levomefolic acid indications/contra

Stem definitionDrug idCAS RN
4621 31690-09-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • L-methylfolate calcium
  • levomefolate magnesium
  • methylfolate
  • levomefolic acid
  • levomefolate calcium
  • metafolin
an ingredient in Contraceptives, Oral, Combined
  • Molecular weight: 459.46
  • Formula: C20H25N7O6
  • CLOGP: -2.25
  • LIPINSKI: 2
  • HAC: 13
  • HDO: 7
  • TPSA: 198.48
  • ALOGS: -3.14
  • ROTB: 9

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 24, 2010 FDA BAYER HLTHCARE

FDA Adverse Event Reporting System

None

Pharmacologic Action:

None

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Premenstrual dysphoric disorder indication 596004
Contraception indication 13197004
Acne vulgaris indication 88616000
Hyperlipoproteinemia contraindication 3744001 DOID:1168
Hypocalcemia contraindication 5291005
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Myocardial infarction contraindication 22298006 DOID:5844
Diplopia contraindication 24982008
Retinal hemorrhage contraindication 28998008
Depressive disorder contraindication 35489007 DOID:2848
Chloasma contraindication 36209000
Migraine contraindication 37796009 DOID:6364
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Body fluid retention contraindication 43498006
Thrombosis of retinal vein contraindication 46085004 DOID:1727
Humoral hypercalcemia of malignancy contraindication 47709007
Chronic heart failure contraindication 48447003
Dementia contraindication 52448006
Hepatic porphyria contraindication 55056006 DOID:3133
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Acute nephropathy contraindication 58574008
Thrombophlebitis contraindication 64156001 DOID:3875
Intermenstrual bleeding - irregular contraindication 64996003
Diabetes mellitus contraindication 73211009 DOID:9351
Epilepsy contraindication 84757009 DOID:1826
Breast lump contraindication 89164003
Kidney disease contraindication 90708001 DOID:2527
Uterine leiomyoma contraindication 95315005 DOID:13223
Deep venous thrombosis contraindication 128053003
Seizure disorder contraindication 128613002 DOID:1826
Endometriosis contraindication 129103003 DOID:289
Bed-ridden contraindication 160685001
Mammography abnormal contraindication 168750009
Asthma contraindication 195967001 DOID:2841
Cerebrovascular accident contraindication 230690007 DOID:6713
Pulmonary thromboembolism contraindication 233935004
Thrombophilia contraindication 234467004 DOID:2452
Disease of liver contraindication 235856003 DOID:409
Endometrial carcinoma contraindication 254878006 DOID:2871
Chorea contraindication 271700006
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Functional visual loss contraindication 313165001
Malignant tumor of ovary contraindication 363443007 DOID:2394
Thromboembolic disorder contraindication 371039008
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Cardiovascular event risk contraindication 395112001
Disorder of coronary artery contraindication 414024009
Obesity contraindication 414916001 DOID:9970
Estrogen receptor positive tumor contraindication 416053008
Porphyria contraindication 418470004 DOID:13268
Optic disc edema contraindication 423341008 DOID:10175
Family history of malignant neoplasm of breast contraindication 429740004
Hypertensive urgency contraindication 443482000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Polycystic ovaries off-label use 69878008 DOID:11612

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.61 acidic
pKa2 4.77 acidic
pKa3 11.04 acidic
pKa4 12.96 acidic
pKa5 5.7 Basic
pKa6 5.28 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.451MG,0.451MG BEYAZ BAYER HLTHCARE N022532 Sept. 24, 2010 RX TABLET ORAL 7163931 March 3, 2022 PREVENTION OF PREGNANCY
0.451MG,0.451MG SAFYRAL BAYER HLTHCARE N022574 Dec. 16, 2010 RX TABLET ORAL 7163931 March 3, 2022 PREVENTION OF PREGNANCY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Thymidylate synthase Enzyme WOMBAT-PK

External reference:

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IDSource
D09353 KEGG_DRUG
C2825462 UMLSCUI
1VZZ62R081 UNII
1429498-11-2 SECONDARY_CAS_RN
8917 INN_ID
CHEMBL1231574 ChEMBL_ID
C569381 MESH_SUPPLEMENTAL_RECORD_UI
CHEMBL1615371 ChEMBL_ID
C005984 MESH_SUPPLEMENTAL_RECORD_UI
1025342 RXNORM
DB11256 DRUGBANK_ID
444412 PUBCHEM_CID
CHEBI:136009 CHEBI

