Nitazoxanide
Generic: NITAZOXANIDE
Basic Information
Manufacturer
Rising Pharma Holdings, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
c0dc0656-3c46-43f9-adea-5285c522cef8
Indications & Usage
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) .
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) .
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea (6.1) .
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464 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 nitazoxanide 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 nitazoxanide 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
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464 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 nitazoxanide 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 nitazoxanide 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