New Web Resource Launched to Educate on Trichomoniasis Treatment
SAN ANTONIO, TX (May 9, 2006) – Mission Pharmacal today announced the launch of a new Web resource, www.tindamax.com, designed to educate visitors about trichomoniasis, or "trich," the most common curable sexually transmitted disease (STD) in the United States. In addition to offering facts and news about trich online, the website will also enable visitors to sign up to receive printed educational materials. The new site was launched at the Mission Pharmacal exhibit during the American College of Obstetricians and Gynecologists annual clinical meeting in Washington, D.C.
"We are pleased to be able to offer a comprehensive site where consumers can learn more about the risk factors, diagnosis and treatment of trichomoniasis, a relatively unknown and underserved condition," said Neill Walsdorf, Jr., president of Mission Pharmacal.
Underlining the need for broader education about trich, the Centers for Disease Control and Prevention (CDC) today released findings from the first report on the prevalence of trich in a nationally representative sample of American women. The report found that 3.1 percent of respondents were infected with trichomoniasis. An estimated 7.4 million new cases of trich are reported annually in the United States today, compared with 3 million new cases of chlamydia and 700,000 cases of gonorrhea, according to the CDC's STD Web site.
Because trich is generally asymptomatic or only mildly symptomatic, trich-infected individuals are often in the dark about their infection, leaving them at greater risk of contracting and/or transmitting HIV by remaining sexually active. Trich appears to enhance the transmission of HIV by both men and women to an uninfected partner by inducing an inflammatory response in the body, bringing a large influx of the white blood cells that act to defend the body. These include HIV target cells to which HIV particles can bind. The microscopic hemorrhages and inflammation in genital tissues caused by trich in the HIV-infected person may also increase the level of virus-laden body fluids and the number of HIV-infected white blood cells in the genital area, which increase the risk of transmission.
Tindamax® (tinidazole tablets) is an FDA-approved, one-day-one-dose treatment for trichomoniasis that has demonstrated cure rates of 92 to 100 percent. Tindamax® is recommended as one of the drugs of choice for treating trich by the CDC and has been shown to be better tolerated than metronidazole, the current standard of treatment.
"As the most prevalent curable STD in the United States, the timely diagnosis and treatment of trichomoniasis may play an important role in curbing HIV infection. Physicians need to be vigilant about testing for trich in patients who are sexually active because they may not experience any symptoms," stated Dr. Jane Schwebke, professor of infectious diseases at the University of Alabama at Birmingham. "Fortunately, trichomoniasis can be cured with single dose therapy in both women and men."
About Trichomoniasis
Trichomoniasis, which is caused by the single-celled parasite Trichomonas vaginalis, is the most common curable sexually transmitted disease (STD) in the United States. There are an estimated 7.4 million cases of trich each year in the U.S.
Trich is often asymptomatic or only mildly symptomatic. Signs and symptoms of trichomoniasis in women include itching, redness and a yellow, green or grey vaginal discharge that may be frothy or sticky and have a foul odor. Urination and intercourse may be painful, and the symptoms may worsen during menstruation. When symptoms are present in men, they may consist of urethral discharge and irritation.
When left untreated, trichomoniasis may enhance both the acquisition and transmission of HIV. The genital inflammation caused by trichomoniasis can increase a woman's susceptibility to HIV infection if she is exposed to the virus. Trich also has been shown to increase the risk of infertility in women and may play a role in promoting cervical cancer and pelvic inflammatory disease. In a large Finnish study, trich was associated with a six-fold increased risk of cervical cancer in women compared with those who were uninfected. The STD has also been linked to preterm birth and postoperative infection in women, and lower sperm motility and nongonococcal urethritis in men.
Sexual partners should be treated simultaneously for maximum efficacy and prevention of re-infection. More information on trich is available at www.trichomoniasis.org.
About Tindamax®
Tindamax®, a second-generation 5-nitroimidazole compound, is indicated in the United States for the treatment of trichomoniasis, the intestinal infections giardiasis and intestinal amebiasis, and amebic liver abscess. It has been approved for use in the United States since May 2004 and is recommended as one of the drugs of choice for the treatment of trichomoniasis by the Centers for Disease Control and Prevention.
Full prescribing information for Tindamax®, as well as information about trichomoniasis, is available at www.tindamax.com.
About Mission Pharmacal
Mission Pharmacal is a family-owned pharmaceutical company based in San Antonio, Texas. For more than 60 years, the company has been dedicated to identifying unmet health needs in the marketplace and developing innovative prescription and over-the-counter products to meet them. Currently, Mission Pharmacal provides physicians and consumers with pharmaceutical, nutritional and diagnostic products. For more information, visit www.missionpharmacal.com.
Media Contact:
Ami Shah
cohn&wolfe
(212) 537-8048
ami.shah@cohnwolfe.com
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.
