All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
antibiotics, kanamycin and bekanamycin derivatives (obtained from Streptomyces kanamyceticus)	157	37517-28-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: amikacin amicacin amikacillin arikace lukadin amikacin sulfate amikacin hydrate	A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics. Molecular weight: 585.61 Formula: C22H43N5O13 CLOGP: -4.12 LIPINSKI: 3 HAC: 18 HDO: 13 TPSA: 331.94 ALOGS: -1.07 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.59	g	Inhal.solution
1	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	98 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	25.61 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	0 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.16 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.88 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.40 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 22, 1981	FDA	APOTHECON
March 23, 2021	PMDA	Insmed GK

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
Drug resistance	357.50	18.62	152	15201	22781	63450888
Dysphonia	201.97	18.62	132	15221	47482	63426187
Pathogen resistance	190.94	18.62	68	15285	6330	63467339
Septic shock	153.80	18.62	128	15225	66501	63407168
Drug reaction with eosinophilia and systemic symptoms	151.30	18.62	97	15256	33739	63439930
Deafness	146.05	18.62	76	15277	17881	63455788
Multiple organ dysfunction syndrome	145.66	18.62	116	15237	56636	63417033
Therapy interrupted	127.94	18.62	86	15267	32369	63441300
Aphonia	115.90	18.62	54	15299	10009	63463660
Ototoxicity	114.81	18.62	32	15321	1330	63472339
Off label use	105.21	18.62	379	14974	674083	62799586
Cough	103.27	18.62	222	15131	292521	63181148
Tinnitus	100.42	18.62	77	15276	35551	63438118
Thrombocytopenia	98.76	18.62	150	15203	151007	63322662
Systemic candida	91.20	18.62	33	15320	3212	63470457
Haemoptysis	89.65	18.62	66	15287	28660	63445009
Eosinophilia	86.56	18.62	59	15294	22697	63450972
Rash maculo-papular	83.51	18.62	66	15287	31830	63441839
Hospitalisation	80.48	18.62	101	15252	84980	63388689
Sputum increased	80.48	18.62	28	15325	2431	63471238
Geotrichum infection	78.23	18.62	19	15334	455	63473214
Pain	75.36	18.62	43	15310	740585	62733084
Mycobacterium abscessus infection	71.87	18.62	19	15334	645	63473024
Toxic skin eruption	70.41	18.62	42	15311	12843	63460826
Klebsiella infection	68.90	18.62	36	15317	8530	63465139
Candida infection	68.55	18.62	56	15297	28295	63445374
Pseudomonas infection	65.08	18.62	38	15315	11175	63462494
Sepsis	63.14	18.62	124	15229	152999	63320670
Paradoxical drug reaction	62.91	18.62	27	15326	4125	63469544
Bronchopulmonary aspergillosis	60.21	18.62	33	15320	8602	63465067
Hepatotoxicity	59.38	18.62	58	15295	36983	63436686
Immune reconstitution inflammatory syndrome	58.95	18.62	29	15324	6055	63467614
Pyrexia	57.27	18.62	245	15108	470233	63003436
Acute kidney injury	56.08	18.62	165	15188	263250	63210419
Nephropathy toxic	52.06	18.62	31	15322	9448	63464221
Enterococcal infection	51.99	18.62	29	15324	7819	63465850
Hepatocellular injury	51.79	18.62	47	15306	27334	63446335
Febrile neutropenia	50.12	18.62	97	15256	118352	63355317
Mycobacterium avium complex infection	49.83	18.62	21	15332	3067	63470602
Drug ineffective for unapproved indication	48.46	18.62	50	15303	34013	63439656
Hyperlactacidaemia	48.07	18.62	20	15333	2829	63470840
Infusion related reaction	47.52	18.62	3	15350	245518	63228151
Fatigue	46.99	18.62	90	15263	887938	62585731
Productive cough	45.91	18.62	66	15287	63142	63410527
Acute respiratory distress syndrome	45.69	18.62	41	15312	23493	63450176
Acute generalised exanthematous pustulosis	45.13	18.62	30	15323	11069	63462600
Joint swelling	44.73	18.62	12	15341	327654	63146015
Mucormycosis	44.58	18.62	19	15334	2852	63470817
Product packaging difficult to open	44.04	18.62	9	15344	94	63473575
Arthralgia	43.84	18.62	44	15309	569666	62904003
Intentional dose omission	43.28	18.62	26	15327	8049	63465620
Toxic epidermal necrolysis	43.11	18.62	41	15312	25293	63448376
Clostridium difficile colitis	42.26	18.62	37	15316	20532	63453137
Encephalopathy	41.61	18.62	49	15304	38571	63435098
Deafness neurosensory	40.75	18.62	21	15332	4834	63468835
Product use in unapproved indication	38.84	18.62	113	15240	178967	63294702
Fall	38.05	18.62	24	15329	392310	63081359
Osteomyelitis bacterial	37.69	18.62	9	15344	200	63473469
Aplasia	37.43	18.62	19	15334	4240	63469429
Acinetobacter infection	36.78	18.62	14	15339	1569	63472100
Product administered to patient of inappropriate age	35.97	18.62	17	15336	3251	63470418
Nosocomial infection	35.64	18.62	14	15339	1707	63471962
Alopecia	35.06	18.62	19	15334	337517	63136152
Swelling	34.13	18.62	12	15341	275366	63198303
Synovitis	34.12	18.62	3	15350	186915	63286754
Neutropenic colitis	33.75	18.62	16	15337	3079	63470590
Headache	33.56	18.62	64	15289	633177	62840492
Leukopenia	33.53	18.62	64	15289	77226	63396443
Abdominal discomfort	33.41	18.62	18	15335	320867	63152802
Nasopharyngitis	33.41	18.62	10	15343	254247	63219422
Weight increased	32.95	18.62	11	15342	260781	63212888
Dysbiosis	32.30	18.62	11	15342	895	63472774
