Alinia

Drug overview for ALINIA (nitazoxanide):

Generic name: NITAZOXANIDE (NYE-ta-ZOX-a-nide)
Drug class: Antiprotozoal Agents
Therapeutic class: Anti-Infective Agents

Nitazoxanide, a synthetic nitrothiazolyl-salicylamide derivative, is an antiprotozoal agent.

No enhanced Uses information available for this drug.

DRUG IMAGES

ALINIA 100 MG/5 ML SUSPENSION
ALINIA 500 MG TABLET

The following indications for ALINIA (nitazoxanide) have been approved by the FDA:

Indications:
Giardiasis
Infection by Cryptosporidium

Professional Synonyms:
Cryptosporidiosis
Infection due to Cryptosporidium parvum
Lambliasis
Lambliosis

Dosing information for ALINIA
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
ALINIA 500 MG TABLET	Maintenance	Adults take 1 tablet (500 mg) by oral route every 12 hours with food

Generic dosing information for NITAZOXANIDE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
NITAZOXANIDE 500 MG TABLET	Maintenance	Adults take 1 tablet (500 mg) by oral route every 12 hours with food

Moderate List
No disease contraindications

More Frequent	Less Frequent
Acute abdominal pain Headache disorder Nausea Urine discoloration	Diarrhea

Rare/Very Rare
Dizziness Dyspnea Gastroesophageal reflux disease Skin rash Urticaria

The following precautions are available for ALINIA (nitazoxanide):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of nitazoxanide have not been established in pediatric patients younger than 1 year of age. Nitazoxanide oral suspension: Safety and efficacy for the treatment of diarrhea caused by C. parvum or G.

intestinalis (also known as G. lamblia or G. duodenalis) in pediatric patients 1-11 years of age have been established based on results of 3 randomized, controlled studies. Safety and efficacy of the oral suspension for the treatment of diarrhea caused by C. parvum or G.

intestinalis in pediatric patients 12-17 years of age have been established based on results of 2 randomized, controlled studies. Nitazoxanide tablets: Safety and efficacy for the treatment of diarrhea caused by C. parvum or G.

intestinalis have been established in pediatric patients 12-17 years of age based on results of 3 randomized, controlled studies. The commercially available 500-mg tablets of nitazoxanide should not be used in pediatric patients 11 years of age or younger since the tablets contain a greater amount of the drug than is recommended in this age group.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Data are not available on use of nitazoxanide in pregnant women to inform a drug-associated risk. In animal reproduction studies, there was no evidence of teratogenicity or fetotoxicity in rats or rabbits when nitazoxanide was given during organogenesis at exposures 30 or 2 times, respectively, the human exposure at the recommended human dosage of 500 mg twice daily based on body surface area.

It is not known whether nitazoxanide is distributed into human milk, affects milk production, or affects a breast-fed child. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for nitazoxanide and potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Clinical studies of nitazoxanide did not include a sufficient number of individuals 65 years of age and older to determine whether geriatric adults respond differently than younger individuals. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy in this age group should be considered.

Giardiasis
A07.1	Giardiasis [lambliasis]
Infection by cryptosporidium
A07.2	Cryptosporidiosis