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

Stem definition	Drug id	CAS RN
beta-lactamase inhibitors	669	58001-44-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: clavulanic acid clavulanate clavulanate potassium clavulante potasium clavulanate potassium salt	A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase. Molecular weight: 199.16 Formula: C8H9NO5 CLOGP: -1.06 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 87.07 ALOGS: 0.23 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

clavulanic acid
clavulanate
clavulanate potassium
clavulante potasium
clavulanate potassium salt

A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.

Molecular weight: 199.16
Formula: C8H9NO5
CLOGP: -1.06
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 87.07
ALOGS: 0.23
ROTB: 2

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	43 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	31.38 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	75 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.91 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.90 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Aug. 6, 1984	FDA	DR REDDYS LABS INC

FDA Adverse Event Reporting System (Female)

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
Acute generalised exanthematous pustulosis	87.24	15.36	40	9907	11059	63468016
Hepatitis cholestatic	84.49	15.36	34	9913	6844	63472231
Bone erosion	77.69	15.36	43	9904	17674	63461401
Bronchiectasis	75.82	15.36	41	9906	16101	63462974
Drug hypersensitivity	63.53	15.36	146	9801	310541	63168534
Drug reaction with eosinophilia and systemic symptoms	60.95	15.36	47	9900	33789	63445286
Cholestasis	59.94	15.36	44	9903	29390	63449685
Toxic skin eruption	55.74	15.36	31	9916	12854	63466221
Jaundice	55.70	15.36	42	9905	29209	63449866
Anaphylactic reaction	50.68	15.36	57	9890	66043	63413032
Hypothyroidism	45.70	15.36	44	9903	42588	63436487
Nail dystrophy	44.07	15.36	13	9934	1030	63478045
Cholecystitis chronic	42.30	15.36	24	9923	10337	63468738
Neutropenia	41.06	15.36	87	9860	174918	63304157
Pruritus	40.10	15.36	136	9811	361317	63117758
Axillary pain	39.63	15.36	14	9933	1969	63477106
Acute kidney injury	37.39	15.36	108	9839	263307	63215768
International normalised ratio increased	33.82	15.36	39	9908	46386	63432689
Catheter site haemorrhage	33.23	15.36	14	9933	3161	63475914
Hepatocellular injury	32.67	15.36	30	9917	27351	63451724
Rash maculo-papular	32.45	15.36	32	9915	31864	63447211
Appendicitis	30.76	15.36	18	9929	8211	63470864
Clostridium difficile colitis	29.46	15.36	25	9922	20544	63458531
Bone marrow eosinophilic leukocyte count increased	28.81	15.36	5	9942	32	63479043
Toxic epidermal necrolysis	28.76	15.36	27	9920	25307	63453768
Anaphylactic shock	28.40	15.36	26	9921	23607	63455468
Allergic hepatitis	27.94	15.36	5	9942	39	63479036
Odynophagia	26.99	15.36	16	9931	7470	63471605
Emotional distress	26.54	15.36	29	9918	32520	63446555
Dermatitis exfoliative	26.00	15.36	14	9933	5445	63473630
Cholelithiasis	25.65	15.36	33	9914	43892	63435183
Gamma-glutamyltransferase increased	25.48	15.36	29	9918	34002	63445073
Purpura	25.41	15.36	18	9929	11367	63467708
Injury	25.33	15.36	43	9904	73204	63405871
Peripheral swelling	24.10	15.36	6	9941	265936	63213139
Contraindicated product administered	23.86	15.36	3	9944	217645	63261430
Blood alkaline phosphatase increased	23.10	15.36	31	9916	42936	63436139
Abdominal discomfort	22.64	15.36	11	9936	320874	63158201
Hyperleukocytosis	22.35	15.36	7	9940	679	63478396
Hyperchlorhydria	22.24	15.36	9	9938	1835	63477240
Arthropathy	21.86	15.36	5	9942	234787	63244288
Stevens-Johnson syndrome	21.69	15.36	23	9924	24927	63454148
Agranulocytosis	21.55	15.36	23	9924	25111	63453964
Bronchospasm	20.74	15.36	19	9928	17261	63461814
Linear IgA disease	20.72	15.36	8	9939	1443	63477632
Thrombocytopenia	20.47	15.36	61	9886	151096	63327979
Alopecia	20.35	15.36	14	9933	337522	63141553
Off label use	19.96	15.36	48	9899	674414	62804661
Eosinophilia	19.82	15.36	21	9926	22735	63456340
Folate deficiency	19.69	15.36	9	9938	2466	63476609
Mixed liver injury	19.41	15.36	11	9936	4724	63474351
Meningitis aseptic	19.22	15.36	11	9936	4812	63474263
Joint swelling	19.22	15.36	14	9933	327652	63151423
Nasopharyngitis	19.04	15.36	8	9939	254249	63224826
Pemphigus	19.04	15.36	3	9944	183723	63295352
Aspartate aminotransferase increased	19.00	15.36	43	9904	90234	63388841
Deep vein thrombosis	18.86	15.36	41	9906	83759	63395316
Product dose omission issue	18.16	15.36	7	9940	234306	63244769
Alanine aminotransferase increased	18.15	15.36	46	9901	103724	63375351
Hydronephrosis	17.44	15.36	14	9933	10648	63468427
Hypokalaemia	17.10	15.36	45	9902	103759	63375316
Loss of personal independence in daily activities	16.88	15.36	43	9904	97247	63381828
Red blood cell sedimentation rate abnormal	16.78	15.36	18	9929	19764	63459311
Ejection fraction decreased	16.66	15.36	19	9928	22313	63456762
Strawberry tongue	16.38	15.36	3	9944	27	63479048
Glossodynia	16.27	15.36	4	9943	178872	63300203
Erythema	15.92	15.36	62	9885	175689	63303386
Dementia	15.76	15.36	17	9930	18777	63460298
Veillonella infection	15.67	15.36	3	9944	35	63479040
Chondroma	15.67	15.36	3	9944	35	63479040
Chromaturia	15.58	15.36	16	9931	16701	63462374
Osteolysis	15.47	15.36	8	9939	2866	63476209
Thrombotic microangiopathy	15.46	15.36	13	9934	10548	63468527
Pyrexia	15.40	15.36	126	9821	470352	63008723

FDA Adverse Event Reporting System (Male)

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
Hepatocellular injury	143.18	16.72	78	7627	22133	34927093
Cholestasis	108.89	16.72	70	7635	26878	34922348
Jaundice	78.04	16.72	61	7644	31821	34917405
Spinal muscular atrophy	67.48	16.72	16	7689	380	34948846
Motor neurone disease	63.24	16.72	16	7689	501	34948725
Hepatitis cholestatic	62.78	16.72	32	7673	7915	34941311
Pneumococcal sepsis	59.21	16.72	18	7687	1119	34948107
Stoma closure	56.67	16.72	13	7692	266	34948960
Anaphylactic shock	53.70	16.72	37	7668	15904	34933322
Ischaemic cerebral infarction	53.41	16.72	17	7688	1230	34947996
Lymphadenectomy	52.44	16.72	13	7692	374	34948852
Purpura	52.33	16.72	31	7674	10280	34938946
Lower respiratory tract infection bacterial	49.11	16.72	13	7692	488	34948738
Bronchial disorder	47.47	16.72	16	7689	1387	34947839
Urethral valves	45.85	16.72	11	7694	275	34948951
Increased bronchial secretion	42.88	16.72	16	7689	1865	34947361
Sputum increased	39.29	16.72	16	7689	2354	34946872
Drug reaction with eosinophilia and systemic symptoms	38.98	16.72	42	7663	32970	34916256
Hepatic cytolysis	38.20	16.72	29	7676	14467	34934759
Toxic epidermal necrolysis	37.60	16.72	34	7671	21612	34927614
Disease complication	37.07	16.72	16	7689	2720	34946506
Scoliosis	36.76	16.72	16	7689	2777	34946449
Hepatitis	36.60	16.72	35	7670	23869	34925357
Resuscitation	35.48	16.72	13	7692	1440	34947786
Rash maculo-papular	35.01	16.72	37	7668	28414	34920812
Demyelination	34.57	16.72	16	7689	3205	34946021
Anaphylactic reaction	34.51	16.72	39	7666	32262	34916964
Jaundice cholestatic	34.11	16.72	18	7687	4776	34944450
Respiratory tract infection bacterial	32.90	16.72	13	7692	1769	34947457
Stevens-Johnson syndrome	31.82	16.72	29	7676	18610	34930616
Motor dysfunction	30.33	16.72	19	7686	6955	34942271
Metabolic disorder	30.24	16.72	16	7689	4267	34944959
Chest X-ray abnormal	29.84	16.72	16	7689	4382	34944844
Pruritus	29.43	16.72	83	7622	141898	34807328
Circulatory collapse	28.84	16.72	29	7676	21009	34928217
Inflammation	28.26	16.72	33	7672	28262	34920964
Off label use	27.84	16.72	31	7674	419493	34529733
Brain injury	27.39	16.72	17	7688	6125	34943101
Blood alkaline phosphatase increased	27.29	16.72	34	7671	31141	34918085
Cerebral ischaemia	26.93	16.72	17	7688	6305	34942921
Intestinal ischaemia	26.02	16.72	18	7687	7776	34941450
Lung consolidation	25.38	16.72	16	7689	5920	34943306
Mechanical ventilation	25.00	16.72	11	7694	1959	34947267
Muscle atrophy	24.49	16.72	17	7688	7387	34941839
Toxic skin eruption	24.04	16.72	20	7685	11365	34937861
Drug ineffective	24.00	16.72	40	7665	456711	34492515
Lung infiltration	23.85	16.72	21	7684	12884	34936342
Chromaturia	23.63	16.72	22	7683	14498	34934728
Eosinophilia	23.59	16.72	29	7676	26193	34923033
Endotracheal intubation	23.21	16.72	12	7693	3053	34946173
Death	22.66	16.72	33	7672	398016	34551210
Meningitis aseptic	22.64	16.72	12	7693	3212	34946014
Kounis syndrome	22.42	16.72	11	7694	2507	34946719
Dermatitis exfoliative	21.39	16.72	15	7690	6624	34942602
Bronchospasm	20.91	16.72	18	7687	10713	34938513
Secretion discharge	20.57	16.72	14	7691	5891	34943335
Pyrexia	20.30	16.72	134	7571	332879	34616347
Atelectasis	19.95	16.72	22	7683	17705	34931521
Aspartate aminotransferase increased	19.62	16.72	45	7660	67738	34881488
Alanine aminotransferase increased	19.49	16.72	50	7655	80765	34868461
Blood bilirubin increased	19.12	16.72	32	7673	38264	34910962
Injury	18.80	16.72	23	7682	20664	34928562
Mixed liver injury	18.23	16.72	10	7695	2863	34946363
Gamma-glutamyltransferase increased	18.16	16.72	27	7678	29204	34920022
Atrophic glossitis	18.10	16.72	3	7702	9	34949217
Toxicity to various agents	17.94	16.72	11	7694	200351	34748875
Liver injury	17.68	16.72	19	7686	14859	34934367
Tachypnoea	17.65	16.72	21	7684	18331	34930895
Erythema	17.49	16.72	51	7654	88729	34860497
Hyperbilirubinaemia	17.41	16.72	20	7685	16823	34932403
Product dose omission issue	16.90	16.72	3	7702	119708	34829518
Aminoaciduria	16.86	16.72	5	7700	285	34948941

FDA Adverse Event Reporting System (Geriatric)

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
Hepatocellular injury	165.67	13.78	106	14829	47487	79681966
Cholestasis	161.71	13.78	108	14827	52001	79677452
Hepatitis cholestatic	124.91	13.78	58	14877	13794	79715659
Jaundice	122.46	13.78	92	14843	53257	79676196
Drug reaction with eosinophilia and systemic symptoms	79.97	13.78	78	14857	64166	79665287
Acute generalised exanthematous pustulosis	76.81	13.78	45	14890	17209	79712244
Anaphylactic reaction	72.81	13.78	84	14851	83659	79645794
Spinal muscular atrophy	69.79	13.78	16	14919	387	79729066
Purpura	69.16	13.78	44	14891	19483	79709970
Anaphylactic shock	67.27	13.78	55	14880	35941	79693512
Toxic epidermal necrolysis	64.80	13.78	59	14876	44522	79684931
Toxic skin eruption	63.85	13.78	44	14891	22249	79707204
Motor neurone disease	63.25	13.78	16	14919	592	79728861
Stoma closure	57.45	13.78	13	14922	296	79729157
Pneumococcal sepsis	55.36	13.78	18	14917	1644	79727809
Pruritus	50.96	13.78	176	14759	394472	79334981
Blood alkaline phosphatase increased	48.95	13.78	60	14875	63604	79665849
Rash maculo-papular	48.30	13.78	56	14879	56022	79673431
Jaundice cholestatic	46.49	13.78	28	14907	11256	79718197
Lymphadenectomy	43.42	13.78	14	14921	1245	79728208
Lower respiratory tract infection bacterial	42.89	13.78	13	14922	943	79728510
Nail dystrophy	42.15	13.78	13	14922	1000	79728453
Drug hypersensitivity	41.81	13.78	137	14798	298779	79430674
Chromaturia	41.23	13.78	36	14899	25710	79703743
Gamma-glutamyltransferase increased	41.17	13.78	51	14884	54629	79674824
Bronchial disorder	41.05	13.78	16	14919	2473	79726980
Ischaemic cerebral infarction	40.76	13.78	16	14919	2519	79726934
Stevens-Johnson syndrome	40.42	13.78	43	14892	39123	79690330
Hepatic cytolysis	39.58	13.78	36	14899	27115	79702338
Hepatitis	38.82	13.78	50	14885	55677	79673776
Meningitis aseptic	38.78	13.78	21	14914	6907	79722546
Aspartate aminotransferase increased	38.37	13.78	82	14853	138559	79590894
Dermatitis exfoliative	37.35	13.78	24	14911	10805	79718648
Injury	36.93	13.78	58	14877	77438	79652015
Increased bronchial secretion	36.56	13.78	16	14919	3311	79726142
Clostridium difficile colitis	36.10	13.78	37	14898	32246	79697207
Axillary pain	36.10	13.78	14	14921	2135	79727318
Alanine aminotransferase increased	35.96	13.78	88	14847	162482	79566971
Peripheral swelling	34.00	13.78	5	14930	269612	79459841
Off label use	33.06	13.78	76	14859	907139	78822314
Respiratory tract infection bacterial	33.01	13.78	13	14922	2064	79727389
Kounis syndrome	32.70	13.78	16	14919	4266	79725187
Drug ineffective	32.27	13.78	100	14835	1080813	78648640
Infusion related reaction	32.18	13.78	3	14932	230234	79499219
Eosinophilia	32.08	13.78	41	14894	45304	79684149
Mixed liver injury	31.72	13.78	19	14916	7559	79721894
Sputum increased	31.57	13.78	16	14919	4597	79724856
Resuscitation	31.17	13.78	13	14922	2391	79727062
Pyrexia	30.92	13.78	225	14710	678484	79050969
Bone erosion	30.70	13.78	26	14909	17821	79711632
Bronchospasm	30.57	13.78	30	14905	24829	79704624
Disease complication	30.55	13.78	16	14919	4921	79724532
International normalised ratio increased	29.29	13.78	55	14880	84666	79644787
Death	29.24	13.78	38	14897	566476	79162977
Demyelination	28.21	13.78	18	14917	8005	79721448
Liver injury	27.84	13.78	43	14892	56571	79672882
Bone marrow eosinophilic leukocyte count increased	27.78	13.78	5	14930	33	79729420
Bronchiectasis	27.50	13.78	27	14908	22359	79707094
Nasopharyngitis	27.19	13.78	7	14928	253874	79475579
Allergic hepatitis	26.72	13.78	5	14930	42	79729411
