Dosing and uses of Tindamax (tinidazole)
Adult dosage forms and 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
Pediatric dosage forms and strengths
tablet
- 250mg
- 500mg
Amebiasis, Intestinal
< 3 years
- Safety and efficacy not established
>3 Years
- 50 mg/kg/day PO for 3 days; 2 g maximum
Amebic Liver Abscess
< 3 years
- Safety and efficacy not established
>3 Years
- 50 mg/kg/day PO for 5 days; 2 g maximum
Giardiasis
< 3 years
- Safety and efficacy not established
>3 Years
- 50 mg/kg PO once; 2 g maximum
Administration
Take with food
Tindamax (tinidazole) adverse (side) 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. Unnecessary use of this drug should be avoided.
Use should be reserved for conditions described in Indications and Usage
Contraindications
Hypersensitivity
1st trimester of pregnancy
Concurrent lactation (interrupt for 3 days)
Cautions
Caution in patients with history of blood dyscrasias or history of hepatic impairment
Risk of convulsive seizures & peripheral neuropathy - caution in neurologically compromised patients
Risk of bacterial overgrowth with prolonged treatment
No safety & efficacy data on pediatric patients <3 years of age
Not studied for bacterial vaginosis in pregnant women
Pregnancy and lactation
Pregnancy category: C
Lactation: discontinue nursing while taking drug & for 3 d after last dose
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 of Tindamax (tinidazole)
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%
