"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(nitazoxanide) for Oral Suspension
Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension contain the active ingredient, nitazoxanide, a synthetic antiprotozoal agent for oral administration. Nitazoxanide is a light yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl)benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is:
Alinia Tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, pregelatinized corn starch, hydroxypropyl methylcellulose, sucrose, sodium starch glycollate, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, talc, FD&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 2 Aluminum Lake.
Alinia (nitazoxanide) for Oral Suspension, after reconstitution, contains 100 mg nitazoxanide per 5 mL and the following inactive ingredients: sodium benzoate, sucrose, xanthan gum, microcrystalline cellulose and carboxymethylcellulose sodium, anhydrous citric acid, sodium citrate dihydrate, acacia gum, sugar syrup, FD&C Red #40 and natural strawberry flavoring.
What are the possible side effects of nitazoxanide (Alinia)?
Stop taking nitazoxanide and seek emergency medical attention if you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
Other, less serious side effects may be more likely to occur. Continue to take the medication and talk to your doctor if you experience
- abdominal pain;
- vomiting; or
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially...
What are the precautions when taking nitazoxanide (Alinia)?
Before taking nitazoxanide, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell the doctor or pharmacist your medical history, especially of: liver disease, kidney disease, weak immune system (e.g., HIV infection).
Do not take over-the-counter medications to treat diarrhea without first checking with your doctor or pharmacist.
Tell your doctor if you are pregnant before using this medication.
It is not known whether this medication passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Alinia Information
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