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

Stem definitionDrug idCAS RN
4779 10040-45-6

Description:

MoleculeDescription

Synonyms:

  • sodium picosulfate
  • picosulfate sodium
  • picosulfol
  • rapilax
  • picolax
contains two active ingredients, sodium picosulfate and magnesium citrate, which are both laxatives; structure
  • Molecular weight: 481.40
  • Formula: C18H13NNa2O8S2
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 145.75
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
5 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 16, 2012 FDA FERRING PHARMS AS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Urinary retention 91.79 21.08 51 6908 30250 63451813
Reduced facial expression 89.37 21.08 24 6935 1942 63480121
Listless 84.83 21.08 25 6934 2835 63479228
General physical health deterioration 84.48 21.08 107 6852 201295 63280768
Cognitive disorder 81.03 21.08 59 6900 55756 63426307
Ileus 74.38 21.08 35 6924 14690 63467373
Apathy 70.74 21.08 29 6930 8765 63473298
Hyponatraemia 69.74 21.08 73 6886 111827 63370236
Cholestatic liver injury 65.26 21.08 20 6939 2590 63479473
Hypokalaemia 58.12 21.08 64 6895 103740 63378323
Altered state of consciousness 56.68 21.08 35 6924 25195 63456868
Head discomfort 56.03 21.08 28 6931 13387 63468676
Drug ineffective 55.21 21.08 23 6936 1044742 62437321
Delirium 52.83 21.08 44 6915 50497 63431566
Product prescribing error 50.41 21.08 33 6926 26256 63455807
Pyrexia 47.97 21.08 136 6823 470342 63011721
Drug interaction 46.49 21.08 87 6872 229044 63253019
Foreign body 46.32 21.08 15 6944 2323 63479740
Prescription drug used without a prescription 46.02 21.08 15 6944 2371 63479692
Dehydration 45.83 21.08 74 6885 173280 63308783
Immobile 45.76 21.08 19 6940 5924 63476139
Affect lability 42.84 21.08 22 6937 11129 63470934
Creatinine renal clearance decreased 42.78 21.08 25 6934 16283 63465780
Inappropriate antidiuretic hormone secretion 38.71 21.08 23 6936 15439 63466624
Fracture 38.56 21.08 25 6934 19559 63462504
Confusional state 37.46 21.08 81 6878 236299 63245764
Multiple drug therapy 36.20 21.08 14 6945 3632 63478431
Abdominal rigidity 36.12 21.08 12 6947 2012 63480051
Sedation complication 35.75 21.08 21 6938 13801 63468262
Oxygen saturation decreased 35.36 21.08 46 6913 88539 63393524
Restlessness 33.61 21.08 27 6932 29426 63452637
Electrolyte imbalance 33.21 21.08 23 6936 20053 63462010
Vascular device infection 32.72 21.08 16 6943 7296 63474767
Overdose 31.58 21.08 50 6909 115028 63367035
Pelvic fracture 31.20 21.08 19 6940 13329 63468734
Encephalopathy 31.08 21.08 29 6930 38591 63443472
Sedation 30.96 21.08 29 6930 38780 63443283
Orthostatic hypotension 30.75 21.08 28 6931 36132 63445931
Constipation 29.98 21.08 72 6887 224871 63257192
Blood calcium decreased 29.66 21.08 24 6935 26427 63455636
Liver function test increased 29.07 21.08 26 6933 32785 63449278
Fall 28.49 21.08 101 6858 392233 63089830
Vomiting 27.82 21.08 128 6831 559489 62922574
Medication error 27.11 21.08 31 6928 52253 63429810
Product administration error 26.56 21.08 21 6938 22376 63459687
Febrile neutropenia 26.53 21.08 47 6912 118402 63363661
Anaemia 26.15 21.08 81 6878 293349 63188714
Depressed level of consciousness 25.96 21.08 33 6926 62045 63420018
Mobility decreased 25.76 21.08 47 6912 121112 63360951
Vertigo 25.30 21.08 32 6927 59855 63422208
Oliguria 23.99 21.08 14 6945 9087 63472976
Bedridden 23.97 21.08 15 6944 11036 63471027
Drug intolerance 23.63 21.08 3 6956 308658 63173405
Concomitant disease aggravated 21.37 21.08 13 6946 9099 63472964
Pemphigoid 21.24 21.08 12 6947 7332 63474731
Joint swelling 21.13 21.08 5 6954 327661 63154402

