Note: This page is for basic patient education only. For detailed information about Tindamax, please consult the full Prescribing Information.
Bacterial vaginosis
To evaluate its effectiveness for treating BV, Tindamax® was tested in 235 non-pregnant women during a randomized, double-blind, placebo-controlled clinical trial (a trial in which neither the researchers nor the subjects know which patients are taking the active medication or the placebo until after the study).
Clinical Diagnosis and Cure
Patients who participated in this study were clinically diagnosed using Amsel's criteria, meaning that their vaginal discharge:
- Was abnormal and homogeneous
- Had a pH greater than 4.5
- Gave off a "fishy" odor when mixed with a 10% potassium hydroxide (KOH) solution
- Contained at least 20% clue cells (vaginal skin cells that have an unusual appearance when examined under a microscope because they are covered with bacteria)
Patients were considered clinically cured upon completion of the study if their vaginal discharge returned to normal and it no longer met these 4 criteria.
Microbiologic Diagnosis and Cure
In addition to receiving a clinical diagnosis, study participants were diagnosed with BV using a Gram stain of their vaginal fluid. This lab test demonstrated:
- Reduced or missing Lactobacillus bacteria
- Predominance of Gardnerella bacteria
- Few, if any, white blood cells, and quantification of bacteria to determine a Nugent score (a score ranging from 0 to 10, based on finding certain types and amounts of bacteria)
A Nugent score of 4 or greater was required for patients to be included in the study, and a score of 0 to 3 was considered a microbiologic cure.
Therapeutic Cure
In this trial, treatment was considered effective if it resulted in both a clinical cure (resolution of all 4 Amsel's criteria) and a microbiologic cure (Nugent score of 0 to 3).
In patients who had all 4 Amsel's criteria and a Nugent score of 4 or greater before the study, tinidazole oral tablets given as either 2 g once daily for 2 days or 1 g once daily for 5 days were proven effective over placebo tablets, as measured by therapeutic cure, clinical cure, and a microbiologic cure.
| Outcome | Tindamax® 1 g × 5 days |
Tindamax® 2 g × 2 days |
Placebo |
|---|---|---|---|
| Therapeutic Cure | |||
| Percent cure | 36.8% | 27.4% | 5.1% |
| Difference‡ | 31.7% | 22.3% | |
| 97.5% CI§ | (16.8, 46.6) | (8.0, 36.6) | |
| Clinical Cure | |||
| Percent cure | 51.3% | 35.6% | 11.5% |
| Difference‡ | 39.8% | 24.1% | |
| 97.5% CI§ | (23.3, 56.3) | (7.8, 40.3) | |
| Nugent Score Cure | |||
| Percent cure | 38.2% | 27.4% | 5.1% |
| Difference‡ | 33.1% | 22.3% | |
| 97.5% CI§ | (18.1, 48.0) | (8.0, 36.6) | |
| n | 76 | 73 | 78 |
|
† Modified Intent-to-Treat defined as all patients randomized with a baseline Nugent score of at least 4 ‡ Difference in cure rates (Tindamax®-placebo) § CI: confidence interval p-values for both Tindamax® regimens vs. placebo for therapeutic, clinical and Nugent score cure rates for both 2 and 5 days <0.001 |
Table 1 | ||
The therapeutic cure rates reported in this clinical study were based on resolution of 4 out of 4 Amsel's criteria and a Nugent score of less than 4. However, the cure rates for previous clinical studies with other products approved for BV were based on resolution of either 2 or 3 out of 4 Amsel's criteria. At the time of approval for those other products, there was no requirement for a Nugent score on Gram stain. This means that reported rates of effectiveness for those products — higher than those reported here for tinidazole — may have been lower if they had used the more stringent criteria used in the tinidazole trial.
Trichomoniasis
Tinidazole (2 g single oral dose) use in treating trichomoniasis has been well documented in 34 published reports worldwide, involving over 2,800 patients.
In 4 published studies of the 2 g tinidazole single oral dose, its effectiveness was assessed by culture (a lab test analyzing bacterial growth) one week to one month after treatment. Reported cure rates for these studies ranged from 92% (37/40) to 100% (65/65) among 172 subjects.
At least 4 published studies evaluated tinidazole's effectiveness by wet mount (placing a sample of vaginal fluid on a slide and examining it under a microscope) between 7 and 14 days after treatment. Reported cure rates among 116 participants ranged from 80% (8/10) to 100% (16/16).
In all of these studies, tinidazole was superior to a placebo and comparable to other drugs used for treating trichomoniasis.
The single oral 2 g tinidazole dose was also tested in 4 trials in men. The patients' urine was tested for Trichomonas parasites before and after treatment, and reported cure rates ranged from 83% (25/30) to 100% (80/80) among 142 patients.
Giardiasis
Tinidazole (2 g single dose) use for treating giardiasis has been documented in 19 published reports worldwide, involving over 1,600 adult and pediatric patients.
In 8 controlled studies that included 619 subjects, 299 were given the 2 g once a day (50 mg/kg once a day for children) oral dose of tinidazole. Their reported cure rates ranged from 80% (40/50) to 100% (15/15).
Intestinal amebiasis
Tinidazole use in intestinal amebiasis has been documented in 26 published reports, involving over 1,400 patients worldwide. Most reports used tinidazole 2 g/day for 3 days.
In 4 published studies of the 2 g per day for 3 days oral dose of tinidazole, reported cure rates among 220 subjects after 3 days ranged from 86% (25/29) to 93% (25/27).
Amebic liver abscess
Tinidazole use in amebic liver abscess has been documented in 18 published reports involving over 470 patients. Most reports used tinidazole 2 g/day for 2 to 5 days.
In 7 published studies of this oral dose of tinidazole, accompanied by aspiration of the liver abscess (removing fluid from the infected area) when necessary, the reported cure rates among 133 subjects ranged from 81% (17/21) to 100% (16/16). Four of these studies used at least 3 days of tinidazole.
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.
