Treatment for diarrhea caused by Cryptosporidium parvum & Giardia lamblia

Alinia® (nitazoxanide) Tablets
Alinia® (nitazoxanide) for Oral Suspension

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

Alinia Tablets and Alinia for Oral Suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.

About Alinia®

Alinia Tablets and Alinia for Oral Suspension are the only FDA-approved treatments for diarrhea caused by Cryptosporidium parvum.

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About Cryptosporidiosis and Giardiasis

Cryptosporidium parvum is a microscopic parasite that causes the diarrheal disease cryptosporidiosis (commonly known as "Crypto")¹.

Giardiasis is a diarrheal disease caused by a parasite called Giardia lamblia.

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Important Safety Information regarding Alinia®:

  • Do NOT take Alinia Tablets or Alinia for Oral Suspension if you are allergic to nitazoxanide or any other ingredient in the formulations.
  • Alinia Tablets or Alinia for Oral Suspension should be taken with food.
  • If you are a diabetic taking Alinia for Oral Suspension, please be aware that it contains 1.48 grams of sucrose for every 5 mL.
  • Alinia Tablets should NOT be taken by children 11 years or younger.
  • Please discuss with your doctor if you:
    • have hepatic, biliary, or renal disease.
    • are taking any other medications (for example, warfarin).
    • are a pregnant or a nursing woman.
    • are 65 years of age and older.
    • are HIV infected or have an immune disease (such as AIDS).
  • The most common side effects reported for Alinia Tablets during clinical trials were abdominal pain, diarrhea, headache and nausea, which were also reported by patients taking a placebo.
  • The most common side effects reported for Alinia for Oral Suspension during clinical trials were abdominal pain diarrhea, vomiting and headache, which were also reported by patients taking a placebo. These were typically mild and transient in nature. Of the 613 patients in pediatric trials, none discontinued therapy due to adverse events.

For more information, please read the Full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Romark at 1-813-282-8544.

References:

  1. Cryptosporidiosis Information. http://www.cdc.gov/parasites/crypto/gen_info/index.html. Accessed May 30, 2014.

Alinia® is a trademark of Romark, L.C.
Alinia® for Oral Suspension is distributed by Lupin Pharmaceuticals, Inc. under license from Romark, L.C.

Intended only for residents of the United States of America. ©2016 Romark, L.C., Tampa, Florida 33607-8416

The information contained in this website is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. Alinia® is not right for everyone. Decisions regarding healthcare must be made with a healthcare provider, considering the unique characteristics of the patient.

RM-AL-018-03V2 R03.16