Please consult your physician before taking any medication. Tablets Dispersible Tablets Nitazoxanide PHARMACEUTICAL FORM AND FORMULATION Made the mixture, 100 ml contain: Nitazoxanide ......................... 2.0 g Excipient, C.S. Each tablet contains: Nitazoxanide ...................... 500 mg Excipient, c.b.p. One tablet. Each dispersible tablet contains: Nitazoxanide ...................... 200 mg Excipient, c.b.p. One tablet. THERAPEUTIC INDICATIONS Acute intestinal amebiasis and amebic dysentery caused by Entamoeba histolytica. Daxon is indicated for the treatment of giardiasis caused by Giardia lamblia. Helminthiasis: Daxon is an anthelmintic effective against nematodes, cestodes and trematodes, indicated for the treatment of Enterobius vermicularis, Ascaris lumbricoides and Strongyloides stercoralis. Necantor americanus, Ancylostoma duodenale, Trichuris trichiura, Taenia saginata, Taenia solium, Hymenolepis nana and Fasciola hepatica, Isospora beli, Cryptosporidium parvum. Amebic liver abscess. Daxon is indicated for the treatment of symptomatic trichomoniasis in women and men. In women with confirmed presence of Trichomonas vaginalis in the laboratory. Asymptomatic Trichomoniasis when the body is associated with endocervicitis, cervicitis and cervical erosion. PHARMACOKINETICS AND PHARMACODYNAMICS Daxon (nitazoxanide) is rapidly absorbed in the intestinal tract, undergoing rapid metabolism by acetyl chain oxidation of 2 - (1-hydroxy-N-(5-nitro 2-tiazol/benzamida). The maximum concentration (Cmax of 1.9 mcg / ml) (Tmax 2-6 hours) Daxon (nitazoxanide) may be detected in blood 2 hours after administration of a single dose of 500 mg. The main metabolite excreted unchanged in urine within 24 hours. In Trichomonas vaginalis, Giardia lamblia and Entamoeba histolytica, the electron resonance studies have shown that biochemical and ferridoxin pyruvate oxidoreductase (PFOR) and hydrogenase less intensity, reduce ferridoxina, which is oxidized by the nitro group of T position on compounds like Daxon nitroheterocíclicos (nitazoxanide). In these organisms, Daxon (nitazoxanide) is reduced to a toxic radical in an organelle in the metabolism of carbohydrates, Hydrogenosome, which contains hydrogenase and ferridoxina PFOR. CONTRAINDICATIONS Nitazoxanide is contraindicated in patients with a history of hypersensitivity to the active. Do not administer to children under two years. GENERAL PRECAUTIONS Patients with gastrointestinal disorders should take the medicine with food, because it can increase their discomfort. RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION Mutagenicity studies using the Ames and micronucleus test, showed no mutagenic activity of nitazoxanide Daxon. Reproduction studies in rats and rabbits at doses of 200 and 201 times the usual dose in humans, respectively, showed no evidence of teratogenicity, embryotoxicity and phototoxicity. The use of this drug in pregnancy and breastfeeding is the responsibility of the physician, assessing the risk benefit. ADVERSE REACTIONS The most commonly reported adverse reactions are at the gastrointestinal tract, particularly nausea, some 8% of patients, sometimes accompanied by headache, anorexia and occasionally vomiting and nonspecific epigastric distress and abdominal cramps. This produces changes in the color of your urine. If amber color persists, notify your doctor. DRUG INTERACTIONS AND OTHER GENDER The concomitant use of coumarin and warfarin may increase plasma levels and prolong the prothrombin time. CHANGES IN THE LABORATORY TEST RESULTS May present moderate increase in transaminases, moderate, which resolves after discontinuation of medication. PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, teratogenesis and ON FERTILITY The Ames and micronucleus tests showed no teratogenic effects. The evidence on the mutagenic effects in Salmonella typhimurium were negative for mutagenic effects.