Tinidazole 250 mg/1
Tinidazole · TABLET · Edenbridge Pharmaceuticals LLC.
Tinidazole is a tablet containing tinidazole at 250 mg/1, taken oral. Manufactured by Edenbridge Pharmaceuticals LLC..
Key Facts
- Brand Name
- Tinidazole
- Generic Name
- Tinidazole
- NDC Code (Product)
42799-207- Manufacturer
- Edenbridge Pharmaceuticals LLC.
- Strength
- 250 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203808
- Drug Class
- Nitroimidazole Antimicrobial [EPC]
- Marketing Start
- 12/20/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tinidazole is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in non-pregnant, adult women ( 1.4 , 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole tablets and other antibacterial drugs, tinidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.5) 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis . The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection [ see Clinical Studies (14.1) ]. 1.2 Giardiasis Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia ) in both adults and pediatric patients older than three years of age [ see Clinical Studies (14.2) ]. 1.3 Amebiasis Tinidazole…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time ( 2.3 ) Giardiasis: Adults: a single 2 g dose taken with food. Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food ( 2.4 ) Amebiasis, Intestinal : Adults: 2 g per day for 3 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3 days with food ( 2.5 ). Amebic liver abscess : Adults: 2 g per day for 3-5 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3-5 days with food ( 2.5 ) Bacterial vaginosis: Non-pregnant, adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food ( 2.6 ) 2.1 Dosing Instructions It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole [ see Clinical Pharmacology (12.3) ]. Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards [ see Drug Interactions (7.1) ]. 2.…
Contraindications
4 CONTRAINDICATIONS The use of tinidazole is contraindicated: In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome [ see Adverse Reactions (6.1 , 6.2) ]. In patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to tinidazole, in patients with Cockayne syndrome [see Adverse Reactions (6.2) ] Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives ( 4 , 6.1 , 6.2 ) Patients with Cockayne syndrome ( 4 , 6.2 )
Drug Interactions
7 DRUG INTERACTIONS Although not specifically identified in studies with tinidazole, the following drug interactions were reported for metronidazole, a chemically-related nitroimidazole. Therefore, these drug interactions may occur with tinidazole. The following drug interactions were reported for metronidazole, a chemically-related nitroimidazole and may therefore occur with tinidazole: Warfarin and other oral coumarin anticoagulants: Anticoagulant dosage may need adjustment during and up to 8 days after tinidazole therapy ( 7.1 ) Alcohol-containing beverages/preparations: Avoid during and up to 3 days after tinidazole therapy ( 7.1 ) Lithium: Monitor serum lithium concentrations ( 7.1 ) Cyclosporine, tacrolimus: Monitor for toxicities of these immunosuppressive drugs ( 7.1 ) Fluorouracil: Monitor for fluorouracil-associated toxicities ( 7.1 ) Phenytoin, fosphenytoin: Adjustment of anticonvulsant and/or tinidazole dose(s) may be needed ( 7.1 , 7.2 ) CYP3A4 inducers/inhibitors: Monitor for decreased tinidazole effect or increased adverse reactions ( 7.2 ) 7.1 Potential Effects of Tinidazole on Other Drugs Warfarin and Other Oral Coumarin Anticoagulants: As with metronidazole, tinid…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Among 3669 patients treated with a single 2 g dose of tinidazole, in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, adverse reactions were reported by 11.0% of patients. For multi-day dosing in controlled and uncontrolled amebiasis studies, adverse reactions were reported by 13.8% of 1765 patients. Common (≥ 1% incidence) adverse reactions reported by body system are as follows. (Note: Data described in Table 1 below are pooled from studies with vari…
Frequently Asked Questions
What is Tinidazole used for?
Tinidazole contains Tinidazole. It is a tablet taken oral. Consult your doctor for specific uses.
Is Tinidazole a controlled substance?
Tinidazole is not classified as a controlled substance by the DEA.
What is the generic name for Tinidazole?
The generic name for Tinidazole is Tinidazole. There are 4 other brand versions of Tinidazole.
What is the NDC code for Tinidazole 250 mg/1?
The NDC (National Drug Code) for Tinidazole 250 mg/1 is 42799-207, listed by Edenbridge Pharmaceuticals LLC..