"The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
- 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 events associated with LOTRONEX (alosetron hydrochloride) , the indication is restricte 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 LOTRONEX (alosetron hydrochloride) in men.
DOSAGE AND ADMINISTRATION
For safety reasons, only physicians who enroll in the Prometheus Prescribing Program for LOTRONEX should prescribe LOTRONEX (see PRECAUTIONS: Prescribing Program for LOTRONEX (alosetron hydrochloride) ).
Usual Dosage in Adults: To lower the risk of constipation, LOTRONEX (alosetron hydrochloride) should be started at a dosage of 0.5 mg twice a day. Patients well controlled on 0.5 mg twice a day may be maintained on this regimen. If, after 4 weeks, the 0.5-mg twice-daily 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, the dose used in controlled clinical trials (see Clinical Trials). LOTRONEX (alosetron hydrochloride) 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.
LOTRONEX can be taken with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Food Effects).
LOTRONEX (alosetron hydrochloride) should be discontinued immediately in patients who develop constipation or signs of ischemic colitis. LOTRONEX (alosetron hydrochloride) 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 LOTRONEX (alosetron hydrochloride) is prescribed for these patients (see also Geriatric Patients).
Pediatric Patients: Safety and effectiveness have not been established in pediatric patients.
Geriatric 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 LOTRONEX is prescribed for these patients (see WARNINGS).
Patients With Renal Impairment: There are insufficient data available on the biological activity of the metabolites of LOTRONEX (alosetron hydrochloride) . It is unknown if dosage adjustment is needed in patients with renal impairment (see CLINICAL PHARMACOLOGY: Population Subgroups: ReducedRenalFunction).
Patients With Hepatic Impairment: LOTRONEX (alosetron hydrochloride) is extensively metabolized by the liver and increased exposure to LOTRONEX (alosetron hydrochloride) is likely to occur in patients with hepatic impairment. Increased drug exposure may increase the risk of serious adverse events. LOTRONEX (alosetron hydrochloride) should be used with caution in patients with mild or moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Population Subgroups: Reduced Hepatic Function, CONTRAINDICATIONS, and PRECAUTIONS: Hepatic Insufficiency).
Information for Pharmacists: LOTRONEX (alosetron hydrochloride) may be dispensed only on presentation of a prescription for LOTRONEX (alosetron hydrochloride) with a sticker for the Prescribing Program for LOTRONEX attached. A Medication Guide for LOTRONEX (alosetron hydrochloride) must be given to the patient each time LOTRONEX (alosetron hydrochloride) is dispensed as required by law. No telephone, facsimile, or computerized prescriptions are permitted with this program. Refills are permitted to be written on prescriptions.
LOTRONEX (alosetron hydrochloride) Tablets, 0.5 mg (0.562 mg alosetron HCl equivalent to 0.5 mg alosetron) are white, oval, film-coated tablets debossed with GX EX1 on one face.
Bottles of 30 (NDC 0173-0738-00) with child-resistant closures.
LOTRONEX (alosetron hydrochloride) Tablets, 1 mg (1.124 mg alosetron HCl equivalent to 1 mg alosetron), are blue, oval, film-coated tablets debossed with GX CT1 on one face.
Bottles of 30 (NDC 0173-0690-05) with child-resistant closures.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Prometheus Laboratories Inc. January 2008. FDA revision date: 4/1/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/16/2008
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