Nitazoxanide

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Nitazoxanide Brand Name– Alinia

What is Nitazoxanide

Nitazoxanide is an oral synthetic antiprotozoal agent for the treatment of cryptosporidiosis or giardiasis.

In the US, the most common causes of cryptosporidiosis and giardiasis are Cryptosporidium parvum and Giardia lamblia, respectively.

Nitazoxanide is the first drug specifically approved for the treatment of cryptosporidiosis. In current guidelines for managing infectious diarrhea, paromomycin, an aminoglycoside antibiotic, has been the only agent used for treating cases of cryptosporidiosis, however, there is limited success with the use of this drug.

Nitazoxanide has also been effective in treating diarrhea due to other protozoa such as Giardia duodenalisG. intestinalis, and Entamoeba histolytica.

In one comparative study, nitazoxanide was as effective as metronidazole in the treatment of giardiasis due to Giardia intestinalis.

On October 15, 1996, the FDA approved an expanded open label compassionate use study of nitazoxanide in AIDS patients with cryptosporidiosis.

Orphan drug status for treatment of cryptosporidiosis was granted on December 12, 1996.

A phase II/III trial for the treatment of cryptosporidiosis in AIDS patients began January 1997 (press release 1/22/97).

Further studies are required to determine the role of nitazoxanide in HIV-positive and immunodeficient patients. Nitazoxanide has also shown efficacy in treating Clostridium difficile-associated diarrhea; further clinical studies are planned in order to seek FDA approval for this condition.

Nitazoxanide oral suspension was approved for use in children on November 22, 2002 for infectious diarrhea.

The tablets, for use in adults and adolescents, were approved by the FDA in July 2004. Nitazoxanide has also been used for shortening the duration of diarrhea in children with rotavirus infection and is being evaluated for treating chronic hepatitis B and C.

Indications

  1. Clostridium difficile
  2. cryptosporidiosis
  3. Cryptosporidium parvum
  4. Entamoeba dispar
  5. Entamoeba histolytica
  6. Enterocytozoon bieneusi
  7. Giardia lamblia
  8. giardiasis
  9. Helicobacter pylori (H. pylori) eradication
  10. infectious diarrhea
  11. microsporidiosis
  12. pseudomembranous colitis
  13. rotavirus
  14. rotavirus infection

Side Effects

  1. abdominal pain
  2. amenorrhea
  3. anemia
  4. anorexia
  5. appetite stimulation
  6. asthenia
  7. back pain
  8. bone fractures
  9. constipation
  10. diaphoresis
  11. diarrhea
  12. dizziness
  13. drowsiness
  14. dyspepsia
  15. dysuria
  16. elevated hepatic enzymes
  17. epistaxis
  18. fever
  19. flatulence
  20. gastroesophageal reflux
  21. headache
  22. hypertension
  23. hypoesthesia
  24. infection
  25. influenza
  26. insomnia
  27. iridal discoloration
  28. leukocytosis
  29. malaise
  30. muscle cramps
  31. myalgia
  32. nausea
  33. otalgia
  34. pelvic pain
  35. pharyngitis
  36. pruritus
  37. rash
  38. rhinitis
  39. sinus tachycardia
  40. syncope
  41. tremor
  42. urine discoloration
  43. urticaria
  44. vomiting
  45. xerostomia

Monitoring Parameters

  • stool exam

Contraindications

  • acquired immunodeficiency syndrome (AIDS)
  • biliary tract disease
  • breast-feeding
  • children
  • diabetes mellitus
  • driving or operating machinery
  • geriatric
  • hepatic disease
  • human immunodeficiency virus (HIV) infection
  • immunosuppression
  • infants
  • laboratory test interference
  • neonates
  • pregnancy
  • renal disease
  • renal failure
  • renal impairment

Nitazoxanide is contraindicated in patients with a prior hypersensitivity to nitazoxanide or any component of the formulation.

Interactions

  • Acetaminophen; Aspirin, ASA; Caffeine
  • Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
  • Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
  • Aminosalicylate sodium, Aminosalicylic acid
  • Aspirin, ASA
  • Aspirin, ASA; Butalbital; Caffeine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Aspirin, ASA; Caffeine; Dihydrocodeine
  • Aspirin, ASA; Caffeine; Orphenadrine
  • Aspirin, ASA; Carisoprodol
  • Aspirin, ASA; Carisoprodol; Codeine
  • Aspirin, ASA; Citric Acid; Sodium Bicarbonate
  • Aspirin, ASA; Dipyridamole
  • Aspirin, ASA; Omeprazole
  • Aspirin, ASA; Oxycodone
  • Aspirin, ASA; Pravastatin
  • Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
  • Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
  • Bismuth Subsalicylate
  • Bismuth Subsalicylate; Metronidazole; Tetracycline
  • Choline Salicylate; Magnesium Salicylate
  • Fosphenytoin
  • Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate
  • Magnesium Salicylate
  • Phenytoin
  • Salicylates
  • Salsalate
  • Sulfonylureas
  • Warfarin

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