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Atorvastatin

CADUET (in combination) LIPITOR

Therapeutic Indications

Atorvastatin is indicated for:

Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old) Adults (18 years old or older)

Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 10 mg once a day

Heterozygous familial hypercholesterolaemia

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old) Adults (18 years old or older)

Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 10-80 mg once a day

Prevention of cardiovascular disease

Irrespective of gender only Adults (18 years old or older)

Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 10 mg once daily

Homozygous familial hypercholesterolaemia

Irrespective of gender only Adults (18 years old or older)

Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 10-80 mg daily

Contraindications

Active ingredient Atorvastatin is contraindicated in the following cases:

Hepatic insufficiency

No gender/age discrimination

Lactation

No gender/age discrimination

It is unknown whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breast-feed their infants. Atorvastatin is contraindicated during breast-feeding.

Pregnancy

No gender/age discrimination

Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Studies in animals have shown toxicity to reproduction.

Maternal treatment with atorvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolaemia.

For these reasons, Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant.

Glecaprevir, pibrentasvir

No gender/age discrimination

Atorvastatin is contraindicated in patients treated with the hepatitis C antivirals glecaprevir/pibrentasvir.

Active liver disease

No gender/age discrimination

Atorvastatin is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal.