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Alinia 500 Mg Tabs 12 By Romark Pharma.

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Alinia 500 Mg Tabs 12 By Romark Pharma.

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Alinia 500 Mg Tabs 12 By Romark Pharma.. Item Number.:RXB10159617
Size : 12
Selling UoM : EA
NDC: 67546-0111-14
UPC Barcode :
Supplier: 0050000931 ROMARK PHARMACEUTICALS
Supplier Material : 011114
Generic Code : 029984 NITAZOXANIDE ORAL TABLET 500 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

ALINIA, 500
tablet , film-coated , yellow , round round
Debossed

Alinia? (nitazoxanide) is the first thiazolide approved by the FDA for the treatment of diarrhea caused by Cryptosporidium and Giardia and is the only FDA-approved treatment for Cryptosporidium.

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. Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.

Nitazoxanide has been used for over ten years in more than twelve million patients worldwide, many of whom are children.

An oral suspension, and tablet formulation are available.

Important Safety Information for Alinia
?Alinia Tablets and Alinia for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.
?The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function have not been studied. Therefore, nitazoxanide must be administered with caution to patients with hepatic and biliary disease, to patients with renal disease and to patients with combined renal and hepatic disease.
?Tizoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g. warfarin).
?It is not known whether nitazoxanide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitazoxanide is administered to a nursing woman.
?In clinical studies involving HIV-uninfected patients age 12 years and older receiving Alinia Tablets, the most common adverse events reported regardless of causality assessment were abdominal pain (6.6%), diarrhea (4.2%), headache (3.1%) and nausea (3.0%). In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo.
?In clinical studies involving HIV-uninfected pediatric patients receiving Alinia for Oral Suspension, the most common adverse events reported regardless of causality assessment were abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%) and headache (1.1%). These were typically mild and transient in nature. In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo.