Alosetron Hydrochloride alosetron hydrochloride

Get an overview of ALOSETRON HYDROCHLORIDE (tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Alosetron Hydrochloride can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Alosetron Hydrochloride.

Drug Basics

Brand Name: Alosetron Hydrochloride

Generic Name: ALOSETRON HYDROCHLORIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2020-02-10

indications & usage

Alosetron hydrochloride tablets are indicated only for 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
  • not responded adequately to conventional therapy.

Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:

  • frequent and severe abdominal pain/discomfort,
  • frequent bowel urgency or fecal incontinence,
  • disability or restriction of daily activities due to IBS.

Because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.

Clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men.

Alosetron Hydrochloride Tablets are a selective serotonin 5-HT3 antagonist indicated only for 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
  • not responded adequately to conventional therapy. (1)

Severe IBS includes diarrhea and 1 or more of the following:

  • frequent and severe abdominal pain/discomfort,
  • frequent bowel urgency or fecal incontinence,
  • disability or restriction of daily activities due to IBS. (1)

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Prescriber and Patient Responsibilities

Patients should be fully counseled on and understand the risks and benefits of alosetron hydrochloride tablets before an initial prescription is written. The patient may be educated by the prescriber or a healthcare provider under a prescriber’s direction.

Prescribers must:

  • counsel patients for whom alosetron hydrochloride tablets are appropriate about the benefits and risks of alosetron hydrochloride tablets and discuss the impact of IBS symptoms on the patient’s life.
  • review the Medication Guide, which outlines the benefits and risks of alosetron hydrochloride tablets, and instruct the patient to read it carefully. Answer all questions the patient may have about alosetron hydrochloride tablets. The complete text of the Medication Guide is printed at the end of this document.
  • provide each patient with appropriate instructions for taking alosetron hydrochloride tablets.

Additional copies of the Medication Guide are available by contacting West-Ward Pharmaceuticals Corp. at 1-800-962-8364.

Patients who are prescribed alosetron hydrochloride tablets should be instructed to:

  • read the Medication Guide before starting alosetron hydrochloride tablets and each time they refill their prescription.
  • not start taking alosetron hydrochloride tablets if they are constipated.
  • immediately discontinue alosetron hydrochloride tablets and contact their prescriber if they become constipated, or have symptoms of ischemic colitis such as new or worsening abdominal pain, bloody diarrhea, or blood in the stool. Contact their prescriber again if their constipation does not resolve after discontinuation of alosetron hydrochloride tablets. Resume alosetron hydrochloride tablets only if their constipation has resolved and after discussion with and the agreement of their treating prescriber.
  • stop taking alosetron hydrochloride tablets and contact their prescriber if alosetron hydrochloride tablets does not adequately control IBS symptoms after 4 weeks of taking 1 mg twice a day.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10006481/04

Revised January 2020

medication guide

Alosetron (a-LOW-zeh-tron) Hydrochloride Tablets USP

Rx only

Read the Medication Guide you get with each refill for alosetron hydrochloride tablets. There may be new information. This Medication Guide does not take the place of talking with your doctor.

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

Alosetron hydrochloride tablets are a medicine only for some women with severe chronic irritable bowel syndrome (IBS) whose:

  • main problem is diarrhea and
  • IBS symptoms have not been helped enough by other treatments.
  •  Some people have developed serious bowel side effects while taking alosetron hydrochloride tablets. Serious bowel (intestine) side effects can happen suddenly, including the following:
  • Serious complications of constipation:
  •  These complications may lead to a hospital stay and, in rare cases, blood transfusions, surgery, and death. People who are older, who are weak from illness, or who take other constipating medicines may be more likely to have serious complications of constipation with alosetron hydrochloride tablets.

To lower your chances of getting serious complications of constipation, do the following:

  • o If you are constipated, do not start taking alosetron hydrochloride tablets.
  • o If you get constipated while taking alosetron hydrochloride tablets, stop taking it right away and call your doctor.
  • o If your constipation does not get better after stopping alosetron hydrochloride tablets, call your doctor again.
  • o If you stopped taking alosetron hydrochloride tablets, do not start taking alosetron hydrochloride tablets again unless your doctor tells you to do so.
  • Inflammation and injury of the intestines caused by reduced blood flow (ischemic colitis): Ischemic colitis is caused by reduced blood flow to parts of the large bowel. The chance of getting ischemic colitis when you take alosetron hydrochloride tablets for more than 6 months is not known. Ischemic colitis may lead to a hospital stay and, in rare cases, blood transfusions, surgery, and death.

Stop taking alosetron hydrochloride tablets and call your doctor or get medical help if you have symptoms of ischemic colitis such as new or worsening stomach-area (abdominal) pain, bloody diarrhea or blood in the stool.

