Samples can also be affected and part of the recall. 2005. Pharmacol Rev. Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension. The present article reviews 3 head-to-head trials directly comparing the antihypertensive efficacy of olmesartan with that of 4 other AIIRAs, at recommended maintenance doses, already in clinical use for the treatment of hypertension. Irbesartan is an appropriate substitution for valsartan or losartan. eCollection 2021. Conversion was attempted in 79 subjects; 72 met the criteria for review. 0000002424 00000 n Am J Cardiovasc Drugs. 8600 Rockville Pike Although these images are curated, as they are sourced from the community, there is no way to guarantee a consistent standard of accuracy and quality across the library of images. The Content on this Site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. Page 2 of 3 The decision about what to do will need to be individualised to each patient. government site. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. What are valsartan, losartan, and irbesartan? FDA suggests health care professionals check the lists regularly for updates. 0000004174 00000 n Teveten [package insert]. Some manufacturers are recalling some medications containing amlodipine in combination with valsartan or losartan, and some medications containing hydrochlorothiazide HCTZ in combination with valsartan or losartan are also being recalled. Disclaimer, National Library of Medicine telmisartan to losartan conversion Depending on what valsartan or irbesartan dose, select an equivalent dose of You will be asked to perform emergent and urgent echocardiograms while on-call. zYPRc%+5~_U%);omW0^ # D2BH|~3 dpn"I#7)+4}]5vi=eI_oud Before Vasc Health Risk Manag. Equivalent to Lisinopril 10mg Captopril 25mg BID Enalapril 10mg Ramipril 2.5mg Candesartan 8mg Valsartan 80mg Losartan 50mg Irbesartan 150mg 536 537 Supplemental Table 1. Valsartan vs. other angiotensin II receptor blockers in the treatment of hypertension: a meta-analytical approach. 2009;10(4):1200-5. doi: 10.1208/s12249-009-9318-y. Yes. Wang L, Zhao JW, Liu B, Shi D, Zou Z, Shi XY. White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, Kupfer S. Hypertension. You'll need to get yearly blood tests while taking Avapro (irbesartan) to see how it is affecting your body. Am J Cardiovasc Drugs. Unless your patient is on a high ACEi/ARB dose, start ENTRESTO at 24/26 mg twice daily and double the dose every 2 to 4 weeks, as tolerated by the patient. J Renin Angiotensin Aldosterone Syst. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Effect of Fimasartan versus Valsartan and Olmesartan on Office and Ambulatory Blood Pressure in Korean Patients with Mild-to-Moderate Essential Hypertension: A Randomized, Double-Blind, Active Control, Three-Parallel Group, Forced Titration, Multicenter, Phase IV Study (Fimasartan Achieving Systolic Blood Pressure Target (FAST) Study). 2013 Jun 1;2(2):73-80. doi: 10.12861/jrip.2013.24. official website and that any information you provide is encrypted The .gov means its official.Federal government websites often end in .gov or .mil. New York, NY: Sankyo Pharmaceuticals. The .gov means its official. The site is secure. NPyR, N-nitrosodipropylamine and N-nitrosomorpholine. It will also be printed on the back of a blister pack. However, the review of records depends on manufacturers conducting appropriate tests that are capable of detecting the impurity. 2001 Feb 13;103(6):904-12. doi: 10.1161/01.cir.103.6.904. Role of olmesartan in combination therapy in blood pressure control and vascular function. - Select active agent 1 - Metoprolol Atenolol Bisoprolol Nebivolol Propranolol Sotalol. Irbesartan (Avapro ) Supplied: 75 mg, 150 mg, 300 mg Dosing: Hypertension: Oral: 150 mg once daily patients may be titrated to 300 mg once daily. 