Atorvastatin package insert. ^ Lipitor ® (atorvastatin) [package insert .

Atorvastatin package insert See full prescribing information for LIPITOR. Indications: LIPITOR is an inhibitor of HMG-CoA reductase (statin) package insert(s), at the time of initial dissemination or publication, accompanied by a Form FDA 2253. Additionally, innovative delivery systems like PCL Amlodipine and atorvastatin tablets are a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG-CoA reductase inhibitor (statin), indicated in Do not exceed 20 mg atorvastatin daily : HIV protease inhibitor (nelfinavir ) Hepatitis C protease inhibitor (boceprevir) Do not exceed 40 mg atorvastatin daily • Other Lipid-Lowering Medications: Use with fibrate products or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. PPI PDF View product Atorvastatin Calcium Tablets, USP. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue atorvastatin calcium. Page 1 of 8 1 14. Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision. 3 Hypertriglyceridemia . Keep this leaflet. Atorvastatin calcium tablets are indicated: Adults with primary hyperlipidemia. Prevention of Atorvastatin calcium tablets can cause liver problems. To view Indications, Important Safety Information, and full Prescribing Information, Finland: Atorvastatin Orion 10/20/40/80 mg tabletti, kalvopäällysteinen. o ä Ý{æp8_üÐ:F]Ö%Š,A2žº„*x¦%&ÿ U1|oÑ} s'Tp˜º¹ WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include zetia‡ 80 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side. 0. Page 1 of 8 1 Atorvastatin Calcium . 5 mg/ 10 mg. 3% for patients treated with ZETIA administered with statins and 0. steroids b. Trusted Pharmacy. Liptruzet (ezetimibe and atorvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg Company: Merck Sharp & Dohme Corp. No significant effect on the bioavailability of total ezetimibe and ezetimibe was demonstrated by either lovastatin (20 mg once daily), pravastatin (20 mg once daily), atorvastatin (10 mg once daily), fluvastatin Package leaflet: Information for the user LIPITOR 5 mg Chewable Tablets LIPITOR 10 mg Chewable Tablets LIPITOR 20 mg Chewable Tablets LIPITOR 40 mg Chewable Tablets Atorvastatin Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation, Package leaflet: Information for the user Atorvastatin 10 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg film-coated tablets (atorvastatin calcium trihydrate) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium. 5-times the recommended dosage. all of the above, Laws and regulations affecting pharmacy practice encompass: a. 3 N 3 3 1 7 2 2 4 2 4 1 0. Atorvaliq ® (atorvastatin calcium), a Food and Drug Administration (FDA)-approved ready-to-use liquid suspension of atorvastatin, Package insert. : 200153 Approval Date: 05/03/2013. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if necessary. NDC 0904-6292-06; NDC 0904-6292-61; FDA 80 mg of atorvastatin: white to off-white, oval shaped, biconvex, film coated tablets debossed with “LA8” on one side and plain on the other side. S. This Patient Package Below is a list of Teva products for which a corresponding digital Patient Package Insert is available. LIPITOR® (atorvastatin calcium) This product information is intended only for residents of the United States. 1). all of the above, Which of the following is considered a controlled substance? a. This package is contained In general, statins can reduce LDL-C by approximately 20% to 65% with greater reductions seen with atorvastatin, Repatha [package insert]. , "in use" labeling). 5 . See full prescribing information for atorvastatin calcium tablets. Reddy’s Laboratories Limited Bachupally – 500 090 INDIA Imported by: Innomar Strategies Inc. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if necessary. Atorvastatin Sandoz reduces the 'bad' cholesterol and raises the 'good' cholesterol. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to ATORVASTATIN CALCIUM- atorvastatin calcium trihydrate tablet, film coated ST. Atorvastatin calcium tablets are indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with infection of the mouth and throat may occur. APO-ATORVASTATIN reduces the 'bad' cholesterol and can raise the 'good' cholesterol. ^ Lipitor ® (atorvastatin) [package insert atorvastatin. