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Tindamax

Fact Sheet: Trichomoniasis

Trichomoniasis, or "trich," is the most common curable sexually transmitted disease (STD) in the United States. Trichomoniasis affects both women and men, although symptoms are more common in women. Trichomoniasis in women may contribute to increased risk of infertility, cervical cancer, pelvic inflammatory disease, preterm birth, postoperative infection, and may also enhance transmission of human immunodeficiency virus (HIV). The consequences of untreated trichomoniasis in men include decreased sperm count and movement, increased risk of infertility, chronic pain in the prostate or pelvic region, and increased acquisition and transmission of HIV.

Cause of trichomoniasis

Trichomoniasis is caused by the single-celled parasite, Trichomonas vaginalis. The parasite is transmitted through sexual intercourse or genital contact with an infected partner. Women can acquire the disease from infected men or women, but men usually contract it only from infected women.

Risk factors

An increased risk of acquiring trichomoniasis is associated with:

  • Bacterial vaginosis
  • Being of African descent
  • Multiple sexual partners
  • Past or present infection with other STDs
  • High vaginal pH levels

Symptoms of trichomoniasis

Many women may not experience symptoms, but still have trichomoniasis. If symptoms are present, they usually appear 5 to 28 days after exposure and may include:

  • Yellow, green, or gray vaginal discharge (often foamy or sticky) with a strong odor
  • Irritation, itching, soreness or redness of the genital area
  • Discomfort or pain during intercourse and urination
  • Lower abdominal pain in rare cases
  • Signs that worsen during menstruation

While men with trichomoniasis are usually asymptomatic, symptoms may include genital discharge, irritation and burning during urination. Symptoms in infected men may disappear within a few weeks without treatment. However, an infected man — even one who has never had symptoms or whose symptoms have stopped — can continue to infect or re-infect a female partner until he has been treated.

Incidence and prevalence of trichomoniasis2

  • There are an estimated 7.4 million new cases of trichomoniasis annually in the U.S. today, compared with 3 million new cases of chlamydia and 650,000 cases of gonorrhea.
  • Trichomoniasis is the most common curable STD in young, sexually active women.

Diagnosis of trichomoniasis

For both men and women, a health care provider must perform a physical examination and laboratory test to diagnose trichomoniasis. In women, a pelvic examination can reveal small red sores or inflammation on the vaginal wall or cervix. The parasite is harder to detect in men than in women.

Treatment of trichomoniasis

The Centers for Disease Control and Prevention (CDC) recommends Tindamax® as one of the drugs of choice for treatment of trichomoniasis. Tindamax® has demonstrated cure rates of 92% to 100% in both women and men.1

Both partners should be treated at the same time to eliminate the parasite and prevent its spread and re-infection.

Trichomoniasis cure rates with Tindamax®1

Trichomoniasis cure rates with Tindamax: 96% of females and 94% of males cured.

* Average of 4 studies1-4 with cure rate range of 92-100% at 1 week to 1 month post-dosing.

** Average of 4 studies5-8 with cure rate range of 83-100%.

For more information about trichomoniasis:

«Fact Sheets

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.

  1. Data on file. Mission Pharmacal Company.

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