LOTRONEX is 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 events associated with LOTRONEX, 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 in men.

For safety reasons, only physicians who enroll in the Prometheus Prescribing Program for LOTRONEX should prescribe LOTRONEX (see PRECAUTIONS: Prescribing Program for LOTRONEX).

Usual Dosage in Adults: To lower the risk of constipation, LOTRONEX 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 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 should be discontinued immediately in patients who develop constipation or signs of ischemic colitis. LOTRONEX 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 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. It is unknown if dosage adjustment is needed in patients with renal impairment (see CLINICAL PHARMACOLOGY: Population Subgroups: ReducedRenalFunction).

Patients With Hepatic Impairment: LOTRONEX is extensively metabolized by the liver and increased exposure to LOTRONEX is likely to occur in patients with hepatic impairment. Increased drug exposure may increase the risk of serious adverse events. LOTRONEX 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 may be dispensed only on presentation of a prescription for LOTRONEX with a sticker for the Prescribing Program for LOTRONEX attached. A Medication Guide for LOTRONEX must be given to the patient each time LOTRONEX 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 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 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: 4/1/2008

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