TINIDAZOLE

Antifungal

Brand names: Tindazole

Oral

Mechanism of Action

12.1 Mechanism of Action Tinidazole is an antiprotozoal, antibacterial agent. [See Clinical Pharmacology (12.4) ].

Indications

8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs

14.4 )]. 1.4 Bacterial Vaginosis Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis

Gardnerella vaginitis

nonspecific vaginitis

or anaerobic vaginosis) in adult women [see Use in Specific Populations ( 8.1 ) and Clinical Studies ( 14.5 )] . Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis

Chlamydia trachomatis

Contraindications

• 6.2 )]. In patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after intiation 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

FDA Warnings

5 WARNINGS AND PRECAUTIONS Seizures and neuropathy have been reported
However, it is unclear if the positive tumor findings in lifetime rodent studies indicate a risk to patients taking a short course or single dose of Tinidazole Tablet
5 Development of Drug-Resistant Bacteria Prescribing Tinidazole Tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria

Known Side Effects

12 documented side effects by frequency

Drug Not Working

1-10%

Nausea

1-10%

Headache

1-10%

Diarrhea

1-10%

Itching

1-10%

Vomiting

1-10%

Fever

1-10%

Anxiety

1-10%

Tingling/Numbness

1-10%

Rash

1-10%

Dizziness

0.1-1%

Shortness of Breath

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral