levocarnitine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
513 541-15-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • carnitine
  • (-)-Carnitine
  • (-)-L-Carnitine
  • (R)-Carnitine
  • carniking
  • carnilean
  • carnitene
  • carnivit
  • l-Carnitine
  • levocarnitine
  • levocarnitine hydrochloride
  • levocarnitine HCl
A constituent of STRIATED MUSCLE and LIVER. It is an amino acid derivative and an essential cofactor for fatty acid metabolism.
  • Molecular weight: 161.20
  • Formula: C7H15NO3
  • CLOGP: -7.73
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 60.36
  • ALOGS: -1.60
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
2 g O
2 g P

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 305.16 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 15 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.40 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 32 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Dec. 27, 1985 FDA SIGMA TAU

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
Fanconi syndrome 83.55 19.21 18 2914 1374 63484716
Seizure 76.72 19.21 57 2875 132577 63353513
Status epilepticus 72.31 19.21 27 2905 15206 63470884
Hypophosphataemic osteomalacia 52.10 19.21 9 2923 211 63485879
Nephrocalcinosis 43.09 19.21 10 2922 1068 63485022
Sudden infant death syndrome 36.39 19.21 7 2925 302 63485788
Urine calcium/creatinine ratio increased 35.94 19.21 6 2926 114 63485976
Mitochondrial cytopathy 31.61 19.21 6 2926 241 63485849
Pharyngeal abscess 24.75 19.21 5 2927 278 63485812
Hypophosphataemia 22.96 19.21 11 2921 11415 63474675
Glycosuria 22.34 19.21 6 2926 1160 63484930
Metabolic disorder 21.92 19.21 9 2923 6494 63479596
Ammonia increased 21.16 19.21 8 2924 4648 63481442
Renal tubular acidosis 20.13 19.21 6 2926 1686 63484404
Multiple organ dysfunction syndrome 19.35 19.21 18 2914 56734 63429356

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
Seizure 55.25 18.80 57 3093 104800 34848981
Dyschromatopsia 46.04 18.80 10 3140 401 34953380
Retinogram abnormal 31.31 18.80 6 3144 127 34953654
Hyperammonaemia 28.17 18.80 13 3137 6354 34947427
Zinc deficiency 23.16 18.80 4 3146 46 34953735
Pyrexia 20.43 18.80 71 3079 332942 34620839
Hepatocellular carcinoma 20.37 18.80 11 3139 7498 34946283
Status epilepticus 19.84 18.80 13 3137 12601 34941180
Upper respiratory tract inflammation 19.74 18.80 7 3143 1737 34952044
Ammonia increased 19.57 18.80 9 3141 4360 34949421

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
Seizure 81.08 17.20 82 5518 188752 79550036
Fanconi syndrome 76.91 17.20 21 5579 2835 79735953
Status epilepticus 74.55 17.20 36 5564 25005 79713783
Retinogram abnormal 44.08 17.20 9 5591 344 79738444
Hypophosphataemic osteomalacia 43.91 17.20 9 5591 351 79738437
Dyschromatopsia 41.20 17.20 10 5590 847 79737941
Hyperammonaemia 39.33 17.20 18 5582 11075 79727713
Ammonia increased 38.89 17.20 16 5584 7619 79731169
Nephrocalcinosis 35.63 17.20 10 5590 1492 79737296
Urine calcium/creatinine ratio increased 32.16 17.20 6 5594 142 79738646
Upper respiratory tract inflammation 29.54 17.20 11 5589 4024 79734764
Zinc deficiency 25.03 17.20 5 5595 171 79738617
Epilepsy 23.70 17.20 21 5579 40839 79697949
Carnitine deficiency 22.70 17.20 5 5595 276 79738512
Hepatic encephalopathy 21.62 17.20 16 5584 24150 79714638
Mitochondrial cytopathy 20.82 17.20 5 5595 405 79738383
Hepatic failure 19.91 17.20 23 5577 61189 79677599
Glycosuria 19.89 17.20 7 5593 2181 79736607
Pneumonia 18.29 17.20 93 5507 660153 79078635
Hepatic function abnormal 18.18 17.20 24 5576 73083 79665705
Pharyngeal abscess 18.16 17.20 5 5595 695 79738093
Metabolic disorder 18.08 17.20 10 5590 9160 79729628
Shunt malfunction 17.41 17.20 4 5596 267 79738521
Hypophosphataemia 17.40 17.20 13 5587 19900 79718888

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AA01 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Amino acids and derivatives
FDA CS M0003493 Carnitine
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
FDA EPC N0000175903 Carnitine Analog
CHEBI has role CHEBI:27314 water-soluble vitamins
CHEBI has role CHEBI:35679 antilipemic drugs
CHEBI has role CHEBI:50733 Dietary Supplement
CHEBI has role CHEBI:66980 intelligence enhancer
CHEBI has role CHEBI:75772 S. cerevisiae metabolites