Brain injury	26.71	13.78	20	14915	11497	79717956
Thrombocytopenia	26.45	13.78	109	14826	265150	79464303
Lung consolidation	26.42	13.78	18	14917	8929	79720524
Product dose omission issue	26.18	13.78	7	14928	247530	79481923
Chest X-ray abnormal	26.03	13.78	17	14918	7866	79721587
Metabolic disorder	26.02	13.78	18	14917	9152	79720301
Hepatitis acute	25.42	13.78	22	14913	15520	79713933
Acute kidney injury	25.25	13.78	175	14760	519229	79210224
Catheter site haemorrhage	24.51	13.78	14	14921	5103	79724350
Scoliosis	24.41	13.78	16	14919	7448	79722005
Intestinal ischaemia	24.20	13.78	20	14915	13250	79716203
Blood bilirubin increased	24.15	13.78	44	14891	66188	79663265
Circulatory collapse	23.46	13.78	32	14903	37636	79691817
Mechanical ventilation	23.14	13.78	11	14924	2753	79726700
Cerebral ischaemia	22.81	13.78	18	14917	11177	79718276
Muscle atrophy	22.75	13.78	18	14917	11214	79718239
Tachypnoea	22.69	13.78	29	14906	32034	79697419
Cholecystitis chronic	22.52	13.78	17	14918	9889	79719564
Agranulocytosis	21.86	13.78	34	14901	44996	79684457
Neutropenia	21.78	13.78	109	14826	287601	79441852
Drug-induced liver injury	21.71	13.78	42	14893	66075	79663378
Atelectasis	21.00	13.78	28	14907	32229	79697224
Rash	20.95	13.78	182	14753	578176	79151277
Face oedema	20.78	13.78	26	14909	28110	79701343
Endotracheal intubation	20.24	13.78	12	14923	4685	79724768
Lung infiltration	19.92	13.78	23	14912	22889	79706564
Joint swelling	19.88	13.78	15	14920	288631	79440822
Contraindicated product administered	19.67	13.78	3	14932	157535	79571918
Faeces pale	19.51	13.78	10	14925	2940	79726513
Vascular purpura	19.05	13.78	10	14925	3088	79726365
Arthropathy	18.74	13.78	5	14930	177106	79552347
Cholangitis	18.73	13.78	17	14918	12759	79716694
Motor dysfunction	18.52	13.78	18	14917	14715	79714738
Rash scarlatiniform	18.46	13.78	5	14930	242	79729211
Headache	18.37	13.78	62	14873	653710	79075743
Toxicity to various agents	18.13	13.78	32	14903	421508	79307945
Erythema	17.89	13.78	86	14849	223204	79506249
Abdominal discomfort	17.30	13.78	13	14922	250714	79478739
Blood pressure increased	17.29	13.78	9	14926	211351	79518102
Rash morbilliform	17.28	13.78	12	14923	6138	79723315
Cholestatic liver injury	17.16	13.78	11	14924	4930	79724523
Dizziness	16.86	13.78	47	14888	526394	79203059
Inflammation	16.86	13.78	47	14888	93706	79635747
Cholelithiasis	16.74	13.78	33	14902	52631	79676822
Appendicitis	16.63	13.78	20	14915	20774	79708679
Hyperchlorhydria	16.57	13.78	8	14927	2071	79727382
Odynophagia	16.47	13.78	15	14920	11312	79718141
Emotional distress	16.44	13.78	28	14907	39941	79689512
Linear IgA disease	16.17	13.78	9	14926	3123	79726330
Aminoaciduria	16.15	13.78	5	14930	389	79729064
Strawberry tongue	16.05	13.78	3	14932	25	79729428
Weight increased	16.00	13.78	17	14918	277369	79452084
Treatment failure	15.92	13.78	6	14929	170480	79558973
Type I hypersensitivity	15.79	13.78	10	14925	4388	79725065
Deep vein thrombosis	15.60	13.78	54	14881	120865	79608588
Hyperbilirubinaemia	15.53	13.78	21	14914	24497	79704956
Injection site pain	15.05	13.78	3	14932	129835	79599618
Therapeutic product effect decreased	14.92	13.78	6	14929	163857	79565596
Product use in unapproved indication	14.83	13.78	15	14920	250344	79479109
Transaminases increased	14.75	13.78	31	14904	51712	79677741
Atrophic glossitis	14.70	13.78	3	14932	41	79729412
Veillonella infection	14.26	13.78	3	14932	48	79729405
Hyperthermia malignant	14.02	13.78	8	14927	2909	79726544
Pseudomembranous colitis	13.97	13.78	10	14925	5364	79724089
Hyperthermia	13.86	13.78	17	14918	18020	79711433

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
FDA MoA	N0000000202	beta Lactamase Inhibitors
FDA EPC	N0000175930	beta Lactamase Inhibitor
CHEBI has role	CHEBI:35474	anti-anxiety agents
CHEBI has role	CHEBI:35625	beta-lactamase inhibitors
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:33281	antibiotics
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D065093	beta-Lactamase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Septicemia due to Escherichia coli	indication	9323009
Bacterial septicemia	indication	10001005	DOID:0040085
Haemophilus Influenzae Acute Otitis Media	indication	19021002
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Staphylococcal pneumonia	indication	22754005
Bacterial pneumonia	indication	53084003	DOID:874
Klebsiella cystitis	indication	60867007
Pneumonia due to Klebsiella pneumoniae	indication	64479007
Urinary tract infectious disease	indication	68566005
Haemophilus influenzae pneumonia	indication	70036007
Infection due to Escherichia coli	indication	71057007
Rhinoscleroma	indication	72409005	DOID:11336
Acute bacterial sinusitis	indication	75498004
Bacterial infection due to Klebsiella pneumoniae	indication	186435004
Pneumococcal pneumonia	indication	233607000
Escherichia coli urinary tract infection	indication	301011002
Bacterial urinary infection	indication	312124009
Infective otitis media	indication	312218008
Infection due to Staphylococcus aureus	indication	406602003
Osteomyelitis due to Staphylococcus aureus	indication	428783003
Pneumonia due to Staphylococcus aureus	indication	441658007
Sepsis due to Staphylococcus aureus	indication	448417001
Sepsis due to Pseudomonas	indication	448813005
Moraxella Catarrhalis Acute Otitis Media	indication	703469002
Bacteroides Endometritis	indication
Pneumococcal Acute Otitis Media	indication
Haemophilus Parainfluenzae Pneumonia	indication
Pseudomonas Aeruginosa Urinary Tract Infection	indication
Klebsiella Endometritis	indication
Klebsiella Pneumoniae Peritonitis	indication
Moraxella Catarrhalis Pneumonia	indication
Staphylococcus Aureus Joint Infection	indication
Staphylococcus Aureus Urinary Tract Infection	indication
E. Coli Peritonitis	indication
Enterobacter Endometritis	indication
Bacteroides Peritonitis	indication
Serratia Urinary Tract Infection	indication
Citrobacter Urinary Tract Infection	indication
Staphylococcus Endometritis	indication
E. Coli Endometritis	indication
Acute otitis media	off-label use	3110003
Pyrexia of unknown origin	off-label use	7520000
Chronic purulent otitis media	off-label use	38394007	DOID:14247
Cholangitis	off-label use	82403002	DOID:9446
Human bite - wound	off-label use	262555007
Chancroid	off-label use	266143009	DOID:13778
Diverticulitis of gastrointestinal tract	off-label use	271366000
Dog bite - wound	off-label use	283734005
Cat bite - wound	off-label use	283782004
Acute exacerbation of chronic bronchitis	off-label use	425748003
Diabetic Foot Infection	off-label use
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis	off-label use
Obstruction of bile duct	contraindication	30144000
Kidney disease	contraindication	90708001	DOID:557
Disease of liver	contraindication	235856003	DOID:409
Infectious mononucleosis	contraindication	271558008	DOID:8568
Pseudomembranous enterocolitis	contraindication	397683000