Pancreatitis acute	31.84	18.62	36	15317	27130	63446539
Multiple-drug resistance	31.27	18.62	18	15335	5152	63468517
Cholestasis	31.14	18.62	37	15316	29397	63444272
Respiratory failure	31.02	18.62	73	15280	101785	63371884
Hepatosplenic candidiasis	30.51	18.62	8	15345	263	63473406
Hypertransaminasaemia	29.64	18.62	19	15334	6590	63467079
Hepatitis	29.55	18.62	42	15311	39746	63433923
Bronchospasm	29.46	18.62	28	15325	17252	63456417
Antithrombin III	29.13	18.62	7	15346	160	63473509
Musculoskeletal stiffness	28.75	18.62	5	15348	184613	63289056
Butterfly rash	28.42	18.62	12	15341	1761	63471908
Retinal ischaemia	28.34	18.62	8	15345	348	63473321
Angular cheilitis	27.57	18.62	9	15344	642	63473027
Glossodynia	27.52	18.62	5	15348	178871	63294798
Bacteraemia	27.48	18.62	27	15326	17321	63456348
Guillain-Barre syndrome	27.47	18.62	15	15338	3878	63469791
Overgrowth fungal	27.29	18.62	6	15347	91	63473578
Haemorrhage intracranial	27.28	18.62	24	15329	13395	63460274
Hepatic function abnormal	27.28	18.62	39	15314	37103	63436566
Coagulopathy	27.15	18.62	29	15324	20515	63453154
Myelosuppression	27.08	18.62	31	15322	23672	63449997
Herpes simplex hepatitis	27.07	18.62	8	15345	410	63473259
Drug ineffective	26.65	18.62	376	14977	1044389	62429280
Wound	26.36	18.62	4	15349	163259	63310410
Granulomatous liver disease	26.00	18.62	9	15344	769	63472900
Klebsiella bacteraemia	25.71	18.62	11	15342	1667	63472002
Chemotherapeutic drug level increased	25.06	18.62	6	15347	135	63473534
Pain in extremity	24.98	18.62	26	15327	331460	63142209
Neuropathy peripheral	24.88	18.62	72	15281	113595	63360074
Peripheral swelling	24.77	18.62	17	15336	265925	63207744
Infective pulmonary exacerbation of cystic fibrosis	24.70	18.62	19	15334	8798	63464871
Status epilepticus	24.68	18.62	24	15329	15209	63458460
Deafness permanent	24.60	18.62	4	15349	9	63473660
Dysgeusia	24.48	18.62	42	15311	46668	63427001
Hypersensitivity	24.34	18.62	21	15332	292664	63181005
Vulvovaginitis	24.26	18.62	7	15346	330	63473339
Electrocardiogram QT prolonged	24.24	18.62	48	15305	59482	63414187
Neutropenia	24.23	18.62	95	15258	174910	63298759
Cholestatic liver injury	23.98	18.62	12	15341	2598	63471071
Deafness bilateral	23.91	18.62	10	15343	1432	63472237
Aspergillus infection	23.91	18.62	18	15335	8075	63465594
Pancytopenia	23.78	18.62	64	15289	96869	63376800
Bone marrow failure	23.36	18.62	32	15321	29258	63444411
Atypical mycobacterial infection	22.96	18.62	9	15344	1091	63472578
Capillary leak syndrome	22.86	18.62	11	15342	2189	63471480
Acute hepatic failure	22.70	18.62	25	15328	18302	63455367
Throat irritation	22.62	18.62	36	15317	37611	63436058
Granulomatosis with polyangiitis	22.55	18.62	11	15342	2254	63471415
Corneal opacity	22.55	18.62	8	15345	735	63472934
Respiratory distress	22.55	18.62	34	15319	33917	63439752
Hypofibrinogenaemia	22.42	18.62	9	15344	1161	63472508
Agranulocytosis	22.41	18.62	29	15324	25105	63448564
Rhinocerebral mucormycosis	22.03	18.62	7	15346	458	63473211
Post-tussive vomiting	21.98	18.62	3	15350	0	63473669
Lower respiratory tract infection bacterial	21.87	18.62	7	15346	469	63473200
Polyneuropathy	21.81	18.62	22	15331	14567	63459102
Kussmaul respiration	21.55	18.62	6	15347	248	63473421
Anxiety	21.49	18.62	13	15340	217528	63256141
Mycobacterium chelonae infection	21.37	18.62	7	15346	505	63473164
Generalised bullous fixed drug eruption	21.16	18.62	5	15348	106	63473563
Hypertension	20.93	18.62	22	15331	279281	63194388
Muscle spasms	20.76	18.62	6	15347	156144	63317525
Back pain	20.72	18.62	20	15333	264125	63209544
Sinusitis	20.42	18.62	15	15338	226638	63247031
Cytomegalovirus infection	19.99	18.62	25	15328	20927	63452742
Purulence	19.85	18.62	9	15344	1565	63472104
Renal failure	19.75	18.62	68	15285	117584	63356085
Insomnia	19.72	18.62	14	15339	215238	63258431
Endocarditis candida	19.64	18.62	4	15349	41	63473628
Haemophagocytic lymphohistiocytosis	19.62	18.62	18	15335	10609	63463060
Drug dose omission by device	19.57	18.62	13	15340	4788	63468881
Retinal artery occlusion	19.43	18.62	9	15344	1644	63472025
Cardiac failure acute	19.29	18.62	17	15336	9506	63464163
Tinea versicolour	19.14	18.62	4	15349	47	63473622
Cryptococcosis	19.11	18.62	8	15345	1149	63472520
Pseudomonal sepsis	19.05	18.62	10	15343	2391	63471278
Fungaemia	19.04	18.62	10	15343	2393	63471276
Respiratory gas exchange disorder	18.89	18.62	6	15347	392	63473277
Vascular device infection	18.85	18.62	15	15338	7297	63466372
Febrile bone marrow aplasia	18.82	18.62	15	15338	7310	63466359
Mycobacterial infection	18.78	18.62	9	15344	1774	63471895
Weaning failure	18.70	18.62	6	15347	405	63473264

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
Drug resistance	313.15	16.61	180	16702	25747	34914302
Ototoxicity	251.29	16.61	74	16808	1843	34938206
Drug reaction with eosinophilia and systemic symptoms	171.91	16.61	136	16746	32876	34907173
Septic shock	160.03	16.61	185	16697	71649	34868400
Pathogen resistance	153.59	16.61	80	16802	9402	34930647
Rash maculo-papular	137.02	16.61	112	16770	28339	34911710
Deafness	132.64	16.61	77	16805	11188	34928861
Electrocardiogram QT prolonged	112.83	16.61	118	16764	40834	34899215
Drug ineffective	108.77	16.61	471	16411	456280	34483769