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Select-OB Plus DHA HUMAN PRESCRIPTION DRUG LABEL 14 0642-0075 KIT 0.60 mg None Unapproved drug other 7 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 11 0642-0077 TABLET, CHEWABLE 0.60 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Vitafol HUMAN PRESCRIPTION DRUG LABEL 15 0642-0093 CAPSULE, LIQUID FILLED 0.60 mg ORAL UNAPPROVED DRUG OTHER 10 sections
Vitafol HUMAN PRESCRIPTION DRUG LABEL 7 0642-0094 TABLET, COATED 0.60 mg ORAL UNAPPROVED DRUG OTHER 10 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 13 0642-0120 TABLET, CHEWABLE 0.60 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium HUMAN PRESCRIPTION DRUG LABEL 4 0781-4075 KIT 0.45 mg None NDA authorized generic 20 sections
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium HUMAN PRESCRIPTION DRUG LABEL 4 0781-4075 KIT 0.45 mg None NDA authorized generic 20 sections
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium HUMAN PRESCRIPTION DRUG LABEL 4 0781-4103 KIT 0.45 mg None NDA authorized generic 20 sections
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium HUMAN PRESCRIPTION DRUG LABEL 4 0781-4103 KIT 0.45 mg None NDA authorized generic 20 sections
Quflora Pediatric Drops HUMAN PRESCRIPTION DRUG LABEL 12 15370-100 LIQUID 35 ug ORAL UNAPPROVED DRUG OTHER 9 sections
Quflora Pediatric Drops HUMAN PRESCRIPTION DRUG LABEL 12 15370-101 LIQUID 81 ug ORAL UNAPPROVED DRUG OTHER 9 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 13 15370-103 TABLET, CHEWABLE 108 ug ORAL UNAPPROVED DRUG OTHER 12 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 13 15370-104 TABLET, CHEWABLE 108 ug ORAL UNAPPROVED DRUG OTHER 12 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 13 15370-105 TABLET, CHEWABLE 108 ug ORAL UNAPPROVED DRUG OTHER 12 sections
TriStart DHA HUMAN PRESCRIPTION DRUG LABEL 15 15370-250 CAPSULE, LIQUID FILLED 600 ug ORAL UNAPPROVED DRUG OTHER 11 sections
Safyral HUMAN PRESCRIPTION DRUG LABEL 4 50419-403 KIT 0.45 mg None NDA 20 sections
Safyral HUMAN PRESCRIPTION DRUG LABEL 4 50419-403 KIT 0.45 mg None NDA 20 sections
Beyaz HUMAN PRESCRIPTION DRUG LABEL 4 50419-407 KIT 0.45 mg None NDA 20 sections
Beyaz HUMAN PRESCRIPTION DRUG LABEL 4 50419-407 KIT 0.45 mg None NDA 20 sections
RAJANI HUMAN PRESCRIPTION DRUG LABEL 4 52544-298 KIT 0.45 mg None ANDA 20 sections
RAJANI HUMAN PRESCRIPTION DRUG LABEL 4 52544-298 KIT 0.45 mg None ANDA 20 sections
EnBrace HR HUMAN PRESCRIPTION DRUG LABEL 5 64661-650 CAPSULE, DELAYED RELEASE PELLETS 5.23 mg ORAL UNAPPROVED DRUG OTHER 12 sections
EnLyte HUMAN PRESCRIPTION DRUG LABEL 7 64661-711 CAPSULE, DELAYED RELEASE PELLETS 7 mg ORAL unapproved drug other 10 sections
TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM HUMAN PRESCRIPTION DRUG LABEL 12 67112-502 KIT 1 mg None unapproved drug other 1 sections
Tydemy HUMAN PRESCRIPTION DRUG LABEL 4 68180-904 KIT 0.45 mg None ANDA 20 sections
Tydemy HUMAN PRESCRIPTION DRUG LABEL 4 68180-904 KIT 0.45 mg None ANDA 20 sections
Prenate Mini HUMAN PRESCRIPTION DRUG LABEL 13 75854-315 CAPSULE, GELATIN COATED 600 ug ORAL unapproved drug other 12 sections
Prenate Pixie HUMAN PRESCRIPTION DRUG LABEL 10 75854-316 TABLET, FILM COATED 600 ug ORAL unapproved drug other 12 sections
Chromagen HUMAN PRESCRIPTION DRUG LABEL 5 75854-320 CAPSULE 750 ug ORAL unapproved drug other 12 sections
Niferex HUMAN PRESCRIPTION DRUG LABEL 5 75854-321 TABLET 750 ug ORAL unapproved drug other 12 sections