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Tindamax (TINIDAZOLE)
Tindamax works by damaging the DNA of susceptible microorganisms, ultimately leading to their death.
Tinidazole (Tindamax), marketed by Mission Pharma, is an antiprotozoal and antibacterial agent primarily indicated for the treatment of trichomoniasis. Its key strength lies in its mechanism of action, which damages the DNA of susceptible microorganisms, leading to their death, providing a robust therapeutic option. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | TINIDAZOLE |
|---|---|
| Sponsor | Mission Pharma |
| Drug class | Nitroimidazole Antimicrobial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
Tinidazole is an antiprotozoal, antibacterial agent. [See Clinical Pharmacology 12.4)].
Approved indications
- Trichomoniasis
- Giardiasis
- Amebiasis
- Bacterial Vaginosis
Boxed warnings
- WARNING: POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology ( 13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use [see Warnings and Precautions ( 5.1 )]. WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1 ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only ( 1.1 , 1.2 , 1.3 ). Avoid chronic use ( 5.1 ).
Common side effects
- urinary tract infection
- painful urination
- urine abnormality
- flatulence
- decreased appetite
- upper respiratory tract infection
- menorrhagia
- vulvo-vaginal discomfort
- vaginal odor
- pelvic pain
- hypersensitivity reactions
- urticaria
Drug interactions
- Warfarin and other oral coumarin anticoagulants
- Alcohol-containing beverages/preparations
- Disulfiram
- Lithium
- Phenytoin, Fosphenytoin
- Cyclosporine, Tacrolimus
- Fluorouracil
- CYP3A4 inducers/inhibitors
Key clinical trials
- "Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)" (PHASE2)
- Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule (PHASE1)
- Clinical Study on the Impact of Eradication of Oral Porphyromonas Gingivalis on the Prognosis of Early Esophageal Cancer After ESD Surgery (NA)
- Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis (NA)
- Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery (PHASE3)
- Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule (PHASE3)
- Eradication of H. Pylori Infection With Moxifloxacin (PHASE3)
- Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tindamax CI brief — competitive landscape report
- Tindamax updates RSS · CI watch RSS
- Mission Pharma portfolio CI