Product use in unapproved indication	101.79	16.61	194	16688	117305	34822744
Thrombocytopenia	98.05	16.61	226	16656	156021	34784028
Multiple organ dysfunction syndrome	86.37	16.61	142	16740	76424	34863625
Eosinophilia	83.98	16.61	82	16800	26140	34913909
Immune reconstitution inflammatory syndrome	82.77	16.61	52	16830	8707	34931342
Acute kidney injury	70.29	16.61	312	16570	304676	34635373
Deafness neurosensory	66.74	16.61	31	16851	2840	34937209
Toxic skin eruption	63.74	16.61	49	16833	11336	34928713
Drug ineffective for unapproved indication	62.90	16.61	67	16815	23648	34916401
Fall	61.00	16.61	12	16870	202873	34737176
Candida infection	59.73	16.61	57	16825	17658	34922391
Klebsiella infection	59.68	16.61	42	16840	8489	34931560
Fatigue	59.56	16.61	55	16827	370598	34569451
Mycobacterium chelonae infection	58.97	16.61	20	16862	795	34939254
Off label use	58.75	16.61	374	16508	419150	34520899
Hepatotoxicity	57.51	16.61	61	16821	21424	34918625
Treatment failure	53.13	16.61	87	16795	46610	34893439
Enterococcal infection	47.65	16.61	38	16844	9268	34930781
Brain abscess	46.71	16.61	25	16857	3100	34936949
Pain	45.50	16.61	21	16861	204654	34735395
Blood pressure measurement	42.34	16.61	11	16871	169	34939880
Therapy interrupted	42.28	16.61	42	16840	13655	34926394
Pseudomonas infection	42.03	16.61	40	16842	12342	34927707
Bronchospasm	40.94	16.61	37	16845	10694	34929355
Pancytopenia	38.44	16.61	117	16765	95040	34845009
Nephropathy toxic	37.75	16.61	38	16844	12550	34927499
Hepatic cytolysis	36.75	16.61	40	16842	14456	34925593
Tuberculosis of central nervous system	36.16	16.61	10	16872	197	34939852
Deafness bilateral	35.46	16.61	15	16867	1099	34938950
Myelosuppression	35.27	16.61	45	16837	19220	34920829
Bronchopulmonary aspergillosis	34.66	16.61	39	16843	14620	34925429
Hypoacusis	34.56	16.61	41	16841	16260	34923789
Acute respiratory distress syndrome	33.13	16.61	51	16831	25918	34914131
Febrile bone marrow aplasia	32.69	16.61	29	16853	8180	34931869
Hydrocephalus	32.57	16.61	24	16858	5208	34934841
Systemic candida	32.41	16.61	21	16861	3705	34936344
Vascular pseudoaneurysm thrombosis	32.05	16.61	7	16875	48	34940001
Aspergillus infection	31.39	16.61	34	16848	12220	34927829
Nocardiosis	31.29	16.61	21	16861	3930	34936119
Hypertransaminasaemia	31.09	16.61	24	16858	5582	34934467
Myocardial infarction	30.89	16.61	10	16872	121075	34818974
Multiple-drug resistance	30.31	16.61	23	16859	5216	34934833
Linear IgA disease	30.04	16.61	15	16867	1611	34938438
Mucormycosis	29.86	16.61	24	16858	5918	34934131
Posterior reversible encephalopathy syndrome	29.76	16.61	30	16852	9924	34930125
Acute generalised exanthematous pustulosis	29.12	16.61	25	16857	6751	34933298
Stenotrophomonas infection	29.09	16.61	16	16866	2094	34937955
Sepsis neonatal	29.05	16.61	9	16873	267	34939782
Hepatocellular injury	28.86	16.61	44	16838	22167	34917882
Acoustic neuroma	28.81	16.61	8	16874	160	34939889
Headache	28.47	16.61	33	16849	200602	34739447
Fusarium infection	28.44	16.61	13	16869	1147	34938902
Cholestasis	27.70	16.61	48	16834	26900	34913149
Trichosporon infection	27.14	16.61	11	16871	723	34939326
Inflammatory marker increased	26.74	16.61	21	16861	5007	34935042
Hypofibrinogenaemia	26.64	16.61	14	16868	1672	34938377
Thalamic infarction	26.48	16.61	11	16871	770	34939279
Respiratory distress	26.12	16.61	55	16827	35610	34904439
Necrotising colitis	26.07	16.61	12	16870	1076	34938973
Incision site pain	25.51	16.61	14	16868	1824	34938225
Sepsis	25.32	16.61	152	16730	166409	34773640
Myasthenia gravis crisis	25.28	16.61	10	16872	617	34939432
Agranulocytosis	25.23	16.61	43	16839	23778	34916271
Scedosporium infection	25.19	16.61	11	16871	871	34939178
Hyperbilirubinaemia	24.23	16.61	35	16847	16808	34923241
Candida sepsis	24.22	16.61	12	16870	1267	34938782
Leukopenia	24.17	16.61	76	16806	62780	34877269
Cardiac valve vegetation	23.97	16.61	9	16873	482	34939567
Disseminated intravascular coagulation	23.93	16.61	40	16842	21776	34918273
Red blood cells urine positive	22.98	16.61	13	16869	1796	34938253
Weight bearing difficulty	22.92	16.61	11	16871	1084	34938965
Condition aggravated	22.90	16.61	165	16717	192031	34748018
Cardiac failure congestive	22.83	16.61	6	16876	83264	34856785
Vestibular disorder	22.80	16.61	11	16871	1096	34938953
Dehydration	22.34	16.61	18	16864	129951	34810098
Tuberculosis	22.32	16.61	24	16858	8553	34931496
Sputum increased	22.21	16.61	14	16868	2356	34937693
Nervous system disorder	22.07	16.61	31	16851	14512	34925537
Protein urine present	21.88	16.61	19	16863	5209	34934840
Respiratory failure	21.84	16.61	107	16775	108465	34831584
Benign soft tissue neoplasm	21.80	16.61	6	16876	116	34939933
Cerebrovascular accident	21.63	16.61	7	16875	84804	34855245
Death	21.60	16.61	109	16773	397940	34542109
Urinary tract infection fungal	20.88	16.61	8	16874	453	34939596
Candida pneumonia	20.81	16.61	8	16874	457	34939592
Back pain	20.77	16.61	17	16865	121772	34818277
Dizziness	20.62	16.61	47	16835	218474	34721575
Drug-induced liver injury	20.58	16.61	44	16838	28788	34911261
Pyrexia	20.47	16.61	248	16634	332765	34607284
Sputum purulent	20.31	16.61	8	16874	488	34939561
