Within the vaginal ecosystem, balanced levels of lactobacilli, the protective bacteria that help to control disease-causing organisms, are vital to maintaining the homeostasis of vaginal flora.1 When the normal concentration of lactobacilli is reduced by overgrowth of anaerobic bacteria such as Gardnerella vaginalis and Bacteroides spp., the characteristic symptoms of bacterial vaginosis develop.2-4
Tinidazole therapy treats BV with proven efficacy while protecting lactobacilli
In treating BV, one of the goals of therapy is to target disease-causing pathogens while sparing lactobacilli, which are essential for the establishment of normal flora patterns.
This protective benefit also helps to reduce the risks of secondary vaginal candidiasis from BV treatment.
- Tinidazole is associated with a low incidence of vaginal candidiasis (4.7%)
- Less risk of secondary vaginal candidiasis infection enhances recovery and helps reduce patient return rate
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
- Schwebke J. Understanding bacterial vaginosis: Diagnosis, treatment, and improved outcomes. J Family Prac. 2007;(suppl):1-8.
- Sweet RL. Gynecologic conditions and bacterial vaginosis: implications for the non-pregnant patient. Infect Dis Obstet Gynecol. 2000;8(3-4):184-90.
- Hillier SL, Krohn MA, Nugent RP, Gibbs RS. Characteristics of three vaginal flora patterns assessed by gram stain among pregnant women. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1992 Mar;166(3):938-44.
- Hillier SL. Diagnostic microbiology of bacterial vaginosis. Am J Obstet Gynecol. 1993 Aug;169(2 Pt 2):455-9.
