Information for Health Professionals: Tindamax (tinidazole)

Think twice, prescribe once with Tindamax^®

An effective therapy that reduces the risks of vaginal candidiasis

The first new oral therapy approved for bacterial vaginosis (BV) in a decade, Tindamax^® protects lactobacilli while targeting BV pathogens—and has a low incidence of secondary vaginal candidiasis (4.7%).

One treatment for bacterial vaginosis (BV) and trichomoniasis (TV)

Studies show that many patients with TV are also positive for BV.^1-5 Tindamax^® is the only medication approved as both an antibacterial agent for BV and antiprotozoal treatment for TV.⁶

Convenient dosing with a favorable side effect profile

Tindamax^® offers a shorter and more convenient treatment for bacterial vaginosis than the current standard of care. A second-generation nitroimidazole, it is well tolerated with a low incidence of GI adverse effects.⁶

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.

Krieger J, Tam M, Stevens C et al. Diagnosis of trichomoniasis, comparison of conventional wet-mount examination with cytologic studies, cultures, and monoclonal antibody staining of direct specimens. JAMA. 1988;259:1223-1227.
Hillier SL, Krohn MA, Nugent RP, Gibbs RS. Characteristics of three vaginal flora patterns assessed by gram stain among pregnant women. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1992 Mar;166(3):938-44.
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.
Data on file. Mission Pharmacal Company.