Product administered to patient of inappropriate age	20.27	16.61	15	16867	3276	34936773
Premature baby death	19.91	16.61	3	16879	0	34940049
Herpes zoster meningoencephalitis	19.79	16.61	7	16875	316	34939733
Mycobacterium abscessus infection	19.59	16.61	8	16874	536	34939513
Allodynia	19.40	16.61	9	16873	822	34939227
Toxic neuropathy	19.38	16.61	8	16874	551	34939498
Purpura non-thrombocytopenic	19.36	16.61	5	16877	75	34939974
Pericarditis tuberculous	19.23	16.61	5	16877	77	34939972
Malaise	19.17	16.61	38	16844	185787	34754262
Hepatitis fulminant	19.11	16.61	16	16866	4174	34935875
Arthralgia	19.11	16.61	33	16849	170008	34770041
Lymphocyte count decreased	19.08	16.61	37	16845	22585	34917464
Acinetobacter infection	19.01	16.61	10	16872	1197	34938852
Flavobacterium infection	19.00	16.61	5	16877	81	34939968
Clostridium difficile colitis	18.82	16.61	30	16852	15700	34924349
Fungaemia	18.79	16.61	13	16869	2555	34937494
Atypical mycobacterial infection	18.78	16.61	9	16873	884	34939165
Gallstone ileus	18.77	16.61	4	16878	24	34940025
Immune effector cell-associated neurotoxicity syndrome	18.66	16.61	15	16867	3698	34936351
Atypical mycobacterium test positive	18.50	16.61	4	16878	26	34940023
Pulmonary cavitation	18.43	16.61	9	16873	921	34939128
General physical condition abnormal	18.36	16.61	15	16867	3784	34936265
Inappropriate schedule of product administration	18.03	16.61	4	16878	62292	34877757
Hypersensitivity vasculitis	17.89	16.61	14	16868	3321	34936728
Pain in extremity	17.72	16.61	21	16861	126492	34813557
Hypertension	17.71	16.61	24	16858	136419	34803630
Renal tubular disorder	17.69	16.61	16	16866	4627	34935422
Hepatosplenic candidiasis	17.65	16.61	6	16876	240	34939809
Infective pulmonary exacerbation of cystic fibrosis	17.64	16.61	19	16863	6782	34933267
Shock	17.37	16.61	37	16845	24142	34915907
Vasculitis	17.02	16.61	24	16858	11272	34928777
Peripheral swelling	16.75	16.61	8	16874	76533	34863516
Haemorrhagic pneumonia	16.73	16.61	5	16877	131	34939918
Blood pressure increased	16.70	16.61	11	16871	88091	34851958
Antibiotic associated colitis	16.62	16.61	3	16879	6	34940043

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
Drug resistance	570.04	16.65	284	27788	41929	79674387
Drug reaction with eosinophilia and systemic symptoms	340.90	16.65	236	27836	64008	79652308
Ototoxicity	338.74	16.65	98	27974	3176	79713140
Pathogen resistance	313.98	16.65	135	27937	14207	79702109
Septic shock	289.23	16.65	281	27791	122520	79593796
Rash maculo-papular	227.04	16.65	175	27897	55903	79660413
Deafness	216.30	16.65	118	27954	20919	79695397
Multiple organ dysfunction syndrome	210.81	16.65	235	27837	120011	79596305
Thrombocytopenia	186.09	16.65	334	27738	264925	79451391
Eosinophilia	169.44	16.65	135	27937	45210	79671106
Drug ineffective	146.79	16.65	757	27315	1080156	78636160
Toxic skin eruption	137.53	16.65	90	27982	22203	79694113
Electrocardiogram QT prolonged	137.06	16.65	164	27908	90222	79626094
Acute kidney injury	131.31	16.65	441	27631	518963	79197353
Immune reconstitution inflammatory syndrome	129.56	16.65	73	27999	13768	79702548
Klebsiella infection	128.73	16.65	76	27996	15644	79700672
Fatigue	120.81	16.65	91	27981	929636	78786680
Hepatotoxicity	116.03	16.65	115	27957	51237	79665079
Pain	112.16	16.65	54	28018	703748	79012568
Product use in unapproved indication	112.12	16.65	262	27810	250097	79466219
Off label use	108.95	16.65	615	27457	906600	78809716
Deafness neurosensory	103.71	16.65	50	28022	6848	79709468
Enterococcal infection	100.95	16.65	65	28007	15595	79700721
Pseudomonas infection	99.65	16.65	72	28000	20831	79695485
Candida infection	92.72	16.65	89	27983	38125	79678191
Fall	91.45	16.65	29	28043	487600	79228716
Bronchopulmonary aspergillosis	91.09	16.65	70	28002	22224	79694092
Drug ineffective for unapproved indication	84.33	16.65	97	27975	51141	79665175
Sepsis	80.86	16.65	243	27829	269185	79447131
Geotrichum infection	78.15	16.65	24	28048	957	79715359
Acute respiratory distress syndrome	76.89	16.65	86	27986	43981	79672335
Headache	74.93	16.65	72	28000	653700	79062616
Mucormycosis	74.77	16.65	43	28029	8426	79707890
Nephropathy toxic	74.55	16.65	60	28012	20359	79695957
Pyrexia	72.71	16.65	447	27625	678262	79038054
Acute generalised exanthematous pustulosis	70.10	16.65	54	28018	17200	79699116
Tinnitus	69.73	16.65	82	27990	44251	79672065
Mycobacterium abscessus infection	68.96	16.65	23	28049	1199	79715117
Arthralgia	66.63	16.65	62	28010	571741	79144575
Myelosuppression	65.82	16.65	76	27996	40220	79676096
Sputum increased	65.03	16.65	32	28040	4581	79711735
Paradoxical drug reaction	64.82	16.65	37	28035	7148	79709168
Hepatocellular injury	61.90	16.65	80	27992	47513	79668803
Joint swelling	60.00	16.65	14	28058	288632	79427684
Mycobacterium chelonae infection	59.99	16.65	25	28047	2431	79713885
Dysphonia	59.45	16.65	86	27986	56786	79659530
Deafness bilateral	59.35	16.65	24	28048	2161	79714155
Multiple-drug resistance	57.86	16.65	37	28035	8771	79707545
Pancytopenia	54.95	16.65	155	27917	165590	79550726
Acinetobacter infection	53.81	16.65	24	28048	2753	79713563
Febrile bone marrow aplasia	53.44	16.65	41	28031	12979	79703337
