Appropriate clinical monitoring is recommended after initiation or following dose adjustments of the inhibitor.Concomitant administration of atorvastatin with inducers of cytochrome P450 3A (e.g. Large quantities of grapefruit juice (over 1.2 l daily for 5 days) increased AUC of atorvastatin 2.5 fold and AUC of active (atorvastatin and metabolites) HMG-CoA reductase inhibitors 1.3 fold. Safety in pregnant women has not been established.
A total of 39 children and adolescents, 6 to 17 years of age, were enrolled. The dose may be increased to 80 mg daily, according to the response and tolerability. The absolute and relative risk reduction effect of atorvastatin was as follows: Total cardiovascular events and revascularization procedures CHD = coronary heart disease; MI = myocardial infarction.Total mortality and cardiovascular mortality were not significantly reduced (185 vs. 212 events, p=0.17 and 74 vs. 82 events, p=0.51). If the dose of atorvastatin is changed or discontinued, the same procedure should be repeated. Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed. Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/mAtorvastatin contains lactose. 8.7 . Mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours. 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. Telaprevir 750 mg q8h, 10 days. It is not known whether atorvastatin or its metabolites are excreted in human milk. In this randomised, double- blind, multicenter, controlled clinical trial, IVUS was performed at baseline and at 18 months in 502 patients. 20 mg, SD. In the MIRACL study, atorvastatin 80 mg has been evaluated in 3,086 patients (atorvastatin n=1,538; placebo n=1,548) with an acute coronary syndrome (non Q-wave MI or unstable angina). Only limited data are available (see section 5.1). Patients were treated with either atorvastatin 10 mg daily (n=1,428) or placebo (n=1,410) for a median follow-up of 3.9 years. Rare: myopathy, myositis, rhabdomyolysis, muscle rupture, tendonopathy, sometimes complicated by rupture.Not known: immune mediated necrotizing myopathy (see section 4.4).Uncommon: malaise, asthenia, chest pain, peripheral oedema, fatigue, pyrexia. Based on the data available, the frequency, type and severity of adverse reactions in children is similar to adults.- Exceptional cases of interstitial lung disease, especially with long-term therapy (see section 4.4).- Diabetes Mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI>30kg/mReporting suspected adverse reactions after authorisation of the medicinal product is important. Study results were obtained with the 80 mg dose strength. Antacid suspension of magnesium and aluminium hydroxides, 30 mL QID, 17 daysIf co-administration cannot be avoided, simultaneous co-administration of atorvastatin with rifampin is recommended, with clinical monitoring. Levels above 10 times the normal upper range occurred in 0.4% atorvastatin-treated patients (see section 4.4). These changes were usually mild, transient, and did not require interruption of treatment. A compassionate use study in patients with severe hypercholesterolaemia (including homozygous hypercholesterolaemia) included 46 paediatric patients treated with atorvastatin titrated according to response (some subjects received 80 mg atorvastatin per day).
Doses should be individualised according to the recommended goal of therapy.
There was no evidence of a difference in the treatment effect by patient's gender, age, or baseline LDL-C level. Atorvastatin is contraindicated in patients with active liver disease (see section 4.3). Atorvastatin increased mean HDL-C by 2.9% (pravastatin: +5.6%, p=NS). Atorvastatin produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles.
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