Tindamax® (tinidazole), a second-generation nitroimidazole, is an antiprotozoal drug which is used to treat certain types of parasitic infections, including the sexually transmitted disease trichomoniasis, also known as "trich." Tindamax® is also indicated to treat the intestinal parasitic infections giardiasis and amebiasis, as well as amebic liver infections.
When approved by the FDA in May 2004, Tindamax® marked the first advancement in the treatment of trichomoniasis in over 40 years. Additionally, the recently approved supplemental indication for the treatment of bacterial vaginosis (BV) makes Tindamax® the first oral therapy approved for this condition in a decade.
Compared to the current standard of care:
- Tindamax® has a long serum half-life (12-14 hours v. 6-7 hours).
- Tindamax® has an excellent safety profile and a low incidence of gastrointestinal side effects.
- Additionally, increased lipid solubility of Tindamax® results in more efficient tissue absorption.
Bacterial vaginosis (BV)
- Clinical trial data show once-daily Tindamax® to be significantly superior to placebo in treating BV, and as well-tolerated and safe as compared to placebo.
- Unlike intravaginal treatments such as creams or gels, Tindamax® treats the entire reproductive tract systematically, including the upper tract, where BV has been shown to migrate.
- Administered as one gram (two tablets) once daily for five days or two grams (four tablets) once daily for two days, Tindamax® provides a shorter and more convenient oral treatment for bacterial vaginosis than the current standard of care.
Trichomoniasis
- Tindamax® is recommended as one of the drugs of choice for the treatment of trichomoniasis by the Centers for Disease Control and Prevention (CDC).1
- In over 30 clinical studies of trichomoniasis, Tindamax® has demonstrated cure rates of 92 to 100 percent in both women and men.
- Tindamax® effectively treats trichomoniasis in one dose, while sparing protective vaginal lactobacilli.
Giardiasis (giardia)
- Tindamax® is recommended as one of the drugs of choice for the treatment of giardiasis by the Centers for Disease Control and Prevention (CDC).2
- Tindamax® is the only single-dose oral therapy approved to treat giardiasis.
- Single-dose Tindamax® for giardiasis has demonstrated cure rates of 80 to 100 percent
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.
- The Centers for Disease Control and Prevention: Sexually Transmitted Diseases Treatment Guidelines, 2006. Available at http://www.cdc.gov/std/treatment/2006/toc.htm. Accessed January 30, 2007.
- The Centers for Disease Control and Prevention: Health Guide for International Travelers, 2005-2006. Available at http://www2.ncid.cdc.gov/travel/yb/utils/ybGet.asp?section=dis&obj=giardiasis.htm. Accessed January 31, 2007.
