levocarnitine indications/contra

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

Drug dosage:

DoseUnitRoute
2 g O
2 g P

Approvals:

DateAgencyCompanyOrphan
Dec. 27, 1985 FDA SIGMA TAU

FDA Adverse Event Reporting System

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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
Drug ineffective 400.99 54.64 120 251 115970 3269518
Rheumatoid arthritis 389.31 54.64 80 291 15558 3369930
Parenteral nutrition associated liver disease 254.99 54.64 27 344 23 3385465
Treatment failure 169.62 54.64 35 336 6489 3378999
Pharyngitis 167.88 54.64 30 341 2590 3382898
Ear infection 166.66 54.64 31 340 3348 3382140
Shoulder arthroplasty 151.95 54.64 21 350 330 3385158
Joint swelling 136.14 54.64 35 336 17022 3368466
Drug intolerance 122.87 54.64 30 341 11768 3373720
Drug hypersensitivity 114.80 54.64 36 335 35644 3349844
Vomiting 102.81 54.64 42 329 89489 3295999
Weight decreased 102.50 54.64 34 337 40077 3345411
Decreased appetite 101.37 54.64 34 337 41456 3344032
Deafness 94.83 54.64 20 351 4034 3381454
Headache 91.50 54.64 39 332 91941 3293547
Gastrointestinal pain 91.19 54.64 16 355 1219 3384269
Gastrointestinal disorder 90.42 54.64 23 348 10546 3374942
Nausea 84.76 54.64 41 330 129604 3255884
Psoriatic arthropathy 84.75 54.64 18 353 3744 3381744
Arthropathy 76.84 54.64 19 352 7732 3377756
Dizziness 74.35 54.64 32 339 76480 3309008
Deafness transitory 72.96 54.64 10 361 145 3385343
Condition aggravated 71.82 54.64 26 345 39207 3346281
Foot operation 71.58 54.64 12 359 694 3384794
Pain 69.70 54.64 30 341 71527 3313961
Abdominal discomfort 68.54 54.64 21 350 18863 3366625
Feeding disorder 68.43 54.64 13 358 1533 3383955
Sciatica 63.51 54.64 13 358 2247 3383241
Drug effect incomplete 61.71 54.64 16 355 7834 3377654
Musculoskeletal disorder 61.10 54.64 13 358 2708 3382780

Pharmacologic Action:

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SourceCodeDescription
ATC A16AA01 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Amino acids and derivatives
CHEBI has role CHEBI:35679 antilipemic drug
CHEBI has role CHEBI:50733 nutraceutical
CHEBI has role CHEBI:66980 nootropic agent
FDA Chemical/Ingredient N0000006688 Carnitine
FDA EPC N0000175903 Carnitine Analog

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Carnitine deficiency indication 421784001
Obstruction of bile duct contraindication 30144000 DOID:13580
Low blood pressure contraindication 45007003
Blood coagulation disorder contraindication 64779008 DOID:1247
Kidney disease contraindication 90708001 DOID:2527
Seizure disorder contraindication 128613002 DOID:1826
Disease of liver contraindication 235856003 DOID:409
Vitamin K Deficiency Induced Hypoprothrombinemia contraindication

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.86 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG/ML CARNITOR LEADIANT BIOSCI INC N020182 Dec. 16, 1992 RX INJECTABLE INJECTION 6335369 Jan. 18, 2021 USE OF LEVOCARNITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
200MG/ML CARNITOR LEADIANT BIOSCI INC N020182 Dec. 16, 1992 RX INJECTABLE INJECTION 6429230 Jan. 18, 2021 USE OF LEVOCARNITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
200MG/ML CARNITOR LEADIANT BIOSCI INC N020182 Dec. 16, 1992 RX INJECTABLE INJECTION 6696493 Jan. 18, 2021 USE OF LEVOCARNITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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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 Unclassified Ki 4 CHEMBL

External reference:

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IDSource
CHEBI:16347 CHEBI
4020953 VUID
N0000148430 NUI
C0007258 UMLSCUI
D02176 KEGG_DRUG
0G389FZZ9M UNII
6098 INN_ID
DB00583 DRUGBANK_ID
372601001 SNOMEDCT_US
4018934 VANDF
147388 MMSL
N0000148374 NDFRT
N0000147225 NDFRT
42955 RXNORM
10540 MMSL
d00491 MMSL
003576 NDDF
4970 MMSL
4020870 VANDF
329486002 SNOMEDCT_US
CHEMBL1149 ChEMBL_ID
CHEMBL172513 ChEMBL_ID
D002331 MESH_DESCRIPTOR_UI
6645-46-1 SECONDARY_CAS_RN
10917 PUBCHEM_CID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 0517-1045 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 14 sections
Xyzal HUMAN PRESCRIPTION DRUG LABEL 1 35356-462 TABLET, FILM COATED 5 mg ORAL NDA 9 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 50383-171 SOLUTION 1 g ORAL NDA 13 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 50383-172 TABLET 330 mg ORAL NDA 14 sections
IQQU Acne Serum HUMAN OTC DRUG LABEL 2 50403-226 LOTION 0.01 g TOPICAL UNAPPROVED DRUG OTHER 7 sections
CARNITOR HUMAN PRESCRIPTION DRUG LABEL 1 54482-144 TABLET 330 mg ORAL NDA 14 sections
Carnitor HUMAN PRESCRIPTION DRUG LABEL 1 54482-145 SOLUTION 1 g ORAL NDA 14 sections
Carnitor HUMAN PRESCRIPTION DRUG LABEL 1 54482-147 INJECTION, SOLUTION 1 g INTRAVENOUS NDA 14 sections
Carnitor SF HUMAN PRESCRIPTION DRUG LABEL 1 54482-148 SOLUTION 1 g ORAL NDA 14 sections
Levocarnitine HUMAN PRESCRIPTION DRUG LABEL 1 64980-503 SOLUTION 1 g ORAL ANDA 12 sections
Lipovite HUMAN PRESCRIPTION DRUG LABEL 11 70104-128 INJECTION 1 mg INTRAMUSCULAR unapproved drug other 1 sections