Dosing & Uses
Dosage Forms & Strengths
tablet
- 250mg
- 500mg
Amebiasis, Intestinal
2 g/day PO for 3 days
Amebic Liver Abscess
2 g/day PO for 3-5 days
Giardiasis or Trichomoniasis
2 g PO once
Bacterial Vaginosis (Nonpregnant)
2 g PO qDay for 2 days OR 1 g PO qDay for 5 days
Administration
Take with food
For trichomoniasis, treat sexual partners concurrently with same dose
Dosage Forms & Strengths
tablet
- 250mg
- 500mg
Amebiasis, Intestinal
< 3 years
- Safety and efficacy not established
>3 Years
Amebic Liver Abscess
< 3 years
- Safety and efficacy not established
>3 Years
Giardiasis
< 3 years
- Safety and efficacy not established
>3 Years
Administration
Take with food
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
1-10%
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%)
Frequency Not Defined
Ataxia
Candida overgrowth
Convulsions & transient peripheral neuropathy
Numbness & paresthesia
Diarrhea
Darkened urine
Tongue discoloration
Transient leukopenia/neutropenia
Warnings
Black Box Warnings
Carcinogenicity has been seen in mice and rats chronically treated with metronidazole, another agent in the nitroimidazole class. Although such data have not been reported with tinidazole, the 2 drugs are structurally related and have similar biological effects
Limit use to approved indications only; avoid chronic use
Contraindications
Hypersensitivity
1st trimester of pregnancy
Cautions
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
Pregnancy & Lactation
Pregnancy
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; there are risks associated with untreated lower genital tract infections during pregnancy
Infertility
- Based on findings in rodents, therapy may impair fertility in males of reproductive potential; not known whether effects on fertility are reversible
Animal data
- In animal reproduction studies, oral administration of tinidazole to pregnant mice and rats during organogenesis at 6 and 3 times, respectively, the maximum recommended human dose (based on body surface area comparison) showed a slight increase in fetal mortality in rats at highest dose, with no other adverse fetal effects noted in either species
Lactation
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
Because of potential for serious adverse reactions, including tumorigenicity, breastfeeding is not recommended during treatment and for 72 hours (based on half-life) after last dose
A nursing mother may choose to pump and discard her milk during treatment and for 72 hours after last dose to minimize exposure to breastfeeding infant
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Antiprotozoal; may cause cytotoxicity by damaging DNA and preventing further DNA synthesis
Pharmacokinetics
Half-life: 12-14 hr
Metabolism: Mainly by CYP3A4
Vd: 50L
Protein binding: 12%
Peak plasma time: 1.6 hr
Metabolites: Undergoes oxidation, hydroxylation & conjugation
Excretion: Mainly in urine (20-25% as unchanged drug); feces: 12%
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
