pharmacopeia
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Boxed warning

POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology ( 13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use [see Warnings and Precautions ( 5.1 )]. WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1 ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only ( 1.1 , 1.2 , 1.3 ). Avoid chronic use ( 5.1 ).

Mechanism of action

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Tinidazole is an antiprotozoal, antibacterial agent. [See Clinical Pharmacology (12.4) ].

Indications

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  • Tinidazole Tablet is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in adult women ( 1.4, 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.5) . 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis.

Contraindications

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  • The use of tinidazole is contraindicated: In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome [see Adverse Reactions ( 6.1 , 6.2 )].contraindicated

Dosage & administration

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Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time ( 2.3 ) Giardiasis: Adults: a single 2 g dose taken with food. Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food ( 2.4 ) Amebiasis, Intestinal: Adults: 2 g per day for 3 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3 days with food ( 2.5 ). Amebic liver abscess: Adults: 2 g per day for 3-5 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3-5 days with food ( 2.5 ) Bacterial vaginosis: Adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food ( 2.6 ) 2.1 Dosing Instructions It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole [see Clinical Pharmacology ( 12.3 )]. Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards [see Drug Interactions ( 7.1 )]. 2.2 Compounding of the Oral Suspension For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup to be taken with food. Procedure for Extemporaneous Pharmacy Compounding of the Oral Suspension: Pulverize four 500 mg oral tablets with a mortar and pestle. Add approximately 10 mL of cherry syrup to the powder and mix until smooth. Transfer the suspension to a graduated amber container.

Warnings & precautions

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Seizures and neuropathy have been reported. Discontinue Tinidazole Tablets if abnormal neurologic signs develop ( 5.1 ) Vaginal candidiasis may develop with Tinidazole Tablets and require treatment with an antifungal agent ( 5.2 ) Use Tinidazole Tablets with caution in patients with blood dyscrasias. Tinidazole Tablets may produce transient leukopenia and neutropenia ( 5.3, 7.3 ) 5.1 Potential for Genotoxicity and Carcinogenicity Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to tinidazole [see Nonclinical Toxicology ( 13.1 )] . 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 the positive tumor findings in lifetime rodent studies indicate a risk to patients taking a short course or single dose of Tinidazole Tablet. Use should be limited to approved indications only. Avoid chronic use. 5.2 Neurological Adverse Reactions Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with tinidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of tinidazole therapy. 5.3 Vaginal Candidiasis The use of tinidazole may result in Candida vaginitis. In a clinical study of 235 women who received tinidazole for bacterial vaginosis, a vaginal fungal infection developed in 11 (4.7%) of all study subjects [see Clinical Studies ( 14.5 )].

Adverse reactions

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Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Among 3669 patients treated with a single 2 g dose of tinidazole, in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, adverse reactions were reported by 11.0% of patients. For multi-day dosing in controlled and uncontrolled amebiasis studies, adverse reactions were reported by 13.8% of 1765 patients. Common (≥1% incidence) adverse reactions reported by body system are as follows. (Note: Data described in Table 1 below are pooled from studies with variable designs and safety evaluations.) Other adverse reactions reported with tinidazole include: Central Nervous System: Two serious adverse reactions reported include convulsions and transient peripheral neuropathy including numbness and paresthesia [see Warnings and Precautions ( 5.1 )]. Other CNS reports include vertigo, ataxia, giddiness, insomnia, drowsiness.

Use in specific populations

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Pediatric Use: Data on tinidazole use in children is limited to treatment of giardiasis and amebiasis in patients age 3 and older ( 8.4 ) Hemodialysis patients: If tinidazole is administered the same day and prior to hemodialysis, administer an additional ½ dose after end of hemodialysis ( 8.6, 12.3 ) Lactation: Breastfeeding is not recommended. Discontinue breastfeeding during and for 72 hours after the last dose of Tinidazole Tablet (8.2) 8.1 Pregnancy Risk Summary Available published data from a case-control study and case report with Tinidazole Tablets use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated lower genital tract infections during pregnancy (see Clinical Considerations) . 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 the highest dose, with no other adverse fetal effects noted in either species (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Pharmacokinetics

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Metabolism
Absorption After oral administration, tinidazole is rapidly and completely absorbed. A bioavailability study of Tinidazole tablets was conducted in adult healthy volunteers.

Overdosage

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There are no reported overdoses with tinidazole in humans. Treatment of Overdosage: There is no specific antidote for the treatment of overdosage with tinidazole; therefore, treatment should be symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis can be considered because approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session.

Approval history

Sourced from openFDA
  • May 17, 2004NDANDA021618Mission Pharma
  • Apr 30, 2012ANDAANDA202044Chartwell Rx
  • Oct 9, 2013ANDAANDA202489Unique
  • Aug 4, 2015ANDAANDA203808Edenbridge Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
436 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective327.3%
  2. 2Nausea286.4%
  3. 3Off Label Use266.0%
  4. 4Headache255.7%
  5. 5Pruritus255.7%
  6. 6Diarrhoea235.3%
  7. 7Vomiting235.3%
  8. 8Pyrexia214.8%
  9. 9Anxiety204.6%
  10. 10Rash204.6%
  11. 11Neuropathy Peripheral194.4%
  12. 12Paraesthesia194.4%
  13. 13Pain173.9%
  14. 14Dizziness153.4%
  15. 15Dyspnoea143.2%

Literature

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Recent PubMed references pinned to Tinidazole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 46 ClinicalTrials.gov registrations naming Tinidazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Tinidazole work?
Tinidazole is an antiprotozoal, antibacterial agent. [See Clinical Pharmacology (12.4) ].
What is Tinidazole used for?
According to FDA labeling, Tinidazole carries indications including: Tinidazole Tablet is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in adult women ( 1.4, 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.5) . 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tinidazole?
Tinidazole is classified as Imidazole derivatives, Nitroimidazole derivatives, Nitroimidazole Antimicrobial, Unknown Cellular or Molecular Interaction, Decreased Protein Synthesis, DNA Integrity Alteration, Increased Cellular Death.
What are the brand names for Tinidazole?
Tinidazole is marketed under brand names including Tindamax.
What are the contraindications for Tinidazole?
Tinidazole labeling lists contraindications including: The use of tinidazole is contraindicated: In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome [see Adverse Reactions ( 6.1 , 6.2 )].. Always consult the full prescribing information and a clinician.
Note. Data for tinidazole is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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