Lipistad Special Precautions

It is considered in patients with risk factors resulting in muscle injury during statin therapy. Statin drugs may cause myogenic adverse reactions including myasthenia, myositis especially in patients at risk factors such as patients over 65 years old, patients with uncontrolled hypothyroidism, patients with renal disease. Therapy with the drug under close monitoring is required.
Before instituting therapy with atorvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors.
Liver dysfunction: Persistent elevations in serum transaminases. It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (eg, semiannually) thereafter.
Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
It is recommended that liver function tests should be performed before the initiation of Lipistad and thereafter when clinically indicated.
Skeletal muscle: Uncomplicated myalgia has been reported in atorvastatin-treated patients. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Atorvastatin therapy should be discontinued if markedly elevated creatine phosphokinase levels occur or myopathy is diagnosed or suspected.
Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).
Use in Children: Safety and efficacy of atorvastatin have not been evaluated in prepubertal children or in children younger than 10 years of age.