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

DiseaseRelationSNOMED_IDDOID
Carnitine deficiency indication 421784001
Recovery during viral myocarditis off-label use 89141000
Obstruction of bile duct contraindication 30144000
Low blood pressure contraindication 45007003
Blood coagulation disorder contraindication 64779008 DOID:1247
Kidney disease contraindication 90708001 DOID:557
Seizure disorder contraindication 128613002
Disease of liver contraindication 235856003 DOID:409
Vitamin K Deficiency Induced Hypoprothrombinemia contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.86 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Carnitine O-palmitoyltransferase 1, liver isoform Enzyme WOMBAT-PK
Carnitine O-palmitoyltransferase 1, muscle isoform Enzyme Ki 4 CHEMBL
Carnitine palmitoyltransferase 2 Enzyme Ki 4 CHEMBL

External reference:

IDSource
4020953 VUID
N0000148430 NUI
D02176 KEGG_DRUG
406-76-8 SECONDARY_CAS_RN
6645-46-1 SECONDARY_CAS_RN
1426681 RXNORM
C0087163 UMLSCUI
CHEBI:16347 CHEBI
152 PDB_CHEM_ID
CHEMBL1149 ChEMBL_ID
CHEMBL172513 ChEMBL_ID
D002331 MESH_DESCRIPTOR_UI
DB00583 DRUGBANK_ID
4780 IUPHAR_LIGAND_ID
6098 INN_ID
0G389FZZ9M UNII
10917 PUBCHEM_CID
10540 MMSL
147388 MMSL
4970 MMSL
d00491 MMSL
329486002 SNOMEDCT_US
372601001 SNOMEDCT_US
59888006 SNOMEDCT_US
4083 INN_ID
4018934 VANDF
4020870 VANDF
4020953 VANDF
000932 NDDF
003576 NDDF
005071 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9852 INJECTION 1 g INTRAVENOUS ANDA 17 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 0517-1045 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 20 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 0517-1045 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 20 sections
Levocarnitine Human Prescription Drug Label 1 16571-762 TABLET 330 mg ORAL ANDA 19 sections
CARDIO TONIC HUMAN OTC DRUG LABEL 12 44911-0184 LIQUID 3 [hp_X] ORAL unapproved homeopathic 9 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 50383-171 SOLUTION 1 g ORAL NDA 19 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 50383-171 SOLUTION 1 g ORAL NDA 19 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 50383-171 SOLUTION 1 g ORAL NDA 19 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 50383-172 TABLET 330 mg ORAL NDA 20 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 50383-172 TABLET 330 mg ORAL NDA 20 sections
IQQU Acne Serum HUMAN OTC DRUG LABEL 3 50403-226 LOTION 0.01 g TOPICAL UNAPPROVED DRUG OTHER 9 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 52817-830 SOLUTION 1 g ORAL ANDA 20 sections
CARNITOR HUMAN PRESCRIPTION DRUG LABEL 1 54482-144 TABLET 330 mg ORAL NDA 20 sections
CARNITOR HUMAN PRESCRIPTION DRUG LABEL 1 54482-144 TABLET 330 mg ORAL NDA 20 sections
Carnitor HUMAN PRESCRIPTION DRUG LABEL 1 54482-145 SOLUTION 1 g ORAL NDA 20 sections
Carnitor HUMAN PRESCRIPTION DRUG LABEL 1 54482-145 SOLUTION 1 g ORAL NDA 20 sections
Carnitor HUMAN PRESCRIPTION DRUG LABEL 1 54482-147 INJECTION, SOLUTION 1 g INTRAVENOUS NDA 20 sections
Carnitor HUMAN PRESCRIPTION DRUG LABEL 1 54482-147 INJECTION, SOLUTION 1 g INTRAVENOUS NDA 20 sections
Carnitor SF HUMAN PRESCRIPTION DRUG LABEL 1 54482-148 SOLUTION 1 g ORAL NDA 20 sections
Carnitor SF HUMAN PRESCRIPTION DRUG LABEL 1 54482-148 SOLUTION 1 g ORAL NDA 20 sections
Levocarnitine Human Prescription Drug Label 1 64980-503 SOLUTION 1 g ORAL ANDA 19 sections
Lipovite HUMAN PRESCRIPTION DRUG LABEL 13 70104-128 INJECTION 1 mg INTRAMUSCULAR unapproved drug other 1 sections
Levocarnitine Human Prescription Drug Label 1 70954-139 SOLUTION 1 g ORAL ANDA 19 sections
Levocarnitine Human Prescription Drug Label 1 70954-139 SOLUTION 1 g ORAL ANDA 19 sections
Levocarnitine Human Prescription Drug Label 1 70954-140 SOLUTION 1 g ORAL ANDA 19 sections
Levocarnitine Human Prescription Drug Label 1 70954-140 SOLUTION 1 g ORAL ANDA 19 sections
Levocarnitine Human Prescription Drug Label 1 70954-492 TABLET 330 mg ORAL ANDA 19 sections