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Appendicolith 325.57 19.98 109 8323 8492 34940007
Appendicitis 274.71 19.98 111 8321 14696 34933803
General physical health deterioration 215.40 19.98 205 8227 128064 34820435
Cardiogenic shock 209.57 19.98 110 8322 26508 34921991
Blood phosphorus increased 208.06 19.98 76 8356 7645 34940854
Abdominal distension 200.97 19.98 142 8290 58350 34890149
Stress 198.76 19.98 111 8321 30236 34918263
Ventricular fibrillation 186.78 19.98 97 8335 22857 34925642
Ascites 169.06 19.98 117 8315 46454 34902045
Hyponatraemia 157.55 19.98 142 8290 82549 34865950
Multiple organ dysfunction syndrome 131.26 19.98 124 8308 76442 34872057
Abdominal pain 130.74 19.98 178 8254 163440 34785059
Dry mouth 114.60 19.98 78 8354 30087 34918412
Constipation 112.32 19.98 151 8281 136831 34811668
Myasthenia gravis 88.71 19.98 40 8392 6900 34941599
Vomiting 84.82 19.98 185 8247 247436 34701063
Blood uric acid increased 82.03 19.98 42 8390 9582 34938917
Sepsis 75.54 19.98 140 8292 166421 34782078
Nausea 74.35 19.98 214 8218 339694 34608805
Somnolence 68.31 19.98 107 8325 111009 34837490
Blood cholesterol increased 50.67 19.98 41 8391 20502 34927997
Incorrect route of product administration 46.16 19.98 34 8398 14811 34933688
Drug therapy 45.26 19.98 15 8417 1126 34947373
Drug ineffective 44.22 19.98 28 8404 456723 34491776
Sleep disorder therapy 42.80 19.98 14 8418 1009 34947490
Hyperphosphataemia 39.65 19.98 20 8412 4417 34944082
Iron deficiency 33.31 19.98 19 8413 5362 34943137
Hypophosphataemia 29.30 19.98 23 8409 11003 34937496
Ileus 28.71 19.98 27 8405 16472 34932027
Abdominal neoplasm 27.42 19.98 8 8424 393 34948106
Faecaloma 25.51 19.98 16 8416 5361 34943138
Cholestatic liver injury 25.14 19.98 12 8420 2352 34946147
Bacterial infection 24.24 19.98 25 8407 17038 34931461
Condition aggravated 23.41 19.98 100 8332 192096 34756403
Neuralgia 23.03 19.98 23 8409 15090 34933409

