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Lotronex, |alosetron Alosetron Hydrochloride

alosetron

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

What is alosetron?

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

Alosetron 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. Alosetron should be used only in women who have tried other IBS treatments without success. Alosetron has not been shown to be effective in men with IBS.

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

What is the most important information I should know about alosetron?

Serious or fatal side effects on the stomach and intestines have occurred in some people taking alosetron. Alosetron 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 alosetron.

Alosetron does not improve the symptoms of IBS for everyone. When alosetron 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.

What should I discuss with my healthcare provider before taking alosetron?

Serious or fatal side effects on the stomach and intestines have occurred in some people taking alosetron. Alosetron 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 alosetron.

• 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.

How should I take alosetron?

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.

Alosetron can be taken with or without food.

Alosetron does not improve the symptoms of IBS for everyone. When alosetron 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.

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

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?

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

What should I avoid while taking alosetron?

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

Alosetron side effects

• new or worsening stomach pain;

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

• fast or uneven heartbeats.

Continue using alosetron 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 alosetron?

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

Before taking alosetron, 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 alosetron. 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 alosetron 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.