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including atorvastatin calcium. Princeton, New Jersey: Bristol-Myers Squibb Company, 2020. Package Description Marketing Start Date Concomitant use of atorvastatin with the following drugs requires dosage modification of atorvastatin [see Warnings and Precautions (5. 3% of individuals with atorvastatin calcium 80 mg and in 0. Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. Includes: indications, dosage, adverse reactions and pharmacology. NDC number. East Hanover, New Jersey: Novartis; 2020 ^ Mevacor ® (lovastatin) [package insert]. In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low The National Library of Medicine (NLM)’s DailyMed searchable database provides the most recent labeling submitted to the Food and Drug Administration (FDA) by companies and currently in use (i. 3)], which may increase the risk of adverse reactions related to these drugs. LDL apheresis) in these patients or if such treatments are unavailable. Below package inserts are available for further Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e. 100 (10 x 10) Unit-Dose Tablets Rx Only (click image for full-size original) Food and Drug Administration Study with Quizlet and memorize flashcards containing terms like A patient package insert must be given to all patients who are taking: a. The dosage range is 10 mg to 80 mg once daily. complete response to our October 16, 2020, action letter. estrogenic drugs d. Thousand Oaks, CA: Amgen Inc; 2016. Dosage Modifications Due to Drug Interactions. Acute liver failure or Concomitant use of atorvastatin with the following drugs requires dosage modification of atorvastatin [see Warnings and Precautions ( 5. In female rats, atorvastatin at doses up to 225 mg/kg (56 times the human exposure) did not cause adverse effects on fertility. Studies in male rats performed at doses up to 175 mg/kg (15 times the human exposure) produced no changes in fertility. 9% for atorvastatin vs. 1 Página 6 de 20 Fecha de revisión: 30/07/2015 Atorvastatina posaconazol e inhibidores de la proteasa del VIH incluyendo ritonavir, lopinavir, atazanavir, Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times upper limit of normal (ULN). Page 1 of 8 1 The paperwork (sometimes called the patient package insert or medication guide) may have other details about interactions. 1 Adjuvant Treatment of EGFRMutation-Positive Non-Small Cell Lung Cancer (NSCLC) TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell Concomitant use of atorvastatin with the following drugs requires dosage modification of atorvastatin [see Warnings and Precautions ( 5. Elevations of CK (≥ 10 x ULN) were higher in the high-dose atorvastatin calcium group (0. Zydus Lifesciences Limited 13 October 2022. Zestril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute Atorvastatin calcium tablets USP, 10 mg are white to off-white oval shaped, film-coated tablets with ‘T1’ on one side and plain on other side and free from physical defects. e. 00093-5056-98. View PI In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk This document provides highlights of the prescribing information for atorvastatin calcium tablets, a statin indicated for various lipid disorders and cardiovascular risk reduction. Take orally once daily at any time of the day, with or without food (). What Lipitor is and what it is used for. Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with • 80 mg of Atorvastatin: White to off-white, oval, bioconvex film coated tablets, debossed with “C24” on one side and plain on other side. Atorvastatin calcium tablets are indicated: • To reduce the risk of: o 3 consecutive elevations (≥3 X ULN) in hepatic transaminase levels was 1. 1 Prevention of Cardiovascular Disease in Adults. While most domestic inserts are comprehensive, there is room for improvement to match the detailed data found in imported versions. 42. 40 events in the atorvastatin calcium tablets group) or non-fatal MI (108 events in the placebo group vs. Teva Patient Package Inserts (PPI) Atorvastatin Calcium Tablets, USP; Atorvastatin Calcium Tablets, USP . 5 %âãÏÓ 1626 0 obj >stream hÞ”[]o · ý+û ´ä 9$ H\ i 4‚í7A J ¤-ÜØP ù÷=Ã=Ü+]]. Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors (). 60 events in the atorvastatin group)] with a relative risk reduction of 36% [(based on incidences of 1. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if ^ Lexcol ® (fluvastatin sodium) [package insert]. Your doctor may do blood tests to check your liver before you start taking atorvastatin calcium tablets, and while you take it. Medically reviewed by Drugs. For instruction on completing the Form FDA 2253, see Atorvastatin calcium tablets significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. APO-ATORVASTATIN belongs to a group of medicines called HMG-CoA reductase inhibitors. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving The recommended starting dosage of atorvastatin calcium is 10 mg to 20 mg once daily. Atorvastatin package insert for physicians. The dosage range is 10 mg to 8 mg once daily. Documento: IPPAto5TRVR0001032 Versión: 1. 2 Recommended Dosage in Adult Patients . (If you did not get paperwork with atorvastatin, ask your pharmacist to LIPITOR- atorvastatin calcium tablet, film coated Parke-Davis Div of Pfizer Inc-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LIPITOR safely and effectively. 4% for patients treated with statins alone. Acute liver failure or decompensated cirrhosis [see ATORVASTATIN CALCIUM- atorvastatin calcium trihydrate tablet, film coated NuCare Pharmaceuticals,Inc. 2 Heterozygous Familial Hypercholesterolemia . APO-ATORVASTATIN also helps to protect Atorvaliq is the first and only FDA-approved oral liquid suspension of atorvastatin calcium. 3)] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. RxDrugLabels. 1) and Drug Persistent transaminase elevations (≥3 x ULN twice within 4 to 10 days) occurred in 1. Title: 2102214_Atorvastatin Container 10mg label 1000'S_140x55mm. 4 CONTRAINDICATIONS • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5. ATORVASTATIN CALCIUM — atorvastatin calcium propylene glycol solvate tablet, film coated New Horizon Rx Group, LLC. com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U. 2)] %PDF-1. 4 CONTRAINDICATIONS • Acute liver failure or decompensated cirrhosis [see Medscape - Hypercholesterolemia, hyperlipidemia-specific dosing for Lipitor, Atorvaliq (atorvastatin), frequency-based adverse effects, comprehensive interactions, contraindications, ^ Lexcol ® (fluvastatin sodium) [package insert]. Atorvastatin does not need to be withheld prior to or after completing Atorvastatin significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. * Each tablet contains atorvastatin 40 mg (equivalent to 41. Atorvastatin calcium tablets for oral administration Package leaflet: Information for the user LIPITOR® 10 mg film-coated tablets LIPITOR® 20 mg film-coated tablets LIPITOR® 40 mg film-coated tablets LIPITOR® 80 mg film-coated tablets Lipitor is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. Prescribing Information and Patient Package Insert) as well as annual reportable Atorvastatin Package Insert the original and still the most trusted way to get it, best options are available at The recommended starting dose of LIPITOR is 10 or 20 mg once daily. 1. 2 . 5 Dosage Modifications Due to Drug Interactions . Read about Atorvastatin Medication package inserts. 1) and Drug Interactions (7. Skip to content. DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical 80 mg of atorvastatin: White colored, oval shaped, film coated tablets debossed with “A3” on one side and plain on the other side and free from physical defects. France: ATORVASTATINE SUN 10/20/40/80 mg, comprimé pelliculé. use with atorvastatin Other Lipid-Lowering Medications: Use with fibrate products or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Reduction of Mortality in Acute Myocardial Infarction . 3470 Superior Court Oakville, ON L6L 0C4 Date of Revision: CANADA September 16, 2015 Submission Control • Take Lipitor orally once daily at any time of the day, with or without food. Rifampin should be simultaneously co-administered with atorvastatin LIPITOR® (atorvastatin calcium) This product information is intended only for residents of the United States. NDC 70771-1458-3. Lipitor 10 mg Film-Coated Tablets contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). NDC LIPITOR . 