SAN ANTONIO, TX (November 13, 2006) – Mission Pharmacal announced today that its antiprotozoal drug Tindamax® (tinidazole) is now recommended as a first line therapy for the treatment of trichomoniasis in the Centers for Disease Control and Prevention's (CDC) recently issued 2006 Sexually Transmitted Diseases Treatment Guidelines. Trichomoniasis (also known as "trich") is the most common curable sexually transmitted disease (STD) in the United States, with an estimated 7.4 million cases occurring each year in women and men, compared with about 3 million new cases of chlamydia and 700,000 cases of gonorrhea. Tindamax®, which is administered orally and taken as a single 2-gram dose, has demonstrated cure rates of 92 to 100 percent.
"Inclusion in the CDC's guidelines reinforces the importance of Tindamax® in treating a very common sexually transmitted disease," said Neill Walsdorf, Jr., president of Mission Pharmacal. "Because Tindamax® has been shown to be better tolerated than metronidazole, patients and physicians alike will benefit from having this new option for first line treatment of trichomoniasis." Tindamax® as a single 2g dose is also recommended by the CDC for patients having failed treatment with single dose metronidazole.
Because trich is generally asymptomatic or only mildly symptomatic, trich-infected individuals are often in the dark about their infection. Moreover, research indicates that many healthcare professionals are under-utilizing newer point-of-care methods that more rapidly and accurately diagnose trich. Untreated, trichomoniasis can lead to both an increased risk of infertility and enhanced transmission of HIV in men and women, as well as increased risk for cervical cancer and pelvic inflammatory disease in women.
"As the most prevalent curable STD in the United States, the timely diagnosis and treatment of trichomoniasis is imperative to reducing other more serious conditions. Healthcare providers need to be vigilant about testing their patients who are sexually active for trich 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."
The Sexually Transmitted Diseases Guidelines are published to assist healthcare providers in their efforts to prevent, diagnose and treat STDs. They were developed by the CDC after consultation with a group of professionals knowledgeable in the field of STDs, and serve as an update to the guidelines issued in 2002. The full report can be accessed at http://www.cdc.gov/std/treatment/default.htm.
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.
Trichomoniasis 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. Trichomoniasis 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.
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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.
Only Tindamax® is approved to treat both bacterial vaginosis and trichomoniasis (TV).
Clinical Insight
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Beyond BV
Tindamax® may be prescribed for other infections including:
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