Revision as of 10:34, 7 November 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Script assisted update of identifiers for the Chem/Drugbox validation project (updated: 'DrugBank').← Previous edit |
Latest revision as of 05:57, 26 December 2024 edit undoWhywhenwhohow (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers49,181 edits infobox |
(351 intermediate revisions by more than 100 users not shown) |
Line 1: |
Line 1: |
|
|
{{Short description|Nonsteroidal anti-inflammatory drug (NSAID)}} |
|
{{Drugbox |
|
|
|
{{Use dmy dates|date=May 2024}} |
|
| verifiedrevid = 419395255 |
|
|
|
{{cs1 config|name-list-style=vanc|display-authors=6}} |
|
| IUPAC_name = 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. |
|
|
|
{{Infobox drug |
|
| image = Meloxicam.svg |
|
|
|
| Verifiedfields = changed |
|
| width = 250 |
|
|
|
| Watchedfields = changed |
|
|
| verifiedrevid = 459437267 |
|
|
| image = Meloxicam2DACS.svg |
|
|
| width = 200 |
|
|
| alt = |
|
|
| image2 = Meloxicam-from-xtal-3D-bs-17.png |
|
|
| alt2 = |
|
|
| caption = |
|
|
|
|
|
<!--Clinical data--> |
|
<!-- Clinical data --> |
|
| tradename = Mobic |
|
| pronounce = |
|
|
| tradename = Mobic, others |
|
| Drugs.com = {{drugs.com|monograph|meloxicam}} |
|
| Drugs.com = {{drugs.com|monograph|meloxicam}} |
|
| MedlinePlus = a601242 |
|
| MedlinePlus = a601242 |
|
|
| DailyMedID = Meloxicam |
|
| pregnancy_US = C |
|
|
|
| pregnancy_AU = C |
|
| pregnancy_category = D in third trimester |
|
|
|
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{drugs.com|pregnancy|meloxicam}}</ref> |
|
|
| pregnancy_category = |
|
|
| routes_of_administration = ], ] |
|
|
| class = ] (NSAID) |
|
|
| ATC_prefix = M01 |
|
|
| ATC_suffix = AC06 |
|
|
| ATC_supplemental = {{ATC|M01|AC56}}, {{ATC|N01|BB59}} |
|
|
|
|
|
<!-- Legal status --> |
|
|
| legal_AU = S4 |
|
|
| legal_AU_comment = |
|
|
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C5, D1, D2, E, F1, F2, F3, F4 --> |
|
|
| legal_BR_comment = |
|
|
| legal_CA = Rx-only |
|
|
| legal_CA_comment = <ref>{{cite web | title=Health product highlights 2021: Annexes of products approved in 2021 | website=] | date=3 August 2022 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/appendices.html | access-date=25 March 2024}}</ref> |
|
|
| legal_DE = <!-- Anlage I, II, III or Unscheduled --> |
|
|
| legal_DE_comment = |
|
|
| legal_NZ = <!-- Class A, B, C --> |
|
|
| legal_NZ_comment = |
|
| legal_UK = POM |
|
| legal_UK = POM |
|
|
| legal_UK_comment = |
|
| legal_US = Rx-only |
|
| legal_US = Rx-only |
|
|
| legal_US_comment = <ref name="Mobic FDA label">{{cite web | title=Mobic- meloxicam tablet | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=676e73fb-51d2-449a-8749-1a7bcc257b11 | access-date=15 May 2021}}</ref><ref name="Anjeso FDA label">{{cite web | title=Anjeso- meloxicam injection | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f517ef8-9478-494e-adfd-4944b9900df4 | access-date=15 May 2021}}</ref> |
|
| routes_of_administration = Oral |
|
|
|
| legal_EU = Rx-only |
|
|
| legal_EU_comment = <ref>{{cite web | title=Loxitab EPAR | website=] (EMA) | date=8 September 2023 | url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/loxitab | access-date=24 May 2024}}</ref><ref>{{cite web | title=Metacam EPAR | website=European Medicines Agency (EMA) | date=31 July 2006 | url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/metacam | access-date=3 December 2024}}</ref><ref>{{cite web | title=Meloxidyl PI | website=Union Register of medicinal products | date=18 January 2007 | url=https://ec.europa.eu/health/documents/community-register/html/v070.htm | access-date=26 December 2024}}</ref> |
|
|
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> |
|
|
| legal_UN_comment = |
|
|
| legal_status = <!-- For countries not listed above --> |
|
|
|
|
|
<!--Pharmacokinetic data--> |
|
<!-- Pharmacokinetic data --> |
|
| bioavailability = 89% |
|
| bioavailability = 89%<ref name=drugs1996/> |
|
| protein_bound = 99.4% |
|
| protein_bound = 99.4%<ref name=drugs1996/> |
|
| metabolism = ] (] and ]-mediated) |
|
| metabolism = ] (] and ]-mediated)<ref name=drugs1996/> |
|
|
| metabolites = |
|
| elimination_half-life = 15 to 20 hours |
|
|
|
| onset = |
|
| excretion = Urine and faeces equally |
|
|
|
| elimination_half-life = 20 hours<ref name=drugs1996/> |
|
|
| duration_of_action = |
|
|
| excretion = ] and ] equally<ref name=drugs1996/> |
|
|
|
|
|
<!--Identifiers--> |
|
<!-- Identifiers --> |
|
| CASNo_Ref = {{cascite|correct|CAS}} |
|
|
| CAS_number_Ref = {{cascite|correct|??}} |
|
| CAS_number_Ref = {{cascite|correct|??}} |
|
| CAS_number = 71125-38-7 |
|
| CAS_number = 71125-38-7 |
|
| ATC_prefix = M01 |
|
|
| ATC_suffix = AC06 |
|
|
| PubChem = 5281106 |
|
| PubChem = 5281106 |
|
|
| IUPHAR_ligand = 7220 |
|
| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
|
| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
|
| DrugBank = DB00814 |
|
| DrugBank = DB00814 |
Line 37: |
Line 72: |
|
| KEGG_Ref = {{keggcite|correct|kegg}} |
|
| KEGG_Ref = {{keggcite|correct|kegg}} |
|
| KEGG = D00969 |
|
| KEGG = D00969 |
|
|
| ChEBI_Ref = {{ebicite|correct|EBI}} |
|
|
| ChEBI = 6741 |
|
| ChEMBL_Ref = {{ebicite|correct|EBI}} |
|
| ChEMBL_Ref = {{ebicite|correct|EBI}} |
|
| ChEMBL = 599 |
|
| ChEMBL = 599 |
|
|
| NIAID_ChemDB = |
|
|
| PDB_ligand = MXM |
|
|
| synonyms = |
|
|
|
|
|
<!--Chemical data--> |
|
<!-- Chemical and physical data --> |
|
|
| IUPAC_name = 4-Hydroxy-2-methyl-''N''-(5-methyl-2-thiazolyl)-2''H''-1,2-benzothiazine-3-carboxamide-1,1-dioxide |
|
| C=14 | H=13 | N=3 | O=4 | S=2 |
|
|
|
| C = 14 |
|
| molecular_weight = 351.403 g/mol |
|
|
|
| H = 13 |
|
| smiles = Cc1cnc(s1)NC(=O)C\3=C(/O)c2ccccc2S(=O)(=O)N/3C |
|
|
|
| N = 3 |
|
| InChI = 1/C14H13N3O4S2/c1-8-7-15-14(22-8)16-13(19)11-12(18)9-5-3-4-6-10(9)23(20,21)17(11)2/h3-7,18H,1-2H3,(H,15,16,19) |
|
|
|
| O = 4 |
|
| InChIKey = ZRVUJXDFFKFLMG-UHFFFAOYAR |
|
|
|
| S = 2 |
|
|
| SMILES = Cc1cnc(s1)NC(=O)C\3=C(/O)c2ccccc2S(=O)(=O)N/3C |
|
| StdInChI_Ref = {{stdinchicite|correct|chemspider}} |
|
| StdInChI_Ref = {{stdinchicite|correct|chemspider}} |
|
| StdInChI = 1S/C14H13N3O4S2/c1-8-7-15-14(22-8)16-13(19)11-12(18)9-5-3-4-6-10(9)23(20,21)17(11)2/h3-7,18H,1-2H3,(H,15,16,19) |
|