🐶 Veterinary Drug Use

Species	Use	Relation
Dogs	Urinary tract infections caused by Escherichia coli	Indication
Dogs	Skin and soft tissue infections caused by beta-lactamase producing Staphylococcus aureus	Indication
Dogs	Skin and soft tissue infections caused by Staphylococcus spp	Indication
Dogs	Skin and soft tissue infections caused by Streptococcus spp	Indication
Dogs	Skin and soft tissue infections caused by Escherichia coli	Indication
Dogs	Skin and soft tissue infections caused by Pasteurella spp	Indication
Cats	Urinary tract infections caused by Escherichia coli	Indication
Cats	Skin and soft tissue infections caused by beta-lactamase producing Staphylococcus aureus	Indication
Cats	Skin and soft tissue infections caused by Staphylococcus spp	Indication
Cats	Skin and soft tissue infections caused by Streptococcus spp	Indication
Cats	Skin and soft tissue infections caused by Escherichia coli	Indication
Cats	Skin and soft tissue infections caused by Pasteurella spp	Indication
Cats	Periodontal infections due aerobic and anaerobic bacteria	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
CLAVAMOX CHEWABLE Tablets, CLAVAMOX tablets	Zoetis Inc.	2
Clavamox Drops	Zoetis Inc.	2
Clavacillin	Dechra Veterinary Products LLC	2
Amoxicillin and Clavulanate Potassium for Oral Suspension	Dechra Veterinary Products LLC	2
Amoxicillin and Clavulanate Potassium Tablets	Cronus Pharma Specialities India Private Limited	2
Amoxicillin and Clavulanate Potassium for Oral Suspension	Cronus Pharma Specialities India Private Limited	2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.07	acidic
pKa2	13.53	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-lactamase TEM	Enzyme	BLAT_ECOLX	INHIBITOR	IC50	10.19	WOMBAT-PK	CHEMBL
Beta-lactamase	Enzyme	BLAC_STAAU		MPC	8.72	WOMBAT-PK
Beta-lactamase	Enzyme	AMPC_ECOLI		IC50	7.82	CHEMBL
Beta-lactamase	Enzyme	Q59401_ENTCL		IC50	4	CHEMBL
Beta-lactamase SHV-1	Enzyme	BLA1_ECOLX		IC50	7.55	CHEMBL
Beta-lactamase	Enzyme	AMPC_ENTCL		Kd	6.40	CHEMBL
Beta-lactamase OXA-1	Enzyme	BLO1_ECOLX		IC50	5.49	CHEMBL
Beta-lactamase	Enzyme	AMPC_PSEAE		IC50	6.10	CHEMBL
Beta-lactamase	Enzyme	A4KCT8_9ENTR		IC50	8.05	CHEMBL
Beta-lactamase	Enzyme	A1E3K9_ECOLX		IC50	7.15	CHEMBL
Beta-lactamase	Enzyme	A8RR46_BACCS		IC50	7.07	CHEMBL
Carbapenem-hydrolizing beta-lactamase SFC-1	Enzyme	Q6JP75_SERFO		IC50	4.14	CHEMBL
Carbepenem-hydrolyzing beta-lactamase KPC	Enzyme	BLKPC_KLEPN		Ki	4.96	CHEMBL
Beta-lactamase	Enzyme	A2RP81_CITFR		IC50	7.17	CHEMBL
Beta-lactamase	Enzyme	Q9EXV5_ECOLX		IC50	8.05	CHEMBL
Beta-lactamase SHV-1	Enzyme	BLA1_KLEPN		IC50	6.77	CHEMBL
Beta-lactamase	Enzyme	Q6GWS8_ECOLX		IC50	5.07	CHEMBL
Beta-lactamase	Enzyme	A0ZX81_KLEPN		IC50	5.76	CHEMBL
Beta-lactamase	Enzyme	Q4TVR4_KLEPN		IC50	7.70	CHEMBL
Class D beta-lactamase	Unclassified	Q50H31_BRAPL		IC50	5.70	CHEMBL
Beta-lactamase	Enzyme	Q2XPY6_SALET		IC50	8	CHEMBL
Beta-lactamase SHV-5	Enzyme	BLA5_KLEPN		Ki	4.60	CHEMBL
Beta-lactamase	Enzyme	D2SSQ3_PSEAI		IC50	7	CHEMBL
