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meloxicam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
anti-inflammatory, isoxicam derivatives	1676	71125-38-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: reumoxicam miloxicam meloxicam metacam meloxicam sodium meloxicam sodium hydrate	Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition. Molecular weight: 351.40 Formula: C14H13N3O4S2 CLOGP: 2.44 LIPINSKI: 0 HAC: 7 HDO: 2 TPSA: 99.60 ALOGS: -3.36 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

reumoxicam
miloxicam
meloxicam
metacam
meloxicam sodium
meloxicam sodium hydrate

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition.

Molecular weight: 351.40
Formula: C14H13N3O4S2
CLOGP: 2.44
LIPINSKI: 0
HAC: 7
HDO: 2
TPSA: 99.60
ALOGS: -3.36
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
15	mg	O
15	mg	P
15	mg	R

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	97 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	18 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.71 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	0.20 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.15 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.12 mL/min/kg	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.00 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
April 13, 2000	FDA	BOEHRINGER INGELHEIM

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Rheumatoid arthritis	229.85	10.02	940	105897	252879	63129306
Synovial cyst	200.24	10.02	155	106682	10278	63371907
Ankylosing spondylitis	163.69	10.02	138	106699	10336	63371849
Spinal column injury	156.31	10.02	74	106763	1977	63380208
Fibromyalgia	152.11	10.02	384	106453	80036	63302149
Surgical failure	147.40	10.02	57	106780	909	63381276
Bronchitis chronic	135.65	10.02	87	106750	4266	63377919
Psoriatic arthropathy	135.12	10.02	399	106438	91121	63291064
Death	126.80	10.02	276	106561	374105	63008080
Tenosynovitis	124.19	10.02	134	106703	13661	63368524

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Psoriasis	210.06	11.73	205	28320	38607	34889799
Psoriatic arthropathy	115.40	11.73	109	28416	19689	34908717
Arthralgia	91.84	11.73	326	28199	169715	34758691
Gastric haemorrhage	82.86	11.73	68	28457	10193	34918213
Joint swelling	76.48	11.73	158	28367	59732	34868674
Pain	62.22	11.73	330	28195	204345	34724061
Ankylosing spondylitis	57.96	11.73	43	28482	5561	34922845
Lipoma	51.23	11.73	26	28499	1700	34926706
Off label use	49.73	11.73	176	28349	419348	34509058
Osteoarthritis	48.04	11.73	71	28454	20571	34907835

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Rheumatoid arthritis	247.49	10.42	717	104134	207753	79431784
Psoriatic arthropathy	229.88	10.42	387	104464	77612	79561925
Fibromyalgia	190.60	10.42	320	104531	64020	79575517
Synovial cyst	182.61	10.42	131	104720	9934	79629603
Psoriasis	177.36	10.42	375	104476	89212	79550325
Arthralgia	163.51	10.42	1297	103554	570506	79069031
Musculoskeletal stiffness	157.24	10.42	547	104304	174461	79465076
Ankylosing spondylitis	155.98	10.42	129	104722	12076	79627461
Surgical failure	155.36	10.42	54	104797	815	79638722
Febrile neutropenia	155.04	10.42	55	104796	230944	79408593

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	M01AC06	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Oxicams
ATC	M01AC56	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Oxicams
ATC	N01BB59	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, LOCAL Amides
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:35842	anti-rheumatic drugs
CHEBI has role	CHEBI:50629	COX-2 inhibitor
FDA CS	M0001335	Anti-Inflammatory Agents, Non-Steroidal
FDA EPC	N0000175722	Nonsteroidal Anti-inflammatory Drug
FDA MoA	N0000000160	Cyclooxygenase Inhibitors
MeSH PA	D000700	Analgesics

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Rheumatoid arthritis	indication	69896004	DOID:7148
Osteoarthritis	indication	396275006
Juvenile rheumatoid arthritis	indication	410795001
Ankylosing spondylitis	off-label use	9631008	DOID:7147
Gastritis	contraindication	4556007	DOID:4029
Alcoholism	contraindication	7200002
Myocardial infarction	contraindication	22298006	DOID:5844
Hypertensive disorder	contraindication	38341003	DOID:10763
Gastrointestinal ulcer	contraindication	40845000
Body fluid retention	contraindication	43498006