| StdInChI = 1S/C14H13N3O4S2/c1-8-7-15-14(22-8)16-13(19)11-12(18)9-5-3-4-6-10(9)23(20,21)17(11)2/h3-7,18H,1-2H3,(H,15,16,19) |
|
|
| StdInChI_comment = |
|
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} |
|
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} |
|
| StdInChIKey = ZRVUJXDFFKFLMG-UHFFFAOYSA-N |
|
| StdInChIKey = ZRVUJXDFFKFLMG-UHFFFAOYSA-N |
|
|
| density = |
|
|
| density_notes = |
|
|
| melting_point = |
|
|
| melting_high = |
|
|
| melting_notes = |
|
|
| boiling_point = |
|
|
| boiling_notes = |
|
|
| solubility = |
|
|
| sol_units = |
|
|
| specific_rotation = |
|
}} |
|
}} |
|
|
|
|
|
|
<!-- Definition and medical uses --> |
|
'''Meloxicam''' is a ] (NSAID) with ] and ] effects. It is a derivative of ], closely related to ], and falls in the ] group of NSAIDs.<ref name = drugs.com>{{cite web |
|
|
|
'''Meloxicam''', sold under the brand name '''Mobic''' among others, is a ] (NSAID) used to treat pain and inflammation in ]s and ].<ref name=BNF76>{{cite book|title=British national formulary: BNF 76|date=2018|publisher=Pharmaceutical Press|isbn=9780857113382|pages=1112–1113|edition=76}}</ref><ref name=AHFS2018/> It is taken by mouth or given by ].<ref name=AHFS2018>{{cite web |title=Meloxicam Monograph for Professionals |url=https://www.drugs.com/monograph/meloxicam.html |website=Drugs.com |publisher=AHFS |access-date=23 December 2018 |archive-date=23 December 2018 |archive-url=https://web.archive.org/web/20181223073727/https://www.drugs.com/monograph/meloxicam.html |url-status=live }}</ref><ref name="Anjeso PR" /> It is recommended that it be used for as short a period as possible and at a low dose.<ref name=AHFS2018/> |
|
| url = http://www.drugs.com/pro/meloxicam.html |
|
|
|
|
|
| work = Drugs.com |
|
|
|
<!-- Side effects and mechanism --> |
|
| accessdate = 17 March 2010 |
|
|
|
Common side effects include abdominal pain, dizziness, swelling, headache, and a rash.<ref name=AHFS2018/> Serious side effects may include ], ], kidney problems, and ]s.<ref name=AHFS2018/> Use is not recommended in the ].<ref name=AHFS2018/> It blocks ] (COX-2) more than it blocks ] (COX-1).<ref name=AHFS2018/> It is in the ] family of chemicals and is closely related to ].<ref name=AHFS2018/> |
|
| title = Meloxicam official FDA information, side effects, and uses |
|
|
|
|
|
| date = March 2010}}</ref> It was developed by ]. |
|
|
|
<!-- Society and culture --> |
|
|
Meloxicam was patented in 1977 and approved for medical use in the United States in 2000.<ref name=AHFS2018/><ref name=Fis2006>{{cite book | vauthors = Fischer J, Ganellin CR |title=Analogue-based Drug Discovery |date=2006 |publisher=John Wiley & Sons |isbn=9783527607495 |page=519 |url=https://books.google.com/books?id=FjKfqkaKkAAC&pg=PA519 |access-date=30 June 2020 |archive-date=10 July 2020 |archive-url=https://web.archive.org/web/20200710155623/https://books.google.com/books?id=FjKfqkaKkAAC&pg=PA519 |url-status=live }}</ref> It was developed by ] and is available as a ].<ref name=AHFS2018/> In 2022, it was the 29th most commonly prescribed medication in the United States, with more than 18{{nbsp}}million prescriptions.<ref>{{cite web | title=The Top 300 of 2022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=30 August 2024 | archive-date=30 August 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Meloxicam Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/Meloxicam | access-date = 30 August 2024 }}</ref> An intravenous version of meloxicam (Anjeso) was approved for medical use in the United States in February 2020.<ref>{{cite web | title=Anjeso- meloxicam injection | website=DailyMed | date=22 February 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f517ef8-9478-494e-adfd-4944b9900df4 | access-date=8 October 2022}}</ref><ref name="Anjeso PR" /> |
|
|
|
|
|
==Adverse effects== |
|
|
{{See also|Nonsteroidal anti-inflammatory drug}} |
|
|
|
|
|
Meloxicam use can result in ] toxicity and bleeding, headaches, rash, and ] (a sign of intestinal bleeding). It has fewer gastrointestinal side effects than ],<ref name="hawkey" /> ],<ref>{{cite journal | vauthors = Dequeker J, Hawkey C, Kahan A, Steinbrück K, Alegre C, Baumelou E, Bégaud B, Isomäki H, Littlejohn G, Mau J, Papazoglou S | title = Improvement in gastrointestinal tolerability of the selective cyclooxygenase (COX)-2 inhibitor, meloxicam, compared with piroxicam: results of the Safety and Efficacy Large-scale Evaluation of COX-inhibiting Therapies (SELECT) trial in osteoarthritis | journal = British Journal of Rheumatology | volume = 37 | issue = 9 | pages = 946–51 | date = September 1998 | pmid = 9783758 | doi = 10.1093/rheumatology/37.9.946 | doi-access = free | title-link = doi }}</ref> ],<ref>{{cite journal | vauthors = Wojtulewski JA, Schattenkirchner M, Barceló P, Le Loët X, Bevis PJ, Bluhmki E, Distel M | title = A six-month double-blind trial to compare the efficacy and safety of meloxicam 7.5 mg daily and naproxen 750 mg daily in patients with rheumatoid arthritis | journal = British Journal of Rheumatology | volume = 35 | issue = Suppl 1 | pages = 22–8 | date = April 1996 | pmid = 8630632 | doi = 10.1093/rheumatology/35.suppl_1.22 | doi-access = free | title-link = doi }}</ref> and perhaps all other NSAIDs which are not COX-2 selective.<ref name="hawkey">{{cite journal | vauthors = Hawkey C, Kahan A, Steinbrück K, Alegre C, Baumelou E, Bégaud B, Dequeker J, Isomäki H, Littlejohn G, Mau J, Papazoglou S | title = Gastrointestinal tolerability of meloxicam compared to diclofenac in osteoarthritis patients. International MELISSA Study Group. Meloxicam Large-scale International Study Safety Assessment | journal = British Journal of Rheumatology | volume = 37 | issue = 9 | pages = 937–45 | date = September 1998 | pmid = 9783757 | doi = 10.1093/rheumatology/37.9.937 | doi-access = free | title-link = doi }}</ref> |
|
|
|
|
|
