Nitazoxanide/Ofloxacin
Antiprotozoal [EPC]
What it is used for
1 INDICATIONS AND USAGE Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum . Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2) ] . Nitazoxanide tablets are antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1 ). Limitations of Use: Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients (1).
Warnings
FDA/EMA boxed risks: tendinopathy/rupture, peripheral neuropathy, CNS effects, aortic aneurysm risk in susceptible patients, QT prolongation (esp. moxifloxacin), dysglycaemia, psychiatric effects. Avoid in patients with significant risk factors unless benefits outweigh risks. Photosensitivity. Separate from polyvalent cations (antacids, Fe, Ca, dairy, sucralfate) by several hours.
Possible side effects
≥2% of patients were abdominal pain, headache, chromaturia, and nausea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of nitazoxanide was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received nitazoxanide tablets or Alina for oral suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with nitazoxanide tablets or Alina for oral suspension, the most common adverse reactions were abdominal pain, headache, chromaturia and nausea (≥2%). Safety data were analyzed separately for 280 HIV-uninfected subjects ≥12 years of age receiving nitazoxanide at the recommended dose for at least three days in 5 placebo-controlled clinical trials and for 256 HIV-uninfected subjects 1 through 11 years of age in 7 controlled clinical trials. There were no differences between the adverse reactions reported for nitazoxanide-treated subjects based upon age. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of nitazoxanide. 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. The following is a list of adverse reactions spontaneously reported with nitazoxanide tablets which were not included in clinical trial listings: Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease Nervous System disorders: dizziness Respiratory, thoracic and mediastinal disorders: dyspnea Skin and subcutaneous tissue disorders: rash, urticaria
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Nitazoxanide Tablets (500 mg) Nitazoxanide tablets 500 mg are green colored, round biconvex film-coated tablets debossed with “V1” on one side and “1” on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 6, 12 and 30 tablets. Bottles of 12 tablets NDC 31722-100-31 Bottles of 30 tablets NDC 31722-100-30 Bottles of 6 tablets NDC 31722-100-32 Store the tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]
No reviewed patient-education article is available. The fields shown are from the currently verified medicine record and unavailable fields are not inferred.