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

Stem definition	Drug id	CAS RN
antihyperlipidaemic substances, HMG CoA reductase inhibitors	2239	81093-37-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pravastatin eptastatin mevalothin pravastatin acid pravastatin sodium pravachol	An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES). Molecular weight: 424.53 Formula: C23H36O7 CLOGP: 2.05 LIPINSKI: 0 HAC: 7 HDO: 4 TPSA: 124.29 ALOGS: -3.24 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pravastatin
eptastatin
mevalothin
pravastatin acid
pravastatin sodium
pravachol

An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).

Molecular weight: 424.53
Formula: C23H36O7
CLOGP: 2.05
LIPINSKI: 0
HAC: 7
HDO: 4
TPSA: 124.29
ALOGS: -3.24
ROTB: 11

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mg	O

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	47 %	Hosey CM, Chan R, Benet LZ
S (Water solubility)	300 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Hosey CM, Chan R, Benet LZ
BA (Bioavailability)	18 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	14 mL/min/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.57 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	0.78 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.50 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.46 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Oct. 31, 1991	FDA	BRISTOL MYERS SQUIBB

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
Myalgia	223.61	10.68	417	51518	146112	63290975
Contraindicated product administered	136.68	10.68	11	51924	217637	63219450
Hand deformity	116.28	10.68	3	51932	159454	63277633
Acute kidney injury	113.43	10.68	471	51464	262944	63174143
Systemic lupus erythematosus	108.21	10.68	20	51915	208898	63228189
Synovitis	103.26	10.68	15	51920	186903	63250184
Glossodynia	97.32	10.68	15	51920	178861	63258226
Product dose omission issue	90.09	10.68	405	51530	233908	63203179
Drug ineffective	88.37	10.68	499	51436	1044266	62392821
Pericarditis	87.39	10.68	5	51930	131574	63305513

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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
Myalgia	191.50	10.76	347	40220	83763	34832601
Acute kidney injury	72.45	10.76	602	39965	304386	34611978
IgM nephropathy	71.91	10.76	19	40548	119	34916245
Drug abuse	71.64	10.76	14	40553	99082	34817282
Blood creatine phosphokinase increased	50.66	10.76	140	40427	44717	34871647
Shone complex	50.56	10.76	13	40554	72	34916292
Myopathy	47.92	10.76	63	40504	11491	34904873
Fall	39.07	10.76	383	40184	202502	34713862
Interstitial lung disease	38.51	10.76	164	40403	65118	34851246
Drug interaction	37.12	10.76	413	40154	225533	34690831

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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
Myalgia	317.83	9.89	614	77204	185027	79481543
Acute kidney injury	188.65	9.89	1001	76817	518403	79148167
Synovitis	95.71	9.89	16	77802	150718	79515852
Drug abuse	95.40	9.89	21	77797	162670	79503900
Drug ineffective	94.64	9.89	643	77175	1080270	78586300
Contraindicated product administered	93.06	9.89	20	77798	157518	79509052
Fall	91.09	9.89	798	77020	486831	79179739
Hand deformity	87.91	9.89	3	77815	103916	79562654
Lactic acidosis	85.84	9.89	203	77615	70156	79596414
Hyperkalaemia	83.83	9.89	274	77544	114124	79552446

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C10AA03	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN HMG CoA reductase inhibitors
ATC	C10BA03	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA11	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA12	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BX02	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:35821	anticholesteremic drugs
CHEBI has role	CHEBI:78298	environmental contaminants
FDA EPC	N0000175589	HMG-CoA Reductase Inhibitor

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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
Hypercholesterolemia	indication	13644009
Arteriosclerotic vascular disease	indication	72092001
Cerebrovascular accident	indication	230690007
Familial hypercholesterolemia - heterozygous	indication	238079002
Mixed hyperlipidemia	indication	267434003
Hypertriglyceridemia	indication	302870006
Familial type 3 hyperlipoproteinemia	indication	398796005	DOID:3145
Primary Prevention of Coronary Heart Disease	indication
Prevention of Transient Ischemic Attacks	indication
Myocardial Infarction Prevention	indication

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.44	acidic
pKa2	13.74	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
3-hydroxy-3-methylglutaryl-coenzyme A reductase	Enzyme	P04035	HMDH_HUMAN	INHIBITOR	IC50	7.52	CHEMBL	CHEMBL
3-hydroxy-3-methylglutaryl-coenzyme A reductase	Enzyme		HMDH_RAT		IC50	8.38	CHEMBL
Solute carrier family 22 member 6	Transporter		S22A6_RAT		Ki	4.28	CHEMBL

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External reference:

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ID	Source
003606	NDDF
003607	NDDF
1884	MMSL
203144	RXNORM
2953	IUPHAR_LIGAND_ID
373566006	SNOMEDCT_US
4020369	VANDF
4020548	VUID
4020548	VANDF
5343	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0771	TABLET	10 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0771	TABLET	10 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0771	TABLET	10 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7201	TABLET	20 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7201	TABLET	20 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7201	TABLET	20 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7202	TABLET	40 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7202	TABLET	40 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7202	TABLET	40 mg	ORAL	ANDA	29 sections
Pravastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7270	TABLET	80 mg	ORAL	ANDA	29 sections

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