In October 2020, the US ] (FDA) required the ] to be updated for all nonsteroidal anti-inflammatory medications to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.<ref name="FDA PR 20201015" /><ref name="FDA safety 20201015" /> They recommend avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy.<ref name="FDA PR 20201015">{{cite press release | title=FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications | website=U.S. ] (FDA) | date=15 October 2020 | url=https://www.fda.gov/news-events/press-announcements/fda-warns-using-type-pain-and-fever-medication-second-half-pregnancy-could-lead-complications | access-date=15 October 2020}} {{PD-notice}}</ref><ref name="FDA safety 20201015">{{cite web | title=NSAIDs may cause rare kidney problems in unborn babies | website=U.S. ] (FDA) | date=21 July 2017 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic | access-date=15 October 2020}} {{PD-notice}}</ref> |
|
|
|
|
|
===Cardiovascular=== |
|
|
Like other ]s, its use is associated with an increased risk of cardiovascular events such as ] and ].<ref>{{cite journal | vauthors = Stamm O, Latscha U, Janecek P, Campana A | title = Development of a special electrode for continuous subcutaneous pH measurement in the infant scalp | journal = American Journal of Obstetrics and Gynecology | volume = 124 | issue = 2 | pages = 193–195 | date = January 1976 | pmid = 2012 | doi = 10.1016/S0002-9378(16)33297-5 }}</ref> Although meloxicam inhibits formation of ] A, it does not appear to do so at levels that would interfere with ] function.<ref name="Zeidan2013">{{cite journal | vauthors = Zeidan AZ, Al Sayed B, Bargaoui N, Djebbar M, Djennane M, Donald R, El Deeb K, Joudeh RA, Nabhan A, Schug SA | title = A review of the efficacy, safety, and cost-effectiveness of COX-2 inhibitors for Africa and the Middle East region | journal = Pain Practice | volume = 13 | issue = 4 | pages = 316–331 | date = April 2013 | pmid = 22931375 | doi = 10.1111/j.1533-2500.2012.00591.x | s2cid = 205715393 }}</ref><ref name="Gates2005" /> A pooled analysis of randomized, controlled studies of meloxicam therapy of up to 60 days duration found that meloxicam was associated with a statistically significantly lower number of ] complications than the NSAID diclofenac (0.2% versus 0.8% respectively) but a similar incidence of thromboembolic events to naproxen and piroxicam.<ref name=Singh>{{cite journal | vauthors = Singh G, Lanes S, Triadafilopoulos G | title = Risk of serious upper gastrointestinal and cardiovascular thromboembolic complications with meloxicam | journal = The American Journal of Medicine | volume = 117 | issue = 2 | pages = 100–106 | date = July 2004 | pmid = 15234645 | doi = 10.1016/j.amjmed.2004.03.012 }}</ref> |
|
|
|
|
|
People with ], ], or ] are at risk for cardiovascular side effects. People with family history of heart disease, heart attack, or stroke should tell their treating physician as the potential for serious cardiovascular side effects is significant.<ref>{{cite web|url=https://www.nlm.nih.gov/medlineplus/druginfo/meds/a601242.html|title=Meloxicam|publisher=]|access-date=15 November 2014|archive-date=29 November 2014|archive-url=https://web.archive.org/web/20141129020509/http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601242.html|url-status=live}}</ref><ref>{{cite web|url=https://www.drugs.com/meloxicam.html|title=Meloxicam|publisher=]|access-date=15 November 2014|archive-date=16 November 2014|archive-url=https://web.archive.org/web/20141116214049/http://www.drugs.com/meloxicam.html|url-status=live}}</ref> |
|
|
|
|
|
===Gastrointestinal=== |
|
|
] cause an increase in the risk of serious ] adverse events including bleeding, ]ation, and perforation of the stomach or intestines, which can be fatal. Elderly patients are at greater risk for serious gastrointestinal events.<ref name="drugs.com" /> |
|
|
|
|
|
==Mechanism of action== |
|
==Mechanism of action== |
|
{{Main|Non-steroidal anti-inflammatory drug}} |
|
{{Main|Non-steroidal anti-inflammatory drug}} |
|
Meloxicam inhibits ] (COX), the ] responsible for converting ] into ]—the first step in the synthesis of ]s, which are mediators of inflammation. |
|
Meloxicam blocks ] (COX), the ] responsible for converting ] into ]—the first step in the synthesis of ]s, which are mediators of inflammation. |
|
Meloxicam has been shown, especially at its low therapeutic dose, selectively to inhibit COX-2 over COX-1.<ref name = noble>{{cite journal |
|
Meloxicam has been shown, especially at low ], to selectively inhibit ] over ].<ref name=drugs1996>{{cite journal | vauthors = Noble S, Balfour JA | title = Meloxicam | journal = Drugs | volume = 51 | issue = 3 | pages = 424–30; discussion 431–32 | date = March 1996 | pmid = 8882380 | doi = 10.2165/00003495-199651030-00007 | s2cid = 260452199 }}</ref> |
|
| doi = 10.2165/00003495-199651030-00007 |
|
|
| journal = Drugs |
|
|
| year = 1996 |
|
|
| month = Mar |
|
|
| volume = 51 |
|
|
| issue = 3 |
|
|
| pages = 424–30; discussion 431–32 |
|
|
| title = Meloxicam |
|
|
| last1 = Noble |
|
|
| first1 = S |
|
|
| last2 = Balfour |
|
|
| first2 = JA |
|
|
| pmid = 8882380}}</ref> |
|
|
|
|
|
|
Meloxicam concentrations in ] range from 40% to 50% of those in plasma. The free fraction in synovial fluid is 2.5 times higher than in plasma, due to the lower albumin content in synovial fluid as compared to plasma. The significance of this penetration is unknown,<ref name = drugs.com /> but it may account for the fact that it performs exceptionally well in treatment of arthritis in animal models.<ref>{{cite journal |
|
Meloxicam concentrations in ] range from 40% to 50% of those in ]. The free fraction in synovial fluid is 2.5 times higher than in plasma, due to the lower albumin content in synovial fluid compared to plasma. The significance of this penetration is unknown,<ref name=drugs.com>{{cite web|url= https://www.drugs.com/pro/meloxicam.html|publisher= Drugs.com|access-date= 17 March 2010|title= Meloxicam official FDA information, side effects, and uses|date= March 2010|archive-date= 16 March 2010|archive-url= https://web.archive.org/web/20100316170923/http://www.drugs.com/pro/meloxicam.html|url-status= live}}</ref> but it may account for the fact that it performs exceptionally well in treatment of arthritis in animal models.<ref>{{cite journal | vauthors = Engelhardt G, Homma D, Schlegel K, Utzmann R, Schnitzler C | s2cid = 37937305 | title = Anti-inflammatory, analgesic, antipyretic and related properties of meloxicam, a new non-steroidal anti-inflammatory agent with favourable gastrointestinal tolerance | journal = Inflammation Research | volume = 44 | issue = 10 | pages = 423–33 | date = October 1995 | pmid = 8564518 | doi = 10.1007/BF01757699 }}</ref> |
|
| first1 = G |
|
|
| last1 = Engelhardt |
|
|
| first2 = D |
|
|
| last2 = Homma |
|
|
| first3 = K |
|
|
| last3 = Schlegel |
|
|
| first4 = R |
|
|
| last4 = Utzmann |
|
|
| first5 = C |
|
|
| last5 = Schnitzler |
|
|
| title = Anti-inflammatory, analgesic, antipyretic and related properties of meloxicam, a new non-steroidal anti-inflammatory agent with favourable gastrointestinal tolerance |
|
|
| journal = Inflammation Research |
|
|
| volume = 44 |
|
|
| issue = 10 |
|
|
| month = Oct |
|
|
| year = 1995 |
|
|
| doi = 10.1007/BF01757699 |
|
|
| pages = 423–433 |
|
|
| pmid = 8564518}}</ref> |
|
|
|
|
|
|
|
==Pharmacokinetics== |
|
==Adverse effects== |
|
|
|
|
|
Meloxicam use can result in gastrointestinal toxicity and bleeding, ], blinding headaches, rash, and very dark or black stool (a sign of intestinal bleeding). It has fewer gastrointestinal side effects than ],<ref name = hawkey /> ],<ref>{{cite journal |
|
|
|
===Absorption=== |
|
| doi = 10.1093/rheumatology/37.9.946 |
|
|
|
The ] of meloxicam is decreased when administered orally compared to an equivalent IV bolus dose. Different oral formulations of meloxicam are not ].<ref name="AHFS2018" /> Use of oral meloxicam following a high-fat breakfast increases the mean peak drug levels by about 22%; however, the manufacturer does not make any specific meal recommendations. In addition, the use of ]s does not show pharmacokinetic interactions.<ref name="Mobic FDA label" /> With chronic dosing, the time to maximum plasma concentration following oral administration is approximately 5–6 hours.<ref name="Bekker 2018" /> |
|
| journal = The British Journal of Rheumatology |
|
|
|
|
|
| volume = 37 |
|
|
|
===Distribution=== |
|
| pages = 946–51 |
|
|
|
The mean volume of distribution of meloxicam is approximately 10 L. It is highly protein-bound, mainly to ].<ref name="Gates2005">{{cite journal | vauthors = Gates BJ, Nguyen TT, Setter SM, Davies NM | title = Meloxicam: a reappraisal of pharmacokinetics, efficacy and safety | journal = Expert Opinion on Pharmacotherapy | volume = 6 | issue = 12 | pages = 2117–2140 | date = October 2005 | pmid = 16197363 | doi = 10.1517/14656566.6.12.2117 | quote = Meloxicam is extensively bound to plasma proteins (99.4%), primarily to albumin. Meloxicam has an apparent volume of distribution (Vd) 10 – 15 L in humans (0.1 – 0.2 L/kg) after oral administration and a mean volume of distribution at steady-state of 0.2 L/kg after intravenous administration." <br />"None of the meloxicam treatment groups demonstrated inhibition of platelet aggregation to either arachidonic acid (AC) or adenosine diphosphate (ADP). However, there were no significant changes in the platelet count, prothrombin, and activated partial thromboplastin time in any of the meloxicam and indomethacin groups. Other crossover studies also confirmed that meloxicam 15 mg/day caused a major reduction of maximum thromboxane production, but no reduction in collagen- or AC-induced platelet aggregation. | s2cid = 25512189 }}</ref><ref name="Bekker 2018">{{cite journal | vauthors = Bekker A, Kloepping C, Collingwood S | title = Meloxicam in the management of post-operative pain: Narrative review | journal = Journal of Anaesthesiology Clinical Pharmacology | volume = 34 | issue = 4 | pages = 450–457 | date = 2018 | pmid = 30774225 | pmc = 6360894 | doi = 10.4103/joacp.JOACP_133_18 | doi-access = free | title-link = doi }}</ref> |
|
| year = 1998 |
|
|
|
|
|
| title = Improvement in gastrointestinal tolerability of the selective cyclooxygenase (COX)-2 inhibitor, meloxicam, compared with piroxicam: results of the Safety and Efficacy Large-scale Evaluation of COX- inhibiting Therapies (SELECT) trial in osteoarthritis |
|
|
|
===Metabolism=== |
|
| first1 = J |
|
|
|
Meloxicam is extensively metabolized in the liver by the enzymes ] and ] (minor) into four inactive metabolites. ] activity is thought to be responsible for the other two remaining metabolites.<ref name="Mobic FDA label" /><ref>{{Cite web|url=https://www.drugs.com/ppa/meloxicam.html|title=Meloxicam (Professional Patient Advice)|publisher=Drugs.com|access-date=6 August 2019|archive-date=6 August 2019|archive-url=https://web.archive.org/web/20190806165006/https://www.drugs.com/ppa/meloxicam.html|url-status=live}}</ref> |
|
| last1 = Dequeker |
|
|
|
|
|
| first2 = C |
|
|
|
===Excretion=== |
|
| last2 = Hawkey |
|
|
|
Meloxicam is predominantly excreted in the form of metabolites and occurs to equal extents in the urine and feces.<ref name="Mobic FDA label" /> Traces of unchanged parent drug are found in urine and feces.<ref name="Mobic FDA label" /> The mean elimination half-life ranges from 15 to 20 hours.<ref name="Mobic FDA label" /> |
|
| first3 = A |
|
|
|
|
|
| last3 = Kahan |
|
|
|
==Specific populations== |
|
| first4 = K |
|
|
|
|
|
| last4 = Steinbruck |
|
|
|
The use of meloxicam is not recommended in people with peptic ulcer disease or increased gastrointestinal bleeding risk, including those over 75 years of age or those taking medications associated with bleeding risk.<ref name=":0">{{cite journal | vauthors = ((2019 American Geriatrics Society Beers Criteria Update Expert Panel)) | s2cid = 59338182 | title = American Geriatrics Society 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults | journal = Journal of the American Geriatrics Society | volume = 67 | issue = 4 | pages = 674–694 | date = April 2019 | pmid = 30693946 | doi = 10.1111/jgs.15767 }}</ref> |
|
| first5 = C |
|
|
|
|
|
| last5 = Alegre |
|
|
|
Adverse events are dose-dependent and associated with length of treatment.<ref name=":0" /><ref name="Mobic FDA label" /> |
|
| first6 = E |
|
|
| last6 = Baumelou |
|
|
| first7 = B |
|
|
| last7 = Begaud |
|
|
| first8 = H |
|
|
| last8 = Isomaki |
|
|
| first9 = G |
|
|
| last9 = Littlejohn |
|
|
| pmid=9783758 |
|
|
| issue = 9 |
|
|
}}</ref> ],<ref>{{cite journal |
|
|
| journal = Rheumatology |
|
|
| volume = 35, Supplement 1 |
|
|
| pages = 22–8 |
|
|
| title = A Six-Month Double-Blind Trial to Compare the Efficacy and Safety of Meloxicam 7.5 mg Daily and Naproxen 750 mg Daily in Patients with Rheumatoid Arthritis |
|
|
| first1 = JA |
