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On 9 November 2012, Indian drugmaker Ranbaxy Laboratories Ltd. voluntarily recalled 10-, 20- and 40-mg doses of its generic version of atorvastatin in the United States. [ 135 ] [ 136 ] [ 137 ] The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, were recalled due to possible contamination with very small glass particles similar ...
Description - includes the proprietary name (if any), nonproprietary name, dosage form(s), qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information, such as physical constants ...
Ezetimibe/atorvastatin (trade names Liptruzet, Atozet) is a cholesterol lowering combination drug.In the United States, it was approved in May 2013, by the Food and Drug Administration for the treatment of elevated low-density lipoprotein (LDL) in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet. [1]
Guidelines by the American College of Cardiology and the American Heart Association recommend statin treatment for primary prevention of cardiovascular disease in adults with LDL cholesterol ≥ 190 mg/dL (4.9 mmol/L) or those with diabetes, age 40–75 with LDL-C 70–190 mg/dL (1.8–4.9 mmol/dL); or in those with a 10-year risk of developing ...
Ezetimibe lacks significant inhibitor or inducer effects on cytochrome P450 isoenzymes, which explains its limited number of drug interactions. No dose adjustment is needed in patients with chronic kidney disease or mild hepatic dysfunction (Child-Pugh score 5–6). Due to insufficient data, the manufacturer does not recommend ezetimibe for ...
The FDA warning, released again on 8 June 2011, suggested that high-dose "simvastatin should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury" and that it "should not be started in new patients, including patients already taking lower doses of the drug." [18]
Pravastatin was patented in 1980 and approved for medical use in 1989. [6] It is on the World Health Organization's List of Essential Medicines. [7] It is available as a generic medication. [5] In 2022, it was the 37th most commonly prescribed medication in the United States, with more than 16 million prescriptions. [8] [9]
It has been tested in clinical trials as single treatment and in combinations with atorvastatin, ezetimibe and fenofibrate. [ 4 ] [ 5 ] The US Food and Drug Administration (FDA) approved lomitapide in December 2012, as an orphan drug to reduce LDL cholesterol , total cholesterol , apolipoprotein B , and non-high-density lipoprotein (non-HDL ...
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