Alosetron Hydrochloride Recall
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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FDA Labeling Changes
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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.
There is currently no drug history available for this drug.
The active ingredient in Alosetron Hydrochloride Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4O•HCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:
Alosetron Hydrochloride Tablets are supplied for oral administration as 0.5 mg (white to off-white) and 1 mg (white to off-white) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch.