Alinia

What is Alinia?

• Alinia (Nitazoxanide) is an antiprotozoal used for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

Nitazoxanide

Nitazoxanide-from-xtal-Mercury-3D-balls

What are the uses of this medicine?

• Alinia (Nitazoxanide) for Oral Suspension (patients 1 year of age and older) and Alinia Tablets (patients 12 years and older) are used 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.

How does this medicine work?

• Nitazoxanide is an antiprotozoal.
• The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism.
• Studies have shown that the PFOR enzyme from G. lamblia directly reduces nitazoxanide by transfer of electrons in the absence of ferredoxin.
• The DNA-derived PFOR protein sequence of C.parvum appears to be similar to that of G.lamblia.
• Interference with the PFOR enzyme-dependent electron transfer reaction may not be the only pathway by which nitazoxanide exhibits antiprotozoal activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention the medications listed below:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven).

Is this medicine FDA approved?

• Nitazoxanide tablets were approved as a generic medication in the United States in 2020.

How should this medicine be used?

Recommended dosage: Dosage for treatment of diarrhea caused by G. lamblia or C. parvum:

• 1-3 years:5 mL of Alinia for Oral Suspension (100 mg nitazoxanide) every 12 hours with food.
• 4-11 years:10 mL of Alinia for Oral Suspension (200 mg nitazoxanide) every 12 hours with food for 3 days.
• 12 years and older: One 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.

Administration:

• Nitazoxanide comes as a tablet and a suspension (liquid) to take by mouth.
• It is usually taken with food every 12 hours for 3 days.
• Take nitazoxanide at around the same times every day.
• Shake the suspension well before each use to mix the medication evenly.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 500 mg
• Oral Suspension: 100 mg/5 mL

This medicine is available in fallowing brand namesː

• ALINIA

What side effects can this medication cause?

The most common side effects of this medicine include:

• abdominal pain
• headache
• chromaturia
• nausea

What special precautions should I follow?

• Alinia Tablets and Alinia for Oral Suspension should be taken with food.
• The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be stored at room temperature for 7 days, after which any unused portion must be discarded.
• Tell your doctor if you have or have ever had human immunodeficiency virus (HIV), problems with the immune system, or liver or kidney disease.
• No information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Limited information on nitazoxanide overdosage is available.

Management of overdosage:

• In the event of overdose, gastric lavage may be appropriate soon after oral administration.
• Patients should be observed and given symptomatic and supportive treatment.
• There is no specific antidote for overdose with ALINIA.
• Because tizoxanide is highly protein bound (>99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

Can this medicine be used in pregnancy?

• There are no data with Alinia in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• The safety and efficacy of Aliniafor 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.
• Safety and efficacy of Alinia for Oral Suspension in pediatric patients less than one year of age has not been studied.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• NITAZOXANIDE

Inactive Ingredients:

• TITANIUM DIOXIDE
• D&C YELLOW NO. 10
• FD&C YELLOW NO. 6
• FD&C BLUE NO. 2
• STARCH, CORN
• HYPROMELLOSES
• SUCROSE
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• TALC
• MAGNESIUM STEARATE
• LECITHIN, SOYBEAN
• POLYVINYL ALCOHOL
• XANTHAN GUM

Who manufactures and distributes this medicine?

• Romark, L.C.
• Bayport Drive, Suite 200, Tampa, FL

• Aliniais a registered trademark of Romark.

What should I know about storage and disposal of this medication?

Alinia Tablets:

• Store the tablets at 25 oC (77 oF); excursions permitted to 15 oC-30 oC (59 oF-86 oF).

Alinia for Oral Suspension:

• Store the unsuspended powder at 25 oC (77 oF); excursions permitted to 15 oC-30 oC (59 oF-86 oF).

• Dailymed label info on Alinia
• FDA Alinia

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