Beta-lactamase	Enzyme	Q3SAW3_PSEAI		IC50	7	CHEMBL
Beta-lactamase GES-13	Enzyme	D1MIX9_PSEAI		IC50	7	CHEMBL
Beta-lactamase	Enzyme	Q670S6_PSELU		IC50	7.44	CHEMBL

External reference:

ID	Source
N0000005804	NUI
D02370	KEGG_DRUG
61177-45-5	SECONDARY_CAS_RN
21216	RXNORM
4018406	VANDF
4019680	VANDF
C0055860	UMLSCUI
CHEBI:48947	CHEBI
J01	PDB_CHEM_ID
CHEMBL777	ChEMBL_ID
DB00766	DRUGBANK_ID
CHEMBL1003	ChEMBL_ID
D019818	MESH_DESCRIPTOR_UI
5280980	PUBCHEM_CID
4948	INN_ID
11128	IUPHAR_LIGAND_ID
23521W1S24	UNII
4463	MMSL
d04405	MMSL
002808	NDDF
002809	NDDF
395938000	SNOMEDCT_US
395939008	SNOMEDCT_US
412318009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2270	TABLET, CHEWABLE	28.50 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2270	TABLET, CHEWABLE	28.50 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2270	TABLET, CHEWABLE	28.50 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2272	TABLET, CHEWABLE	57 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2272	TABLET, CHEWABLE	57 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2272	TABLET, CHEWABLE	57 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2274	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2274	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2274	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2275	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2275	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2275	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2277	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2277	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2277	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2279	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2279	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2279	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-8675	POWDER, FOR SUSPENSION	42.90 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-8675	POWDER, FOR SUSPENSION	42.90 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-8675	POWDER, FOR SUSPENSION	42.90 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9249	TABLET	125 mg	ORAL	ANDA	29 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9249	TABLET	125 mg	ORAL	ANDA	29 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9853	SUSPENSION	42.90 mg	ORAL	ANDA	32 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9853	SUSPENSION	42.90 mg	ORAL	ANDA	32 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9853	SUSPENSION	42.90 mg	ORAL	ANDA	32 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9981	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	30 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9981	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	30 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9982	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	30 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9982	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	30 sections