Excellent tolerability plus low incidence of GI side effects
Tindamax® is a second-generation nitroimidazole. While chemically related to metronidazole, it has a more favorable pharmacokinetic profile, longer plasma half-life, and significantly reduced incidence of side effects.
Pharmacokinetic profile: plasma half-life1
Figure 1
In bacterial vaginosis
In a large-scale study of tinidazole for treatment of bacterial vaginosis, both oral dosing options (2 g × 2 days and 1 g × 5 days) provided effective therapy with a low incidence of nausea and other GI side effects typically associated with metronidazole therapy.2
| Side effect profile | Tinidazole 1 g qd for 5 days | Tinidazole 2 g qd for 2 days | Placebo | Total |
|---|---|---|---|---|
| Number of participants | 77 | 78 | 80 | 235 |
| Any gastrointestinal symptom(s) | 19 (24.7) | 25 (32.1) | 18 (22.5) | 62 (26.0) |
| Dysgeusia (bad or metallic taste in mouth) | 20 (26.0)* | 31 (39.7)* | 4 (5.0) | 55 (23.4) |
| Headache | 9 (11.7) | 14 (17.9) | 13 (16.3) | 36 (15.3) |
| Nausea | 8 (10.4) | 14 (17.9)† | 6 (7.5) | 28 (11.9) |
| Abdominal discomfort | 7 (9.1) | 4 (5.1) | 6 (7.5) | 17 (7.2) |
| Vulvovaginal discomfort | 7 (9.1) | 7 (9.0) | 2 (2.5) | 16 (6.8) |
| Genital pruritus (female) | 6 (7.8) | 5 (6.4) | 2 (2.5) | 13 (5.5) |
| Fatigue | 1 (1.3) | 4 (5.1) | 6 (7.5) | 11 (4.7) |
| Dizziness | 4 (5.2) | 4 (5.1) | 1 (1.3) | 9 (3.8) |
| Vaginal discharge | 2 (2.6) | 3 (3.8) | 3 (3.8) | 8 (3.4) |
| Urine abnormality | 3 (3.9) | 4 (5.1) | 1 (1.3) | 8 (3.4) |
| Stomach discomfort | 2 (2.6) | 3 (3.8) | 2 (2.5) | 7 (3.0) |
| Vaginal candidiasis | 4 (5.2) | 2 (2.6) | 1 (1.3) | 7 (3.0) |
| Diarrhea | 1 (1.3) | 2 (2.6) | 2 (2.5) | 5 (2.1) |
| Vaginal odor | 1 (1.3) | 1 (1.3) | 3 (3.8) | 5 (2.1) |
|
Adverse events reported in more than 2% of participants, tinidazole treatment of bacterial vaginosis, intent-to-treat population2 Data are n (%). A patient was counted, at most, once per preferred term, system organ class, or any event. * P<0.001 compared with placebo. † P<0.5 compared with placebo. |
Table 1 | |||
In trichomoniasis
Tinidazole also demonstrated excellent tolerability during a study evaluating 2-g × 1-day dosing for trichomoniasis3 and was found to be a "potent and well-tolerated option" vs metronidazole in another TV treatment study.4
Incidence of GI adverse events: Pooled data from 3 comparative studies3,5,6
Figure 2
Simplify dosing and reduce complications
With the convenience of oral treatment, short dosing schedules, and reduced complications from secondary vaginal candidiasis, Tindamax® offers a simple, effective solution to treating bacterial vaginosis and trichomoniasis as well as GI infections.
- Research shows that patients prefer oral therapy vs vaginal creams in the treatment of BV1
- Compared to metronidazole, Tindamax® therapy requires fewer than half the doses required for effective BV treatment2
- Tindamax® targets infection-causing pathogens while sparing protective lactobacilli; this results in a lower risk of secondary vaginal candidiasis, a treatment complication that can increase patient return rates
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.
- Nanda N, Michel RG, Kurdgelashvili G, Wendel KA. Trichomoniasis and its treatment. Expert Rev Anti Infect Ther. 2006 Feb;4(1):125-35.
- 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.
