Alosetron

Generic name: Alosetron (oral)
Brand names: Lotronex
Dosage form: oral tablet (0.5 mg; 1 mg)
Drug class: Serotoninergic neuroenteric modulators

Usage of 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 with diarrhea as the main symptom for at least 6 months. Alosetron is given after other treatments have failed.

Alosetron is not a cure for irritable bowel syndrome. After you stop taking alosetron, your symptoms may return within 1 week.

Alosetron has not been shown to be effective in men with IBS.

Alosetron may also be used for purposes not listed in this medication guide.

Alosetron side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious or fatal side effects on the stomach and intestines have occurred in some people taking alosetron. In rare cases, alosetron has caused severe constipation, or ischemic colitis (caused by reduced blood flow to the intestines).

Stop taking alosetron and call your doctor right away if you develop:

  • new or worsening constipation;
  • stomach pain;
  • bright or dark red blood in your stools; or
  • bloody diarrhea.
  • You may need to permanently discontinue alosetron if you have these side effects.

    Older adults and those who are ill or debilitated may be more likely to have serious complications from constipation.

    Common side effects of alosetron may include:

  • constipation;
  • nausea; or
  • pain or discomfort in your stomach or intestines.
  • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Alosetron

    Do not take alosetron if you have ever had any of the following conditions:

  • 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;
  • severe liver disease; or
  • a condition for which you also take fluvoxamine (Luvox).
  • Tell your doctor if you are pregnant or breastfeeding.

    If you breastfeed while taking alosetron, call your doctor if your baby shows signs of constipation or has bloody stools.

    Alosetron is not approved for use by anyone younger than 18 years old.

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    How to use Alosetron

    Usual Adult Dose for Irritable Bowel Syndrome:

    Initial dose: 0.5 mg orally twice a dayMaintenance dose: 0.5 mg orally once or twice a day; may be increased up to 1 mg orally twice a day after 4 weeks of treatment.Maximum dose: 2 mg/dayComment: Due to the serious gastrointestinal adverse reactions associated with this drug, treatment should be restricted to female patients for whom the benefit-to-risk balance is most favorable.Use: Women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and have not responded adequately to conventional therapy

    Warnings

    Alosetron should be used only by women with severe irritable bowel syndrome and diarrhea as the main symptom.

    Do not start taking alosetron if you are constipated. You also should not take alosetron if you take another medicine called fluvoxamine (Luvox).

    Serious or fatal side effects on the stomach and intestines have occurred in some people taking alosetron. In rare cases, alosetron has caused severe constipation, or ischemic colitis (caused by reduced blood flow to the intestines).

    Stop taking alosetron and call your doctor right away if you have: new or worsening constipation, stomach pain, bright or dark red blood in your stools, or bloody diarrhea. You may need to permanently discontinue alosetron if you have these side effects.

    If you stop taking alosetron for any reason, do not start taking it again without your doctor's advice.

    What other drugs will affect Alosetron

    Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

    Many drugs can affect alosetron, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

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