(tye NI da zole)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tindamax: 250 mg, 500 mg [scored; contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]
Generic: 250 mg, 500 mg
Brand Names: U.S.
- Antibiotic, Miscellaneous
- Antiprotozoal, Nitroimidazole
After diffusing into the organism, it is proposed that tinidazole causes cytotoxicity by damaging DNA and preventing further DNA synthesis.
Rapid and complete
Vd: 50 L
Hepatic via CYP3A4 (primarily); undergoes oxidation, hydroxylation and conjugation; forms a metabolite
Urine (20% to 25%); feces (12%)
Time to Peak
Use: Labeled Indications
Treatment of trichomoniasis caused by T. vaginalis; treatment of giardiasis caused by G. duodenalis (G. lamblia); treatment of intestinal amebiasis and amebic liver abscess caused by E. histolytica; treatment of bacterial vaginosis caused by Bacteroides spp, Gardnerella vaginalis, and Prevotella spp in nonpregnant females
Hypersensitivity to tinidazole, nitroimidazole derivatives (including metronidazole), or any component of the formulation; pregnancy (1st trimester); breast-feeding
Children >3 years:
Amebiasis, intestinal: 50 mg/kg/day for 3 days (maximum dose: 2 g/day)
Amebiasis, liver abscess: 50 mg/kg/day for 3-5 days (maximum dose: 2 g/day)
Giardiasis: 50 mg/kg as a single dose (maximum dose: 2 g)
Amebiasis, intestinal: 2 g/day for 3 days
Amebiasis, liver abscess: 2 g/day for 3-5 days
Bacterial vaginosis: 2 g/day for 2 days or 1 g/day for 5 days
Giardiasis: 2 g as a single dose
Trichomoniasis: Oral: 2 g as a single dose; sexual partners should be treated at the same time
Urethritis (off-label use): Oral: 2 g as a single dose with azithromycin (CDC, 2010)
Dosage adjustment in renal impairment: No dosage adjustment necessary.
Hemodialysis: An additional dose equal to 1/2 the usual dose, should be administered at the end of hemodialysis if tinidazole is administered prior to hemodialysis on a dialysis days.
Dosage adjustment in hepatic impairment: No dosage adjustment provided in manufacturer’s labeling (has not been studied). Use with caution.
A 67 mg/mL suspension may be made with tablets and cherry syrup. Crush four 500 mg tablets in a mortar and reduce to a fine powder. Add 10 mL cherry syrup and mix to a uniform paste; mix while adding cherry syrup in incremental proportions to almost 30 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 30 mL. Label "shake well". Stable for 7 days.Tindamax® prescribing information, Mission Pharmacal Company, San Antonio, TX, 2007. Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021618s003lbl.pdf
Administer with food
Take with food. The manufacturer recommends that ethanol be avoided during treatment and for 3 days after therapy is complete.
Store at controlled room temperature of 15°C to 30°C (59°F to 86°F). Protect from light.
Alcohol (Ethyl): Tinidazole may enhance the adverse/toxic effect of Alcohol (Ethyl). A disulfiram-like reaction may occur. Avoid combination
Disulfiram: Tinidazole may enhance the adverse/toxic effect of Disulfiram. Avoid combination
May interfere with AST, ALT, triglycerides, glucose, and LDH testing
1% to 10%:
Central nervous system: Fatigue/malaise (1% to 2%), dizziness (≤1%), headache (≤1%)
Endocrine & metabolic: Menorrhagia (>2%)
Gastrointestinal: Metallic/bitter taste (4% to 6%), nausea (3% to 5%), anorexia (2% to 3%), appetite decreased (>2%), flatulence (>2%), dyspepsia/cramps/epigastric discomfort (1% to 2%), vomiting (1% to 2%), constipation (≤1%)
Genitourinary: Candida vaginitis (5%), painful urination (>2%), pelvic pain (>2%), urine abnormality (>2%), vaginal odor (>2%), vulvovaginal discomfort (>2%)
Neuromuscular & skeletal: Weakness (1% to 2%)
Renal: Urinary tract infection (>2%)
Respiratory: Upper respiratory tract infection (>2%)
Frequency not defined:
Cardiovascular: Flushing, palpitation
Central nervous system: Ataxia, coma (rare), confusion (rare), depression (rare), drowsiness, fever, giddiness, insomnia, seizure, vertigo
Dermatologic: Angioedema, pruritus, rash, urticaria
Gastrointestinal: Abdominal pain, diarrhea, furry tongue (rare), oral candidiasis, salivation, stomatitis, thirst, tongue discoloration, xerostomia
Genitourinary: Urine darkened, vaginal discharge increased
Hematologic: Leukopenia (transient), neutropenia (transient), thrombocytopenia (reversible; rare)
Hepatic: Transaminases increased
Neuromuscular & skeletal: Arthralgia, arthritis, myalgia, peripheral neuropathy (transient, includes numbness and paresthesia)
Respiratory: Bronchospasm (rare), dyspnea (rare), pharyngitis (rare)
Miscellaneous: Burning sensation, Candida overgrowth, diaphoresis
Postmarketing and/or case reports: Acute hypersensitivity reaction (severe), erythema multiforme, Stevens-Johnson syndrome
Concerns related to adverse effects:
• Carcinogenic: [U.S. Boxed Warning]: Carcinogenicity has been observed with another nitroimidazole derivative (metronidazole) in animal studies; use should be reserved for approved indications only.
• CNS effects: Seizures and peripheral neuropathy have been reported with tinidazole and other nitroimidazole derivatives; use with caution in patients with CNS diseases.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD), pseudomembranous colitis, and/or vaginal candidiasis. CDAD has been observed >2 months postantibiotic treatment.
• Amebiasis: Appropriate use: When used for amebiasis, not indicated for the treatment of asymptomatic cyst passage.
• Blood dyscrasias: Use with caution in patients with current or a history of blood dyscrasias.
• Hepatic impairment: Use with caution in patients with current or a history of hepatic impairment.
Pregnancy Risk Factor
The manufacturer contraindicates use of tinidazole during the first trimester of pregnancy. Tinidazole crosses the human placenta and enters the fetal circulation. The safety of tinidazole for the treatment of bacterial vaginosis or trichomoniasis in pregnant women has not been well evaluated. Other agents are preferred for use during pregnancy (CDC [Workowski 2015]).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea or parageusia. Have patient report immediately to prescriber paresthesia, vaginitis, ecchymosis, or hemorrhaging (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about tinidazole
- Other brands: Tindamax