You may report side effects to the FDA at 1-800-332-1088. any drug without checking with your doctor. Some drugs may have another patient information leaflet. Do not store in a bathroom. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Protozoa are suspected as the cause when diarrhea lasts more than 7 days. Pronunciation. Multiple doses of nitazoxanide also appear to be efficacious against infections with A. lumbricoides and T. trichiura ( … Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ALINIA Tablets and ALINIA for Oral Suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by C. parvum in HIVinfected or immunodeficient patients [ see Clinical Studies]. Usual Adult Dose for Giardiasis: 500 mg orally every 12 hours for 3 days Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum The following adverse reactions have been identified during post approval use of ALINIA. A double-blind, placebo-controlled trial did not produce clinical cure rates that were significantly different from the placebo control when conducted in hospitalized, severely malnourished pediatric patients with acquired immune deficiency syndrome (AIDS) in Zambia. home Do not share your drugs with others and do not take anyone else's drugs. In rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20. In HIV-infected patients, clinical practice guidelines suggest that a regimen of 500 to 1,000 mg PO twice daily for 14 days in combination with optimized antiretroviral therapy and symptomatic treatment may be useful. Round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Lancer Therapeutics - Offering Nitazoxanide 500mg Tablets, Packaging Size: 10x10 at Rs 800/box in Chandigarh. Nitazoxanide (Alinia) has comparable efficacy to metronidazole and is available in suspension for children as young as 1 year of age (100 mg twice a day for 3 days for younger than 4 years, 200 mg twice a day for 3 days for ages 4 to 11 years, 500 mg twice a day for adults). Alinia (Nitazoxanide) 500 mg tablets are FDA-approved for the treatment of Cryptosporidium Parvum & Giardia Lamblia infections in adults and kids 12 and over You will need to talk about the benefits and risks of using this medicine (nitazoxanide tablets) (NYE-ta-ZOX-a-nide) Brand name (s) Alinia. The pharmacokinetic parameners of the metabolites, tizoxanide and tizoxanide glucuronide are shown in Tables 2 and 3 below. Nitazoxanide is an inhibitor of pyruvate-ferredoxin oxidoreductase (PFOR); Antimicrobial recently found to kill both non-replicating and replicating mycobacteria. The safety of ALINIA was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received ALINIA Tablets or ALINIA for Oral Suspension at the recommended dose for at least three days. Tell your doctor if you are breast-feeding. This medicine may interact with other drugs or health problems. Get contact details and address | ID: 15079670733 Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum. ALINIA Tablets and ALINIA for Oral Suspension contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. You must check Do not flush down a toilet or pour down a drain unless you are told to do so. Alinia may cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. You may report side effects to FDA at 1-800-FDA-1088. ALINIA for Oral Suspension: The container should be kept tightly closed, and the suspension should be shaken well before each administration. In vitro studies have demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes. Bottles of 12 tablets NDC 67546-111-14 Bottles of 30 tablets NDC 67546-111-12 It is used to treat diarrhea caused by some parasites. Single Ingredient No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposure 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA). Take a missed dose as soon as you think about it. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with ALINIA Tablets or ALINIA for Oral Suspension, the most common adverse reactions were abdominal pain, headache, chromaturia and nausea (≥2%). In a double-blind, controlled trial (Study 1) conducted in Peru and Egypt in adults and adolescents with diarrhea and with one or more enteric symptoms (e.g., abdominal pain, nausea, vomiting, fever, abdominal distention, loss of appetite, flatulence) caused by G. lamblia, a three-day course of treatment with ALINIA Tablets administered 500 mg BID was compared with a placebo tablet for 3 days. This medication is used to treat diarrhea caused by certain parasite infections of the intestines (Cryptosporidium parvum and Giardia lamblia). There were no differences between the adverse reactions reported for ALINIA-treated subjects based upon age. You will need to talk about any risks to your baby. A second double-blind, controlled trial (Study 2) conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal colic, abdominal tenderness, abdominal cramps, abdominal distention, fever, bloody stool) caused by G. lamblia compared ALINIA Tablets administered 500 mg BID for 3 days to a placebo tablet. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Long-term carcinogenicity studies have not been conducted. In two double-blind, controlled trials in pediatric patients with diarrhea and with or without enteric symptoms (e.g., abdominal distention, colic, left iliac fossa tenderness) caused by C. parvum, a three-day course of treatment with nitazoxanide (100 mg BID in pediatric patients ages 12-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) was compared with a placebo. The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded. (100 mg nitazoxanide) taken orally every 12 hours with food controlled clinical trials. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. It is poorly soluble in ethanol and practically insoluble in water. Each tablet contains 500 mg of nitazoxanide. When ALINIA Tablets are administered with food, the AUCt of tizoxanide and tizoxanide glucuronide in plasma is increased almost two-fold and the Cmax is increased by almost 50%. Call your doctor or get medical while you are pregnant. See additional information. Patients should be managed based upon clinical response to treatment. Nitazoxanide and its metabolite, tizoxanide, are active in vitro in inhibiting the growth of (i) sporozoites and oocysts of C. parvum and (ii) trophozoites of G. lamblia. Be ready to tell or show what was Bottles of 12 tablets NDC 67546-111-14Bottles of 30 tablets NDC 67546-111-12, Store the tablets at 25 C (77 F); excursions permitted to 15 C-30 C (59 F-86 F). Keep taking this medicine (nitazoxanide tablets) as you have been told by your doctor or other health care provider, even if you feel well. Available for Android and iOS devices. Clinical response was evaluated 4 to 7 days following the end of treatment. If you are allergic to this medicine (nitazoxanide tablets); any part of this medicine (nitazoxanide tablets); or any other drugs, foods, or substances. Visit the FDA MedWatch website or call 1-800-FDA-1088. Chemically, nitazoxanide is 2-acetyloxy- N- (5-nitro-2-thiazolyl)benzamide. In a double-blind, controlled trial conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal pain/cramps, nausea, vomiting) caused by C. parvum, a three-day course of treatment with ALINIA Tablets administered 500 mg BID was compared with a placebo tablet for 3 days. Generic Alinia (nitazoxanide) is an antiprotozoal agent.Generic Alinia (nitazoxanide) is used to treat diarrhea in adults and … ALINIA tablets are round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. If you have any questions about this medicine (nitazoxanide tablets), please talk The reconstituted suspension has a pink color and strawberry flavor. Revised: Jun 2019. How is this medicine (Nitazoxanide Tablets) best taken? Generico Alinia (nitazoxanide) è un agente antiprotozoi.Generico Alinia (nitazoxanide) è usato per trattare la diarrea negli adulti e nei bambini, causati dal protozoi Giardia lamblia. Generic Name: Nitazoxanide Tablets (nye ta ZOX a nide)Brand Name: Alinia. Patients should be managed based upon clinical response to treatment. [See USP Controlled Room Temperature], The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded [see DOSAGE AND ADMINISTRATION], Manufacturer Information: Romark, L.C., 3000 Bayport Drive, Suite 200, Tampa, FL 33607. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. One study was conducted in Egypt in outpatients ages 1 through 11 years with diarrhea caused by C. parvum. Advise patients and parents/caregivers of pediatric patients taking ALINIA Tablets or ALINIA for Oral Suspension of the following information: ALINIA Tablets and ALINIA for Oral Suspension should be taken with food. The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of ALINIA Tablets in pediatric patients 12-17 years of age are provided above in Table 2. Tizoxanide then undergoes conjugation, primarily by glucuronidation. ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations. Nitazoxanide oral suspension (100 mg/5ml; patients ≥ 1 year of age) and Nitazoxanide tablets (500 mg; patients ≥ 12 years of age) are indicated for the treatment of diarrhea caused by Cryptosporidium. side effects drug center alinia (nitazoxanide) drug. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%). Limited information on nitazoxanide overdosage is available. Clinical response was evaluated 3 to 7 days post-therapy with a ‘well’ response defined as ‘no symptoms, no watery stools and no more than 2 soft stools within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained: Table 7: Clinical Response Rates in Pediatric Patients 3 to 7 Days Post-therapy Intent-to-Treat Analyses % (Number of Successes/Total). Table 2: Mean (+/- SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administration of a single dose of one 500 mg ALINIA Tablet with food to subjects ≥12 years of age, Table 3: Mean (+/-SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of single dose of ALINIA for Oral Suspension with food to subjects ≥1year of age.
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