Information about Cryptosporidiosis


Cryptosporidiosis

Cryptosporidium is a microscopic parasite that causes the diarrheal disease cryptosporidiosis (commonly known as "Crypto"). Symptoms of cryptosporidiosis generally begin 2 to 10 days (average 7 days) after becoming infected with the parasite and usually last about 1 to 2 weeks. The most common symptom of cryptosporidiosis is watery diarrhea. Other symptoms include: stomach cramps or pain, dehydration, nausea, vomiting, fever and weight loss. Some people with Crypto will have no symptoms at all.1

Crypto can be spread1:

  • By putting something in your mouth or accidentally swallowing something that has come into contact with stool of a person or animal infected with Crypto.
  • By swallowing recreational water contaminated with Crypto. Recreational water is water in swimming pools, hot tubs, Jacuzzis, fountains, lakes, rivers, springs, ponds, or streams. Recreational water can be contaminated with sewage or feces from humans or animals.
  • By swallowing water or beverages contaminated with stool from infected humans or animals.
  • By eating uncooked food contaminated with Crypto. Thoroughly wash with uncontaminated water all vegetables and fruits you plan to eat raw.
  • By touching your mouth with contaminated hands. Hands can become contaminated through a variety of activities, such as touching surfaces (e.g., toys, bathroom fixtures, changing tables, diaper pails) that have been contaminated by stool from an infected person, changing diapers, caring for an infected person, and handling an infected cow or calf.
  • By exposure to human feces (poop) through sexual contact.

If you experience diarrhea and have been in any of the situations described below, you should contact your doctor to find out if you have a Cryptosporidium infection1:

  • In contact with children who attend day care centers, including diaper-aged children
  • Child care workers
  • Parents of infected children
  • People who take care of other people with cryptosporidiosis
  • International travelers
  • Backpackers, hikers, and campers who drink unfiltered, untreated water
  • People who drink from untreated shallow, unprotected wells.
  • People, including swimmers, who swallow water from contaminated sources
  • People who handle infected cattle
  • People exposed to human feces (poop) through sexual contact

Contaminated water may include water that has not been boiled or filtered, as well as contaminated recreational water sources (e.g., swimming pools, lakes, rivers, ponds, and streams).1

For further information please refer to: Centers for Disease Control and Prevention website at
http://www.cdc.gov/parasites/crypto/

Indications for Alinia®

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.

Please note: Alinia is not approved to treat other possible symptoms of Cryptosporidiosis and/or Giardiasis (such as cramps, dehydration, nausea, fever, vomiting). It also is not approved to prevent the spread of infection.

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