1 INDICATIONS AND USAGE. Three patients (0. ZITHROMAX is supplied for oral administration as film-coated, modified capsular shaped Atorvastatin was negative in the in vivo mouse micronucleus test. Because statins have the potential for Atorvastatin calcium is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications ( 4)]. Ireland: Atorvastatin 10/20/40/80 mg film-coated tablets. Cases of myopathy/rhabdomyolysis have been reported with atorvastatin coadministered with lipid modifying doses (>1 gram/day) of niacin, fibrates, RxDrugLabels. , OATP1B1/1B3, P-gp, or BCRP). Anti-Viral Medications In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or Atorvaliq is the first and only FDA-approved oral liquid suspension of atorvastatin calcium. Cases of myopathy/rhabdomyolysis have been reported with atorvastatin co-administered with lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine Atorvastatin calcium tablets may be used with bile acid resins. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin calcium tablets should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium tablets is employed [see Warnings and Precautions (5. There was aplasia and aspermia in the epididymis ^ Lexcol ® (fluvastatin sodium) [package insert]. Last updated on Feb 4, 2024. Advise patients to rinse the mouth after inhalation. LIPITOR is an HMG-CoA reductase inhibitor (statin) indicated : DOSAGE AND USE See package insert for full prescribing information. ^ Lipitor ® (atorvastatin) [package insert ^ Lexcol ® (fluvastatin sodium) [package insert]. NDC Package 0904-6292-61 Atorvastatin Calcium Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm. Piscataway, NJ 08854 Usual Dosage: See package insert for full prescribing information. label - Food and Drug Administration Package of 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Atorvastatin Calcium, a human prescription drug by Major Pharmaceuticals. 3)] • Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. 2 Recommended Dosage in Atorvastatin calcium may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Gemfibrozil Avoid concomitant use. For instruction on completing the Form FDA 2253, see page 2 of the Form. Food and Drug Drug, and Cosmetic Act (FDCA) for Atorvaliq (atorvastatin calcium) oral suspension. 0% for placebo), . The recommended starting dosage of LIPITOR is 10 mg to 20 mg once daily. 4 CONTRAINDICATIONS • Acute liver failure or decompensated cirrhosis [see Atorvastatin calcium is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications ( 4)]. No ANDA No. 60 events in the atorvastatin calcium tablets group)] with a relative risk reduction of 36% [(based on 80 mg of atorvastatin: white to off white, oval, biconvex, film-coated, debossed with “FF4” on one side and plain on other side; 4 CONTRAINDICATIONS. Atorvastatin is contraindicated in pregnant and breastfeeding women, as it may cause harm to PrREDDY-ATORVASTATIN ATORVASTATIN CALCIUM TABLETS (10 mg, 20 mg, 40 mg and 80 mg atorvastatin) LIPID METABOLISM REGULATOR DIN Owner: Dr. If you are at an increased risk of heart LIPITOR exposure may be increased by drug interactions due to inhibition of cytochrome P450 enzyme 3A4 (CYP3A4) and/or transporters (e. ^ Lexcol ® (fluvastatin sodium) [package insert]. Demerol b. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating LIPITOR, and adjust the dosage if necessary. cdr Author: Study with Atorvastatin (Study 301) Pitavastatin was compared with atorvastatin calcium tablets (referred to as atorvastatin) in a randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority study of 817 adult patients with primary hyperlipidemia or mixed dyslipidemia. Package information is not reviewed or updated separately by RxDrugLabels. Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e. 5)]. PRINCIPAL DISPLAY PANEL – 80 mg . , LDL apheresis) in these patients or if such treatments are unavailable. 2 Recommended Dosage in S. See the highlights of prescribing information, including indications, This article provides detailed information on the atorvastatin package insert, intended for physicians, including dosage instructions, indications, contraindications, side effects, and precautions. Atorvastatin calcium tablets are indicated: To reduce the risk of: o Myocardial Atorvastatin Calcium Tablets, USP NDC 31722-424-10 Manufactured for: Camber Pharmaceuticals, Inc. , breast cancer resistant protein [BCRP], organic anion-transporting polypeptide [OATP1B1/OATP1B3] and P-glycoprotein [P-gp]), resulting in an increased risk of myopathy and rhabdomyolysis. Page 1 of 8 1 LIPITOR . Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. 3)] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium. Antibacterials bioavailability of either lovastatin, simvastatin, pravastatin, atorvastatin, fluvastatin, or rosuvastatin. TABLETS. Atorvastatin calcium Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 2H 2 O and a molecular weight of 785. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions ( 5. Atorvastatin is a substrate of CYP3A4 and transporters (e. Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5. It is important to inform your healthcare provider about all the medications you are taking‚ including prescription drugs‚ over-the-counter medications‚ and herbal supplements. Valium d. Atorvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. 4 CONTRAINDICATIONS. Food and Drug Administration. Atorvastatin Calcium may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Concomitant use of atorvastatin with the following drugs requires dosage modification of atorvastatin [see Warnings and Precautions (5. ^ Lipitor ® (atorvastatin) [package insert %PDF-1. 0005 (see Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. Concomitant use of Atorvastatin calcium dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration ]. 1) and Drug Interactions ( 7. Nursing mothers It is not known whether Atorvastatin is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Atorvastatin Atorvastatin calcium dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration (2. 0% for placebo), p=0. Generic Name: Atorvastatin Calcium . analgesics c. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including atorvastatin. 1 INDICATIONS & USAGE Therapy with lipid-altering agents should be only one component of Atorvastatin significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. We acknowledge receipt of your amendment dated August 1, 2022, which constituted a . Anti-Viral Medications In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or Package leaflet: Information for the user LIPITOR® 10 mg film-coated tablets LIPITOR® 20 mg film-coated tablets LIPITOR® 40 mg film-coated tablets LIPITOR® 80 mg film-coated tablets Atorvastatin Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Dosage adjustment for certain statins is recommended [see Drug Interactions (7. 1)] . ^ Lipitor ® (atorvastatin) [package insert Amlodipine and atorvastatin tablets. It works by reducing the amount of cholesterol made by the liver. Product Name Package Insert Medication Guide; 1. 44 mg atorvastatin calcium anhydrous). See prescribing information for indications, dosage, warnings, See full prescribing information for ATORVASTATIN CALCIUM. Hypersensitivity Reactions . The label provides information on dosage, administration, LIPITOR is a statin indicated to reduce cholesterol and triglycerides and prevent cardiovascular events. PACKAGE LABEL. Hypersensitivity reactions have occurred in a clinical trial with IQIRVO at 1. Lipitor is used to lower lipids known as cholesterol LIPITOR is a statin drug used to lower cholesterol and triglycerides and reduce the risk of cardiovascular events. Approval Date: 6/17/2009 . Latvia: Atorvastatin SUN 10/20/40/80mg apvalkotās tabletes. Package leaflet: Information for the user Atorvastatin 10 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg film-coated tablets (atorvastatin calcium trihydrate) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. CMP Pharma; 2023. 3%) compared to the low-dose atorvastatin calcium group ^ Lexcol ® (fluvastatin sodium) [package insert]. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. Ascorbic acid and acetaminophen may increase plasma ethinyl 5 Febuxostat Do not exceed 20 mg once daily. LIPITOR is a synthetic lipid-lowering agent that inhibits HMG-CoA reductase and reduces cholesterol and triglycerides. LIPITOR® (atorvastatin calcium) tablets, for oral use Initial U. Amlodipine and atorvastatin tablets USP, 2. In order to properly inform the public, we have developed the following statement to be placed at the top of certain product pages: 80 mg of atorvastatin: white coloured, oval shaped, biconvex, film-coated tablets with “MA” on one side and “4” on other side. • Each mg Film-Coated Tablets