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alosetron 0.5 MG Oral Tablet

1 INDICATIONS AND USAGE Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and not responded adequately to conventional therapy. Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to IBS. Because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. Clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. Alosetron hydrochloride tablets are a selective serotonin 5-HT 3 antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded and not responded adequately to conventional therapy. (1) Severe IBS includes diarrhea and 1 or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to IBS. (1)

Amneal Pharmaceuticals LLC


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8 months ago OVAL WHITE AN248 alosetron 0.5 MG Oral Tablet

OVAL WHITE AN248

16 HOW SUPPLIED/STORAGE AND HANDLING

ALOSETRON HYDROCHLORIDE tablets, 0.5 mg (0.562 mg

ALOSETRON HYDROCHLORIDE equivalent to 0.5 mg alosetron), are supplied as white, oval shaped, film-coated tablets debossed with “AN248” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-248-03 with child-resistant closures. Bottles of 500: NDC 65162-248-50 with child-resistant closures.

ALOSETRON HYDROCHLORIDE tablets, 1 mg (1.124 mg

ALOSETRON HYDROCHLORIDE equivalent to 1 mg alosetron), are supplied as light blue, oval shaped, film-coated tablets debossed with “AN249” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-249-03 with child-resistant closures. Bottles of 500: NDC 65162-249-50 with child-resistant closures. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

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alosetron 1 MG Oral Tablet

Amneal Pharmaceuticals LLC












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