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

Stem definitionDrug idCAS RN
antiprotozoals and radiosensitizers, metronidazole derivatives 2671 19387-91-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tindamax
  • tinidazole
  • tinidazol
  • trimonase
A nitroimidazole alkylating agent that is used as an antitrichomonal agent against TRICHOMONAS VAGINALIS; ENTAMOEBA HISTOLYTICA; and GIARDIA LAMBLIA infections. It also acts as an antibacterial agent for the treatment of BACTERIAL VAGINOSIS and anaerobic bacterial infections.
  • Molecular weight: 247.27
  • Formula: C8H13N3O4S
  • CLOGP: -0.32
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 0
  • TPSA: 97.78
  • ALOGS: -1.91
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.50 g P
2 g O
2 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 20 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 22.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 134.67 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 98 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.59 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.80 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 13 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 17, 2004 FDA MISSION PHARMA

FDA Adverse Event Reporting System (Female)

None

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
Drug effective for unapproved indication 64.96 53.28 10 108 1445 29572964

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
Drug effective for unapproved indication 56.65 48.98 10 217 3698 64494807

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BD09 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC J01RA11 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J01RA13 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J01XD02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER ANTIBACTERIALS
Imidazole derivatives
ATC P01AB02 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTIPROTOZOALS
AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
Nitroimidazole derivatives
FDA CS M0014907 Nitroimidazoles
FDA EPC N0000175435 Nitroimidazole Antimicrobial
MeSH PA D000477 Alkylating Agents
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D000994 Antitrichomonal Agents
MeSH PA D009676 Noxae

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Acute amebiasis indication 39224005
Infection by Trichomonas indication 56335008 DOID:1947
Giardiasis indication 58265007 DOID:10718
Amebic liver abscess indication 75119003
Bacterial vaginosis indication 419760006 DOID:3385
Epilepsy contraindication 84757009 DOID:1826
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001




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 1.96 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D01426 KEGG_DRUG
4021467 VANDF
C0040263 UMLSCUI
CHEMBL1220 ChEMBL_ID
DB00911 DRUGBANK_ID
D014011 MESH_DESCRIPTOR_UI
5479 PUBCHEM_CID
2653 INN_ID
033KF7V46H UNII
10612 RXNORM
17775 MMSL
54062 MMSL
72539 MMSL
d04935 MMSL
004057 NDDF
324550004 SNOMEDCT_US
395907001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tinidazole HUMAN PRESCRIPTION DRUG LABEL 1 0054-0347 TABLET, FILM COATED 250 mg ORAL ANDA 28 sections
Tinidazole HUMAN PRESCRIPTION DRUG LABEL 1 0054-0348 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Tindamax HUMAN PRESCRIPTION DRUG LABEL 1 0178-8250 TABLET, FILM COATED 250 mg ORAL NDA 29 sections
Tindamax HUMAN PRESCRIPTION DRUG LABEL 1 0178-8500 TABLET, FILM COATED 500 mg ORAL NDA 29 sections
Tindazole HUMAN PRESCRIPTION DRUG LABEL 1 16571-214 TABLET, FILM COATED 250 mg ORAL ANDA 28 sections
Tindazole HUMAN PRESCRIPTION DRUG LABEL 1 16571-215 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Tinidazole HUMAN PRESCRIPTION DRUG LABEL 1 40032-550 TABLET 250 mg ORAL ANDA 28 sections
Tinidazole HUMAN PRESCRIPTION DRUG LABEL 1 40032-551 TABLET 500 mg ORAL ANDA 28 sections
Tinidazole Human Prescription Drug Label 1 42799-207 TABLET 250 mg ORAL ANDA 29 sections
Tinidazole Human Prescription Drug Label 1 42799-207 TABLET 250 mg ORAL ANDA 29 sections
Tinidazole Human Prescription Drug Label 1 42799-208 TABLET 500 mg ORAL ANDA 29 sections
Tinidazole Human Prescription Drug Label 1 42799-208 TABLET 500 mg ORAL ANDA 29 sections
Tinidazole HUMAN PRESCRIPTION DRUG LABEL 1 43386-550 TABLET 250 mg ORAL ANDA 27 sections
Tinidazole HUMAN PRESCRIPTION DRUG LABEL 1 43386-551 TABLET 500 mg ORAL ANDA 27 sections
Tinidazole Human Prescription Drug Label 1 53002-1611 TABLET 500 mg ORAL ANDA 29 sections
Tindamax HUMAN PRESCRIPTION DRUG LABEL 1 54868-6155 TABLET, FILM COATED 500 mg ORAL NDA 28 sections
Tinidazole HUMAN PRESCRIPTION DRUG LABEL 1 63629-8386 TABLET 500 mg ORAL ANDA 27 sections
Tindazole Human Prescription Drug Label 1 64980-426 TABLET, FILM COATED 250 mg ORAL ANDA 28 sections
Tindazole Human Prescription Drug Label 1 64980-427 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Tinidazole HUMAN PRESCRIPTION DRUG LABEL 1 67296-1729 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections