Alosetron Hydrochloride, Oral a-LOH-se-tron hy-droh-KLOR-ide

What are other names for this medicine?

Type of medicine: 5-HT3 receptor antagonist

Generic and brand names: alosetron hydrochloride, oral; Lotronex

What is this medicine used for?

This medicine is taken by mouth to treat irritable bowel syndrome in women when the main problem is severe diarrhea and other medicines have not helped.

You must be enrolled in a special program and sign forms stating that you understand the risks and benefits of taking this medicine. Talk to your healthcare provider about this.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• blood clots
• bowel problems such as intestinal blockage, severe constipation, bowel perforation, Crohn's disease, diverticulitis, or colitis
• liver disease

Do not take this medicine if you have taken fluvoxamine (Luvox) within the past 2 weeks.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Ask your healthcare provider or pharmacist about anything you do not understand.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. If you stop taking this medicine, your symptoms may return within 1 or 2 weeks. Ask your healthcare provider or pharmacist about anything you do not understand.

You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you become constipated, or have bloody diarrhea, rectal bleeding, or abdominal pain while taking this medicine, stop taking the medicine and contact your healthcare provider immediately. These may be signs of very serious side effects.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

You need to see your provider regularly to check your progress and see if your dosage needs to be adjusted. Keep all appointments.

If you need emergency care or surgery, tell the healthcare provider you are taking this medicine.

Contact your healthcare provider if your condition does not improve in 4 weeks.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Constipation, rectal bleeding, bloody diarrhea, worsening abdominal pain.

Other: Nausea, bloating, heartburn, gas, headache, hemorrhoids, rash.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• anastrozole (Arimidex)
• antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), gemifloxacin (Factive), isoniazid (Laniazid), levofloxacin (Levaquin), lomefloxacin, Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin, (Floxin), and telithromycin (Ketek)
• antidepressants such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and nefazodone
• antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), voriconazole (VFEND), and ketoconazole (Nizoral)
• anti-HIV medicines such as atazanavir (Reyataz), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• apomorphine (Apokyn)
• cimetidine (Tagamet)
• heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Dilacor, Tiamate, Tiazac), hydralazine (Apresoline), and procainamide (Procan)

The effects of this medicine may be increased if you take it with grapefruit juice. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the tablets at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Do not share medicines with other people.