Nitazoxanide Class: Antiprotozoals, INTRODUCTION Antiprotozoal; nitrothiazolyl-salicylamide derivative. USES Cryptosporidiosis Treatment
immunocompetent adults, adolescents, and children ≥1 year of age; designated an orphan drug by FDA for this use. A drug of choice for treatment of cryptosporidiosis in adults and pediatric patients who do not have HIV infection. Anti-infectives may suppress the infection, but none has been found to reliably eradicate Cryptosporidium. Safety and efficacy not established for treatment of diarrhea caused by C. parvum in immunocompromised individuals (including HIV patients); has not been more effective than placebo in such patients. CDC, NIH, IDSA, and others state that the most appropriate treatment for cryptosporidiosis in HIV- infected individuals is the use of potent antiretroviral agents (to restore immune function) and symptomatic treatment of diarrhea. Giardiasis Treatment of diarrhea caused by Giardia lamblia (also known as G. duodenalis or G. intestinalis) in immunocompetent adults, adolescents, and children ≥1 year of age. Designated an orphan drug by FDA for treatment of intestinal giardiasis. Metronidazole, tinidazole, and nitazoxanide are drugs of choice for treatment of giardiasis. Safety and efficacy not established for treatment of giardiasis in immunocompromised individuals (including HIV patients). Cestode (Tapeworm)Infections Has been used for treatment of infections caused by Hymenolepis nan(dwarf tapeworm). Praziquantel is drug of choice; nitazoxanide is an alternative. Nematode (Roundworm) Infections Has been used for treatment of ascariasis caused by Ascaris lumbricoides. Albendazole, ivermectin, and mebendazole are drugs of choice for ascariasis. Has been used for treatment of trichuriasis caused by Trichuris trichiura (whipworm). Mebendazole is drug of choice; alternatives are albendazole and ivermectin. DOSAGE AND ADMINISTRATION Administration Oral Administration Administer orally twice daily with food. Reconstitution Reconstitute powder for oral suspension at the time of dispensing by adding the amount of water specified on the container in 2 portions; shake well after each addition.
Reconstituted suspension contains 100 mg/5 mL. Shake suspension well prior to administration of each dose. Oral suspension is the appropriate dosage form for children ≤11 years of age. The amount of nitazoxanide in the tablet (500 mg) exceeds the recommended dosage in this age group.
DOSAGE Nitazoxanide tablets and oral suspension are not bioequivalent. Pediatric Patients Cryptosporidiosis Oral Children 1–3 years of age: 100 mg every 12 hours for 3 days. Children 4–11 years of age: 200 mg every 12 hours for 3 days. Children ≥12 years of age: 500 mg every 12 hours for 3 days. Giardiasis Oral Children 1–3 years of age: 100 mg every 12 hours for 3 days. Children 4–11 years of age: 200 mg every 12 hours for 3 days. Children ≥12 years of age: 500 mg every 12 hours for 3 days. Cestode (Tapeworm) Infections Hymenolepsis nana Infections Oral Children 1–3 years of age: 100 mg twice daily for 3 days. Children 4–11 years of age: 200 mg twice daily for 3 days. Children ≥12 years of age: 500 mg daily for 3 days. Adults Cryptosporidiosis Oral 500 mg every 12 hours for 3 days. Giardiasis Oral 500 mg every 12 hours for 3 days. Cestode (Tapeworm) Infections Hymenolepsis nana Infections Oral 500 mg daily for 3 days. CAUTIONS Contraindications
Hypersensitivity to nitazoxanide or any ingredient in the formulation
Warnings/Precautions General Precautions Diabetes Mellitus
Individuals with diabetes mellitus and/or their caregivers should be informed that reconstituted nitazoxanide oral suspension contains 1.48 g of sucrose/5 mL. Immunodeficiency Has not been more effective than placebo for treatment of diarrhea caused by C. parvum in HIV-infected or immunocompromised patients. Safety and efficacy for treatment of diarrhea caused by Giardia notestablished in immunocompromised individuals, including those with HIV infection. SPECIFIC POPULATIONS Pregnancy Category B. Lactation Not known whether distributed into milk. Caution advised if used in nursing women. Pediatric Use Safety and efficacy not established in children <1 year of age. Geriatric Use Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy should be considered. Caution advised in geriatric patients with renal and/or hepatic impairment. Hepatic Impairment Use with caution; pharmacokinetics not evaluated. Renal Impairment Use with caution; pharmacokinetics not evaluated. COMMON ADVERSE EFFECTS Abdominal pain, diarrhea, nausea, vomiting, headache. INTERACTIONS FOR NITAZOXANIDE Protein-bound Drugs Pharmacokinetic interaction possible with other highly protein-bound drugs; use with caution in patients receiving highly protein-bound drugs with a narrow therapeutic index (e.g., warfarin). Drugs Metabolized by Hepatic Microsomal Enzymes Pharmacokinetic interaction unlikely; does not inhibit CYP isoenzymes. PHARMACOKINETICS Absorption Bioavailability Rapidly absorbed from GI tract and hydrolyzed to tizoxanide. Both nitazoxanide and tizoxanide have antiprotozoal activity. Peak plasma concentrations of tizoxanide and tizoxanide glucuronide attained within 1–4 hours; nitazoxanide undetectable in plasma.
The tablets and oral suspension are not bioequivalent. Bioavailability of the oral suspension is 70% relative to that of the tablet. Food Food increases extent of absorption. Distribution Plasma Protein Binding >99%. Elimination Metabolism Rapidly hydrolyzed to tizoxanide; tizoxanide subsequently undergoes conjugation, principally by glucuronidation. Elimination Route Tizoxanide eliminated in urine, bile, and feces; tizoxanide glucuronide eliminated in urine and bile. SPECIAL POPULATIONS Pharmacokinetics not studied in patients with hepatic or renal impairment STABILITY STORAGE Oral For Suspension 25°C (may be exposed to 15–30°C). After reconstitution, store in tight container at 25°C (may be exposed to 15– 30°C); discard after 7 days. Tablets 25°C (may be exposed to 15–30°C).
Both nitazoxanide and its metabolite, tizoxanide, have antiprotozoal
Antiprotozoal activity may be related principally to interference with
the pyruvate: ferredoxin 2-oxidoreductase enzyme-dependent electron transfer reaction essential to anaerobic energy metabolism in susceptible organisms.
Active against sporozoites and oocysts of Cryptosporidium parvum and
trophozoites of Giardia lamblia (also known as G. duodenalis or G. intestinalis).
Also active against some other organisms, including Entamoeba histolytica, Trichomonas vaginalis, and certain anaerobic and microaerophilic gram-positive and gram-negative bacteria (e.g., Helicobacter pylori).
ADVICE TO PATIENTS
Importance of taking with food. Advise diabetic patients and/or their caregivers that the oral
Importance of informing clinicians of existing or contemplated
concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.
Importance of women informing clinicians if they are or plan to become
Importance of informing patients of other important precautionary
SICHERHEITSDATENBLATT Überarbeitet: Seite 1 von 7 gem. 1907/2006/EG, Artikel 31 (REACH-VO) Druckdatum: BEZEICHNUNG DES STOFFES / DER ZUBEREITUNG UND FIRMENBEZEICHNUNG Angaben zum Produkt Handelsname: Etisso® Wespex Quick 1.1.2 Artikelnummer: 1305-160 1.1.3 Verwendung: Gebrauchsfertiges Spritzmittel zur Wespenbekämpfung (detaillierte
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