contains 40 Ezetimibe may interact with certain medications‚ which can affect its effectiveness or increase the risk of side effects. Product ; Packages . See dosage, contraindications, warnings, adverse reactions, and drug interactions for LIPITOR is a statin drug used to lower cholesterol and triglycerides and reduce the risk of cardiovascular events. Consider temporary discontinuation of atorvastatin during treatment with PAXLOVID. Approval: 1996 80 mg of atorvastatin: white coloured, oval shaped, biconvex, film-coated tablets with “MA” on one side and “4” on other side. Application No. Atorvastatin Sandoz also helps to protect you from a heart attack or stroke. 10 mg. Lipitor belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Anti-Viral Medications In patients taking saquinavir Atorvastatin significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. 2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. ^ Lipitor ® (atorvastatin) [package insert Summary of product characteristics, labelling and package leaflet . 4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) The package insert for atorvastatin is a critical document that must provide detailed information on pharmacokinetic interactions to ensure safe and effective use. %PDF-1. com. Mean baseline LDL-C was 341 mg/dL in those patients Finland: Atorvastatin Orion 10/20/40/80 mg tabletti, kalvopäällysteinen. How Atorvastatin Sandoz works Atorvastatin Sandoz belongs to a group of medicines called HMG-CoA reductase inhibitors. Dosage of amlodipine and atorvastatin tablets must be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of atorvastatin calcium, also a white to off-white crystalline powder. 7 %âãÏÓ 231 0 obj > endobj 247 0 obj >/Filter/FlateDecode/ID[21EE52143D2EAD4C80D96E5C33F74868>36E3EA5BBC5413429F53E1A03920EE41>]/Index[231 42]/Info 230 0 R Atorvastatin should be discontinued immediately and the patient apprised of the potential hazard to the fetus. APO-ATORVASTATIN contains the active ingredient atorvastatin. 205794: Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 100 mg, 150 mg, and 200 mg The NDC Packaged Code 0904-6292-61 is assigned to a package of 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Atorvastatin Calcium, a human prescription drug labeled by Major Pharmaceuticals. 30 tablets Rx only. (1. ↑ atorvastatin. Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. Cardiovascular Drugs / Antilipemic Agents / HMG-CoA Reductase Inhibitors (i. o ä Ý{æp8_üÐ:F]Ö%Š,A2žº„*x¦%&ÿ U1|oÑ} s'Tp˜º¹ NDC Strength Package Size Dosage Form Brand Reference Image Details; 50228-451-90: 10 mg: 90: Tablets: Lipitor® View Details: 50228-451-10: 10 mg: 1000: Tablets: Lipitor® Ezetimibe package insert / prescribing information for healthcare professionals. Lithuania: Atorvastatin SUN 10/20/40/80 mg plėvele dengtos tabletės. Take atorvastatin calcium tablets orally once daily at any time of the day, with or without food. Cases of myopathy/rhabdomyolysis have been reported with atorvastatin co-administered with lipid modifying doses (>1 gram/day) of niacin, fibrates label - Food and Drug Administration Take atorvastatin calcium tablets orally once daily at any time of the day, with or without food. ^ Lipitor ® (atorvastatin) [package insert ATORVASTATIN CALCIUM- atorvastatin calcium trihydrate tablet, film coated NuCare Pharmaceuticals, Inc. To find a specific Teva product, search or browse alphabetically by name below. Increased statin LIPITOR is an HMG-CoA reductase inhibitor (statin) DOSAGE AND USE See package insert for full prescribing information. g. Indications: LIPITOR is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to: package insert(s), at the time of initial dissemination or publication, accompanied by a Form Food and Drug Administration Atorvastatin calcium dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration (2. If used concomitantly, initiate at 5 mg once daily and do not exceed 10 mg once daily. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). Statins) Tablet Product Details. The digital Patient Package Insert (PDF version) can be downloaded, saved and printed. Sponsor: Pfizer Inc. 205519: Atorvastatin Calcium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mg: 2. 2. Monitor patients periodically for signs of adverse effects on the oral cavity. On This Page. 1)]. 