Bacterial Vaginosis (BV) Fact Sheet

Bacterial vaginosis, or "BV," is the most common vaginal infection in women of childbearing age, affecting nearly one-third of women in the United States. BV is one of the main causes of the 10 million doctor visits for vaginitis in the country annually. BV is caused by an imbalance of bacteria levels in the vagina. According to the Centers for Disease Control and Prevention, if left untreated, BV can increase a woman's susceptibility to sexually transmitted diseases (STDs) such as chlamydia, gonorrhea, and HIV, if she is exposed to these diseases. The untreated bacteria also may infect other female organs and cause serious complications such as pelvic inflammatory disease and cervicitis. In pregnant women, BV is associated with an increased risk of early pregnancy loss, premature delivery, and delivery of a low-birth-weight baby.

Cause of bacterial vaginosis

The causes of BV are not fully understood. It is believed that BV is caused by a disturbance in the normal balance of the bacteria in the vagina where helpful Lactobacillus bacteria are replaced by Gardnerella vaginalis and other bacteria.

Risk Factors

Although any woman can develop BV, sexually active women are at higher risk. Some activities or behaviors can alter the normal balance of vaginal bacteria and therefore increase a woman's risk of developing BV. Such activities or behaviors include:

Having a new sexual partner or multiple sexual partners
Douching
Using an intrauterine device (IUD)
Not using a condom during sex

Symptoms of bacterial vaginosis

Many women may not experience symptoms, but still have BV. If symptoms are present, they can often be confused with those of a yeast infection, and may include:

Gray or white vaginal discharge, usually with an unpleasant odor
A fish-like vaginal odor, often worse following intercourse
Discomfort or pain during urination
Itching in the genital area

Although BV can sometimes clear up without treatment, all women with symptoms of BV should be tested and treated to avoid medical complications.

Incidence and prevalence of bacterial vaginosis

In the United States, BV affects almost one-third of women (29.2 percent). BV is more common among black, non-Hispanic women (51.6 percent) and Mexican women (32.1 percent) than it is among white, non-Hispanic women (23.2 percent). Prevalence in women ages 14-19 is 23.3 percent, while prevalence in women over 20 years of age is estimated between 28-31 percent. Sixteen percent of pregnant women have BV.

Diagnosis of bacterial vaginosis

A health care provider must perform both a pelvic examination and an examination of vaginal fluid to diagnose BV.
BV can be treated with oral prescription drugs or with prescription vaginal creams and gels. Unlike intravaginal treatments, oral therapies treat the entire reproductive tract, including the upper tract where BV has been shown to migrate in recent studies.
Men may be carriers for BV; because they do not experience symptoms, they may unknowingly pass it on to their partners.
Having BV once does not protect a woman from getting it again. Following successful treatment, women are susceptible to re-infection.

Treatment of bacterial vaginosis

Tindamax^® is a rapidly absorbed, systemic therapy for bacterial vaginosis. Unlike topical vaginal creams, systemic treatment has also been shown to reduce the risk of infection from migration of vaginal pathogens to reproductive and/or urinary tracts.

Bacterial vaginosis therapeutic cure rate with Tindamax^®¹

Chart showing therapeutic cure rates for BV after treatment with Tindamax<sup class='reg'>®</sup> oral tablets (1 g daily for 5 days) vs placebo. A 36.8% cure rate was achieved with Tindamax<sup class='reg'>®</sup>. A 5.1% cure rate resulted with placebo.

The therapeutic cure rate is based on the modified Intent-to-Treat (mITT) population, defined as patients with a Nugent score of less than 4^† and resolution of all 4 Amsel's criteria^††

For more information about bacterial vaginosis:

The Centers for Disease Control and Prevention, (800) 232-4636, www.cdc.gov/std
American Social Health Association, (919) 361-8400, www.ashastd.org
www.tindamax.com

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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.

† Nugent score is determined by a Gram stain of a vaginal smear, taking into account the presence of normal flora (lactobacilli) and pathogenic organisms including Gardnerella vaginalis and Mobiluncus spp.

†† Amsel's criteria include: a homogeneous thin vaginal discharge; pH > 4.5; positive KOH "whiff" test (release of amine odor with alkalination of vaginal fluid); and presence of ≥ 20% "clue" cells (vaginal epithelial cells whose borders are obscured by adherent small bacteria).