Atorvastatin Sandoz

Atorvastatin Sandoz Use In Pregnancy & Lactation

atorvastatin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma

Marketer:

Novartis
Full Prescribing Info
Use In Pregnancy & Lactation
Use in Pregnancy: Atorvastatin is contraindicated during pregnancy (see Contraindications). 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. Animal studies have shown toxicity to reproduction (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Maternal treatment with atorvastatin may reduce the fetal 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 (see Contraindications).
Use in Lactation: It is not known 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 (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Because of the potential for serious adverse reactions, women taking atorvastatin should not breast-feed their infants (see Contraindications). Atorvastatin is contraindicated during breastfeeding (see Contraindications).
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