ALINIA Tablet / Oral suspension (2022)

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Romark Laboratories, L.C.

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1. Indications and Usage

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 ...

2. Dosage and Administration

2.1 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...

3. Dosage Forms and Strengths

3.1 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. 3.2 ALINIA for Oral Suspensio...

4. Contraindications

4.1 Hypersensitivity ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.

6. Adverse Reactions

8.6 Renal and Hepatic Impairment The pharmacokinetics of nitzoxanide in patients with compromised renal or hepatic function has not been studied. 8.7 HIV-Infected or Immunodeficient Patients ALINIA...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials ...

7. Drug Interactions

7.1 Highly Protein Bound Drugs with Narrow Therapeutic Indices Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%). Therefore, monitor for adverse react...

8.1. Pregnancy

Risk Summary There are no data with ALINIA in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of n...

8.2. Lactation

Risk Summary No information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available. The development and health ben...

8.4. Pediatric Use

The safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on th...

8.5. Geriatric Use

Clinical studies of ALINIA Tablets and ALINIA for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects...

10. Overdosage

Limited information on nitazoxanide overdosage is available. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be observed and given sympto...

11. Description

ALINIA Tablets and ALINIA for Oral Suspension contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a light yellow crystalline powder. It i...

12.1. Mechanism of Action

Nitazoxanide is an antiprotozoal [see Microbiology (12.4))] .

12.3. Pharmacokinetics

Absorption Single Dosing Following oral administration of ALINIA Tablets or Oral Suspension, the parent drug, nitazoxanide, is not detected in plasma. The pharmacokinetic parameners of the metaboli...

12.4. Microbiology

Mechanism of Action The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction w...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term carcinogenicity studies have not been conducted. Mutagenesis Nitazoxanide was not genotoxic in the Chinese hamster ovary (CHO) cell chromosomal aberration assay or the mous...

14. Clinical Studies

14.1 Diarrhea Caused by G. lamblia Diarrhea caused by G. lamblia in adults and adolescents 12 years of age or older In a double-blind, controlled trial (Study 1) conducted in Peru and Egypt in ad...

16.1. How Supplied

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 a...

16.2. Storage and Handling

ALINIA Tablets (500 mg): 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): Store the u...

17. Patient Counseling Information

Advise patients and parents/caregivers of pediatric patients taking ALINIA Tablets or ALINIA for Oral Suspension of the following information: Dosage and Administration: ALINIA Tablets and ALINIA f...