Tinidazole

What it is and how it works

Mechanism of Action Tinidazole is an antiprotozoal, antibacterial agent. [ See Clinical Pharmacology ].

Indications

Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: Trichomoniasis Giardiasis: in patients age 3 and older Amebiasis: in patients age 3 and older Bacterial Vaginosis: in 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 tinidazole tablets are proven or strongly suspected to be caused by bacteria . 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 . 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 ].

Dosage and administration (summary)

Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partner s with the same dose and at the same time 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 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 . 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 .

Contraindications

Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives ( 4 , 6.1 , 6.2 ) Patients with Cockayne syndrome ( 4 , 6.2 ) 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.

Warnings and precautions

Seizures and neuropathy have been reported. Discontinue tinidazole tablets if abnormal neurologic signs develop Vaginal candidiasis may develop with tinidazole tablets and require treatment with an antifungal agent Use tinidazole tablets with caution in patients with blood dyscrasias. Tinidazole tablets may produce transient leukopenia and neutropenia ( 5.3 , 7.3 ) Potential for Genotoxicity and Carcinogenicity Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to tinidazole .

Pregnancy

Pregnancy Risk Summary Available published data from a case-control study and case report with tinidazole use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Storage and supply

Tinidazole Tablets 250 mg tablets are pink, round, scored tablets, debossed with "N" scored "L" on one side and "550" on the other side, supplied in bottles with child-resistant caps as: NDC 43386-550-04 Bottle of 40 Tinidazole Tablets 500 mg tablets are pink, oval, scored tablets, debossed with "N" scored "L" on one side and "551" on the other sid…

Source: Tinidazole (Tinidazole) — US FDA prescribing information, 2022-02-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.