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1-888-INFO-FDA (1-888-463-6332) Contact FDA. Approval: 1991 -----RECENT MAJOR CHANGES -----Dosage and Administration Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of Niacin-Containing Products (2. 2) • Patients who are currently tolerating the 80-mg dose of ZOCOR who need to be initiated on an interacting drug that is contraindicated or. According to Herper, quoting FDA statistics, 2. 1) and Use in Specific Populations (8. " Zocor is used to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood) The recommended dosage range of ZOCOR is 10 mg to 40 mg daily. ZOCOR1(simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. The drugs that will get the warning. WASHINGTON, March 19 (Reuters) - Patients on the highest approved dose of the cholesterol. ) and reports of increased blood sugar and glycosylated hemoglobin. 6)] * FDA sees greater muscle risk with high-dose Zocor * Warning is part of FDA review of statin risks. After oral ingestion, simvastatin, which is an inactive lactone, is. , for 12 months or more) without evidence of muscle toxicity. Regulators warned on Friday FDA-approved doses for the drug range from 5 milligrams to 80 milligrams. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction. : 019766/S026/S028 Approval Date: 7/10/1998. [2] It is also used to decrease the risk of heart problems in those at high risk. Patients on the highest approved dose of the cholesterol-lowering drug Zocor may be at increased risk of muscle injury, U. Use of the 80-mg dose of ZOCOR should be restricted to patients who have been taking simvastatin 80 mg chronically (e. Simvastatin is sold as a single-ingredient generic medication and under the brand-name Zocor. Increasing the levels of simvastatin in the body can increase the risk for myopathy (see Simvastatin Dose Limitations below). [3-19-2010] based on review of data from a large clinical trial and data from other sources, the u. After oral ingestion, simvastatin, which is an inactive. DESCRIPTION ZOCOR1(simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. Zocor is a brand name of simvastatin, approved by the FDA in the following formulation(s): ZOCOR (simvastatin - tablet;oral) Manufacturer: ORGANON Approval date: December 23, 1991 Strength(s): 5MG , 10MG , 20MG , 40MG ; Manufacturer: ORGANON. The federal safety agency said Tuesday it plans to add the diabetes-risk language to the "warnings and precautions" sections of labeling for the statin drugs. [2] It is used along with exercise, diet, and weight loss to decrease elevated lipid levels. Regulators warned on Friday Zocor/Simvastatin Tablets Company: Merck and Company, Inc. Simvastatin, sold under the brand name Zocor among others, is a statin, a type of lipid-lowering medication. See full prescribing information for ZOCOR. Food and drug administration (fda) is informing the public about an increased risk of muscle. Back to Top Drugs@FDA * FDA sees greater muscle risk with high-dose Zocor * Warning is part of FDA review of statin risks. 6)] Patients on the highest approved dose of the cholesterol-lowering drug Zocor may be at increased risk of muscle injury, U. 4 Recommended Dosage in Patients with Renal Impairment For patients with severe renal impairment [creatinine clearance (CLcr) 15 – 29 mL/min], the recommended starting dosage of simvastatin is 5 mg once daily [see Warnings and Precautions (5. Zocor belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. ZOCOR is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal. Were given a prescription for the Zocor or generic simvastatin last year. 1 million Americans were prescribed the 80-milligram dose of Zocor last year—either on its own or xenical buy in combination via a hybrid product such as. In March 2010, FDA announced it was reviewing the safety of simvastatin. Information about the potential for generally non-serious and reversible cognitive side effects (memory loss, confusion, etc. In June 2011, FDA restricted the use of the highest approved dose of simvastatin (80 mg) to. It is also sold in combination with ezetimibe as Vytorin, and niacin as Simcor. The recommended dosage range of ZOCOR is 10 mg to 40 mg daily.

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