No evidence of mutagenicity was observed in vitro in a microbial mutagenicity Ames test with Salmonella typhimurium and Escherichia coli with or without metabolic activation. No evidence of clastogenicity was observed in vitro in a chromosomal aberration assay in human peripheral blood lymphocytes with or without metabolic activation.
In addition, there was no evidence of genotoxicity in the in vivo mouse micronucleus test. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Ezetimibe crossed the placenta when pregnant rats and rabbits were given multiple oral doses. Multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis result in higher ezetimibe and statin exposures.
Reproductive findings occur at lower doses in combination therapy compared to monotherapy. All statins are contraindicated in pregnant and nursing women. When ZETIA is administered with a statin in a woman of childbearing potential, refer to the pregnancy category and product labeling for the statin.
In rat studies, exposure to total ezetimibe in nursing pups was up to half of that observed in maternal plasma. A nutrient-rich diet and weekly exercise contribute to increased HDL levels. About Zetia Can be taken with or without food.
Keep out of reach of children and pets. Do not take more Zetia that you need to. Do not take Zetia unless it was prescribed by your doctor. Do not give someone else unprescribed Zetia or any other medications, even if they experience similar symptoms, as it could harm them.
Tell your doctor about all other medications you are taking including prescription and over-the-counter drugs, vitamins, supplements, and herbal remedies. Zetia can interact with certain medications. Continue to eat a low-cholesterol diet and to ask your doctor for nutritional advice. Schedule regular blood tests with your doctor to determine cholesterol levels.
Zetia can be taken alone or with another cholesterol medication. Tell your doctor if you are pregnant, nursing, or thinking of becoming pregnant. You should not take Zetia with another statin medication if you are pregnant or breastfeeding, as this can seriously harm your unborn baby.
Store your medication at room temperature in a cool, dark, dry area. To get the maximum benefit of Zetia, use regularly. If you miss a dose, take it as soon as you remember. Do not take a double dose to catch up. In the event of an overdose, contact poison control or seek immediate medical attention. Inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.
If you notice other effects not listed above, contact your doctor. Drug interactions Tell your doctor about all other medications you use, especially: Interaction between two medications does not always mean that you must stop taking one of them. Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking. Missed dose Take the missed dose as soon as possible.
Skip the missed dose if it is time for your next scheduled dose. Don't take extra medicine to make up the missed dose. Overdose The overdose symptoms are unknown. If you think you have overdosed the medicine seek emergency medical help at once.
Storage Store the medicine at room temperature between degrees F degrees C away from light and moisture.
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