|
|
| last1 = Wojtulewski |
|
|
| first2 = M |
|
|
| last2 = Schattenkirchner |
|
|
| first3 = P |
|
|
| last3 = Barceló |
|
|
| first4 = X |
|
|
| last4 = Le Loët |
|
|
| first5 = PJR |
|
|
| last5 = Bevis |
|
|
| first6 = E |
|
|
| last6 = Bluhmki |
|
|
| first7 = M |
|
|
| last7 = Distel}}</ref> and perhaps all other NSAIDs which are not COX-2 selective.<ref name = hawkey>{{cite journal |
|
|
| title = Gastrointestinal tolerability of meloxicam compared to diclofenac in osteoarthritis patients |
|
|
| last1 = Hawkey |
|
|
| first1 = C |
|
|
| last2 = Kahan |
|
|
| first2 = A |
|
|
| last3 = Steinbrü |
|
|
| first3 = K |
|
|
| last4 = Alegre |
|
|
| first4 = C |
|
|
| last5 = Baumelou |
|
|
| first5 = E |
|
|
| last6 = Bégaud |
|
|
| first6 = B |
|
|
| last7 = Dequeker |
|
|
| first7 = J |
|
|
| last8 = Isomäki |
|
|
| first8 = H |
|
|
| last9 = Littlejohn |
|
|
| first9 = G |
|
|
| journal = Rheumatology |
|
|
| volume = 37 |
|
|
| issue = 9 |
|
|
| month = Sept |
|
|
| year = 1998 |
|
|
| pages = 937–45(9)}}</ref> Although meloxicam does inhibit ] A, it does not appear to do so at levels that would interfere with ] function. |
|
|
|
|
|
|
==Veterinary use== |
|
==Veterinary use== |
|
Meloxicam is also used in the ] field, most commonly in dogs, but also sees ] in other animals such as cattle, cats and exotics. <ref>Off-label use discussed in: Arnold Plotnick MS, DVM, ACVIM, ABVP, , and Stein, Robert, Part IV, Looking Beyond Butorphanol, Sep 2006.</ref><ref>For off-label use example in rabbits, see Krempels, Dana, , University of Miami Biology Department.</ref> The U.S. ] sent a Notice of Violation to the manufacturer for its promotional materials which included promotion of the drug for off-label use.<ref> for off-label use promotion, April 2005.</ref> In the U.S. the drug is indicated for management of pain and inflammation associated with ] in dogs only. In Europe, where the product has been available since the early 1990s, it is also prescribed and licensed for other anti-inflammatory benefits including relief from both ] and ] in dogs. Side effects in animals are similar to those found in humans; the principal side effect is gastrointestinal irritation (vomiting, diarrhea and ]). Rarer but important side effects include liver and kidney toxicity. |
|
Meloxicam is used in ] mainly to treat dogs,<ref name="Metacam oral FDA label">{{cite web | title=Metacam- meloxicam suspension | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ed2227e6-8c69-4057-a8b2-94f74cb11264 | access-date=15 May 2021}}</ref><ref name="Metacam injection FDA label">{{cite web | title=Metacam- meloxicam injection, solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ca78caf5-2b47-46c1-abec-0f925b39f455 | access-date=15 May 2021}}</ref> but also sees ] in other animals such as cattle and exotics.<ref>Off-label use discussed in: Arnold Plotnick MS, DVM, ACVIM, ABVP, {{webarchive|url=https://web.archive.org/web/20110714025604/http://www.manhattancats.com/Articles/pain.html |date=14 July 2011 }}, and Stein, Robert, {{Webarchive|url=https://web.archive.org/web/20100418035553/http://www.vasg.org/perioperative_pain_management_part_iv.htm |date=18 April 2010 }} Part IV, Looking Beyond Butorphanol, Sep 2006, Veterinary Anesthesia & Analgesia Support Group.</ref><ref>For off-label use example in rabbits, see Krempels, Dana, {{Webarchive|url=https://web.archive.org/web/20100617192652/http://www.bio.miami.edu/hare/paresis.html |date=17 June 2010 }}, University of Miami Biology Department.</ref> In the European Union and other countries it is not considered off-label and can be used in cattle, pigs, horses, dogs, cats and guinea pigs.<ref>{{Cite web |date=2006-07-31 |title=Metacam |url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/metacam |access-date=2024-11-17 |website=European Medicines Agency (EMA) }}</ref> It has also been investigated as an alternative to ] by the ] (RSPB) to prevent deaths of ]s.<ref name="Swan Naidoo Cuthbert">{{cite journal |vauthors=Swan G, Naidoo V, Cuthbert R, Green RE, Pain DJ, Swarup D, Prakash V, Taggart M, Bekker L, Das D, Diekmann J, Diekmann M, Killian E, Meharg A, Patra RC, Saini M, Wolter K |date=March 2006 |title=Removing the threat of diclofenac to critically endangered Asian vultures |journal=PLOS Biology |volume=4 |issue=3 |pages=e66 |doi=10.1371/journal.pbio.0040066 |pmc=1351921 |pmid=16435886 | doi-access = free | title-link = doi }}</ref> |
|
|
|
|
|
|
Depending on the animal species, each country or union of countries applies different guidelines or legal frameworks for the use of the drug, as well as different recorded side effects. The most common side effects in dogs include gastrointestinal irritation (vomiting, diarrhea, and ]).<ref name="Metacam oral FDA label" /> As far as the perioperative administration is concerned, in healthy dogs given meloxicam, no perioperative adverse effects on the cardiovascular system have been reported at recommended dosages.<ref>{{cite journal | vauthors = Boström IM, Nyman G, Hoppe A, Lord P | title = Effects of meloxicam on renal function in dogs with hypotension during anaesthesia | journal = Veterinary Anaesthesia and Analgesia | volume = 33 | issue = 1 | pages = 62–9 | date = January 2006 | pmid = 16412133 | doi = 10.1111/j.1467-2995.2005.00208.x }}</ref> Perioperative administration of meloxicam to cats did not affect postoperative respiratory rate nor heart rate.<ref>{{cite journal | vauthors = Höglund OV, Dyall B, Gräsman V, Edner A, Olsson U, Höglund K | s2cid = 30649716 | title = Effect of non-steroidal anti-inflammatory drugs on postoperative respiratory and heart rate in cats subjected to ovariohysterectomy | journal = Journal of Feline Medicine and Surgery | volume = 20 | issue = 10 | pages = 980–984 | date = October 2018 | pmid = 29165006 | doi = 10.1177/1098612X17742290 | pmc = 11129237 }}</ref> |
|
