May 25, 2017
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Alosetron Hydrochloride

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Alosetron Hydrochloride Tablets

ALOSETRON HYDROCHLORIDE
(alosetron hydrochloride) Tablet

WARNING

SERIOUS GASTROINTESTINAL ADVERSE REACTIONS

Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron hydrochloride tablets. These events, including is chemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death.

  • Alosetron hydrochloride tablets are indicated only for women with severe diarrheapredominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy [see INDICATIONS AND USAGE].
  • Alosetron hydrochloride tablets should be discontinued immediately in patients who develop constipation or symptoms of is chemic colitis. Patients should immediately report constipation or symptoms of is chemic colitis to their prescriber. Alosetron hydrochloride tablets should not be resumed in patients who develop is chemic colitis. Patients who have constipation should immediately contact their prescriber if the constipation does not resolve after alosetron hydrochloride tablets is discontinued. Patients with resolved constipation should resume alosetron hydrochloride tablets only on the advice of their treating prescriber [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

The active ingredient in Alosetron Hydrochloride Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 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 hydrochloride is achiral and has the empirical formula C17H18N4O•HCl, representing a molecular weight of 330.8. Alosetron hydrochloride 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 - Structural Formula Illustration

Alosetron Hydrochloride Tablets are supplied for oral administration as 0.5 mg or 1 mg, white to offwhite tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients: lactose (anhydrous), magnesium stearate, pregelatinized starch and silicified microcrystalline cellulose.

Last reviewed on RxList: 2/2/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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