Alosetron tablets

What are alosetron tablets?

ALOSETRON (Lotronex®) is used to treat irritable bowel syndrome (IBS) in women who have severe diarrhea as the primary symptom and who have not had success with other IBS treatments. Do not use alosetron if you are constipated. Irritable bowel syndrome is also called irritable colon or spastic colon. Alosetron helps to reduce the cramping, abdominal pain, discomfort, urgency (sudden need to move the bowels), and diarrhea caused by IBS. Alosetron has not been shown to work in men with IBS. Alosetron is available only from health care providers who participate in a special Prescribing Program because this drug may cause serious side effects. Your health care provider will discuss your condition and these side effects with you prior to prescribing this drug. Generic alosetron tablets are not available.

What should my health care professional know before I take alosetron?

They need to know if you have any of these conditions:

• if you are currently constipated or constipated most of the time, have a history of chronic or severe constipation, or if you have had adverse reactions or hospitalizations due to severe constipation

• Crohn's disease

• diverticulitis

• history of ischemic colitis, impaired intestinal circulation, bleeding, or blood clots

• history of a serious stomach or bowel blockage, like stomach or intestinal obstruction, stricture, or adhesions

• history of stomach or intestinal perforation

• kidney disease

• liver disease

• toxic megacolon

• ulcerative colitis

• an unusual or allergic reaction to alosetron, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Your health care professional will review a Medication Guide and a Patient-Physician Agreement with you prior to prescribing alosetron. It is important that you read and understand these materials. Let your provider know if you have any questions. If you are unable or unwilling to understand and comply with the Agreement and Medication Guide, you should not take alosetron. Read the Medication Guide before you first take alosetron and each time you refill your prescription.

Take alosetron tablets by mouth with or without food. Follow the directions on the prescription label and in the Medication Guide. Swallow the tablets with a glass of water. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. Alosetron is not for use in children.

What if I miss a dose?

It is best to skip the missed dose. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with alosetron?

• amantadine

• amiodarone

• amoxapine

• antidiarrheal medications, such as Imodium®, KaoPectate®, Lomotil®

• antimuscarinic medications, such as Donnatal®, hyoscyamine, Librax®

• bethanechol

• bupropion

• cimetidine

• cisapride

• clarithromycin, erythromycin or troleandomycin

• clozapine

• cyclobenzaprine

• diltiazem

• disopyramide

• fluoxetine

• fluvoxamine

• isoniazid, INH

• maprotiline

• metoclopramide

• mibefradil

• nefazodone

• nicardipine

• olanzapine

• opiate pain medications, such as codeine, hydrocodone or morphine

• orphenadrine

• procainamide

• quinine

• St. John's Wort

• tricyclic antidepressants, such as amitriptyline or imipramine

• verapamil

• zileuton

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking alosetron?

Constipation is a common and serious side effect of alosetron. Stop taking alosetron and call your health care provider immediately if you become constipated while taking alosetron. If your constipation does not resolve, contact your prescriber again. Resume alosetron only if your constipation has resolved and you and your prescriber have agreed to restart treatment. You should not start taking alosetron if you are already constipated or constipated most of the time.

Ischemic colitis is a serious and potentially life-threatening condition that has been rarely reported with alosetron. If you experience new or worsening abdominal pain, bloody diarrhea or blood in the stool, immediately stop taking alosetron and contact your prescriber.

Alosetron may not work for all women who take it. For women who are helped by alosetron, relief may occur within the first week or within four weeks of starting the drug. If alosetron is stopped, it is likely that your symptoms will return within one week.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how alosetron affects you. Alcohol can increase drowsiness or dizziness; avoid alcoholic drinks.

If you are going to have surgery, tell your prescriber or health care professional that you are taking alosetron.

What side effects may I notice from taking alosetron?

Side effects that you should report to your prescriber or health care professional immediately:

• blood in stool, bloody diarrhea or rectal bleeding

• constipation

• darkened urine

• hemorrhoids

• fever

• irregular heart beat (unusually fast or slow)

• worsening of abdominal pain

• yellowing of the eyes or the skin

• unusual fatigue or weakness

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• anxiety

• difficulty sleeping

• drowsiness

• dry mouth

• frequent urination

• gas

• headache

• nausea

• restlessness

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.