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Appendicolith 346.49 16.89 108 15152 8443 79720685
Appendicitis 282.99 16.89 117 15143 20677 79708451
General physical health deterioration 274.86 16.89 299 14961 274939 79454189
Blood phosphorus increased 207.04 16.89 77 15183 10270 79718858
Hyponatraemia 201.73 16.89 207 15053 177641 79551487
Cardiogenic shock 186.39 16.89 110 15150 41804 79687324
Ventricular fibrillation 180.35 16.89 98 15162 31828 79697300
Ascites 166.01 16.89 128 15132 75434 79653694
Abdominal distension 164.90 16.89 155 15105 119495 79609633
Constipation 137.81 16.89 216 15044 282834 79446294
Stress 124.98 16.89 111 15149 79501 79649627
Multiple organ dysfunction syndrome 115.03 16.89 128 15132 120118 79609010
Abdominal pain 110.21 16.89 235 15025 389334 79339794
Drug ineffective 89.56 16.89 48 15212 1080865 78648263
Ileus 89.08 16.89 58 15202 26153 79702975
Vomiting 88.80 16.89 304 14956 665524 79063604
Blood uric acid increased 83.82 16.89 44 15216 13316 79715812
Myasthenia gravis 82.07 16.89 40 15220 10359 79718769
Sepsis 73.14 16.89 160 15100 269268 79459860
Cholestatic liver injury 71.25 16.89 29 15231 4912 79724216
Urinary retention 69.68 16.89 69 15191 56561 79672567
Nausea 65.41 16.89 357 14903 956839 78772289
Somnolence 63.79 16.89 141 15119 238840 79490288
Reduced facial expression 60.55 16.89 22 15238 2743 79726385
Listless 60.29 16.89 24 15236 3837 79725291
Dry mouth 60.06 16.89 79 15181 87940 79641188
Altered state of consciousness 53.17 16.89 53 15207 43769 79685359
Drug therapy 52.13 16.89 16 15244 1185 79727943
Sleep disorder therapy 45.97 16.89 14 15246 1010 79728118
Apathy 42.34 16.89 28 15232 12949 79716179
Delirium 41.61 16.89 65 15195 84562 79644566
Faecaloma 40.29 16.89 26 15234 11538 79717590
Hyperphosphataemia 39.99 16.89 21 15239 6355 79722773
Hypokalaemia 39.53 16.89 86 15174 143954 79585174
Anaemia 39.42 16.89 179 15081 444836 79284292
Joint swelling 38.31 16.89 5 15255 288641 79440487
Pyrexia 37.65 16.89 240 15020 678469 79050659
Fatigue 36.76 16.89 77 15183 929650 78799478
Inappropriate antidiuretic hormone secretion 36.00 16.89 34 15226 26279 79702849
Immobile 35.49 16.89 20 15240 6953 79722175
Head discomfort 34.97 16.89 26 15234 14476 79714652
Cognitive disorder 34.77 16.89 54 15206 69872 79659256
Hypophosphataemia 33.69 16.89 29 15231 19884 79709244
Foreign body 31.78 16.89 14 15246 2880 79726248
Product prescribing error 30.21 16.89 40 15220 44773 79684355
Incorrect route of product administration 29.66 16.89 35 15225 34894 79694234
Product dose omission issue 29.03 16.89 6 15254 247531 79481597
Hepatic function abnormal 29.00 16.89 51 15209 73056 79656072
Affect lability 28.98 16.89 21 15239 11238 79717890
Dehydration 28.34 16.89 108 15152 248079 79481049
Abdominal rigidity 27.78 16.89 13 15247 3075 79726053
Iron deficiency 27.72 16.89 20 15240 10634 79718494
Arthralgia 27.35 16.89 42 15218 571761 79157367
Multiple drug therapy 27.21 16.89 14 15246 4064 79725064
Prescription drug used without a prescription 27.18 16.89 14 15246 4071 79725057
Sinusitis 26.88 16.89 3 15257 195498 79533630
Creatinine renal clearance decreased 26.85 16.89 25 15235 18977 79710151
Electrolyte imbalance 26.31 16.89 31 15229 30850 79698278
Headache 25.90 16.89 54 15206 653718 79075410
Pneumonia aspiration 25.64 16.89 46 15214 66921 79662207
Peripheral swelling 25.24 16.89 10 15250 269607 79459521
Systemic infection 24.67 16.89 18 15242 9734 79719394
Fracture 23.95 16.89 25 15235 21776 79707352
Vascular device infection 23.83 16.89 18 15242 10258 79718870
pH body fluid increased 23.78 16.89 5 15255 78 79729050
Drug interaction 23.05 16.89 147 15113 415036 79314092
Sedation complication 22.88 16.89 21 15239 15648 79713480
Rheumatoid arthritis 22.56 16.89 6 15254 208464 79520664
Diabetes mellitus 21.71 16.89 47 15213 78343 79650785
Therapeutic product effect decreased 21.34 16.89 3 15257 163860 79565268
Pelvic fracture 21.10 16.89 18 15242 12186 79716942
Ileus paralytic 20.45 16.89 16 15244 9604 79719524
Fall 20.28 16.89 161 15099 487468 79241660
Treatment failure 20.26 16.89 4 15256 170482 79558646
Neutrophil count decreased 20.19 16.89 51 15209 93908 79635220
Liver function test increased 20.17 16.89 31 15229 39742 79689386
Bacterial infection 19.67 16.89 27 15233 31253 79697875
Decreased appetite 19.46 16.89 122 15138 342296 79386832
Upper respiratory tract inflammation 19.00 16.89 11 15249 4024 79725104
Hypersensitivity 18.35 16.89 14 15246 262225 79466903
Orthostatic hypotension 18.29 16.89 36 15224 56128 79673000
Depressed level of consciousness 18.25 16.89 50 15210 96602 79632526
Contraindicated product administered 18.09 16.89 4 15256 157534 79571594
Abdominal discomfort 18.04 16.89 13 15247 250714 79478414
Restlessness 17.88 16.89 32 15228 46460 79682668
Blood calcium decreased 17.84 16.89 26 15234 31793 79697335
Infusion related reaction 17.83 16.89 11 15249 230226 79498902
Anti factor X activity increased 17.72 16.89 4 15256 88 79729040
Medication error 17.70 16.89 40 15220 68602 79660526
Pemphigoid 17.61 16.89 18 15242 15297 79713831
Paraesthesia 17.41 16.89 6 15254 176317 79552811
Chronotropic incompetence 17.39 16.89 4 15256 96 79729032

