Alosetron (By mouth)

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• You may take this medicine with or without food.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using cimetidine (Tagamet®), hydralazine (Apresoline®), isoniazid (Nydrazid®), or procainamide (Procanbid®, Pronestyl®).
• Tell your doctor if you are using medicine to treat an infection (such as ciprofloxacin, clarithromycin, gatifloxacin, levofloxacin, telithromycin, Biaxin®, Ciloxan®, Cipro®, Ketek®, Levaquin®, or Tequin®), medicine to treat a fungus infection (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), or medicine to treat HIV or AIDS (such as nelfinavir, ritonavir, saquinavir, Fortovase®, Invirase®, Norvir®, or Viracept®).

Warnings While Using This Medicine

• You will be asked to sign a patient acknowledgment form before you take this medicine. This form tells you about the risks of using this medicine. Make sure you understand what is on the form before you sign it. If you have any questions, ask your doctor.
• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease.
• This medicine may cause a very serious bowel disease called ischemic colitis. Call your doctor right away if you have bleeding from your rectum, blood in your diarrhea or stools, or new or worse stomach pain or cramps.
• If you develop constipation, stop taking this medicine and call your doctor. Tell your doctor if the constipation does not go away after you have stopped using the medicine. Do not start taking the medicine again until your doctor tells you to.
• If your symptoms do not improve or if they get worse, call your doctor.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding from your rectum.
• Constipation.
• Red or black stools.
• Stomach pain or cramps (new or worse).

If you notice these less serious side effects, talk with your doctor:

• Diarrhea.
• Headache.
• Mild gas or bloating.
• Mild nausea.
• Skin rash.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Alosetron (a-LOE-se-tron)

Treats irritable bowel syndrome (IBS) in women who have diarrhea as the main symptom. This medicine is only used in severe cases that have not responded to other therapy.

Brand Name(s)

Lotronex

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to alosetron. Do not use this medicine if you have severe liver disease, a history of blood clots or severe constipation, or certain other bowel diseases (such as bowel bleeding, blockage, perforations, sores, swelling, ischemic colitis, toxic megacolon, Crohn's disease, or diverticulitis). Do not use this medicine if you are also using fluvoxamine (Luvox®). Tell your doctor about all digestive problems you have now or have ever had. This medicine should not be given to children. You should not use this medicine if you do not understand the information written in the patient acknowledgment form.