What are alosetron hydrochloride tablets?

Alosetron hydrochloride tablets are a prescription medicine used only for some women with severe chronic IBS whose:

  • main problem is diarrhea and
  • IBS symptoms have not been helped enough by other treatments.

Alosetron hydrochloride tablets does not cure IBS, and it may not help every person who takes it. For those who are helped, alosetron hydrochloride tablets reduces lower stomach area (abdominal) pain and discomfort, the sudden need to have a bowel movement (bowel urgency), and diarrhea from IBS. If you stop taking alosetron hydrochloride tablets, your IBS symptoms may return within 1 or 2 weeks to what they were before you started taking alosetron hydrochloride tablets.

It is not known if alosetron hydrochloride tablets are safe and effective in men with IBS.

It is not known if alosetron hydrochloride tablets are safe and effective in children.

Who should not take alosetron hydrochloride tablets?

Do not take alosetron hydrochloride tablets if you:

  • have constipation or you are constipated most of the time.
  • have had a serious problem from constipation. If you are constipated now, do not start taking alosetron hydrochloride tablets.
  • have had serious bowel blockages.
  • have had blood flow problems to your bowels, such as ischemic colitis.
  • have had blood clots.
  • have had Crohn’s disease, ulcerative colitis, diverticulitis, or severe liver disease.
  • are taking fluvoxamine (LUVOX®).

What should I talk about with my doctor before taking alosetron hydrochloride tablets?

Talk with your doctor:

  • about the possible benefits and risks of alosetron hydrochloride tablets.
  • about how much of a problem IBS is in your life and what treatments you have tried.
  • about any other illnesses you have and medicines you take or plan to take. These include prescription and non-prescription medicines, supplements, and herbal remedies. Certain illnesses and medicines can increase your chance of getting serious side effects while taking alosetron hydrochloride tablets. Other medicines may interact with how the body handles alosetron hydrochloride tablets.
  • about any allergies that you have. See the end of the Medication Guide for a complete list of ingredients in alosetron hydrochloride tablets.
  • if you have liver problems.
  • if you are pregnant or planning to become pregnant. It is not known if alosetron hydrochloride tablets can harm your unborn baby.
  • if you are breastfeeding or plan to breastfeed. It is not known if alosetron hydrochloride tablets can harm your baby. Talk to your doctor about the best way to feed your baby if you are taking alosetron hydrochloride tablets.

How should I take alosetron hydrochloride tablets?

  • Take alosetron hydrochloride tablets exactly as your doctor prescribes it. You can take alosetron hydrochloride tablets with or without food.
  • Begin with 0.5 mg two times a day for 4 weeks to see how alosetron hydrochloride tablets affects you. You and your doctor may decide that you should keep taking this dose if you are doing well.
  • Check with your doctor 4 weeks after starting alosetron hydrochloride tablets:
  • oIf you try 0.5 mg two times a day for 4 weeks, it may not control your symptoms. If you do not get constipation or other side effects from alosetron hydrochloride tablets, your doctor may increase your dose up to 1 mg two times a day.
  • oIf 1 mg two times a day does not work after 4 weeks, alosetron hydrochloride tablets is not likely to help you. You should stop taking it and call your doctor.
  • Follow the instructions in the section “What is the most important information I should know about alosetron hydrochloride tablets?” about when you must stop taking the medicine and when you should call your doctor.

What are the possible side effects of alosetron hydrochloride tablets?

Alosetron hydrochloride tablets can cause serious side effects, including:

See “What is the most important information I should know about alosetron hydrochloride tablets?”

The most common side effects of alosetron hydrochloride tablets include:

  • oconstipation
  • ostomach (abdominal) discomfort and pain
  • onausea
  • ointestinal discomfort and pain

These are not all the possible side effects of alosetron hydrochloride tablets.

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

How should I store alosetron hydrochloride tablets?

  • Store alosetron hydrochloride tablets at 68º to 77ºF (20º to 25ºC). [See USP Controlled Room Temperature.]
  • Protect alosetron hydrochloride tablets from light and moisture.

Keep alosetron hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use of alosetron hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use alosetron hydrochloride tablets for a condition for which it was not prescribed. Do not give alosetron hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about alosetron hydrochloride tablets that is written for healthcare professionals.

What are the ingredients of alosetron hydrochloride tablets USP?

Active Ingredient: alosetron hydrochloride.

Inactive Ingredients: lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Trademarks are the property of their respective owners.

LUVOX is a registered trademark of Abbott Products, Inc., Abbott Park IL

Distr. By: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10006481/04

Revised January 2020

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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