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Nitazoxanide(cas 55981-09-4) is a broad-spectrum antiparasitic and broad-spectrum antiviral drug that is used in medicine for the treatment of various helminthic, protozoal, and viral infections. It is indicated for the treatment of infection by Cryptosporidium parvum and Giardia lamblia in immunocompetent individuals and has been repurposed for the treatment of influenza. Nitazoxanide(cas 55981-09-4) has also been shown to have in vitro antiparasitic activity and clinical treatment efficacy for infections caused by other protozoa and helminths; emerging evidence suggests that it possesses efficacy in treating a number of viral infections as well.

Chemically, Nitazoxanide(cas 55981-09-4) is the prototype member of the thiazolides, a class of drugs which are synthetic nitrothiazolyl-salicylamide derivatives with antiparasitic and antiviral activity. Tizoxanide, an active metabolite of Nitazoxanide(cas 55981-09-4) in humans, is also an antiparasitic drug of the thiazolide class.

Nitazoxanide(cas 55981-09-4) Uses

Nitazoxanide(cas 55981-09-4) is an effective first-line treatment for infection by Blastocystis species and is indicated for the treatment of infection by Cryptosporidium parvum or Giardia lamblia in immunocompetent adults and children. It is also an effective treatment option for infections caused by other protozoa and helminths (e.g., Entamoeba histolytica, Hymenolepis nana, Ascaris lumbricoides, and Cyclospora cayetanensis).

As of September 2015, it is in phase 3 clinical trials for the treatment influenza due to its inhibitory effect on a broad range of influenza virus subtypes and efficacy against influenza viruses that are resistant to neuraminidase inhibitors like tamiflu. Nitazoxanide(cas 55981-09-4) is also being researched as a potential treatment for chronic hepatitis B, chronic hepatitis C, rotavirus and norovirus gastroenteritis.

Nitazoxanide(cas 55981-09-4) Chronic hepatitis B

Nitazoxanide(cas 55981-09-4) alone has shown preliminary evidence of efficacy in the treatment of chronic hepatitis B over a one-year course of therapy. Nitazoxanide(cas 55981-09-4) 500 mg twice daily resulted in a decrease in serum HBV DNA in all of 4 HBeAg-positive patients, with undetectable HBV DNA in 2 of 4 patients, loss of HBeAg in 3 patients, and loss of HBsAg in one patient. Seven of 8 HBeAg-negative patients treated with Nitazoxanide(cas 55981-09-4) 500 mg twice daily had undetectable HBV DNA and 2 had loss of HBsAg. Additionally, Nitazoxanide(cas 55981-09-4) monotherapy in one case and Nitazoxanide(cas 55981-09-4) plus adefovir in another case resulted in undetectable HBV DNA, loss of HBeAg and loss of HBsAg. These preliminary studies showed a higher rate of HBsAg loss than any currently licensed therapy for chronic hepatitis B. The similar mechanism of action of interferon and Nitazoxanide(cas 55981-09-4) suggest that stand-alone Nitazoxanide(cas 55981-09-4) therapy or Nitazoxanide(cas 55981-09-4) in concert with nucleos(t)ide analogs have the potential to increase loss of HBsAg, which is the ultimate end-point of therapy. A formal phase Ⅱ study is being planned for 2009. you can see results for off label use of alinia (Nitazoxanide(cas 55981-09-4)) on medhelp hbv community, it is reported a significant drop of more than 50% hbsag quantity from baseline values on hbeag negative hbv at 1,5-2g daily dose (500 mg pills every 6-8hrs with food) already at 3–6 months therapy, especially in combination with peginterferon or entecavir.

Nitazoxanide(cas 55981-09-4) Chronic hepatitis C

Romark initially decided to focus on the possibility of treating chronic hepatitis C with Nitazoxanide(cas 55981-09-4). The drug garnered interest from the hepatology community after three phase II clinical trials involving the treatment of hepatitis C with Nitazoxanide(cas 55981-09-4) produced positive results for treatment efficacy and similar tolerability to placebo without any signs of toxicity. Subsequent clinical trials are ongoing.

A new dosage form of Nitazoxanide(cas 55981-09-4) for use in chronic hepatitic C was developed for future clinical trials. The extended release tablet provides a larger dose of Nitazoxanide(cas 55981-09-4) (675 mg) than the current tablets (500 mg) and is intended to be used twice daily for 7 days.

Nitazoxanide(cas 55981-09-4) Clinical trials

Romark Laboratories has announced encouraging results from international Phase I and II clinical trials evaluating a controlled release version of Nitazoxanide(cas 55981-09-4) in the treatment of chronic hepatitis C virus infection. The company used 675 mg and 1,350 mg twice daily doses of controlled release Nitazoxanide(cas 55981-09-4) showed favorable safety and tolerability throughout the course of the study, with mild to moderate adverse events. Primarily GI-related adverse events were reported.

Nitazoxanide(cas 55981-09-4) is has gone through Phase II clinical trials for the treatment of hepatitis C, in combination with peginterferon alfa-2a and ribavirin.

