Tinidazole (2 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- TINDAMAX
- TINIDAZOLE
Boxed Warning
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) ].
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)]
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.
Mechanism of Action
Tinidazole is an antiprotozoal, antibacterial agent. [See Clinical Pharmacology (12.4) ].
Overdosage
There are no reported overdoses with tinidazole in humans. Treatment of Overdosage:There is no specific antidote for the treatment of overdosage with tinidazole; therefore, treatment should be symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis can be considered because approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session.