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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.
Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients (see Clinical Studies).
DOSAGE AND ADMINISTRATION
|T reatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum*||1-3 years||5 mL of Alinia for Oral Suspension (100 mg nitazoxanide) every 12 hours with food||3 days|
|4-11 years||10 mL of Alinia for Oral Suspension (200 mg nitazoxanide) every 12 hours with food|
|≥ 12 years||1 Alinia Tablet (500 mg nitazoxanide) every 12 hours with food or 25 mL of Alinia for Oral Suspension (500 mg nitazoxanide) every 12 hours with food|
|* Alinia Tablets and Alinia for Oral Suspension have not been studied for the treatment of Giardia lamblia in HIV-infected or immunodeficient patients. 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 (see Clinical Studies).|
A single Alinia tablet contains a greater amount of nitazoxanide than is recommended for pediatric dosing and should therefore not be used in pediatric patients 11 years or younger.
Directions For Mixing Alinia For Oral Suspension
Prepare a suspension at time of dispensing as follows: The amount of water required for preparation of the suspension is 48 mL. Tap bottle until all powder flows freely. Add approximately one-half of the total amount of water required for reconstitution and shake vigorously to suspend powder. Add remainder of water and again shake vigorously.
The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be stored for 7 days, after which any unused portion must be discarded.
Alinia Tablets are round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 30 tablets.
Bottles of 30 NDC 67546-111-12
Alinia For Oral Suspension is a pink-colored powder formulation that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL. The reconstituted suspension has a pink color and strawberry flavor. Alinia for Oral Suspension is available as:
Bottles of 60 mL NDC 27437-106-01
Storage And Stability
Store the tablets, unsuspended powder, and the reconstituted oral suspension at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]
Romark Laboratories, L.C., 3000 Bayport Drive, Suite 200, Tampa, FL 33607. Telephone: 813-282-8544, Fax: 813-282-1162. E-mail: email@example.com. Web site: www.romark.com. Revised: Aug 2013.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/14/2016
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