Since 2003, the ] (]) formulations of meloxicam have been licensed in the U.S for use in dogs only,<ref>{{cite web|url=http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118006.pdf|title=NADA 141-213: New Animal Drug Application Approval (for Metacam® (meloxicam) 0.5 mg/mL and 1.5 mg/mL Oral Suspension)|date=April 15, 2003|publisher=US Food and Drug Administration|accessdate=24 July 2010}}</ref> with the January 2005 product insert specifically warning in bold-face type: "Do not use in cats."<ref name="ProdInsert">Metacam , product description: "Non-steroidal anti-inflammatory drug for oral use in dogs only", and in the "What Is Metacam" section in bold-face type: "Do not use in cats.", January 2005.</ref> An ] formulation for use in dogs was approved by the FDA November 2003,<ref></ref> with a formulation for cats, for surgical use only, approved in October, 2004.<ref> October 28, 2004.</ref> |
|
|
|
|
|
|
|
=== Use of meloxicam in cats === |
|
In the U.S., per the manufacturer's clinical instructions as of July 2010, injectable meloxicam is indicated in operative use with felines as a single, one-time dose only, with specific and repeated warnings not to administer a second dose.<ref>See the manufacturer's on its website, and its </ref> In June 2007, a new oral version of meloxicam was licensed in ] for the long-term relief of pain in cats. As of June 2008, meloxicam is registered for long term use in cats in Australia, New Zealand, and throughout Europe. |
|
|
|
The issue of using meloxicam in cats involves conflicting guidelines, differing legislation, and a narrow therapeutic safety margin that can easily turn the drug from cure to poison. More specifically: |
|
|
|
|
|
|
==== US policy vs EU policy ==== |
|
==Consumer confidence== |
|
|
|
The US ] (FDA) approves the use of meloxicam in cats ''only in injectable form'' and only as a one-time injection given before surgery.<ref>{{Cite journal | author = Center for Veterinary Medicine |date=29 September 2022 |title=Get the Facts about Pain Relievers for Pets |url=https://www.fda.gov/animal-veterinary/animal-health-literacy/get-facts-about-pain-relievers-pets |journal=FDA }}</ref><ref>{{Cite journal | author = Center for Veterinary Medicine |date=15 August 2023 |title=What Veterinarians Should Advise Clients About Pain Control and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Dogs and Cats |url=https://www.fda.gov/animal-veterinary/resources-you/what-veterinarians-should-advise-clients-about-pain-control-and-nonsteroidal-anti-inflammatory-drugs |journal=FDA }}</ref> It ''does not approve'' meloxicam oral suspension for cats and it ''does not approve'' meloxicam spray for cats because after reviewing numerous reports of meloxicam side effects in cats, it has identified many cases of ''] and ]'' and has added the following boxed warning to the products' label: "Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer additional injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information."<ref>{{Cite journal | author = Center for Veterinary Medicine |date=14 August 2023 |title=Information about the Boxed Warning on Meloxicam Labels regarding Safety Risks in Cats |url=https://www.fda.gov/animal-veterinary/product-safety-information/information-about-boxed-warning-meloxicam-labels-regarding-safety-risks-cats |journal=FDA }}</ref> |
|
As issues arise with any drug used ], the off-label use of meloxicam in cats has led to many reports of irreversible renal damage and death.<ref>Discussion of Metacam use at persiancats.org in , and at the consumer site .</ref> A peer-reviewed journal article cites feline overdose of NSAIDs, including meloxicam, as being a cause of severe kidney damage in cats.<ref>Merola, Valentina, DVM, DABT, and Dunayer Eric, MS, VMD, DABT, , Toxicology Brief, Veterinary Medicine, pp. 340-342, June, 2006.</ref> |
|
|
|
|
|
|
|
In contrast, in the European Union and other continents or countries, the use of the drug in cats is allowed with no such warning.<ref>{{Cite web |title=Metacam |url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/metacam |access-date=29 March 2024 |website=] (EMA)|date=31 July 2006 }}</ref><ref>{{Cite news |title=Cats: Meloxicam Question for Department for Environment, Food and Rural Affairs |url=https://questions-statements.parliament.uk/written-questions/detail/2021-05-11/HL10/ |work=UK Parliament Written questions, answers and statements}}</ref> The product instruction leaflet for meloxicam for cats in the form of oral suspension 0.5 mg/ml states that: "Typical adverse reactions of ] such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy, and renal failure have occasionally been reported. These side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal."<ref name=":1">{{Cite web |title=Clinical particulars - Meloxidyl 0.5 mg/ml oral suspension for cats |url=https://www.noahcompendium.co.uk/?id=-474521 |access-date=29 March 2024 |website=www.noahcompendium.co.uk }}</ref> |
|
==Brands== |
|
|
] |
|
|
In Europe, meloxicam is marketed under the brand names Movalis, Melox, and Recoxa. In the UK, U.S., Middle East, Argentina, Paraguay, Uruguay and Australia it is marketed under the brand name Mobic, in Germany as Mobec, and in Canada as Mobicox. In Latin America, the drug is marketed as Tenaron, Ilacox, Mavicam, Melocam, or Artriflam. A ] formulation of the drug is marketed as Metacam, Meloxidyl, Meloxoral, Meloxidolor or Petcam. In the Philippines, it is generally marketed under the brand name Moxen. In ], it is manufactured under licence from aVianex S.A under the name Loxitan.<ref>Εθνικό συνταγολόγιο, Greece's National subscription list, entry on Meloxicam .</ref> |
|
|
|
|
|
|
|
==== Dosage and safety margin ==== |
|
==References== |
|
|
|
The data sheets for meloxicam products for cats also state that: "Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels."<ref name=":1" /> The dosage policy for meloxicam oral suspension products for cats as described in the data sheets defines the amount administered as proportional to body weight. There is no separate dosage guideline for overweight or obese cats. Similarly, there is no separate dosage instruction for elderly cats. |
|
{{reflist}} |
|
|
|
|
|
|
|
This information is important because, shifting attention briefly to the human medical field, where more studies have been conducted, there are medical opinions suggesting that the typical dosage of certain medications can lead to toxicity if factors such as obesity<ref>{{cite journal |vauthors=Barras M, Legg A |date=October 2017 |title=Drug dosing in obese adults |journal=Australian Prescriber |volume=40 |issue=5 |pages=189–193 |doi=10.18773/austprescr.2017.053 |pmc=5662437 |pmid=29109603}}</ref> or the patient’s age<ref>{{Cite journal |last=Turnheim |first=Klaus |date=2004 |title=Drug therapy in the elderly |url=https://pubmed.ncbi.nlm.nih.gov/15582289/ |journal=Experimental Gerontology |volume=39 |issue=11–12 |pages=1731–1738 |doi=10.1016/j.exger.2004.05.011 |issn=0531-5565 |pmid=15582289}}</ref> are not taken into account. |