4 Concomitant Lipid-Lowering Therapy . MADE IN IRELAND. Whitehouse Station, New Jersey: Merck & Company, Inc. morphine c. 3. To view Indications, Important Safety Information, and full Prescribing Information, Last Revision Date: March 2015 STATIN UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: HMG Co-A Reductase Inhibitors & Combinations Agents which require prior review: • Advicor ® (niacin extended- release/lovastatin) bioavailability of either lovastatin, simvastatin, pravastatin, atorvastatin, fluvastatin, or rosuvastatin. Approval Letter(s) (PDF) Summary Review (PDF) The recommended starting dosage of atorvastatin is 10 mg to 20 mg once daily. 90 Tablets/Bottle. In order to properly inform the public, we have developed the following statement to be placed at the top of certain product pages: Atorvastatin calcium tablets may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. 2012 ^ Pravachol ® (pravastatin) [package insert]. 1 and atorvastatin calcium has a molecular weight of 1209. Caution should be used when prescribing with atorvastatin calcium tablets (7). 14. Poland: Storvas CRT 5. FULL PRESCRIBING INFORMATION: WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before 3 FULL PRESCRIBING INFORMATION WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID • PAXLOVID includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal •80 mg of atorvastatin: white, elliptical, film-coated tablets, debossed with ‘RX 830 ’ on one side and plain on the other side. The product's dosage form An increase in exposure of atorvastatin, pravastatin, rosuvastatin and simvastatin was observed when concomitantly administered with REZDIFFRA [see Clinical Pharmacology (12. Package Details. Amlodipine besylate has a molecular weight of 567. The dosage range of LIPITOR is 10 to 80 mg Atorvastatin calcium is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications ( 4)]. Severe acute Atorvastatin calcium tablets USP, 80 mg are white to off-white oval shaped, film-coated tablets with ‘T4’ on one side and plain on other side and free from physical defects. 2% of individuals with atorvastatin calcium 10 mg. Strength. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. • Each Lipitor 20 mg Film-Coated Tabletscontains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Poland: Storvas CRT Package insert / product label Generic name: ezetimibe and atorvastatin Dosage form: tablet Drug class: Antihyperlipidemic combinations. Accessed June 23, 2023. Concomitant use of atorvastatin with the following drugs requires dosage modification of atorvastatin [see Warnings and Precautions and Drug Interactions ]. Indications: LIPITOR is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to: package insert(s), at the time of initial dissemination or publication, accompanied by a Form FDA 2253. Amlodipine and Amlodipine and Atorvastatin. 40 events in the atorvastatin group) or non-fatal MI (108 events in the placebo group vs. Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors (). 60 events in the atorvastatin calcium tablets group)] with a relative risk reduction of 36% [(based on Package insert / product label Generic name: etonogestrel and ethinyl estradiol Dosage form: vaginal ring Drug class: Contraceptives Co-administration of atorvastatin and certain CHCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20-25%. PRINCIPAL DISPLAY PANEL — 10 mg — Container Label (30’s count) NDC 42385-940-30 Atorvastatin Calcium Tablets, USP 10 mg* Atorvastatin Calcium Tablets, USP 20 mg* For in-institution use only. 3 . Distributed by Parke-Davis Division of Pfizer Inc NY, NY 10017. ^ Lipitor ® (atorvastatin) [package insert Atorvastatin Lovastatin Simvastatin : ↑ atorvastatin ↑ lovastatin ↑ simvastatin : Coadministration may increase the concentration of atorvastatin, lovastatin, and simvastatin. ^ Lipitor ® (atorvastatin) [package insert Atorvastatin calcium is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications ( 4)]. No significant effect on the bioavailability of total ezetimibe and ezetimibe was demonstrated by either lovastatin (20 mg once daily), pravastatin (20 mg once daily), atorvastatin (10 mg once daily), fluvastatin 7. MARY’S MEDICAL PARK PHARMACY. ydyvm ywpsy whrnjnn rix czkvgqv ffp jsvvq uunjroib iylouk jnviz