A randomised double-blind placebo-controlled study published in 2006, with a group of 38 young children (Lancet, vol 368, page 124-129)[25] concluded that a 3-day course of Nitazoxanide(cas 55981-09-4) significantly reduced the duration of rotavirus disease in hospitalized pediatric patients. Dose given was "7.5 mg/kg twice daily" and the time of resolution was "31 hours for those given Nitazoxanide(cas 55981-09-4) compared with 75 hours for those in the placebo group." Rotavirus is the most common infectious agent associated with diarrhea in the pediatric age group worldwide.

Teran et al.. conducted a study at the Pediatric Center Albina Patin?, a reference hospital in the city of Cochabamba, Bolivia, from August 2007 to February 2008. The study compared Nitazoxanide(cas 55981-09-4) and probiotics in the treatment of acute rotavirus diarrhea. They found Small differences in favor of Nitazoxanide(cas 55981-09-4) in comparison with probiotics and concluded that Nitazoxanide(cas 55981-09-4) is an important treatment option for rotavirus diarrhea.

Lateef et al.. conducted a study in India that evaluated the effectiveness of Nitazoxanide(cas 55981-09-4) in the treatment of beef tapeworm (Taenia saginata) infection. They concluded that Nitazoxanide(cas 55981-09-4) is a safe, effective, inexpensive, and well-tolerated drug for the treatment of niclosamide- and praziquantel-resistant beef tapeworm (Taenia saginata) infection.

A retrospective review of charts of patients treated with Nitazoxanide(cas 55981-09-4) for trichomoniasis by Michael Dan and Jack D. Sobel demonstrated negative result. They reported three case studies; two of which with metronidazole-resistant infections. In Case 3, they reported the patient to be cured with high divided dose tinidazole therapy. They used a high dosage of the drug (total dose, 14–56 g) than the recommended standard dosage (total dose, 3 g) and observed a significant adverse reaction (poorly tolerated nausea) only with the very high dose (total dose, 56 g). While confirming the safety of the drug, they showed Nitazoxanide(cas 55981-09-4) is ineffective for the treatment of trichomoniasis.

Nitazoxanide(cas 55981-09-4) Contraindications

Nitazoxanide(cas 55981-09-4) is contraindicated only in individuals who have experienced a hypersensitivity reaction to Nitazoxanide(cas 55981-09-4) or the inactive ingredients of a Nitazoxanide(cas 55981-09-4) formulation.

Nitazoxanide(cas 55981-09-4) Adverse effects

The side effects of Nitazoxanide(cas 55981-09-4) do not significantly differ from a placebo treatment for giardiasis;these symptoms include stomach pain, headache, upset stomach, vomiting, discolored urine, excessive urinating, skin rash, itching, and others. Nitazoxanide(cas 55981-09-4) does not appear to cause any significant adverse effects when taken by healthy adults.

Nitazoxanide(cas 55981-09-4) Overdose

Information on Nitazoxanide(cas 55981-09-4) overdose is limited. Oral doses of 4 grams in healthy adults do not appear to cause any significant adverse effects. In various animals, the oral LD50 is higher than 10 g/kg.

Nitazoxanide(cas 55981-09-4) Interactions

Due to the exceptionally high plasma protein binding (>99.9%) of Nitazoxanide(cas 55981-09-4)'s metabolite, tizoxanide, the concurrent use of Nitazoxanide(cas 55981-09-4) with other highly plasma protein-bound drugs with narrow therapeutic indices (e.g., warfarin) increases the risk of drug toxicity.[1] In vitro evidence suggests that Nitazoxanide(cas 55981-09-4) does not affect the CYP450 system.[1]

Nitazoxanide(cas 55981-09-4) Pharmacology

Nitazoxanide(cas 55981-09-4) Pharmacodynamics

The anti-protozoal activity of Nitazoxanide(cas 55981-09-4) is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism.

It has also been shown to have activity against influenza A virus in vitro. The mechanism appears to be by selectively blocking the maturation of the viral hemagglutinin at a stage preceding resistance to endoglycosidase H digestion. This impairs hemagglutinin intracellular trafficking and insertion of the protein into the host plasma membrane.

Nitazoxanide(cas 55981-09-4) Pharmacokinetics

Following oral administration, Nitazoxanide(cas 55981-09-4) is rapidly hydrolyzed to the pharmacologically active metabolite, tizoxanide, which is 99% protein bound. Tizoxanide is then glucuronide conjugated into the active metabolite, tizoxanide glucuronide. Peak plasma concentrations of the metabolites tizoxanide and tizoxanide glucuronide are observed 1–4 hours after oral administration of Nitazoxanide(cas 55981-09-4), whereas Nitazoxanide(cas 55981-09-4) itself is not detected in blood plasma.

Roughly 2?3 of an oral dose of Nitazoxanide(cas 55981-09-4) is excreted as its metabolites in feces, while the remainder of the dose excreted in urine. Tizoxanide is excreted in the urine, bile and feces. Tizoxanide glucuronide is excreted in urine and bile.

