Dosing & Administration

For safety reasons, only physicians who enroll in the Prometheus Prescribing Program for LOTRONEX^TM (PPL) should prescribe LOTRONEX^®. Only physicians who attest to their qualifications, accept responsibility, and enroll in the Prometheus Prescribing Program for LOTRONEX should prescribe LOTRONEX.

>> Dosing & Administration of LOTRONEX
>> Monitoring and Patient Involvement Are Important When Using LOTRONEX

Dosing & Administration of LOTRONEX

Starting dose:

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
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 is available in 0.5-mg and 1-mg tablets.

Counsel your patient about the risks and benefits of LOTRONEX in the patients for whom LOTRONEX is indicated, and discuss the impact of IBS symptoms on your patient's life.

Monitoring and Patient Involvement Are Important When Using LOTRONEX
Patients using LOTRONEX should follow up with their physicians 4 weeks after the initial dose to evaluate their treatment.

As outlined in the Medication Guide, patients should immediately discontinue LOTRONEX and contact their physicians if:

They become constipated
- Contact their physician if they develop constipation
- Patients should immediately contact their physicians again if their constipation does not resolve after discontinuation of LOTRONEX
- Resume LOTRONEX only if their constipation has resolved and after discussion with and the agreement of their physicians
They have symptoms of ischemic colitis such as new or worsening abdominal pain, bloody diarrhea, or blood in the stool

If signs or symptoms of ischemic colitis are reported, physicians should:

Discontinue LOTRONEX
Confirm the diagnosis of ischemic colitis by performing appropriate tests
Not restart LOTRONEX if ischemic colitis diagnosis was confirmed

Some patients have experienced serious complications of constipation or ischemic colitis without warning.

Please consult the Complete Prescribing Information.