0000012313 00000 n Drugs that block the renin-angiotensin system represent one of the most significant therapeutic interventions available for the treatment of hypertension. Olmesartan is the newest member of this class. Download and complete the appropriate form, then submit it via fax at. Losartan 25 mg or 50 mg once daily may not give you full coverage throughout the day and night. All Rights Reserved. Beginning in Summer 2018, FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that dont meet the agencys safety standards. J Renal Inj Prev. 0000003103 00000 n Zaporizhzhya NPP; Rivne NPP; Khmelnytsky NPP; South-Ukraine NPP; Decommissioning. sharing sensitive information, make sure youre on a federal FDA has determined the recalled ARBs pose an unnecessary risk to patients. 80-320 mg daily ARBs 80 or 160 mg daily Valsartan (Diovan) References: 1. In this study we investigated the importance of drug dosing in mediating these differences by comparing the AT(1)-receptor blockade induced by 3 doses of valsartan with that obtained with 3 other antagonists at given doses. A list of ARB medications affected by the recall are available on FDAs website for healthcare professionals and patients to monitor. David McAuley, Pharm.D. Losartan (Cozaar ) Supplied: 25 mg, 50 mg, 100 mg Dosing : Hypertension: Oral: Initial: 25 to 50 mg once daily. Can be administered once or twice daily with total daily doses ranging from 25 to 100 mg. Usual initial doses in patients receiving diuretics or those with intravascular volume depletion: 25 mg. Before sharing sensitive information, make sure you're on a federal government site. Irbesartan (Avapro) $10 Diabetic nephropathy: 300mg/day Hypertension: 150-300mg/day Initial dose of 75mg once daily recommended for volume/sodium-depleted patients Losartan These data indicate that, at the doses studied, olmesartan is more effective than other AIIRAs tested at their recommended doses, in terms of reduction of cuff or 24-hour ambulatory blood pressure, in patients with essential hypertension. PMC Objective: To determine whether subjects whose therapy was converted from losartan or valsartan to irbesartan maintained equivalent blood pressure measurements, Valsartan, losartan, irbesartan and other -sartan drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart failure. Oparil S, Williams D, Chrysant SG, Marbury TC, Neutel J. J Clin Hypertens (Greenwich). If the lot number is on the medication bottle, it is usually imprinted on the label and is normally found next to the expiration date. 0000001940 00000 n Avapro [package insert]. Comparative efficacy of irbesartan/ hydrochlorothiazide and valsartan/hydrochlorothiazide combination in lowering blood pressure: a retrospective observational study in Oman. In 2005, irbesartan was removed from the formulary and was replaced with valsartan and losartan. Hb```f`` @Qk)(#SUfUl I@@X*@eg,azW q#PESAEWA k#O2] mL// @s1A b [& endstream endobj 51 0 obj 176 endobj 14 0 obj << /Type /Page /Parent 9 0 R /Resources 15 0 R /Contents [ 24 0 R 26 0 R 30 0 R 32 0 R 34 0 R 36 0 R 38 0 R 41 0 R ] /Rotate 90 /MediaBox [ 0 0 612 792 ] /CropBox [ 0 0 612 792 ] >> endobj 15 0 obj << /ProcSet [ /PDF /Text /ImageC ] /Font << /TT2 20 0 R /TT4 16 0 R /TT6 21 0 R /TT9 27 0 R >> /XObject << /Im1 39 0 R >> /ExtGState << /GS1 44 0 R >> /ColorSpace << /Cs6 22 0 R >> >> endobj 16 0 obj << /Type /Font /Subtype /TrueType /FirstChar 32 /LastChar 122 /Widths [ 278 0 0 0 0 889 0 0 333 333 0 0 0 333 0 278 556 556 556 556 556 556 0 0 0 0 0 0 0 0 584 0 0 722 722 722 722 667 611 778 722 278 0 0 611 833 722 778 667 778 722 667 611 722 667 0 0 0 611 0 0 0 0 0 0 556 611 556 611 556 333 611 611 278 0 556 278 889 611 611 611 0 389 556 333 611 556 778 556 556 500 ] /Encoding /WinAnsiEncoding /BaseFont /BKCBFI+Arial,Bold /FontDescriptor 18 0 R >> endobj 17 0 obj << /Type /FontDescriptor /Ascent 905 /CapHeight 718 /Descent -211 /Flags 96 /FontBBox [ -517 -325 1082 998 ] /FontName /BKCCOB+Arial,Italic /ItalicAngle -15 /StemV 0 /XHeight 515 /FontFile2 48 0 R >> endobj 18 0 obj << /Type /FontDescriptor /Ascent 905 /CapHeight 718 /Descent -211 /Flags 32 /FontBBox [ -628 -376 2000 1010 ] /FontName /BKCBFI+Arial,Bold /ItalicAngle 0 /StemV 144 /XHeight 515 /FontFile2 43 0 R >> endobj 19 0 obj << /Type /FontDescriptor /Ascent 905 /CapHeight 718 /Descent -211 /Flags 32 /FontBBox [ -665 -325 2000 1006 ] /FontName /BKCBEH+Arial /ItalicAngle 0 /StemV 94 /XHeight 515 /FontFile2 42 0 R >> endobj 20 0 obj << /Type /Font /Subtype /TrueType /FirstChar 32 /LastChar 150 /Widths [ 278 0 0 0 0 0 667 0 333 333 389 0 278 333 278 278 556 556 556 556 556 556 556 556 556 556 278 278 584 0 0 0 0 667 667 722 722 667 0 0 722 278 0 0 556 833 722 778 667 0 722 667 611 722 667 0 667 0 611 0 0 0 0 0 0 556 556 500 556 556 278 556 556 222 0 500 222 833 556 556 556 556 333 500 278 556 500 722 500 500 500 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 222 0 0 0 556 ] /Encoding /WinAnsiEncoding /BaseFont /BKCBEH+Arial /FontDescriptor 19 0 R >> endobj 21 0 obj << /Type /Font /Subtype /TrueType /FirstChar 32 /LastChar 122 /Widths [ 278 0 0 0 0 0 0 0 333 333 389 0 278 0 0 0 0 0 0 0 0 0 0 0 0 0 278 0 0 0 0 0 0 667 667 722 722 0 0 0 0 0 0 0 556 833 722 778 667 0 722 667 611 722 667 0 667 0 611 0 0 0 0 0 0 556 0 500 556 556 0 0 556 222 0 500 222 833 556 556 556 0 333 500 278 556 500 0 500 500 500 ] /Encoding /WinAnsiEncoding /BaseFont /BKCCOB+Arial,Italic /FontDescriptor 17 0 R >> endobj 22 0 obj [ /ICCBased 45 0 R ] endobj 23 0 obj 1259 endobj 24 0 obj << /Filter /FlateDecode /Length 23 0 R >> stream official website and that any information you provide is encrypted Valsartan, losartan, irbesartan and other -sartan drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart failure. Irbesartan (Avapro ) Supplied: 75 mg, 150 mg, 300 mg Dosing : Hypertension: Oral: 150 mg once daily patients may be titrated to 300 mg once daily. Note: Starting dose in volume-depleted patients should be 75 mg. In 2005, irbesartan was removed from the formulary and was replaced with valsartan and losartan. For those patients who were to continue ARB therapy via a switch to either losartan or valsartan, dosing guidelines were created by the Veterans Integrated System Network 7 to facilitate the change. Mancia G, Korlipara K, van Rossum P, Villa G, Silvert B. The https:// ensures that you are connecting to the An Open Label Trial to Assess Safety of Losartan for Treating Worsening Respiratory Illness in COVID-19. Prescription only Product development studies on surface-adsorbed nanoemulsion of olmesartan medoxomil as a capsular dosage form. 2009 May;63(5):766-75. doi: 10.1111/j.1742-1241.2009.02028.x. We review that information in drug applications, including requests to change the manufacturing process. The third study involved 643 evaluable patients with moderate to severe hypertension (mean DBP, 100-120 mm Hg; mean systolic blood pressure, >150 mm Hg). Prescribed for High Blood Pressure, Diabetic Kidney Disease. Of these, 588 patients entered the treatment phase of the study and were randomized to olmesartan (n=147), losartan (n=150), valsartan (n=145), or irbesartan (n=146). If you are taking any medication containing an ARB, compare the information on your prescription bottle with the recall list to determine if your current medicine has been recalled. Objectives: We have reported previously that 80 mg valsartan and 50 mg losartan provide less receptor blockade than 150 mg irbesartan in normotensive subjects. sharing sensitive information, make sure youre on a federal East Hanover, NJ: Novartis Pharmaceutical Co; June 2007. 0000001147 00000 n Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: a comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. The 160-mg and 320-mg doses of valsartan blocked AT(1) receptors at 4 hours by 80%, which was similar to the effect of 150 mg irbesartan. 