August 31, 2016
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Alinia

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Alinia




Indications
Dosage
How Supplied

INDICATIONS

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].

DOSAGE AND ADMINISTRATION

Recommended Dosage And Important Administration Instructions

Important Administration Instructions For Pediatric Patients 11 Years Of Age Or Younger

ALINIA tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of nitazoxanide than the recommended dosing in this pediatric age group.

Table 1: Recommended Dosage

Age Dosage Duration
1-3 years 5 mL of ALINIA for Oral Suspension (100 mg nitazoxanide) taken orally every 12 hours with food 3 days
4-11 years 10 mL of ALINIA for Oral Suspension (200 mg nitazoxanide) taken orally every 12 hours with food
12 years and older One ALINIA Tablet (500 mg nitazoxanide) taken orally every 12 hours with food or 25 mL of ALINIA for Oral Suspension (500 mg nitazoxanide) taken orally every 12 hours with food

Directions For Mixing ALINIA For Oral Suspension

Reconstitute ALINIA for Oral Suspension as follows:

  • Measure 48 mL of water for preparation of the 100 mg/5 mL suspension.
  • Tap bottle until all powder flows freely.
  • Add approximately one-half of the 48 mL of water required for reconstitution and shake vigorously to suspend powder.
  • Add remainder of water and again shake vigorously.

Keep container tightly closed, and shake the suspension well before each administration. The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded.

HOW SUPPLIED

Dosage Forms And Strengths

ALINIA Tablets (500 mg)

Round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide.

ALINIA For Oral Suspension (100 mg/5 mL)

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.

Storage And Handling

ALINIA Tablets (500 mg)

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 12 and 30 tablets.

Bottles of 12 tablets NDC 67546-111-14
Bottles of 30 tablets NDC 67546-111-12

Store the tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]

ALINIA For Oral Suspension (100 mg/5 mL)

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

Store the unsuspended powder, at 25°C (77°F); excursions permitted to 15°C-30°C (59°F -86°F). [See USP Controlled Room Temperature]

The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded [see DOSAGE AND ADMINISTRATION]

Romark, L.C. 3000 Bayport Drive, Suite 200, Tampa, FL 33607 Telephone: 813-282-8544, Fax: 813-282-1162 E-mail: customer.service@romark.com Web site: www.romark.com . Revised: July 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/25/2016

Indications
Dosage
How Supplied

Alinia - User Reviews

Alinia User Reviews

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