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Basic Drug Info

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Drug Name:	TINDAMAX
Manufacturer:	Mission Pharmacal Company
Other Info:	Patients should be counseled that antibacterial drugs including Tindamax should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Tindamax is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Tindamax or other antibacterial drugs in the future.

Clinical Trials:	NIH - Clinical Trials

Indications and Usage

Tindamax is a nitroimidazole antimicrobial indicated for:Trichomoniasis (1.1)Giardiasis: in patients age 3 and older (1.2)Amebiasis: in patients age 3 and older (1.3)Bacterial Vaginosis: in non-pregnant, adult women (1.4, 8.1)

Giardiasis -- An infection of the SMALL INTESTINE caused by the flagellated protozoan GIARDIA LAMBLIA. It is spread via contaminated food and water and by direct person-to-person contact.

Amebiasis -- Infection with any of various amebae. It is an asymptomatic carrier state in most individuals, but diseases ranging from chronic, mild diarrhea to fulminant dysentery may occur.

Bacterial Vaginosis -- Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli.

Contraindications

The use of tinidazole is contraindicated:In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives.

Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome [see Adverse Reactions (6.1, 6.2)].During first trimester of pregnancy [see Use in Specific Populations (8.1)].In nursing mothers: Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose [see Use in Specific Populations (8.3)].

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Urticaria -- A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.

Stevens-Johnson Syndrome -- A variant of bullous erythema multiforme. It ranges from mild skin and mucous membrane lesions to a severe, sometimes fatal systemic disorder. Ocular symptoms include ulcerative conjunctivitis, keratitis, iritis, uveitis, and sometimes blindness. The cause of the disease is unknown.