Classes
DEA Class; Rx
Common Brand Names; Tindamax
- Antiparasitic Agents;
- Nitroimidazoles
Description
Oral nitroimidazole antimicrobial
Used for trichomoniasis, giardiasis, amebiasis, and bacterial vaginosis
Limit use to approved indications and short-term only
Indications
Indicated for
- Amebiasis, Intestinal
- Amebic Liver Abscess
- Giardiasis or Trichomoniasis
- Bacterial Vaginosis (Nonpregnant)
Contraindications
Hypersensitivity
1st trimester of pregnancy
Patients with Cockayne syndrome
Adverse Effects
- Anorexia (2-3%)
- Constipation (<1%)
- Dizziness (<1%)
- Dysgeusia (4-6%)
- Dyspepsia (1-2%)
- Headache (<1%)
- Nausea (3-5%)
- Vomiting (1-2%)
- Weakness/fatigue/malaise (1-2%)
Warnings
Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole drugs, which are structurally related to tinidazole; although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects; however, it is unclear if positive tumor findings in lifetime rodent studies indicate a risk to patients taking a short course or single dose of the drug; use should be limited to approved indications only; avoid chronic use
Caution in patients with history of blood dyscrasias or history of hepatic impairment
Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, reported; appearance of abnormal neurologic signs demands the prompt discontinuation of therapy
Prescribing drug in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria
Risk of bacterial overgrowth with prolonged treatment
No safety & efficacy data on pediatric patients <3 years of age
Therapy may result in Candida vaginitis, a fungal infection, when used to treat bacterial vaginosis
Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes reported after initiation of metronidazole, another nitroimidazole drug, in patients with Cockayne syndrome
Pregnancy and Lactation
Available published data from a case-control study and case report with use in pregnant women are insufficient to identify risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Limited published literature, based on breast milk sampling, reports that drug is present in human milk; there are no reports of adverse effects on breastfed infant and no information on effects on milk production
Maximum Dosage
2 g/day PO.
2 g/day PO.
50 mg/kg/dose (Max: 2 g/dose) PO.
4 to 12 years: 50 mg/kg/dose (Max: 2 g/dose) PO.
1 to 3 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tinidazole
tablet
- 250mg
- 500mg
