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Alinia

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Alinia

Indications
Dosage
How Supplied

INDICATIONS

Diarrhea caused by Giardia lamblia

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

Diarrhea caused by Cryptosporidium parvum

Alinia (nitazoxanide) for Oral Suspension is indicated for patients 1 through 11 years of age for the treatment of diarrhea caused by Cryptosporidium parvum.

Alinia (nitazoxanide) for Oral Suspension and Alinia (nitazoxanide) 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).

The safety and effectiveness of Alinia (nitazoxanide) for Oral Suspension or Alinia (nitazoxanide) Tablets for the treatment of diarrhea caused by Cryptosporidium parvum in patients 12 years of age and older have not been established.

DOSAGE AND ADMINISTRATION

Indication Age Dosage Duration
Treatment of diarrhea caused by Giardia lamblia 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
Treatment of diarrhea caused by 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

Safety and effectiveness of Alinia (nitazoxanide) for Oral Suspension and Alinia (nitazoxanide) Tablets for the treatment of diarrhea caused by Cryptosporidium parvum in patients 12 years and older have not been established.

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.

Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension have not been studied for the treatment of Giardia lamblia in HIV-infected or immunodeficient patients. Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) 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 ).

Directions For Mixing Alinia (nitazoxanide) 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.

HOW SUPPLIED

Alinia (nitazoxanide) Tablets are round, yellow, film-coated tablets debossed with ALINIA (nitazoxanide) on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 60 tablets and blister cards of 6 tablets.

Bottles of 60                            NDC 67546-111-11
Boxes of 3 blister cards          NDC 67546-111-32
(Alinia (nitazoxanide) 3-Day Therapy Packs™)

Alinia (nitazoxanide) 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 (nitazoxanide) for Oral Suspension is available as:

Bottles of 60 mL                       NDC 67546-212-21

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 PHARMACEUTICALS, A division of Romark Laboratories, L.C. 3000 Bayport Drive, Suite 200, Tampa FL 33607. Telephone: 813-282-8544, Fax: 813-282-4910 E-mail: customer.service@romark.com Web site: www.romark.com. FDA revision date: 7/21/2004

Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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