Lotronex

Generic Name: alosetron (oral) (a LO ze tron)
Brand Names: Lotronex

What is Lotronex?

Lotronex blocks the action of a chemical called serotonin in the intestines. This slows the movement of stools (bowel movements) through the intestines.

Lotronex is used to treat severe, chronic irritable bowel syndrome (IBS) in women who have had diarrhea as the main symptom for at least 6 months. Lotronex should be used only in women who have tried other IBS treatments without success. Lotronex has not been shown to be effective in men with IBS.

Lotronex may also be used for purposes other than those listed in this medication guide.

Important information about Lotronex

Do not start taking Lotronex if you are constipated. If you have constipation while taking Lotronex, call your doctor right away.

Serious or fatal side effects on the stomach and intestines have occurred in some people taking Lotronex. Lotronex should be prescribed only by a qualified doctor who is enrolled in a prescribing program specific for this drug. You will be required to read and sign a Patient-Physician Agreement form before you get a prescription for Lotronex.

In rare cases, Lotronex has caused severe constipation, or ischemic colitis (caused by reduced blood flow to the intestines). Stop taking Lotronex and call your doctor right away if you develop new or worsening constipation, stomach pain, bloody diarrhea, or blood in your stools (bowel movements). If the constipation is severe or gets worse, and you also have increasing stomach discomfort, stop taking Lotronex and do not start taking it again until you talk to your doctor. If your constipation does not improve after you stop taking Lotronex, call your doctor again.

Lotronex does not improve the symptoms of IBS for everyone. When Lotronex does work well, it helps reduce stomach pain and discomfort, bowel urgency, and diarrhea. Some or all symptoms may improve within one to two weeks of treatment.

Before taking Lotronex

Serious or fatal side effects on the stomach and intestines have occurred in some people taking Lotronex. Lotronex should be prescribed only by a qualified doctor who is enrolled in a prescribing program specific for this drug. You will be required to read and sign a Patient-Physician Agreement form before you get a prescription for Lotronex.

Do not use Lotronex if you have:

• constipation (especially if it is your main IBS symptom);

• a history of severe or ongoing constipation;

• obstruction or perforation of your intestines;

• Crohn's disease, ulcerative colitis, or diverticulitis;

• blood clots or circulation problems affecting your intestines;

• liver disease; or

• if you are also taking fluvoxamine (Luvox) to treat obsessive-compulsive disorder.

Tell your doctor if you have ever had any of the conditions listed above.

In rare cases, Lotronex has caused severe constipation. Do not start taking Lotronex if you are constipated. If you have constipation while taking Lotronex, call your doctor right away. If the constipation is severe or gets worse, and you also have increasing stomach discomfort, stop taking Lotronex and do not start taking it again until you talk to your doctor. If your constipation does not improve after you stop taking Lotronex, call your doctor again. In rare cases, Lotronex has caused ischemic colitis, which is caused by reduced blood flow to the intestines. Stop taking Lotronex and call your doctor right away if you develop new or worsening abdominal pain, bloody diarrhea, or blood in your stools (bowel movements). FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Lotronex passes into breast milk or if it could harm a nursing baby. Do not take Lotronex without telling your doctor if you are breast-feeding a baby. Older adults and those who are ill or debilitated may be more likely to have serious complications from constipation. This medicine should not be given to a child younger than 18 years old.

How should I take Lotronex?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Take each dose with a full glass of water.

Lotronex can be taken with or without food.

Lotronex does not improve the symptoms of IBS for everyone. When Lotronex does work well, it helps reduce stomach pain and discomfort, bowel urgency, and diarrhea. Some or all symptoms may improve within one to two weeks of treatment.

Stop taking Lotronex if your IBS symptoms do not improve after 4 weeks of taking this medication. If you stop taking Lotronex, do not start taking it again without your doctor's consent.

Lotronex is not a cure for irritable bowel syndrome. If you stop taking Lotronex, symptoms may return within one week.

Store Lotronex at room temperature away from moisture and heat.

What happens if I miss a dose?

Skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses at once, or take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an Lotronex overdose may include breathing problems, tiredness, loss of muscle control, tremors, and seizure (convulsions).

What should I avoid while taking Lotronex?

There are no restrictions on food, beverages, or activity while taking Lotronex, unless otherwise directed by your doctor.

Lotronex side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Lotronex and call your doctor right away if you have any of these serious side effects:

• new or worsening stomach pain;

• bleeding from your rectum or blood in your stools; or

• fast or uneven heartbeats.

Continue using Lotronex and talk with your doctor if you have any of these less serious side effects:

• mild stomach discomfort, bloating, or nausea;

• burping with heartburn;

• rectal hemorrhoids; or

• bloating or gas.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Lotronex?

Do not take Lotronex if you are also taking fluvoxamine (Luvox) to treat obsessive-compulsive disorder.

Before taking Lotronex, tell your doctor if you are using any of the following drugs:

• cimetidine (Tagamet);

• ketoconazole (Nizoral), itraconazole (Sporanox), voriconazole, (VFEND);

• isoniazid (Nydrazid);

• hydralazine (BiDil);

• procainamide (Procanbid, Procan SR, Pronestyl);

• clarithromycin (Biaxin) or telithromycin (Ketek);

• HIV medicines such as amprenavir (Agenerase), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept); or

• an antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), or ofloxacin (Floxin).

There may be other drugs that can affect Lotronex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has additional information about Lotronex written for health professionals that you may read.

What does my medication look like?

Alosetron is available with a prescription under the brand name Lotronex. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Lotronex 0.5 mg - white, oval tablets

• Lotronex 1 mg - blue, oval tablets

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
• Click here for more information on Lotronex from the manufacturer.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 5/9/06 1:38:36 PM.

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