Lipistad 20

Rx

Indications:

• The treatment of primary hypercholesterolemia (heterozygous familial & non-familial hypercholesterolemia), mixed hyperlipidemia (Fredrickson types IIa & IIb), elevated serum triglyceride levels (Fredrickson type IV) and dysbetalipoproteinemia (Fredrickson type III) that patients do not respond adequately to diet.
• The treatment of homozygous familial hypercholesterolaemia.
• Prevention of cardiovascular complications in adult patients without clinically evident cardiovascular disease, and with or without dyslipidemia, but with multiple risk factors for coronary heart disease or a family history of early coronary heart disease.
• Prevention of cardiovascular complications in adult patients with clinically evident coronary heart disease.
• The treatment of heterozygous familial hypercholesterolemia in boys and postmenarchal girls, 10 to 17 years of age.

Dosage:

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 underlying medical problems. The patient should continue on a standard cholesterol-lowering diet during treatment with atorvastatin.

Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia: 10 mg once a day.

Homozygous familial hypercholesterolaemia: 10 to 80 mg daily. Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable.

Prevention of cardiovascular diseases: 10 mg/day.

Paediatric population with heterozygous familial hypercholesterolemia:

• ≥ 10 years of age: The starting dose is 10 mg per day. The dose may be increased to 80 mg daily.
• < 10 years of age: Atorvastatin is not indicated.

For patients taking drugs that interact with atorvastatin:

• Cyclosporin, tipranavir, ritonavir, telaprevir: Therapy with atorvastatin should be avoided.
• Lopinavir + ritonavir: caution should be used when prescribing atorvastatin and the lowest dose necessary employed.
• Clarithromycin, itraconazole, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir, fosamprenavir + ritonavir: therapy with atorvastatin should be limited to 20 mg, and appropriate clinical assessment is recommended.
• Nelfinavir, boceprevir: therapy with atorvastatin should be limited to 40 mg, and appropriate clinical assessment is recommended.

Usage:

Lipistad 20 is administered orally. Atorvastatin can be taken at any time of the day, with or without food.

• Hypersensitivity to any of the active substance or excipients.
• With active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (ULN).
• During pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazard to the foetus.

The most common adverse reactions thought to be related to atorvastatin are nasopharyngitis, allergic reactions, hyperglycaemia, headache, pharyngolaryngeal pain, constipation, flatulence, dyspepsia, nausea, diarrhea, myalgia, arthralgia, pain in extremity. Other uncommon adverse reactions include hypoglycaemia, weight gain, anorexia, nightmare, insomnia, dizziness, dysgeusia, vision blurred, tinnitus, urticaria, skin rash, pruritus, alopecia.

Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Atorvastatin is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases.

A CPK 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. If CPK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started. Atorvastatin therapy should be discontinued if markedly elevated CPK 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.

When patients are receiving medicinal products that increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins (e.g. cyclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc), a lower maximum dose of atorvastatin is recommended.