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Postoperative pain and inflammation associated with orthopedic surgery	Indication
Cats	Postoperative pain and inflammation associated with ovariohysterectomy	Indication
Cats	Postoperative pain and inflammation associated with castration	Indication
Dogs	Pain and inflammation associated with osteoarthritis	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Loxicom	Norbrook Laboratories, Ltd.	1
Loxicom	Norbrook Laboratories, Ltd.	1
Meloxicam Injection	Accord Healthcare Inc.	1
Meloxicam Solution for Injection	Dechra Veterinary Products LLC	1
Meloxidyl	Ceva Sante Animale	1
Metacam 5 mg/mL Solution for Injection	Boehringer lngelheim Animal Health USA Inc.	1
Metacam Oral Suspension	Boehringer lngelheim Animal Health USA Inc.	1
OroCAM Transmucosal Oral Spray	Zoetis Inc.	1

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.65	acidic
pKa2	5.42	acidic
pKa3	4.32	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIVLODEX	ICEUTICA OPERATIONS	N207233	Oct. 22, 2015	DISCN	CAPSULE	ORAL	9808468	March 31, 2035	MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 10 MG OF MELOXICAM
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIVLODEX	ICEUTICA OPERATIONS	N207233	Oct. 22, 2015	DISCN	CAPSULE	ORAL	9808468	March 31, 2035	MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 5 MG OF MELOXICAM
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11253504	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9592227	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	9913909	March 13, 2034	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10098957	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10213510	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10632199	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	10898575	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	11083730	April 20, 2035	TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	May 12, 2024	NEW PRODUCT
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	May 12, 2024	NEW PRODUCT
30MG/ML (30MG/ML)	ANJESO	BAUDAX	N210583	Feb. 20, 2020	DISCN	SOLUTION	INTRAVENOUS	Feb. 20, 2023	NEW PRODUCT
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	RX	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	May 12, 2024	NEW PRODUCT
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	ZYNRELEF KIT	HERON THERAPS INC	N211988	May 12, 2021	DISCN	SOLUTION, EXTENDED RELEASE	PERIARTICULAR	May 12, 2024	NEW PRODUCT

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN	INHIBITOR	IC50	6.80	CHEMBL	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN		IC50	5.85	CHEMBL
Prostaglandin G/H synthase 2	Enzyme		PGH2_MOUSE		IC50	6.82	CHEMBL
Prostaglandin G/H synthase 1	Enzyme		PGH1_SHEEP		IC50	6	CHEMBL
Prostaglandin G/H synthase 2	Enzyme		PGH2_SHEEP		IC50	5.86	CHEMBL

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External reference:

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ID	Source
MXM	PDB_CHEM_ID
006272	NDDF
1086708	RXNORM
125694008	SNOMEDCT_US
387055000	SNOMEDCT_US
4021203	VUID
4021203	VANDF
54677470	PUBCHEM_CID
5615	INN_ID
7220	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Meloxicam	HUMAN PRESCRIPTION DRUG LABEL	1	0440-5841	TABLET	7.50 mg	ORAL	ANDA	28 sections
MELOXICAM	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8040	TABLET	7.50 mg	ORAL	ANDA	26 sections
MELOXICAM	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8040	TABLET	7.50 mg	ORAL	ANDA	26 sections
MELOXICAM	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8040	TABLET	7.50 mg	ORAL	ANDA	26 sections
MELOXICAM	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8124	TABLET	15 mg	ORAL	ANDA	26 sections
MELOXICAM	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8124	TABLET	15 mg	ORAL	ANDA	26 sections
MELOXICAM	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8124	TABLET	15 mg	ORAL	ANDA	26 sections
Meloxicam	HUMAN PRESCRIPTION DRUG LABEL	1	10544-052	TABLET	15 mg	ORAL	ANDA	31 sections
Meloxicam	HUMAN PRESCRIPTION DRUG LABEL	1	10544-090	TABLET	7.50 mg	ORAL	ANDA	31 sections
Meloxicam	HUMAN PRESCRIPTION DRUG LABEL	1	10544-251	TABLET	15 mg	ORAL	ANDA	27 sections

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