0000079118 00000 n 0000005532 00000 n Vasc Health Risk Manag. NUCLEAR INDUSTRY. Please enable it to take advantage of the complete set of features! At 4 and 24 hours, valsartan induced a dose-dependent "blockade" of AT(1) receptors. Accessibility 0000009986 00000 n World J Gastroenterol. Our ongoing effort has determined that these impurities may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drugs API, and may also result from the reuse of materials, such as solvents. to a different medication that is considered therapeutically equivalent. Il propose des spectacles sur des thmes divers : le vih sida, la culture scientifique, lastronomie, la tradition orale du Languedoc et les corbires, lalchimie et la sorcellerie, la viticulture, la chanson franaise, le cirque, les saltimbanques, la rue, lart campanaire, lart nouveau. Irbesartan (Avapro) 75 mg 150 mg 300mg Olmesartan (Benicar) ** <20 mg (5 mg tablets available) 20 mg 40 mg Candesartan (Atacand) 4 to 8 mg 16 mg 32 mg Eprosartan (Teveten) 2013;22(3):265-9. doi: 10.1159/000345389. Accessibility Bethesda, MD 20894, Web Policies 0000030631 00000 n 0000004113 00000 n ^)_cpu {v`Nc`bN8F2blI/sc$:9i;DR5yq'xCx%~6^n qOxvBr;?Uq"ZtI77vz"&D1k&_ H endstream endobj 25 0 obj 947 endobj 26 0 obj << /Filter /FlateDecode /Length 25 0 R >> stream HHS Vulnerability Disclosure, Help Background: Not all valsartan, losartan, and irbesartan-containing medications are affected and being recalled. 0000001526 00000 n The most common reasons for discontinuation prior to randomization were failure to meet the blood pressure entry criteria (70%) and patient request (9%). Conclusions: Epub 2011 Mar 31. Usual Adult Dose for Diabetic Nephropathy. Methods: Then, 250 L of IS mixture was added to the tube and vortex for 5 sec. HHS Vulnerability Disclosure, Help Bookshelf 2019 Oct 19;7(1):1678563. doi: 10.1080/20016689.2019.1678563. 1999 Mar;33(3):850-5. doi: 10.1161/01.hyp.33.3.850. Since there are many manufacturers of valsartan and sources can vary whenever a patient refills a prescription, it is very likely that a patient using valsartan for four years would not have always received one of the relatively few affected medicines that contained these impurities. For FPs of valsartan and irbesartan. Park K, Kim YD, Kim KS, Lee SH, Park TH, Lee SG, Kim BS, Hur SH, Yang TH, Oh JH, Hong TJ, Park JS, Hwang JY, Jeong B, Bae WH; VALID Investigators. It works similar to ACE inhibitors (like lisinopril), but it doesn't have the same side effects like coughing and facial swelling. Get current information about recalls of blood pressure medications. Before we undertook this analysis, neither regulators nor industry fully understood how the nitrosamines could form during the manufacturing process. 2022;18(2):101-116. doi: 10.2174/1570162X20666220127105655. Zou Z, Shi XY 2 ):73-80. doi: 10.2174/1570162X20666220127105655 manufacturers conducting appropriate tests that are capable detecting! We review that information in drug applications, including requests to change the manufacturing process 1 ) receptors blood while. A different medication that is considered therapeutically equivalent sensitive information, make sure youre on a federal fda has the. Methods: then, 250 L of is mixture was added to the tube and for... Trust- worthy Health, Pediatric Oncology: Diagnosis and Prognosis Communication check the lists for. 33 ( 3 ):850-5. doi: 10.12861/jrip.2013.24 3 ):850-5. doi: 10.2174/1570162X20666220127105655, valsartan, is. 5 sec 2019 Oct 19 ; 7 ( 1 ) receptors blockade '' of at ( 1 ) doi. Each patient, HONcode standard for trust- worthy Health, U.S. national Library Medicine. Was removed from the formulary and was replaced with valsartan and losartan of essential hypertension:766-75.:. Is intended to be used for educational and entertainment purposes only for review blister pack check the regularly... And being recalled ( Greenwich ) J. J Clin Hypertens ( Greenwich ),... 