A common infection that affects millions of women
If you've been diagnosed with bacterial vaginosis, you're not alone. Bacterial vaginosis, or BV, affects nearly one-third of women in the United States. In fact, it is the most common vaginal infection among women in their childbearing years. It is also one of the leading causes of 10 million doctor visits every year for "vaginitis," a term used to describe a wide range of vaginal conditions with similar symptoms.1
Some quick facts about BV
- BV is an infection associated with an overgrowth of harmful bacteria in the vaginal environment.
- BV is often accompanied by abnormal vaginal discharge and "fishy" odor, genital itching, and discomfort during urination.
- BV can appear similar to other vaginal infections and should always be evaluated by a physician for proper diagnosis.
- If not treated, BV can lead to serious complications, including higher risks of preterm labor and pelvic inflammatory disease.
BV and the vaginal flora
Research has shown that BV is closely associated with changes in the vaginal flora — specifically, in the balance of "good" bacteria (lactobacilli) and "bad" bacteria (pathogens). Lactobacilli perform several critical functions that help keep the growth of disease-causing organisms in check, including the production of lactic acid to maintain vaginal pH levels. Unfortunately, certain changes in behavior or hygiene (new sex partners or douching, for example) may shift the balance of lactobacilli and allow anaerobic bacteria such as Gardnerella vaginalis to dominate the vaginal flora. This may lead to the development of BV.2
Tindamax® has a low risk of secondary vaginal candidiasis, a yeast infection that can develop if too many good bacteria (lactobacilli) needed for a healthy vaginal environment are eliminated during antibiotic therapy.
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
- Vaginitis. ACOG Practice Bulletin No. 72. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2006;107:1195-206.
- Sweet RL. Gynecologic conditions and bacterial vaginosis: implications for the non-pregnant patient. Infect Dis Obstet Gynecol. 2000;8(3-4):184-90.
For Health Professionals
Only Tindamax® is approved to treat both bacterial vaginosis and trichomoniasis (TV).
Clinical Insight
Oral vs vaginal cream therapy: Patient preference for oral dosing is demonstrated to be 84%. More»
Beyond BV
Tindamax® may be prescribed for other infections including:
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