Hypertransaminasaemia	52.15	16.65	39	28033	11885	79704431
Mycobacterium avium complex infection	50.60	16.65	27	28045	4573	79711743
Nocardiosis	50.58	16.65	29	28043	5650	79710666
Respiratory failure	50.33	16.65	159	27913	180752	79535564
Therapy interrupted	49.33	16.65	58	28014	31283	79685033
Weight increased	49.32	16.65	18	28054	277368	79438948
Aphonia	47.96	16.65	35	28037	10277	79706039
Nasopharyngitis	47.70	16.65	15	28057	253866	79462450
Aspergillus infection	47.17	16.65	45	28027	19116	79697200
Pain in extremity	46.72	16.65	36	28036	364502	79351814
Therapeutic product effect decreased	45.87	16.65	3	28069	163860	79552456
Leukopenia	45.71	16.65	116	27956	116397	79599919
Hydrocephalus	45.51	16.65	32	28040	8868	79707448
Agranulocytosis	45.47	16.65	67	28005	44963	79671353
Hepatosplenic candidiasis	45.21	16.65	14	28058	574	79715742
Clostridium difficile colitis	44.71	16.65	56	28016	32227	79684089
Respiratory distress	44.04	16.65	76	27996	58263	79658053
Nosocomial infection	44.00	16.65	21	28051	2811	79713505
Neuropathy peripheral	43.79	16.65	129	27943	141176	79575140
Hyperlactacidaemia	43.07	16.65	26	28046	5569	79710747
Infusion related reaction	42.55	16.65	14	28058	230223	79486093
Peripheral swelling	42.33	16.65	21	28051	269596	79446720
Malaise	42.30	16.65	67	28005	489802	79226514
Aplasia	42.05	16.65	29	28043	7791	79708525
Hypoacusis	41.28	16.65	52	28020	30098	79686218
Anxiety	41.11	16.65	18	28054	248494	79467822
Hypofibrinogenaemia	41.04	16.65	18	28054	1984	79714332
Cholestasis	40.80	16.65	69	28003	52040	79664276
Neutropenic colitis	40.05	16.65	25	28047	5682	79710634
Hypertension	39.54	16.65	35	28037	330957	79385359
Alopecia	39.48	16.65	16	28056	231339	79484977
Osteomyelitis bacterial	39.28	16.65	12	28060	470	79715846
Pancreatitis acute	39.26	16.65	66	28006	49538	79666778
Infective pulmonary exacerbation of cystic fibrosis	39.12	16.65	34	28038	12817	79703499
Toxic epidermal necrolysis	38.91	16.65	62	28010	44519	79671797
Synovitis	38.76	16.65	4	28068	150730	79565586
Systemic candida	38.75	16.65	26	28046	6680	79709636
Polyneuropathy	38.51	16.65	45	28027	24106	79692210
Guillain-Barre syndrome	38.49	16.65	29	28043	8936	79707380
Contusion	38.13	16.65	4	28068	148772	79567544
Inflammatory marker increased	38.02	16.65	31	28041	10709	79705607
Bronchospasm	37.46	16.65	45	28027	24814	79691502
Musculoskeletal stiffness	37.33	16.65	8	28064	175000	79541316
Haemoptysis	37.20	16.65	69	28003	55930	79660386
Haemophagocytic lymphohistiocytosis	37.03	16.65	42	28030	21795	79694521
Swelling	36.96	16.65	15	28057	216696	79499620
Atypical mycobacterial infection	36.79	16.65	16	28056	1727	79714589
Neutropenia	36.18	16.65	198	27874	287512	79428804
Hepatic cytolysis	35.86	16.65	46	28026	27105	79689211
Abdominal discomfort	35.78	16.65	22	28050	250705	79465611
Blood pressure measurement	35.73	16.65	11	28061	442	79715874
Stenotrophomonas infection	35.57	16.65	20	28052	3753	79712563
Dizziness	35.04	16.65	84	27988	526357	79189959
Product packaging difficult to open	34.92	16.65	7	28065	43	79716273
Back pain	34.17	16.65	34	28038	304146	79412170
Posterior reversible encephalopathy syndrome	33.89	16.65	44	28028	26237	79690079
Treatment failure	33.75	16.65	134	27938	170352	79545964
Vascular pseudoaneurysm thrombosis	33.53	16.65	7	28065	54	79716262
Discomfort	33.18	16.65	3	28069	125614	79590702
Brain abscess	33.08	16.65	21	28051	4915	79711401
Coagulopathy	32.70	16.65	51	28021	35955	79680361
Dehydration	32.43	16.65	24	28048	248163	79468153
Blood pressure increased	32.37	16.65	17	28055	211343	79504973
Hepatitis fulminant	32.31	16.65	24	28048	7238	79709078
Incision site pain	32.23	16.65	17	28055	2813	79713503
Immune effector cell-associated neurotoxicity syndrome	32.18	16.65	22	28050	5826	79710490
Fungaemia	31.94	16.65	20	28052	4571	79711745
Febrile neutropenia	31.79	16.65	163	27909	230836	79485480
Sinusitis	31.02	16.65	15	28057	195486	79520830
Myocardial infarction	30.98	16.65	13	28059	184116	79532200
Tuberculosis of central nervous system	30.71	16.65	10	28062	483	79715833
Gait disturbance	29.89	16.65	18	28054	207488	79508828
Leukocytosis	28.18	16.65	53	28019	43402	79672914
Linear IgA disease	27.91	16.65	16	28056	3116	79713200
Wound	27.62	16.65	4	28068	116175	79600141
Thalamic infarction	27.60	16.65	12	28060	1295	79715021
Serratia infection	27.08	16.65	13	28059	1763	79714553
Renal failure	27.08	16.65	141	27931	200827	79515489
Corneal opacity	27.01	16.65	11	28061	1009	79715307
Muscle spasms	26.83	16.65	14	28058	174716	79541600
Otitis media fungal	26.53	16.65	5	28067	21	79716295
Herpes zoster meningoencephalitis	26.47	16.65	10	28062	751	79715565
Acoustic neuroma	26.44	16.65	8	28064	303	79716013
Encephalopathy	26.32	16.65	67	28005	67330	79648986
Gastrooesophageal reflux disease	26.21	16.65	3	28069	104243	79612073
Scedosporium infection	26.18	16.65	12	28060	1466	79714850
Myasthenia gravis crisis	26.10	16.65	11	28061	1100	79715216
Depression	25.78	16.65	23	28049	216767	79499549
Red blood cells urine positive	25.74	16.65	18	28054	4945	79711371
Renal tubular disorder	25.69	16.65	20	28052	6466	79709850
Immune reconstitution inflammatory syndrome associated tuberculosis	25.55	16.65	10	28062	826	79715490
