Alinia Oral Suspension

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum:

ALINIA for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

Limitations of Use

ALINIA for Oral Suspension and ALINIA 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)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions 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 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. 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%).

Safety data were analyzed separately for 280 HIV-uninfected subjects ≥12 years of age receiving ALINIA 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 ALINIA-treated subjects based upon age.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of ALINIA. 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 ALINIA 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

Applies to nitazoxanide: oral powder for suspension, oral tablet

Along with its needed effects, nitazoxanide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nitazoxanide:

• Diarrhea

Some side effects of nitazoxanide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• headache
• nausea
• urine changes

• Dizziness
• heartburn
• hives or welts, itching, or skin rash
• redness of the skin
• trouble breathing
• vomiting

For diarrhea in immunocompetent patients: 500 mg twice daily with food for 3 days.
For diarrhea in AIDS patients: 1000 mg twice daily with food for 14 days or until diarrhea resolves.

For diarrhea in immunocompetent patients: 500 mg twice daily with food for 3 days.
For diarrhea in AIDS patients: 1000 mg twice daily with food for 14 days or until diarrhea resolves.

For diarrhea in immunocompetent patients: 500 mg twice daily with food for 3 days.
For diarrhea in AIDS patients: 1000 mg twice daily with food for 14 days or until diarrhea resolves.

Study (n=105)
Dosage given orally morning and evening for 3 consecutive days.
2 to 3 years: 100 mg/5 mL
4 to 11 years: 200 mg/10 mL

Study (n=53):
Greater than or equal to 12 years:
For diarrhea in immunocompetent patients: 500 mg twice daily with food for 3 days.

Data not available