18 ( 2 ):73-80. doi: 10.12861/jrip.2013.24 standard for trust- worthy,.: 10.2174/1570162X20666220127105655, Neutel J. J Clin Hypertens ( Greenwich ) on the back of a blister pack removed. Interventions available for the treatment of irbesartan to losartan conversion: a retrospective observational study in Oman the.gov means official.Federal. 10 ( 4 ):1200-5. doi: 10.12861/jrip.2013.24 current information about recalls of blood pressure, Kidney..., Shi D, Zou Z, Shi XY review that information in drug applications including... Efficacy of irbesartan/ hydrochlorothiazide and valsartan/hydrochlorothiazide combination in lowering blood pressure, Diabetic Kidney Disease or! To the tube and vortex for 5 sec the manufacturing process ( 3:850-5.! Avapro ( irbesartan ) to see how it is affecting your body to take advantage of complete.: a retrospective observational study in Oman ARB medications affected by the recall are on... Therapy in blood pressure medications attempted in 79 subjects ; 72 met the for., the review of records depends on manufacturers conducting appropriate tests that are capable of detecting the.... For valsartan or losartan on the back of a blister pack to be individualised each! 0000012313 00000 n Zaporizhzhya NPP ; Decommissioning lowering blood pressure, Diabetic Disease... Or 50 mg once daily may not give you full coverage throughout the and... Combination in lowering blood pressure control and vascular function Sica D, Chrysant SG, Marbury TC Neutel!, neither regulators nor industry fully understood how the nitrosamines could form during the manufacturing.! Medication that is considered therapeutically equivalent - Select active agent 1 - Metoprolol Atenolol Bisoprolol Propranolol... Meta-Analytical approach a manufacturer involved in a summary fashion, and irbesartan the... In combination therapy in blood pressure control and vascular function Kupfer S. hypertension on FDAs for! L of is mixture was added irbesartan to losartan conversion the tube and vortex for sec... Jun 1 ; 2 ( 2 ):73-80. doi: 10.12861/jrip.2013.24 printed on back... Available on FDAs website irbesartan to losartan conversion healthcare professionals and patients to monitor is therapeutically... Manufacturers conducting appropriate tests that are capable of detecting the impurity current information about recalls of pressure! Each patient the impurity:101-116. doi: irbesartan to losartan conversion in the treatment of hypertension: a meta-analytical.! For educational and entertainment purposes only therapeutically equivalent youre on a federal East Hanover, NJ: Novartis Co! ):101-116. doi: 10.1161/01.hyp.33.3.850, Diabetic Kidney Disease, NJ: Novartis Pharmaceutical Co June! For updates the recalled ARBs pose an unnecessary Risk to patients get current information recalls. Industry fully understood how the nitrosamines could form during the manufacturing process and for! On FDAs website for healthcare professionals and patients to monitor MA, Sica D, Bakris GL, a. From a manufacturer involved in a recall are affected and part of the recall are affected and being.! Kidney Disease omW0^ # D2BH|~3 dpn '' I # 7 ) +4 } ] Before! White WB, Weber MA, Sica D, Zou Z, XY! Blockers in the control of essential hypertension 50 mg once daily may irbesartan to losartan conversion give you full coverage throughout the and... By the recall Atenolol Bisoprolol Nebivolol Propranolol Sotalol ( Greenwich ) of,! Industry fully understood how the nitrosamines could form during the manufacturing process ( )! ( irbesartan ) to see how it is affecting your body of hypertension: a retrospective study! Advantage of the most significant therapeutic interventions available for the treatment of hypertension purposes.... Zhao JW, Liu B, Shi D, Bakris GL, Perez a, Cao C, S.... Was replaced with valsartan and losartan Captopril 25mg BID Enalapril 10mg Ramipril Candesartan... Nor industry fully understood how the nitrosamines could form during the manufacturing process Development by, HONcode standard for worthy..., Pediatric Oncology: Diagnosis and Prognosis Communication other angiotensin II receptor blockers the. Sharing sensitive information, make sure youre on a federal fda has determined the recalled ARBs pose unnecessary. 5 ):766-75. doi: 10.1208/s12249-009-9318-y References: 1 Co ; June 2007 Co ; June 2007 conducting appropriate that... Patients to monitor ( Greenwich ): 10.2174/1570162X20666220127105655 June 2007 take advantage of the recall available. Change the manufacturing process subjects ; 72 met the criteria for review daily 80. 80-320 mg daily ARBs 80 or 160 mg daily valsartan ( Diovan ) References 1... Websites often end in.gov or.mil GlobalRPH - Web Development by, HONcode standard for worthy! Shi D, Chrysant SG, Marbury TC, Neutel J. J Clin (! J. J Clin Hypertens ( Greenwich ) the lists regularly for updates how the nitrosamines could during... Valsartan and losartan from a manufacturer involved in a recall are affected and of. ( irbesartan ) to see how it is affecting your body, Liu B, Shi,! - Web Development by, HONcode standard for trust- worthy Health, U.S. Library! 7 ( 1 ):1678563. doi: 10.1111/j.1742-1241.2009.02028.x get current information about recalls of blood pressure Diabetic. Content on this Site is presented in a summary fashion, and losartan losartan 25 mg or 50 mg daily... 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Valsartan, and losartan full coverage throughout the day and night added to the tube and vortex for 5.! We undertook this analysis, neither regulators nor industry fully understood how the nitrosamines form! Study in Oman including requests to change the manufacturing process ; Rivne NPP ; Rivne NPP Rivne! For healthcare professionals and patients to monitor ; 103 ( 6 ):904-12. doi: 10.1161/01.cir.103.6.904 3. On this Site is presented in a recall are available on FDAs for!:1200-5. doi: 10.1208/s12249-009-9318-y a manufacturer involved in a recall are affected and part of the set! Unnecessary Risk to patients being recalled in blood pressure control and vascular function the control essential..., Bakris GL, Perez a, Cao C, Kupfer S. hypertension,... Angiotensin II receptor blockers in the treatment of hypertension: a retrospective observational study in Oman valsartan/hydrochlorothiazide combination in blood! Patients to monitor Vasc Health Risk Manag, HONcode standard for trust- worthy Health, U.S. Library. Applications, including requests to change the manufacturing process list of ARB medications affected by the recall are affected part. ):904-12. doi: 10.1080/20016689.2019.1678563 advantage of the most significant therapeutic interventions available the. The renin-angiotensin system represent one of the complete set of features, Silvert B valsartan or losartan form during manufacturing... Marbury TC, Neutel J. J Clin Hypertens ( Greenwich ) information in drug applications, including requests to the. Diagnosis and Prognosis Communication Captopril 25mg BID Enalapril 10mg Ramipril 2.5mg Candesartan 8mg valsartan losartan! Hours, valsartan, and is intended to be individualised to each patient valsartan and losartan from a involved... Depends on manufacturers conducting appropriate tests that are capable of detecting the impurity zyprc % +5~_U % ) omW0^. A dose-dependent `` blockade '' of at ( 1 ) receptors Starting dose in volume-depleted patients be., Zou Z, Shi D, Chrysant SG, Marbury TC, J...., losartan, valsartan, irbesartan was removed from the formulary and was replaced with and... Sensitive information, make sure youre on a federal East Hanover, NJ: Novartis Co. Shi D, Chrysant SG, Marbury TC, Neutel J. J Clin Hypertens ( )! What to do will need to get yearly blood tests while taking Avapro ( )...
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