Tuberculosis	25.38	16.65	29	28043	15169	79701147
Protein urine present	25.37	16.65	24	28048	10088	79706228
Bacteraemia	25.08	16.65	43	28029	32781	79683535
Staphylococcal infection	24.92	16.65	60	28012	58235	79658081
Pulmonary cavitation	24.88	16.65	12	28060	1644	79714672
Overgrowth fungal	24.75	16.65	6	28066	96	79716220
Escherichia infection	24.54	16.65	31	28041	17986	79698330
Feeling abnormal	24.08	16.65	13	28059	159186	79557130
Dermatitis exfoliative	23.98	16.65	24	28048	10805	79705511
Granulomatosis with polyangiitis	23.82	16.65	14	28058	2856	79713460
Trichosporon infection	23.74	16.65	10	28062	998	79715318
Lower respiratory tract infection	23.61	16.65	8	28064	129212	79587104
Disseminated intravascular coagulation	23.60	16.65	44	28028	35798	79680518
Status epilepticus	23.48	16.65	36	28036	25005	79691311
Lung disorder	23.48	16.65	72	28000	80485	79635831
Hypersensitivity	23.43	16.65	35	28037	262204	79454112
Bone marrow failure	23.37	16.65	54	28018	51053	79665263
Benign soft tissue neoplasm	23.21	16.65	6	28066	126	79716190
Constipation	23.20	16.65	40	28032	283010	79433306
Inappropriate schedule of product administration	23.18	16.65	9	28063	133619	79582697
Rash pustular	23.10	16.65	24	28048	11287	79705029
Deafness permanent	23.10	16.65	4	28068	9	79716307
Cerebrovascular accident	23.03	16.65	13	28059	155279	79561037
Candida sepsis	22.83	16.65	13	28059	2500	79713816
Pneumonia bacterial	22.82	16.65	31	28041	19300	79697016
Blood urea increased	22.80	16.65	52	28020	48738	79667578
Retinal ischaemia	22.60	16.65	9	28063	779	79715537
Hepatitis	22.38	16.65	56	28016	55671	79660645
Vulvovaginitis	22.35	16.65	7	28065	298	79716018
Anuria	22.34	16.65	32	28040	20931	79695385
Pulmonary tuberculosis	22.32	16.65	20	28052	7845	79708471
Capillary leak syndrome	22.16	16.65	15	28057	3910	79712406
Memory impairment	22.07	16.65	6	28066	111728	79604588
Drug-induced liver injury	22.05	16.65	62	28010	66055	79650261
Herpes simplex hepatitis	22.04	16.65	8	28064	537	79715779
Dermatitis bullous	21.81	16.65	26	28046	14219	79702097
Haemolytic anaemia	21.68	16.65	29	28043	17791	79698525
Face oedema	21.68	16.65	37	28035	28099	79688217
Butterfly rash	21.65	16.65	11	28061	1685	79714631
Pneumothorax	21.50	16.65	37	28035	28286	79688030
Glossodynia	21.47	16.65	5	28067	103332	79612984
Cardiac valve vegetation	21.26	16.65	9	28063	910	79715406
Granulomatous liver disease	21.06	16.65	10	28062	1323	79714993
Shock	21.00	16.65	47	28025	43501	79672815
Cardiac failure congestive	21.00	16.65	12	28060	142390	79573926
Impaired healing	20.88	16.65	3	28069	87652	79628664
Haemoperitoneum	20.79	16.65	15	28057	4328	79711988
Toxic neuropathy	20.70	16.65	9	28063	971	79715345
Mycobacterial infection	20.66	16.65	14	28058	3654	79712662
Klebsiella bacteraemia	20.65	16.65	13	28059	2997	79713319
Hypoalbuminaemia	20.51	16.65	31	28041	21266	79695050
Gallstone ileus	20.33	16.65	4	28068	22	79716294
Mycobacterium fortuitum infection	20.18	16.65	6	28066	214	79716102
Hyperbilirubinaemia	19.90	16.65	33	28039	24485	79691831
Transaminases increased	19.74	16.65	51	28021	51692	79664624
Flavobacterium infection	19.67	16.65	5	28067	98	79716218
Drug hypersensitivity	19.61	16.65	48	28024	298868	79417448
Angular cheilitis	19.43	16.65	8	28064	754	79715562
Urogenital infection bacterial	19.39	16.65	5	28067	104	79716212
Hospitalisation	19.39	16.65	75	27997	94161	79622155
Pericarditis tuberculous	19.30	16.65	5	28067	106	79716210
Clostridial infection	19.20	16.65	16	28056	5698	79710618
Deafness unilateral	19.14	16.65	14	28058	4124	79712192
Syncope	19.08	16.65	21	28051	179428	79536888
Allodynia	19.05	16.65	10	28062	1638	79714678
Nervous system disorder	18.98	16.65	34	28038	26822	79689494
Insomnia	18.87	16.65	36	28036	245134	79471182
Migraine	18.65	16.65	4	28068	87489	79628827
Haemorrhagic pneumonia	18.18	16.65	5	28067	134	79716182
Fusarium infection	18.06	16.65	10	28062	1822	79714494
Choroiditis	17.75	16.65	9	28063	1372	79714944
Haemodynamic instability	17.74	16.65	26	28046	17356	79698960
Asthma	17.72	16.65	13	28059	135082	79581234
Injury	17.67	16.65	3	28069	77493	79638823
Cough	17.62	16.65	202	27870	366587	79349729
Product administered to patient of inappropriate age	17.52	16.65	15	28057	5538	79710778
Chemotherapeutic drug level increased	17.32	16.65	6	28066	351	79715965
Alanine aminotransferase increased	17.23	16.65	107	27965	162463	79553853
Mobility decreased	17.03	16.65	11	28061	122164	79594152
Acid fast bacilli infection	17.02	16.65	5	28067	171	79716145
Urinary tract infection fungal	16.95	16.65	8	28064	1045	79715271
Cholestatic liver injury	16.94	16.65	14	28058	4927	79711389
Rhinocerebral mucormycosis	16.91	16.65	8	28064	1050	79715266
AIDS related complication	16.87	16.65	4	28068	58	79716258
Fungal infection	16.81	16.65	42	28030	41706	79674610
Pneumonia pseudomonal	16.71	16.65	15	28057	5896	79710420

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D06AX12	DERMATOLOGICALS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE ANTIBIOTICS FOR TOPICAL USE Other antibiotics for topical use
ATC	J01GB06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE AMINOGLYCOSIDE ANTIBACTERIALS Other aminoglycosides
ATC	J01RA06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials
ATC	S01AA21	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antibiotics
FDA CS	M0000946	Aminoglycosides
FDA EPC	N0000175477	Aminoglycoside Antibacterial
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:61015	nephrotoxins
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents

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
Infection due to Pseudomonas aeruginosa	indication	11218009
Staphylococcal meningitis	indication	12166008
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Staphylococcal pneumonia	indication	22754005
Pneumonia due to Pseudomonas	indication	41381004
Pneumonia due to Escherichia coli	indication	51530003
Bacterial pneumonia	indication	53084003	DOID:874
Osteomyelitis	indication	60168000
Infection due to Escherichia coli	indication	71057007
Bacterial infection due to Serratia	indication	71120004
Rhinoscleroma	indication	72409005	DOID:11336
Septicemia due to Serratia	indication	82091000
Cholangitis	indication	82403002	DOID:9446
Bacterial meningitis	indication	95883001	DOID:9470
Infection of bone	indication	111253001
Staphylococcal septicemia	indication	111821004
Infectious disease of abdomen	indication	128070006
Infection due to Enterobacteriaceae	indication	128945009
Bacterial infection due to Klebsiella pneumoniae	indication	186435004
Escherichia coli meningitis	indication	192655005
Proteus pneumonia	indication	195888009
Sepsis of the newborn	indication	206376005
Neonatal pneumonia	indication	233619008
Diverticulitis of gastrointestinal tract	indication	271366000
Neonatal meningitis	indication	276674008
Nontuberculous mycobacterial pulmonary disease caused by amikacin-sensitive Mycobacteriumavium complex	indication	277869007
Proteus septicemia	indication	300986008
Escherichia coli urinary tract infection	indication	301011002
Proteus meningitis	indication	302877009
Bacterial urinary infection	indication	312124009
Infectious disorder of joint	indication	363162000
Meningitis due to Klebsiella mobilis	indication	420585007
Nosocomial pneumonia	indication	425464007
Bacterial meningitis due to Gram-negative bacteria	indication	425887005
Pneumonia due to Gram negative bacteria	indication	430395005
Sepsis due to Pseudomonas	indication	448813005
Sepsis due to Gram negative bacteria	indication	449082003
Urinary tract infection caused by Klebsiella	indication	369001000119100
Skin and Skin Structure Pseudomonas Aeruginosa Infection	indication
Pseudomonas Aeruginosa Osteomyelitis	indication
Skin and Skin Structure Proteus Infection	indication
Pseudomonas Aeruginosa Meningitis	indication
Serratia Meningitis	indication
Complicated UTI with Pseudomonas Aeruginosa	indication
Complicated Urinary Tract Infections	indication
Klebsiella Septicemia	indication
Skin and Skin Structure Staphylococcus Infection	indication
Enterobacter Meningitis	indication
Burn Wound Infections	indication
Pseudomonas Aeruginosa Biliary Tract Infection	indication
Gram-Negative Aerobic Bacillary Pneumonia	indication
Complicated Bacterial Peritonitis	indication
Complicated Proteus UTI	indication
Complicated Urinary Tract Infection due to Acinetobacter	indication
Pseudomonas Aeruginosa Joint Infection	indication
Serratia Osteomyelitis	indication
Serratia Complicated UTI	indication
Enterobacter Pneumonia	indication
Skin and Skin Structure Serratia Infection	indication
Necrotizing enterocolitis in fetus OR newborn	off-label use	2707005
Pyrexia of unknown origin	off-label use	7520000
Enteric campylobacteriosis	off-label use	18081009
Acute tuberculosis	off-label use	25629007
Pseudotuberculosis	off-label use	36753006
Infection by Yersinia enterocolitica	off-label use	80960004
Pulmonary tuberculosis	off-label use	154283005	DOID:2957
Synergy for Group B Streptococcal Septicemia	off-label use
Citrobacter Osteomyelitis	off-label use
Synergy for Nosocomial Pneumonia due to Pseudomonas Aeruginosa	off-label use
Citrobacter Septicemia	off-label use
Citrobacter Complicated UTI	off-label use
Listeria Monocytogenes Septicemia	off-label use
Skin and Skin Structure Citrobacter Infection	off-label use
Synergy for P. Aeruginosa Infection in Cystic Fibrosis	off-label use
Synergy for Neonatal Meningitis	off-label use
Citrobacter Meningitis	off-label use
Synergy for Bacterial Meningitis	off-label use
Citrobacter Pneumonia	off-label use
Synergy for Staphylococcal Infections	off-label use
Synergy for Staphylococcal Endocarditis	off-label use
Skin and Skin Structure Acinetobacter Infection	off-label use
Hypocalcemia	contraindication	5291005
Parkinsonism	contraindication	32798002
Dehydration	contraindication	34095006
Tinnitus	contraindication	60862001
Kidney disease	contraindication	90708001	DOID:557
Myasthenia gravis	contraindication	91637004	DOID:437
Pregnancy, function	contraindication	289908002
Vertigo	contraindication	399153001
Disorder of the 8th Cranial Nerve	contraindication
Infant Botulism	contraindication
Amikacin Toxicity	contraindication

🐶 Veterinary Drug Use

Species	Use	Relation
Dogs	Genitourinary tract infections caused by Escherichia coli	Indication
Dogs	Genitourinary tract infections caused by Proteus species	Indication
Dogs	Skin and soft tissue infections caused by Pseudomonas species	Indication
Dogs	Skin and soft tissue infections caused by Escherichia coli	Indication
Horses	Genital tract infections caused by Escherichia coli	Indication
Horses	Genital tract infections caused by Pseudomonas species	Indication
Horses	Genital tract infections caused by Klebsiella species	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Amiglyde-V	Zoetis Inc.	1
Amikacin Sulfate Injection	Cronus Pharma Specialities India Private Limited	1
AmiMax E Solution	Elanco US Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.04	acidic
pKa2	12.95	acidic
pKa3	13.39	acidic
pKa4	13.72	acidic
pKa5	9.4	Basic
pKa6	7.84	Basic
pKa7	7.41	Basic
pKa8	6.86	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	8802137	April 8, 2024	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	9827317	April 8, 2024	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	7718189	June 6, 2025	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	8632804	Dec. 5, 2026	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS WITH CYSTIC FIBROSIS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	8679532	Dec. 5, 2026	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	9566234	Jan. 18, 2034	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	10251900	May 15, 2035	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	10751355	May 15, 2035	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	11446318	May 15, 2035	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	9895385	May 15, 2035	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN NON-CYSTIC FIBROSIS ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	Sept. 28, 2025	TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY
EQ 590MG BASE/8.4ML	ARIKAYCE KIT	INSMED INC	N207356	Sept. 28, 2018	RX	SUSPENSION, LIPOSOMAL	INHALATION	Sept. 28, 2030	GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Macrolide 2'-phosphotransferase II; Macrolide 2'-phosphotransferase II protein MphB; Macrolide 2-phosphotransferase, mph(B)	Enzyme		O32553_ECOLX		Km	4.20		WOMBAT-PK

External reference:

ID	Source
4019602	VUID
N0000147698	NUI
D00865	KEGG_DRUG
39831-55-5	SECONDARY_CAS_RN
641	RXNORM
C0002499	UMLSCUI
CHEBI:2637	CHEBI
AKN	PDB_CHEM_ID
CHEMBL177	ChEMBL_ID
CHEMBL1164318	ChEMBL_ID
CHEMBL4208954	ChEMBL_ID
D000583	MESH_DESCRIPTOR_UI
DB00479	DRUGBANK_ID
10894	IUPHAR_LIGAND_ID
3492	INN_ID
84319SGC3C	UNII
37768	PUBCHEM_CID
2863	MMSL
35287	MMSL
4165	MMSL
d00087	MMSL
1269009	SNOMEDCT_US
387266001	SNOMEDCT_US
48836000	SNOMEDCT_US
4018137	VANDF
4019602	VANDF
002781	NDDF
004899	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6166	INJECTION	250 mg	INTRAMUSCULAR	ANDA	22 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6166	INJECTION	250 mg	INTRAMUSCULAR	ANDA	22 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6167	INJECTION	250 mg	INTRAMUSCULAR	ANDA	22 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6167	INJECTION	250 mg	INTRAMUSCULAR	ANDA	22 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0703-9032	INJECTION, SOLUTION	500 mg	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0703-9040	INJECTION, SOLUTION	1 g	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-290	INJECTION, SOLUTION	250 mg	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-290	INJECTION, SOLUTION	250 mg	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-290	INJECTION, SOLUTION	250 mg	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-785	INJECTION, SOLUTION	500 mg	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-785	INJECTION, SOLUTION	500 mg	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-785	INJECTION, SOLUTION	500 mg	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-786	INJECTION, SOLUTION	1 g	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-786	INJECTION, SOLUTION	1 g	INTRAMUSCULAR	ANDA	20 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-786	INJECTION, SOLUTION	1 g	INTRAMUSCULAR	ANDA	20 sections
amikacin sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	25021-173	INJECTION, SOLUTION	250 mg	INTRAVENOUS	ANDA	23 sections
amikacin sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	25021-173	INJECTION, SOLUTION	250 mg	INTRAVENOUS	ANDA	23 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	63323-815	INJECTION, SOLUTION	250 mg	INTRAVENOUS	ANDA	21 sections
Amikacin Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	63323-815	INJECTION, SOLUTION	250 mg	INTRAVENOUS	ANDA	21 sections
Amikacin Sulfate Injection, 500 mg/2ml	HUMAN PRESCRIPTION DRUG LABEL	1	70297-996	INJECTION	500 mg	INTRAMUSCULAR	Export only
Amikacin Sulfate Injection, 500 mg/2ml	HUMAN PRESCRIPTION DRUG LABEL	1	71309-996	INJECTION	500 mg	INTRAMUSCULAR	Export only
ARIKAYCE	HUMAN PRESCRIPTION DRUG LABEL	1	71558-590	SUSPENSION	590 mg	RESPIRATORY (INHALATION)	NDA	34 sections
ARIKAYCE	HUMAN PRESCRIPTION DRUG LABEL	1	71558-590	SUSPENSION	590 mg	RESPIRATORY (INHALATION)	NDA	34 sections
ARIKAYCE	HUMAN PRESCRIPTION DRUG LABEL	1	71558-590	SUSPENSION	590 mg	RESPIRATORY (INHALATION)	NDA	34 sections