Tindamax (tinidazole) Patient Information

Tindamax^® is easy to take

Tindamax^® is an easy, convenient treatment for bacterial vaginosis (BV). It is available in 2 oral dose schedules: 1 gram (2 tablets) once daily for 5 days or 2 grams (4 tablets) once daily for 2 days. Your doctor will know which is right for you.

Tindamax^® is also easy on your system, with a low incidence of side effects such as nausea, vomiting, and diarrhea.¹

Tindamax^® targets and protects

The vagina normally contains a balance of both "good" and "bad" bacteria that make up the vaginal flora. If this balance is altered by changes in sexual behavior or other risk factors, overgrowth of harmful bacteria (i.e., Gardnerella vaginalis) and reductions in good bacteria (lactobacilli) can lead to infections such as BV.²

Tindamax^® targets and stops the growth of disease-causing pathogens. Just as importantly, it protects the good bacteria still present in the vaginal flora, which helps to support a healthier vaginal environment.

Tindamax^® treats more than just BV

Trichomoniasis

Tindamax^® is also a widely used, proven treatment for trichomoniasis (TV), a vaginal infection caused by the organism Trichomonas vaginalis. TV (or "trich") is the most common non-viral sexually transmitted disease in the US, with an estimated 7.4 million new cases every year.³ Studies show that many patients with TV also have BV — in fact, the frequency of dual infection ranges from 24%-57%.^4-8

Tindamax^® is the only medication approved to treat both BV and TV.

Giardiasis (giardia)

Giardiasis is a highly contagious cause of diarrhea that often strikes travelers, campers and hikers, swimmers in public pools, individuals who drink contaminated water, and children in day care centers.⁹ Giardia infection is the most commonly reported pathogenic protozoan disease in the United States.¹⁰

Amebiasis

Each year, amebiasis affects approximately 50 million people worldwide.¹¹ Caused by a parasite called Entamoeba histolytica, the disease is typically spread by ingesting food or water contaminated with fecal matter from an infected person.

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.

Contraindications

Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives
First trimester of pregnancy
Nursing mothers, unless breast-feeding is interrupted during tinidazole therapy and for 3 days following the last dose

Warnings and Precautions

Seizures and neuropathy have been reported. Discontinue Tindamax if abnormal neurologic signs develop
Vaginal candidiasis may develop with Tindamax and require treatment with an antifungal agent
Use Tindamax with caution in patients with blood dyscrasias. Tindamax may produce transient leukopenia and neutropenia

Adverse Reactions

Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.

Please see full Prescribing Information

Data on file. Mission Pharmacal Company.
Sweet RL. Gynecologic conditions and bacterial vaginosis: implications for the non-pregnant patient. Infect Dis Obstet Gynecol. 2000;8(3-4):184-90.
Weinstock H, Berman S, Cates W Jr. Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004 Jan-Feb;36(1):6-10.
Krieger JN, Tam MR, Stevens CE, Nielsen IO, Hale J, Kiviat NB, Holmes KK. Diagnosis of trichomoniasis. Comparison of conventional wet-mount examination with cytologic studies, cultures, and monoclonal antibody staining of direct specimens. JAMA. 1988 Feb 26;259(8):1223-7.
Hillier SL, Krohn MA, Nugent RP, Gibbs RS. Characteristics of three vaginal flora patterns assessed by gram stain among pregnant women. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1992 Mar;166(3):938-44.
Dan M, Sobel JD. Trichomoniasis as seen in a chronic vaginitis clinic. Infect Dis Obstet Gynecol. 1996;4(2):77-84.
Heine RP, McGregor JA, Patterson E, Draper D, French J, Jones W. Trichomonas vaginalis: Diagnosis and Clinical Characteristics in Pregnancy. Infect Dis Obstet Gynecol. 1994;1(5):228-34.
Demirezen S, Korkmaz E, Beksaç MS. Association between trichomoniasis and bacterial vaginosis: examination of 600 cervicovaginal smears. Cent Eur J Public Health. 2005 Jun;13(2):96-8.
Giardia Infection [Internet]. CDC; 2004 [accessed 2008 July 10]. Available from: http://www.cdc.gov/ncidod/dpd/parasites/giardiasis/2004_PDF_Giardiasis.pdf
Gradus MS. Water quality and waterborne protozoa. Clin Microbiol News 1989;11:121-125.
Bercu TE, Petri WA, Behm JW. Amebic colitis: new insights into pathogenesis and treatment. Curr Gastroenterol Rep. 2007 Oct;9(5):429-33.