 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.
Whilst on treatment - Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever. Concomitant treatment with other medicinal products Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins e. The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, erythromycin, niacin and 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.
In addition, in the case of potent CYP3A4 inhibitors, a lower starting dose of atorvastatin should be considered and appropriate clinical monitoring of these patients is recommended see section 4. Atorvastatin must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment.
In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
There have been reports of rhabdomyolysis including some fatalities in patients receiving fusidic acid and statins in combination see section 4. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of fusidic acid. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e. Immune-mediated necrotizing myopathy There have been very rare reports of an immune-mediated necrotizing myopathy IMNM during or after treatment with some statins.
IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment. Interstitial lung disease Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy see section 4. 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 developed 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 risk 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 established see section 4.
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 with other medicinal products that have a potential to induce myopathy, such as fibric acid derivates and ezetimibe see section 4.
Co-administration of potent CYP3A4 inhibitors e. In cases where co-administration of 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. An increased risk of myopathy has been observed with the use of erythromycin in combination 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.
So here are two studies, one very recent, addressing statins in the setting of PCIs. The authors of the first study, in justifying their meta-analysis, noted that a large series of trials has suggested that statins may decrease the rate of peri-procedural MIs in those getting PCIs, but most of the prospective trials reporting a benefit of statins were small in size, with varying endpoints and varying statin regimen and collectively these studies lacked the power to demonstrate a clinical difference.
The authors also excluded patients who were already on statin therapy seems reasonable. However, the meta-analysis demonstrated that only in the subset of NSTEMI patients did statins reduce the composite end-point of death, spontaneous MI and target vessel revascularization OR 0. More specifically, in the statin-loaded group, the combined end-point occurred in 0. Dosing of statins in potential ACS patients is another issue. The Benjo study below noted that in the subset of NSTEMI patients, the dosing of statins used was atorvastatin 80mg or rosuvastatin 20mg or 40mg.
First, it will be the rare patient with an ACS who is not started on a statin during their hospitalization — independent of their lipid levels — so beginning therapy in the ED should not be an issue.
Second, there are conflicting studies indicating that statins may reduce the incidence of contrast-induced nephrotoxicity associated with the IV contrast material used when a PCI is performed.
Some have suggested that statin loading prior to PCI reduces this risk. In fact, we recently demonstrated that even borderline increases in troponin following elective PCI predicted a higher mortality Compelling data suggest that the statins may reduce the rate of periprocedural myocardial infarction MI 12,13, In an accompanying editorial, Tsimikas 15 reviewed 6 studies, including 2 in ACS 16,17 , of over 2, PCI patients 4 studies with atorvastatin [3 using 80 mg and 1 using 40 mg] 13,17—19 , 1 with rosuvastatin 40 mg 16 , and the other using various statins , demonstrating statistically significant reductions in periprocedural MI using statin therapy.
Tsimikas suggested that high doses of a potent statin should be given similar priority as aspirin and clopidogrel prior to patients undergoing PCI. In this issue of JACC: Cardiovascular Interventions, Kim et al.
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