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.
Tindamax® is a prescription antibiotic used to treat certain infections caused by bacteria and parasites. It is approved for treating trichomoniasis, also known as "trich," and bacterial vaginosis, or "BV" (in non-pregnant, adult women). It is also approved for treating giardiasis, also known as "giardia," amebiasis, and amebic liver abscess in patients age 3 and older.
Important Safety Information
Tindamax® is not for everyone. You should not take Tindamax® if you are in the first trimester of pregnancy. If you are nursing, Tindamax® can pass through your breast milk, so you should not take it unless you stop breastfeeding during your prescription and for 3 days after your last dose.
Tindamax® can lead to a temporary reduction in your white blood cells, so if you have been diagnosed with a blood disorder, talk to your doctor before starting a prescription.
Do not take Tindamax® if you have a history of sensitivity to tinidazole or related drugs in the nitroimidazole family. Reactions can range from mild itching, hives, or fever to Stevens-Johnson syndrome, which is a rare, life-threatening skin condition.
Certain drugs may interact with Tindamax®, so always tell your doctor about the medications you're taking before you start a prescription.
Take each dose of Tindamax® with food to lessen the risk of stomach upset and other GI side effects. Avoid any alcoholic beverages while taking Tindamax® and for 3 days afterward.
If you are undergoing hemodialysis while taking Tindamax® on the same day, consult your doctor for the appropriate dose of Tindamax®. An additional half-dose of Tindamax® at the end of dialysis may be recommended.
Antibacterial drugs, including Tindamax®, do not treat viral infections such as the common cold. When taking Tindamax® to treat a bacterial infection, it is very common to feel better early in your prescription; however, you should keep taking the medication as directed and for as long as directed by your doctor. Skipping doses or not taking all of your medication can make Tindamax® less effective. It can also allow the bacteria to build up resistance to the drug, so that it won't be treatable with Tindamax® or similar drugs in the future.
The most common side effects of Tindamax® are a metallic or bitter taste, nausea, weakness, fatigue, discomfort, indigestion, cramps, vomiting, loss of appetite, headache, dizziness, and constipation.
Some patients taking Tindamax® may also develop a yeast infection, which can require treatment with an anti-fungal drug. Talk to your doctor if you notice any unusual symptoms.
Certain patients taking Tindamax® have experienced seizures or nerve problems, with symptoms such as numbness or tingling of the hands or feet. Other side effects included vertigo, unsteady movements, insomnia, or drowsiness. Stop taking Tindamax® if you develop any abnormal symptoms.
Tinidazole, the key ingredient in Tindamax®, is related to a drug called metronidazole, which has been linked to cancer in lab rats and mice that received the drug over long periods of time. Although these effects have not been reported for tinidazole, the two drugs are chemically related and have similar effects on the body. Therefore, Tindamax® should only be used to treat infections it has been approved to treat.
To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 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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