(tye NI da zole)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tindamax: 250 mg [DSC] [scored; contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]
Tindamax: 500 mg [DSC] [contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]
Tindamax: 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; distributes to most body tissues and fluids; crosses the blood-brain barrier
Hepatic via CYP3A4 (primarily); undergoes oxidation, hydroxylation and conjugation; forms a metabolite
Urine (~20% to 25%); feces (~12%)
Time to Peak
1.6 hours (fasting, delayed ~2 hours when given with food)
Use: Labeled Indications
Amebiasis: Treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in adults and pediatric patients older than 3 years.
Limitations of use: Not indicated for the treatment of asymptomatic cyst passage.
Bacterial vaginosis: Treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in nonpregnant women.
Giardiasis: Treatment of giardiasis caused by Giardiasis duodenalis (also termed Giardiasis lamblia) in adults and pediatric patients older than 3 years.
Trichomoniasis: Treatment of trichomoniasis caused by T. vaginalis; treat partners of infected patients simultaneously to prevent reinfection.
Hypersensitivity to tinidazole, nitroimidazole derivatives, or any component of the formulation; pregnancy (first trimester); breast-feeding
Amebiasis, intestinal: Oral: 2 g once daily for 3 days
Amebiasis, liver abscess: Oral: 2 g once daily for 3 to 5 days
Bacterial vaginosis: Oral: 2 g once daily for 2 days or 1 g once daily for 5 days
Bacterial vaginosis, recurrent (off-label dose): Oral: 500 mg twice daily for 7 days followed by intravaginal therapy with boric acid, followed by intravaginal metronidazole suppressive therapy (CDC [Workowski 2015])
Giardiasis: Oral: 2 g as a single dose
Prophylaxis against sexually transmitted diseases following sexual assault (off-label use): Oral: 2 g as a single dose in combination with azithromycin plus ceftriaxone (CDC [Workowski 2015])
Trichomoniasis: Oral: 2 g as a single dose; sexual partners should be treated at the same time
Trichomoniasis, persistent or recurrent (ie, treatment failure of nitroimidazole [eg, metronidazole]) (index case; treatment of sex partner; off-label dose): Oral: 2 g once daily for 7 days (CDC [Workowski 2015])
Urethritis, nongonococcal (recurrent or persistent urethritis in men who have sex with women and who live in regions where T. vaginalis is prevalent; off-label use): Oral: 2 g as a single dose. Note: Compliance with initial regimen and lack of reexposure to an untreated sex partner should be excluded prior to use (CDC [Workowski 2015])
Refer to adult dosing.
Amebiasis, intestinal: Oral: Children >3 years and Adolescents: 50 mg/kg/day for 3 days (maximum dose: 2 g/day)
Amebiasis, liver abscess: Oral: Children >3 years and Adolescents: 50 mg/kg/day for 3 to 5 days (maximum dose: 2 g/day)
Giardiasis: Oral: Children >3 years and Adolescents: 50 mg/kg as a single dose (maximum dose: 2 g)
Prophylaxis against sexually transmitted diseases following sexual assault (off-label use): Adolescents: Refer to adult dosing.
Dosing: 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.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the 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.
The manufacturer recommends that ethanol be avoided during treatment and for 3 days after therapy is complete.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 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 (≤2%), malaise (≤2%), dizziness (≤1%), headache (≤1%)
Dermatologic: Body odor (vaginal: >2%)
Endocrine & metabolic: Hypermenorrhea (>2%)
Gastrointestinal: Dysgeusia (bitter taste, metallic taste: 4% to 6%), nausea (3% to 5%), anorexia (2% to 3%), decreased appetite (>2%), flatulence (>2%), dyspepsia (≤2%), abdominal cramps (≤2%), epigastric distress (≤2%), vomiting (1% to 2%), constipation (≤1%)
Genitourinary: Vulvovaginal candidiasis (5%), dysuria (>2%), pelvic pain (>2%), urine abnormality (>2%), vulvovaginal disease (discomfort) (>2%)
Neuromuscular & skeletal: Weakness (1% to 2%)
Renal: Urinary tract infection (>2%)
Respiratory: Upper respiratory tract infection (>2%)
Frequency not defined:
Cardiovascular: Flushing, palpitations
Central nervous system: Ataxia, burning sensation, drowsiness, insomnia, peripheral neuropathy (transient; includes numbness and paresthesia), seizure, vertigo
Dermatologic: Diaphoresis, pruritus, skin rash, urticaria
Endocrine & metabolic: Increased thirst
Gastrointestinal: Abdominal pain, diarrhea, oral candidiasis, salivation, stomatitis, tongue discoloration, xerostomia
Genitourinary: Dark urine, vaginal discharge
Hematologic & oncologic: Leukopenia (transient), neutropenia (transient)
Hepatic: Increased serum transaminases
Infection: Candidiasis (overgrowth)
Neuromuscular & skeletal: Arthralgia, arthritis, myalgia
<1% (Limited to important or life-threatening): Bronchospasm, coma, confusion, depression, dyspnea, erythema multiforme, hairy tongue, hypersensitivity reaction (acute, severe), pharyngitis, Stevens-Johnson syndrome, thrombocytopenia (reversible)
Concerns related to adverse effects:
• Carcinogenic: [US 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 (eg, extremity numbness and paresthesia) have been reported with tinidazole and other nitroimidazole derivatives; discontinue treatment if abnormal neurologic signs or symptoms occur.
• 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.
• 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. Adverse events have been observed in some animal reproduction studies. 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 bad taste. Have patient report immediately to prescriber burning or numbness feeling, seizures, or vaginitis (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 health care 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.
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Other brands: Tindamax