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

Stem definition	Drug id	CAS RN
	1536	4618-18-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: lactulose bifiteral cephulac D-Lactulose isolactose lactulose hydrate	A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887) Molecular weight: 342.30 Formula: C12H22O11 CLOGP: -3.59 LIPINSKI: 2 HAC: 11 HDO: 8 TPSA: 189.53 ALOGS: 0.36 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lactulose
bifiteral
cephulac
D-Lactulose
isolactose
lactulose hydrate

A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887)

Molecular weight: 342.30
Formula: C12H22O11
CLOGP: -3.59
LIPINSKI: 2
HAC: 11
HDO: 8
TPSA: 189.53
ALOGS: 0.36
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
6.70	g	O

ADMET properties:

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Property	Value	Reference
S (Water solubility)	68 mg/mL	Bocci G, Oprea TI, Benet LZ
BA (Bioavailability)	3 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	1669.38 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
March 25, 1976	FDA
Sept. 21, 2018	PMDA	Sanwa Kagaku Kenkyusho Co., Ltd.

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
Sedation complication	760.70	11.24	325	54680	13497	63420520
Orthostatic hypotension	747.51	11.24	437	54568	35723	63398294
Creatinine renal clearance decreased	718.52	11.24	328	54677	15980	63418037
Sedation	635.30	11.24	404	54601	38405	63395612
Cognitive disorder	621.59	11.24	458	54547	55357	63378660
Blood calcium decreased	590.06	11.24	336	54669	26115	63407902
Balance disorder	490.19	11.24	476	54529	83946	63350071
Depressed level of consciousness	475.70	11.24	409	54596	61669	63372348
Drug ineffective	372.62	11.24	224	54781	1044541	62389476
Hepatic encephalopathy	322.68	11.24	169	54836	11113	63422904

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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
Hepatic encephalopathy	688.55	11.03	352	45867	14333	34896379
Hepatic cirrhosis	182.04	11.03	164	46055	17150	34893562
Confusional state	158.57	11.03	484	45735	143676	34767036
Hepatic failure	147.31	11.03	204	46015	34327	34876385
Inability to afford medication	140.94	11.03	58	46161	1412	34909300
Ammonia increased	136.09	11.03	80	46139	4289	34906423
Ascites	132.35	11.03	228	45991	46343	34864369
Drug ineffective	121.05	11.03	266	45953	456485	34454227
Constipation	83.89	11.03	381	45838	136601	34774111
Hepatorenal syndrome	78.29	11.03	47	46172	2619	34908093

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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
Hepatic encephalopathy	905.66	10.34	472	88806	23694	79631416
Sedation complication	688.97	10.34	341	88937	15328	79639782
Creatinine renal clearance decreased	618.60	10.34	338	88940	18664	79636446
Orthostatic hypotension	611.07	10.34	505	88773	55659	79599451
Blood calcium decreased	506.62	10.34	359	88919	31460	79623650
Cognitive disorder	478.75	10.34	485	88793	69441	79585669
Sedation	475.60	10.34	423	88855	51472	79603638
Balance disorder	413.36	10.34	531	88747	98326	79556784
Drug ineffective	377.79	10.34	394	88884	1080519	78574591
Depressed level of consciousness	344.06	10.34	480	88798	96172	79558938

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A06AD11	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Osmotically acting laxatives
ATC	A06AD61	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Osmotically acting laxatives
CHEBI has role	CHEBI:50503	laxante
CHEBI has role	CHEBI:55324	gastrointestinal drugs
FDA EPC	N0000175811	Osmotic Laxative
FDA MoA	N0000010288	Osmotic Activity
FDA MoA	N0000175833	Acidifying Activity
FDA PE	N0000009871	Stimulation Large Intestine Fluid/Electrolyte Secretion
MeSH PA	D005765	Gastrointestinal Agents

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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
Hyperammonemia	indication	9360008
Hepatic encephalopathy	indication	13920009	DOID:13413
Constipation	indication	14760008	DOID:2089
Diabetes mellitus	contraindication	73211009	DOID:9351
Appendicitis	contraindication	74400008	DOID:8337
Gastrointestinal obstruction	contraindication	126765001
Galactosemia	contraindication	190745006	DOID:9870

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.04	acidic
pKa2	13.36	acidic
pKa3	13.8	acidic
pKa4	13.97	acidic

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Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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External reference:

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ID	Source
001241	NDDF
111137007	SNOMEDCT_US
11333	PUBCHEM_CID
117	MMSL
2137	INN_ID
215949	RXNORM
273945008	SNOMEDCT_US
4018617	VUID
4018617	VANDF
4512	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Constulose	HUMAN PRESCRIPTION DRUG LABEL	1	45963-439	SOLUTION	10 g	ORAL	ANDA	19 sections
Constulose	HUMAN PRESCRIPTION DRUG LABEL	1	45963-439	SOLUTION	10 g	ORAL	ANDA	19 sections
Enulose	HUMAN PRESCRIPTION DRUG LABEL	1	45963-438	SOLUTION	10 g	ORAL	ANDA	17 sections
Enulose	HUMAN PRESCRIPTION DRUG LABEL	1	45963-438	SOLUTION	10 g	ORAL	ANDA	17 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	0116-4005	SOLUTION	10 g	ORAL	ANDA	20 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	0116-4005	SOLUTION	10 g	ORAL	ANDA	20 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0577	SOLUTION	10 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0577	SOLUTION	10 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0577	SOLUTION	10 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0873	SOLUTION	10 g	ORAL	ANDA	22 sections

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