|
==External links== |
|
|
* |
|
|
* |
|
|
* |
|
|
|
|
|
|
|
==== Additional studies ==== |
|
{{Anti-inflammatory and antirheumatic products}} |
|
|
|
Some additional information about giving meloxicam to cats from researchers is as follows: A peer-reviewed journal article cites NSAIDs, including meloxicam, as causing gastrointestinal upset and, at high doses, ] and ] signs such as seizures and comas in cats. It adds that cats have a low tolerance for NSAIDs.<ref>{{cite journal |date=1 June 2006 |title=Toxicology Brief: The 10 most common toxicoses in cats |url=http://veterinarymedicine.dvm360.com/toxicology-brief-10-most-common-toxicoses-cats?id=&sk=&date=&pageID=3 |url-status=live |journal=Dvm360 |archive-url=https://web.archive.org/web/20180829212043/http://veterinarymedicine.dvm360.com/toxicology-brief-10-most-common-toxicoses-cats?id=&sk=&date=&pageID=3 |archive-date=29 August 2018 |access-date=16 September 2018}}</ref><ref>{{cite journal |vauthors=Merola V, Dunayer E |date=June 2006 |title=The 10 most common toxicoses in cats |url=https://www.aspcapro.org/sites/default/files/zl-vetm0606_339-342.pdf |url-status=live |journal=Veterinary Medicine |pages=340–342 |archive-url=https://web.archive.org/web/20190809040133/https://www.aspcapro.org/sites/default/files/zl-vetm0606_339-342.pdf |archive-date=9 August 2019 |access-date=9 August 2019}}</ref> Also, in another scientific journal there is talk of research according to which cats that received meloxicam had greater ] at 6 months than cats that received placebo. It was concluded that meloxicam should be used with caution in cats with chronic kidney disease.<ref>{{cite journal |vauthors=KuKanich K, George C, Roush JK, Sharp S, Farace G, Yerramilli M, Peterson S, Grauer GF |date=February 2021 |title=Effects of low-dose meloxicam in cats with chronic kidney disease |journal=Journal of Feline Medicine and Surgery |volume=23 |issue=2 |pages=138–148 |doi=10.1177/1098612X20935750 |pmid=32594827 |s2cid=220256059|pmc=10741344 }}</ref> |
|
{{NSAIDs}} |
|
|
|
|
|
|
|
===Pharmacokinetics=== |
|
] |
|
|
|
In dogs, the ] of meloxicam from the stomach is not affected by the presence of food,<ref name="Khan 2012">{{cite journal | vauthors = Khan SA, McLean MK | title = Toxicology of frequently encountered nonsteroidal anti-inflammatory drugs in dogs and cats | journal = The Veterinary Clinics of North America. Small Animal Practice | volume = 42 | issue = 2 | pages = 289–306, vi-vii | date = March 2012 | pmid = 22381180 | doi = 10.1016/j.cvsm.2012.01.003 }}</ref> with the peak concentration (]) of meloxicam occurring in the blood 7–8 hours after administration.<ref name="Khan 2012" /> The ] of meloxicam is approximately 24 hours in dogs.<ref name="Khan 2012"/> In the ] (''Phascolarctos cinereus''), very little meloxicam is absorbed into the blood after ] (that is, it has poor ]).<ref>{{cite journal | vauthors = Kimble B, Black LA, Li KM, Valtchev P, Gilchrist S, Gillett A, Higgins DP, Krockenberger MB, Govendir M | title = Pharmacokinetics of meloxicam in koalas (Phascolarctos cinereus) after intravenous, subcutaneous and oral administration | journal = Journal of Veterinary Pharmacology and Therapeutics | volume = 36 | issue = 5 | pages = 486–93 | date = October 2013 | pmid = 23406022 | doi = 10.1111/jvp.12038 | doi-access = free | title-link = doi }}</ref> |
|
] |
|
|
|
|
|
] |
|
|
|
===Legal status=== |
|
|
====United States==== |
|
|
2003: Meloxicam was approved in the US for use in dogs for the management of pain and inflammation associated with ], as an ] (]) formulation of meloxicam.<ref>{{cite web |url=https://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118006.pdf|title=NADA 141-213: New Animal Drug Application Approval (for Metacam (meloxicam) 0.5 mg/mL and 1.5 mg/mL Oral Suspension)|date=15 April 2003|publisher=U.S. ] (FDA)|access-date=24 July 2010|archive-url=https://wayback.archive-it.org/7993/20170406084237/https://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118006.pdf|archive-date=6 April 2017|url-status=dead}}</ref> |
|
|
|
|
|
2003 (November): An ] formulation for use in dogs was approved by the US ] (FDA).<ref>{{cite web |date=12 November 2003 |title=NADA 141-219: Metacam (meloxicam) 5 mg/mL Solution for Injection |url=https://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118026.pdf |url-status=dead |archive-url=https://wayback.archive-it.org/7993/20171115072315/https://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118026.pdf |archive-date=15 November 2017 |access-date=8 August 2019 |publisher=U.S. ] (FDA) |df=dmy-all}}</ref> |
|
|
|
|
|
2004 (October): A formulation for use in cats was approved for use before surgery only.<ref>{{cite web |date=28 October 2004 |title=Metacam 5 mg/mL Solution for Injection, Supplemental Approval |url=https://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118027.pdf |url-status=dead |archive-url=https://wayback.archive-it.org/7993/20171115072316/https://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118027.pdf |archive-date=15 November 2017 |access-date=8 August 2019 |publisher=U.S. ] (FDA) |df=dmy-all}}</ref> This is an injectable meloxicam, indicated for as a single, one-time dose only, with specific and repeated warnings not to administer a second dose.<ref>See the manufacturer's {{Webarchive|url=https://web.archive.org/web/20110702180646/http://www.metacam.com/index.php/FAQs-Veterinary-Professionals|date=2 July 2011}} on its website, and its {{webarchive|url=https://web.archive.org/web/20080906211039/http://www.bi-vetmedica.com/product_sites/METACAMINCats/documents/Metacam_Inj_cats_label.pdf|date=6 September 2008}}</ref> |
|
|
|
|
|
