Treatment of bacterial vaginosis (BV)
There are a number of treatment options available for BV, including oral prescription drugs and prescription vaginal creams and gels. Unlike intravaginal treatments, oral antibiotic therapies treat the entire reproductive tract, where BV has been shown to migrate.
There are currently no over-the-counter (OTC) treatments for BV. The only effective therapies are antibiotics that can be prescribed by your doctor. These include tinidazole, metronidazole, and clindamycin. One of these drugs, tinidazole (Tindamax®) is also indicated for the treatment of trichomoniasis and is the only therapy available that can treat both conditions at the same time.
Therapy that works without worry
What should you expect from your Tindamax® prescription? The answer is simple: peace of mind. That's because Tindamax® combines the convenience of easy oral dosing with the confidence of a comfortable, effective BV therapy.
No messy creams or applicators
Topical vaginal treatments for BV require creams and special applicators that can be messy and inconvenient. Tindamax® is an easy-to-swallow oral therapy you take just once or twice a day, depending on the dosing schedule your doctor has prescribed.
Not surprisingly, a recent survey found that oral BV therapy is the treatment more women prefer!1
| 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 |
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Low risk of side effects
Tindamax® effectively treats BV with a low incidence of GI side effects. In fact, a large study comparing Tindamax® to a placebo medication confirmed that Tindamax® has a low risk of gastrointestinal symptoms, as well as low incidence of fatigue and headache.2 The most commonly prescribed oral therapy for BV, metronidazole, is frequently associated with unpleasant side effects such as nausea, vomiting, and diarrhea.3-5
The advantage of systemic treatment
Studies have shown that the pathogens that cause vaginal infections such as BV can migrate to the urinary tract as well as to other areas of the reproductive system.6 Tindamax® is a systemic treatment that is absorbed quickly and efficiently in your body's tissues. Unlike topical vaginal creams, systemic treatments have been shown to help reduce the risks of pathogen migration from the vaginal environment.
A recent survey confirmed that 84% of patients prefer oral vs. vaginal cream therapy.1
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.
- Data on file. Mission Pharmacal Company.
- Livengood CH 3rd, Ferris DG, Wiesenfeld HC, Hillier SL, Soper DE, Nyirjesy P, Marrazzo J, Chatwani A, Fine P, Sobel J, Taylor SN, Wood L, Kanalas JJ. Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):302-9.
- Manorama HT, Shenoy DR. Single-dose oral treatment of vaginal trichomoniasis with tinidazole and metronidazole. J Int Med Res. 1978;6(1):46-9.
- Anjaeyulu R, Gupte SA, Desai DB. Single-dose treatment of trichomonal vaginitis: a comparison of tinidazole and metronidazole. J Int Med Res. 1977;5(6):438-41.
- Weidenbach A, Leix H. Treatment of trichomonal vaginitis with a single dose of tinidazole. Curr Med Res Opin. 1974;2(3):147-52.
- Sobel JD. Vaginitis. N Engl J Med. 1997 Dec 25;337(26):1896-903.
