Alosetron Hydrochloride
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Alosetron Hydrochloride Manufacturers
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Roxane Laboratories, Inc.
![Alosetron Hydrochloride Tablet [Roxane Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Alosetron Hydrochloride | Roxane Laboratories, Inc.
For safety reasons, only physicians who enroll in the Alosetron REMS Program should prescribe Alosetron Hydrochloride Tablets [see Warnings and Precautions (5.3)].
2.1 Adult PatientsTo lower the risk of constipation, Alosetron Hydrochloride Tablets should be started at a dosage of 0.5 mg twice a day. Patients who become constipated at this dosage should stop taking Alosetron Hydrochloride Tablets until the constipation resolves. They may be restarted at 0.5 mg once a day. If constipation recurs at the lower dose, Alosetron Hydrochloride Tablets should be discontinued immediately.
Patients well controlled on 0.5 mg once or twice a day may be maintained on this regimen. If after 4 weeks the dosage is well tolerated but does not adequately control IBS symptoms, then the dosage can be increased to up to 1 mg twice a day. Alosetron Hydrochloride Tablets should be discontinued in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1 mg twice a day.
Alosetron Hydrochloride Tablets can be taken with or without food [see Clinical Pharmacology (12.3)].
Alosetron Hydrochloride Tablets should be discontinued immediately in patients who develop constipation or signs of ischemic colitis. Alosetron Hydrochloride Tablets should not be restarted in patients who develop ischemic colitis.
Clinical trial and postmarketing experience suggest that debilitated patients or patients taking additional medications that decrease gastrointestinal motility may be at greater risk of serious complications of constipation. Therefore, appropriate caution and follow-up should be exercised if Alosetron Hydrochloride Tablets are prescribed for these patients.
Postmarketing experience suggests that elderly patients may be at greater risk for complications of constipation; therefore, appropriate caution and follow-up should be exercised if Alosetron Hydrochloride Tablets are prescribed for these patients [see Warnings and Precautions (5.1)].
2.2 Patients With Hepatic ImpairmentAlosetron Hydrochloride Tablets is extensively metabolized by the liver, and increased exposure to Alosetron Hydrochloride Tablets is likely to occur in patients with hepatic impairment. Increased drug exposure may increase the risk of serious adverse reactions. Alosetron Hydrochloride Tablets should be used with caution in patients with mild or moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment [see CONTRAINDICATIONS (4)] and USE IN SPECIFIC POPULATIONS (8.6)].
2.3 Information for PharmacistsAlosetron Hydrochloride Tablets may be dispensed only on presentation of a prescription for Alosetron Hydrochloride Tablets with a sticker for the Alosetron REMS Program attached. A Medication Guide for Alosetron Hydrochloride Tablets must be given to the patient each time Alosetron Hydrochloride Tablets are dispensed as required by law. No telephone, facsimile, or computerized prescriptions are permitted with this program. Refills are permitted to be written on prescriptions.
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