2005 (January): The product insert added a warning in bold-face type: "Do not use in cats."<ref name="ProdInsert">{{cite web | url=https://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/DrugLabels/UCM050394.pdf | title=Client Information Sheet For Metacam (meloxicam) 1.5 mg/mL Oral Suspension | publisher=U.S. ] (FDA) | quote=Metacam is a prescription non-steroidal anti-inflammatory drug (NSAID) that is used to control pain and inflammation (soreness) due to osteoarthritis in dogs. Osteoarthritis (OA) is a painful condition caused by “wear and tear” of cartilage and other parts of the joints that may result in the following changes or signs in your dog: Limping or lameness, decreased activity or exercise (reluctance to stand, climb stairs, jump or run, or difficulty in performing these activities), stiffness or decreased movement of joints. Metacam is given to dogs by mouth. Do not use Metacam Oral Suspension in cats. ] and death have been associated with the use of meloxicam in cats. | date=January 2005 | archive-url=https://wayback.archive-it.org/7993/20171115070141/https://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/DrugLabels/UCM050394.pdf | archive-date=15 November 2017 | url-status=dead | df=dmy-all}}</ref> |
|
|
|
|
|
2005: The FDA sent a Notice of Violation to the manufacturer for its promotional materials which included promotion of the drug for off-label use.<ref>{{cite web | url=https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm042460.pdf | title=Notice of Violation | date=19 April 2005 | publisher=U.S. ] (FDA) |access-date=8 August 2019 | archive-url=https://wayback.archive-it.org/7993/20170113141217/https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm042460.pdf | archive-date=13 January 2017 | url-status=dead | df=dmy-all }}</ref> |
|
|
|
|
|
2020 (February): A meloxicam injection was approved for use in the United States. Specifically, the FDA granted the approval of Anjeso to ].<ref name="Anjeso PR">{{cite press release | title=Baudax Bio Announces FDA Approval of Anjeso for the Management of Moderate to Severe Pain | website=], Inc. | date=20 February 2020 | url=https://www.baudaxbio.com/news-and-investors/press-releases/detail/160/baudax-bio-announces-fda-approval-of-anjeso-for-the | access-date=20 February 2020 | archive-date=21 February 2020 | archive-url=https://web.archive.org/web/20200221055028/https://www.baudaxbio.com/news-and-investors/press-releases/detail/160/baudax-bio-announces-fda-approval-of-anjeso-for-the | url-status=live }}</ref><ref>{{cite web | title=Anjeso (meloxicam) injection, for intravenous use | url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210583s000lbl.pdf | publisher=U.S. ] (FDA) | date=February 2020 | access-date=21 February 2020 | archive-date=22 February 2020 | archive-url=https://web.archive.org/web/20200222070146/https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210583s000lbl.pdf | url-status=live }}</ref> |
|
|
|
|
|
====European Union==== |
|
|
In the European Union, meloxicam is licensed for other anti-inflammatory benefits including relief from both ] and ] in dogs. Meloxicam is also licensed for use in horses, to relieve the pain associated with ] disorders.<ref>{{cite book| veditors = Maddison JE, Page SW, Church D |title=Small animal clinical pharmacology | url = https://archive.org/details/smallanimalclini00mrcv | url-access = limited |date=2008 |publisher= Saunders/Elsevier |location=Edinburgh |isbn=9780702028588 |pages=–302 |edition=2nd |chapter=Meloxicam }}</ref> |
|
|
|
|
|
1998 (January): Meloxicam was authorised for use in cattle throughout the European Union, via a ].<ref name="Wright 2007">{{cite journal | vauthors = Wright E |title=Generic and biosimilar medicinal products in the European Union |journal=Chemistry Today |date=March 2007 |volume=25 |issue=2 |pages=4–6 |url=https://www.hoganlovells.com/~/media/hogan-lovells/pdf/publication/chemistrytodayapr07_pdf.pdf |access-date=28 January 2020 |archive-date=28 January 2020 |archive-url=https://web.archive.org/web/20200128032019/https://www.hoganlovells.com/~/media/hogan-lovells/pdf/publication/chemistrytodayapr07_pdf.pdf |url-status=live }}</ref> |
|
|
|
|
|
2006: The first ] meloxicam product was approved.<ref name="Wright 2007" /> |
|
|
|
|
|
2024 (January): EMA issued an 'Opinion'<ref>{{Cite web |date=2024-01-19 |title=Metacam - opinion on variation to marketing authorisation |url=https://www.ema.europa.eu/en/medicines/veterinary/variation/metacam |access-date=2024-11-16 |website=] (EMA) }}</ref> on a change to this medicine's authorisation concerning the follow-up oral treatment after initial injectable administration in cats. This change remains as an 'Opinion', while the medication continues to be approved as usual.<ref>{{Cite web |date=2006-07-31 |title=Metacam |url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/metacam |access-date=2024-11-16 |website=] (EMA) }}</ref> |
|
|
|
|
|
====Other countries==== |
|
|
{{As of|June 2008}}, meloxicam is registered for long-term use in cats in Australia, New Zealand, and Canada.<ref name="Gashen 2016">{{cite book | veditors = Gaschen FP, Schaer M |title=Clinical medicine of the dog and cat |date=2016 |publisher=CRC Press |isbn=9781482226065 |page=<!-- no page numbers in ebook --> |edition=3rd |chapter-url=https://books.google.com/books?id=fjqLDQAAQBAJ&dq=meloxicam+cat+australia&pg=PT2004 |chapter=Recent NSAID developments |access-date=28 January 2020 |archive-date=1 September 2020 |archive-url=https://web.archive.org/web/20200901204800/https://www.google.com/books/edition/Clinical_Medicine_of_the_Dog_and_Cat/fjqLDQAAQBAJ?hl=en&gbpv=1&dq=meloxicam+cat+australia&pg=PT2004 |url-status=live }}</ref> |
|
|
|
|
|
In the United Kingdom, meloxicam is licensed for use in cats, guinea pigs, horses, and livestock including pigs and cattle. <ref>{{cite web |title=Product Information Database |url=https://www.vmd.defra.gov.uk/ProductInformationDatabase/current?page=79&order=ActiveSubstances&descending=True |website=Veterinary Medicines Directorate |publisher=DEFRA |access-date=29 March 2023}}</ref> |
|
|
|
|
|
== See also == |
|
|
* ] |
|
|
|
|
|
== References == |
|
|
{{Reflist}} |
|
|
|
|
|
{{Anti-inflammatory products}} |
|
|
{{Portal bar | Medicine}} |
|
|
{{Authority control}} |
|
|
|
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
] |
|
] |
|
] |
|
] |
|
] |
|
] |
|
] |
|
|
|
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|
|
] |
|