Nitazoxanide(cas 55981-09-4) Physical and chemical properties

[icon] This section requires expansion. (January 2016)
Nitazoxanide(cas 55981-09-4) is the prototype member of the thiazolides, which is a drug class of structurally-related broad-spectrum antiparasitic compounds. Nitazoxanide(cas 55981-09-4) is a light yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water.

Nitazoxanide(cas 55981-09-4) History

Nitazoxanide(cas 55981-09-4) was originally discovered in the 1980s by Jean-Fran?ois Rossignol at the Pasteur Institute. Initial studies demonstrated activity versus tapeworms. In vitro studies demonstrated much broader activity. Dr. Rossignol co-founded Romark Laboratories, with the goal of bringing Nitazoxanide(cas 55981-09-4) to market as an anti-parasitic drug. Initial studies in the USA were conducted in collaboration with Unimed Pharmaceuticals, Inc. (Marietta, GA) and focused on development of the drug for treatment of cryptosporidiosis in AIDS. Controlled trials began shortly after the advent of effective anti-retroviral therapies. The trials were abandoned due to poor enrollment and the FDA rejected an application based on uncontrolled studies.

Rather than abandon their efforts, Romark launched a series of controlled trials. A placebo-controlled study of Nitazoxanide(cas 55981-09-4) in cryptosporidiosis demonstrated significant clinical improvement in adults and children with mild illness. Among malnourished children in Zambia with chronic cryptosporidiosis, a three-day course of therapy led to clinical and parasitologic improvement and improved survival. In Zambia and in a study conducted in Mexico, Nitazoxanide(cas 55981-09-4) was not successful in the treatment of cryptosporidiosis in advanced infection with human immunodeficiency virus at the doses used. However, it was effective in patients with higher CD4 counts. In treatment of giardiasis, Nitazoxanide(cas 55981-09-4) was superior to placebo and comparable to metronidazole. Nitazoxanide(cas 55981-09-4) was successful in the treatment of metronidazole-resistant giardiasis. Studies have suggested efficacy in the treatment of cyclosporiasis, isosporiasis, and amebiasis.

Nitazoxanide(cas 55981-09-4) Pharmaceutical products

Nitazoxanide(cas 55981-09-4) Dosage forms
Nitazoxanide(cas 55981-09-4) is currently available in two oral dosage forms: a tablet (500 mg) and an oral suspension (100 mg per 5 ml when reconstituted).

An extended release tablet (675 mg) has been used in clinical trials for chronic hepatitis C; however, this form is not currently marketed and available for prescription.

Nitazoxanide(cas 55981-09-4) Brand names
Nitazoxanide(cas 55981-09-4) is sold under the brand names Adonid, Alinia, Allpar, Annita, Colufase, Daxon, Dexidex, Kidonax, Mitafar, Netazox, Niazid, Nitamax, Nitax, Nitaxide, Nizonide, NT-TOX, Pacovanton, Paramix, Toza, and Zox.

Nitazoxanide(cas 55981-09-4) is used for:

Treating certain parasitic infections of the intestine.

Nitazoxanide(cas 55981-09-4) is an antiparasitic agent. It works by interfering with the production of certain substances that are needed by the parasite to live.

Do NOT use Nitazoxanide(cas 55981-09-4) if:
you are allergic to any ingredient in Nitazoxanide(cas 55981-09-4)
Contact your doctor or health care provider right away if any of these apply to you.

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Before using Nitazoxanide(cas 55981-09-4):
Some medical conditions may interact with Nitazoxanide(cas 55981-09-4). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver or gallbladder problems, kidney problems, immune system problems, or HIV infection
Some MEDICINES MAY INTERACT with Nitazoxanide(cas 55981-09-4). Tell your health care provider if you are taking any other medicines, especially any of the following:

Warfarin because its actions and side effects may be increased by Nitazoxanide(cas 55981-09-4)
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitazoxanide(cas 55981-09-4) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitazoxanide(cas 55981-09-4):
Use Nitazoxanide(cas 55981-09-4) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Nitazoxanide(cas 55981-09-4) with food.
If you miss a dose of Nitazoxanide(cas 55981-09-4), take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Nitazoxanide(cas 55981-09-4).

Important safety information:

Nitazoxanide(cas 55981-09-4) may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Nitazoxanide(cas 55981-09-4). Using Nitazoxanide(cas 55981-09-4) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Nitazoxanide(cas 55981-09-4) is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Nitazoxanide(cas 55981-09-4), discuss with your doctor the benefits and risks of using Nitazoxanide(cas 55981-09-4) during pregnancy. It is not known if Nitazoxanide(cas 55981-09-4) is excreted in breast milk. If you are or will be breast-feeding, check with your doctor or pharmacist to discuss the risk to your baby.
Possible side effects of Nitazoxanide(cas 55981-09-4):
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; fainting; fast heartbeat; severe or persistent dizziness; shortness of breath; unusual tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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