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Tindamax

Dosing

Note: This page is for basic patient education only. For detailed information about Tindamax, please consult the full Prescribing Information.

Tinidazole should always be taken with food to minimize any gastrointestinal side effects. Food does not affect its absorption into the body. Patients should also avoid alcoholic beverages when taking tinidazole and for 3 days afterwards.

Bacterial vaginosis

The recommended dose in non-pregnant women is a 1 g tablet taken orally, once a day for 5 days, or 2 g orally, once a day for 2 days. Patients should always take the medication with food.

Two convenient dosing options for BV
2 g/2-day dosing4 x 500 mg tablets once daily for 2 days, taken with food 1 g/5-day dosing2 x 500 mg tablets once daily for 5 days, taken with food
Day 1: 4 x 500 mg Tindamax tablets Day 1: 2 x 500 mg Tindamax tablets
Day 2: 4 x 500 mg Tindamax tablets Day 2: 2 x 500 mg Tindamax tablets
  Day 3: 2 x 500 mg Tindamax tablets
Day 4: 2 x 500 mg Tindamax tablets
Day 5: 2 x 500 mg Tindamax tablets
Table 1

Trichomoniasis

For treating trichomoniasis in both men and women, the recommended dose is one 2 g oral dose, taken with food. Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose, at the same time.

Giardiasis

The recommended dose for treating giardiasis in adults is a single 2 g dose, taken with food. In children older than 3, the recommended dose is a single dose of 50 mg/kg (up to 2 g) with food.

Amebiasis

Intestinal

The recommended dose for treating intestinal amebiasis in adults is a 2 g dose per day for 3 days, taken with food. In children older than 3 years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3 days, taken with food.

Amebic liver abscess

The recommended dose for treating adults diagnosed with amebic liver abscess is a 2 g dose per day for 3 to 5 days, taken with food. In children older than 3, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3 to 5 days, taken with food.

Limited data are available about pediatric therapy lasting longer than 3 days, although a small number of children were treated for 5 days without additional reported side effects. Children should be closely monitored when treatment exceeds 3 days.

Tindamax® dosing recommendations
Indication Adults Children > 3 Years of Age
Trichomoniasis 2 g single dose* n/a
Giardiasis 2 g single dose 50 mg/kg single dose
(up to 2 g)
Intestinal Amebiasis 2 g QD
× 3 days
50 mg/kg QD
× 3 days
(up to 2 g/day)
Amebic Liver Abscess 2 g QD
× 3-5 days
50 mg/kg QD
× 3-5 days
(up to 2 g/day)

* Treat sexual partners with the same dose and at the same time.

Please see full Prescribing Information.

Table 2

Important Safety Information

WARNING: POTENTIAL RISK FOR CARCINOGENICITY

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE.

Contraindications

  • Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives
  • First trimester of pregnancy
  • Nursing mothers, unless breast-feeding is interrupted during tinidazole therapy and for 3 days following the last dose

Warnings and Precautions

  • Seizures and neuropathy have been reported. Discontinue Tindamax if abnormal neurologic signs develop
  • Vaginal candidiasis may develop with Tindamax and require treatment with an antifungal agent
  • Use Tindamax with caution in patients with blood dyscrasias. Tindamax may produce transient leukopenia and neutropenia

Adverse Reactions

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. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.

Please see full Prescribing Information


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