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Tindazole

TINIDAZOLE

Manufacturer: Rising Pharma Holdings, Inc.

Score: 148.0

Quick Summary

Tinidazole is a synthetic antiprotozoal and antibacterial agent used to treat various infections, including trichomoniasis, giardiasis, amebiasis, and bacterial vaginosis. It is available in 250mg and 500mg tablets and should be taken with food to minimize gastrointestinal side effects. The dosage and duration of treatment vary depending on the condition being treated, and special considerations are needed for pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Trichomoniasis
  • Giardiasis
  • Amebiasis
  • Bacterial vaginosis

Important Safety Information

Warning

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Limit use of Tinidazole Tablets to approved indications only and avoid chronic use.

Contraindications

  • Previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives

Adverse Reactions

  • Metallic/bitter taste
  • Nausea
  • Weakness/fatigue/malaise
  • Dyspepsia/cramps/epigastric discomfort
  • Vomiting
  • Anorexia
  • Headache
  • Dizziness
  • Constipation

Dosing Recommendations

General Guidance

No dose adjustments are necessary for patients with renal impairment, but caution is advised in patients with hepatic impairment.

Trichomoniasis

Adult Dose

Single 2g oral dose taken with food

Pediatric Dose

Not established

Giardiasis

Adult Dose

Single 2g oral dose taken with food

Pediatric Dose

Single dose of 50mg/kg (up to 2g) taken with food for patients older than 3 years

Amebiasis

Adult Dose

2g per day for 3 days taken with food

Pediatric Dose

50mg/kg/day (up to 2g per day) for 3 days taken with food for patients older than 3 years

Bacterial vaginosis

Adult Dose

2g once daily for 2 days taken with food or 1g once daily for 5 days taken with food

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • 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

Nursing Mothers

  • It is not known whether tinidazole is excreted in human milk, but because many drugs are excreted in human milk, caution should be exercised when tinidazole is administered to a nursing woman

Pediatric Use

  • Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of tinidazole in pediatric patients have not been established

Geriatric Use

  • Clinical studies of tinidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
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