tinidazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antiprotozoals and radiosensitizers, metronidazole derivatives | 2671 | 19387-91-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | V |
| 1.50 | g | P |
| 2 | g | O |
| 2 | g | R |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 17, 2004 | FDA | MISSION PHARMA |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Drug effective for unapproved indication | 58.75 | 54.36 | 10 | 134 | 2592 | 34954195 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Drug effective for unapproved indication | 52.46 | 42.46 | 10 | 253 | 5991 | 79738134 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 | G01AF21 | GENITO URINARY SYSTEM AND SEX HORMONES GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS Imidazole derivatives |
| 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 | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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:
| ID | Source |
|---|---|
| D01426 | KEGG_DRUG |
| 4021467 | VANDF |
| C0040263 | UMLSCUI |
| CHEMBL1220 | ChEMBL_ID |
| DB00911 | DRUGBANK_ID |
| D014011 | MESH_DESCRIPTOR_UI |
| 5479 | PUBCHEM_CID |
| 12341 | IUPHAR_LIGAND_ID |
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 31 sections |
| Tinidazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43386-550 | TABLET | 250 mg | ORAL | ANDA | 31 sections |
| Tinidazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43386-551 | TABLET | 500 mg | ORAL | ANDA | 31 sections |
| Tinidazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43386-551 | TABLET | 500 mg | ORAL | ANDA | 31 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 | 64980-426 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 28 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 |
| Tindazole | Human Prescription Drug Label | 1 | 64980-427 | TABLET, FILM COATED | 500 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 |
| Tindazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67296-1836 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 28 sections |