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A06AB08 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR CONSTIPATION
DRUGS FOR CONSTIPATION
Contact laxatives
ATC A06AB58 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR CONSTIPATION
DRUGS FOR CONSTIPATION
Contact laxatives
MeSH PA D002400 Cathartics
MeSH PA D005765 Gastrointestinal Agents

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

DiseaseRelationSNOMED_IDDOID
Colonoscopy indication 73761001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
12GM/BOT;3.5GM/BOT;10MG/BOT CLENPIQ FERRING PHARMS INC N209589 Nov. 28, 2017 RX SOLUTION ORAL 11191753 June 23, 2034 FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY
12GM/BOT;3.5GM/BOT;10MG/BOT CLENPIQ FERRING PHARMS INC N209589 Nov. 28, 2017 RX SOLUTION ORAL 9827231 June 26, 2034 FOR CLEANSING THE LARGE INTESTINE AS A PREPARATION FOR COLONOSCOPY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
LR57574HN8 UNII
4032318 VUID
N0000186955 NUI
4032318 VANDF
C0071042 UMLSCUI
CHEBI:32147 CHEBI
CHEMBL1697768 ChEMBL_ID
68654 PUBCHEM_CID
C005701 MESH_SUPPLEMENTAL_RECORD_UI
DB14232 DRUGBANK_ID
1872905 RXNORM
18056 MMSL
d04939 MMSL
003762 NDDF
317558003 SNOMEDCT_US
395881001 SNOMEDCT_US
C0058139 UMLSCUI
1307301-38-7 SECONDARY_CAS_RN
69046 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID HUMAN PRESCRIPTION DRUG LABEL 3 31722-874 POWDER, METERED 10 mg ORAL ANDA 25 sections
CLENPIQ HUMAN PRESCRIPTION DRUG LABEL 3 55566-6700 LIQUID 10 mg ORAL NDA 32 sections
CLENPIQ HUMAN PRESCRIPTION DRUG LABEL 3 55566-6800 LIQUID 10 mg ORAL NDA 31 sections