Bacterial vaginosis frequently occurs in conjunction with trichomoniasis, with significant overlap of BV and TV noted in both clinical findings and bacterial cultures.1 In published reports, the prevalence of patients with TV who are also positive for BV ranges from 24%-57%.2-5
- Trichomoniasis is the most common non-viral STD in the US, with an estimated 7.4 million new cases annually6
- Bacterial vaginosis is the most common vaginal infection among women of childbearing years7
By reducing normal levels of lactobacilli in the vaginal flora and altering vaginal pH, the presence of Trichomonas vaginalis is believed to create an environment that fosters overgrowth of BV-related microorganisms.5
Signs and symptoms of BV and TV present a diagnostic challenge8
Multiple challenges exist in the diagnosis of mixed BV and TV infection. Because many patients are asymptomatic, sensitivity of signs and symptoms as a basis for diagnosis of trichomoniasis is low. The most common diagnostic test (wet mount) has a sensitivity of only 60%-70%, which decreases further if samples are not evaluated promptly.9
Among patients who are symptomatic, BV and TV infections may have similar signs, including elevated vaginal pH, amine odor, and the presence of homogeneous discharge, which is considered a significant clinical indicator for dual BV/TV diagnosis.5
Only Tindamax® is approved to treat both BV and TV10
BV and TV share many of the same serious health risks if left untreated, including a higher rate of pelvic inflammatory disease and increased risk for infertility and pre-term birth.7,9
Tindamax® offers a single, effective treatment for both BV and TV that is easy to dose and is well tolerated by patients.10
| 2 convenient dosing options for BV | 1 simple oral dosing regimen for trichomoniasis (TV) | |
|---|---|---|
| 2 g/2-day dosing 4 x 500 mg tablets once daily for two days, with food | 1 g/5-day dosing 2 x 500 mg tablets once daily for five days, with food | 2 g/1-day dosing 4 x 500 mg tablets one time, with food |
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| Table 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.
- Heller DS, Maslyak S, Skurnick J. Is the presence of Trichomonas on a Pap smear associated with an increased incidence of bacterial vaginosis? J Low Genit Tract Dis. 2006 Jul;10(3):137-9.
- Krieger JN, Tam MR, Stevens CE, Nielsen IO, Hale J, Kiviat NB, Holmes KK. Diagnosis of trichomoniasis. Comparison of conventional wet-mount examination with cytologic studies, cultures, and monoclonal antibody staining of direct specimens. JAMA. 1988 Feb 26;259(8):1223-7.
- Dan M, Sobel JD. Trichomoniasis as seen in a chronic vaginitis clinic. Infect Dis Obstet Gynecol. 1996;4(2):77-84.
- Heine RP, McGregor JA, Patterson E, Draper D, French J, Jones W. Trichomonas vaginalis: Diagnosis and Clinical Characteristics in Pregnancy. Infect Dis Obstet Gynecol. 1994;1(5):228-34.
- Demirezen S, Korkmaz E, Beksaç MS. Association between trichomoniasis and bacterial vaginosis: examination of 600 cervicovaginal smears. Cent Eur J Public Health. 2005 Jun;13(2):96-8.
- Weinstock H, Berman S, Cates W Jr. Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004 Jan-Feb;36(1):6-10.
- Sweet RL. Gynecologic conditions and bacterial vaginosis: implications for the non-pregnant patient. Infect Dis Obstet Gynecol. 2000;8(3-4):184-90.
- Sobel JD. Vaginitis. N Engl J Med. 1997 Dec 25;337(26):1896-903.
- Nanda N, Michel RG, Kurdgelashvili G, Wendel KA. Trichomoniasis and its treatment. Expert Rev Anti Infect Ther. 2006 Feb;4(1):125-35.
- Data on file. Mission Pharmacal Company.
