Alosetron Hydrochloride (Page 6 of 6)

14.3 Long-Term Use

In a 48-week multinational, double-blind, placebo-controlled study, alosetron hydrochloride 1 mg twice daily was evaluated in 714 women with non-constipated IBS. A retrospective analysis of the subset of women with severe diarrhea-predominant IBS (urgency on at least 10 days during the 2-week baseline period) was performed. Of the 417 patients with severe diarrhea-predominant IBS, 62% completed the trial.

Alosetron hydrochloride (n = 198) provided a greater average rate of adequate relief of IBS pain and discomfort (52% vs. 41%) and a greater average rate of satisfactory control of bowel urgency (60% vs. 48%) compared with placebo (n = 219). Significant improvement of these symptoms occurred for most of the 48-week treatment period with no evidence of tachyphylaxis.

15 REFERENCES

  1. Thompson WG, Creed F, Drossman DA, et al. Functional bowel disease and functional abdominal pain. Gastroenterol Int. 1992;5:75-91.

16 HOW SUPPLIED/STORAGE AND HANDLING

Alosetron hydrochloride Tablets, 0.5 mg (0.562 mg alosetron HCl equivalent to 0.5 mg alosetron) are white, oval, film-coated tablets debossed with GX EX1 on one face. Bottles of 30 (NDC 45963-479-03) with child-resistant closures.

Alosetron hydrochloride Tablets, 1 mg (1.124 mg alosetron HCl equivalent to 1 mg alosetron), are blue, oval, film-coated tablets debossed with GX CT1 on one face. Bottles of 30 (NDC 45963-480-03) with child-resistant closures.

Store at 20-25˚C (USP Controlled Room Temperature). Protect from light and moisture.

17 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 before an initial prescription is written. The patient may be educated by the prescriber or a healthcare provider under a prescriber’s direction. Patients should be fully counseled on and understand the risks and benefits of alosetron hydrochloride 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 is appropriate about the benefits and risks of alosetron hydrochloride and discuss the impact of IBS symptoms on the patient’s life. counsel patients for whom alosetron hydrochloride is appropriate about the benefits and risks of alosetron hydrochloride 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, and instruct the patient to read it carefully. Answer all questions the patient may have about alosetron hydrochloride. The complete text of the Medication Guide is printed at the end of this document. review the Medication Guide, which outlines the benefits and risks of alosetron hydrochloride, and instruct the patient to read it carefully. Answer all questions the patient may have about alosetron hydrochloride. 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. provide each patient with appropriate instructions for taking alosetron hydrochloride.

Additional copies of the Medication Guide are available by contacting the company that makes alosetron hydrochloride tablets at 1-888-423-5227 or visiting www.lotronex.com. Additional copies of the Medication Guide are available by contacting the company that makes alosetron hydrochloride tablets at 1-888-423-5227 or visiting www.lotronex.com.

Patients who are prescribed alosetron hydrochloride should be instructed to:

  • read the Medication Guide before starting alosetron hydrochloride and each time they refill their prescription. read the Medication Guide before starting alosetron hydrochloride and each time they refill their prescription.
  • not start taking alosetron hydrochloride if they are constipated. not start taking alosetron hydrochloride if they are constipated.
  • immediately discontinue alosetron hydrochloride 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. Resume alosetron hydrochloride only if their constipation has resolved and after discussion with and the agreement of their treating prescriber. immediately discontinue alosetron hydrochloride 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. Resume alosetron hydrochloride only if their constipation has resolved and after discussion with and the agreement of their treating prescriber.
  • stop taking alosetron hydrochloride and contact their prescriber if alosetron hydrochloride does not adequately control IBS symptoms after 4 weeks of taking 1 mg twice a day. stop taking alosetron hydrochloride and contact their prescriber if alosetron hydrochloride does not adequately control IBS symptoms after 4 weeks of taking 1 mg twice a day.

MEDICATION GUIDEALOSETRON HYDROCHLORIDE (a-LOE-se-tron HYE-droe-KLOR-ide) TABLETS

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 is 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:

If you are constipated, do not start taking alosetron hydrochloride tablets.
If you get constipated while taking alosetron hydrochloride tablets, stop taking it right away and call your doctor.
If your constipation does not get better after stopping alosetron hydrochloride tablets, call your doctor again.
If you stopped taking alosetron hydrochloride, do not start taking alosetron hydrochloride 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 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 usedonly 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 does not cure IBS, and it may not help every person who takes it. For those who are helped, alosetron hydrochloride 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?

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.
You are taking fluvoxamine (LUVOX).

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

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 take alosetron hydrochloride tablets.

How should I take alosetron hydrochloride tablets?

Take alosetron hydrochloride tablets exactly as your doctor prescribes them. You can take alosetron hydrochloride with or without food.
Begin with 0.5 mg two times a day for 4 weeks to see how alosetron hydrochloride tablets affect 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:
If 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.
If 1 mg two times a day does not work after 4 weeks, alosetron hydrochloride tablets are 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 tables may 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 talets include:

constipation
stomach (abdominal) discomfort and pain
nausea
intestinal 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 between 68ºF to 77ºF (20ºC to 25ºC).
Protect alosetron hydrochloride from light and moisture.

Keep alosetron hydrochloride 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 oter 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?

Active Ingredient: alosetron hydrochloride.

Inactive Ingredients: lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film-coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film-coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.

Brands listed are the trademarks of their respective owners.

Distributed by:
Actavis Pharma, Inc. Parsippany, NJ 07054

Made in CANADA

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

Revised April 2019

0.5mg Bottle Label
(click image for full-size original)

Principal Display Panel — Bottle Label

actavis

NDC 45963- 479 -03 Rx Only 30 tablets

Alosetron Hydrochloride Tablets 0.5 mg

Each film-coated tablet contains alosetron hydrochloride equivalent to 0.5 mg alosetron.

0.5mg Carton
(click image for full-size original)
Principal Display Panel — Carton Label

actavis

NDC 45963- 479 -03

Rx only

Alosetron
Hydrochloride
Tablets

0.5 mg

Each film-coated tablet contains alosetron
hydrochloride equivalent to 0.5 mg alosetron.

30 tablets

Principal Display Panel — Bottle Label

actavis

NDC 45963- 480 -03 Rx Only 30 tablets

Alosetron Hydrochloride
Tablets 1 mg

Each film-coated tablet contains alosetron hydrochloride equivalent to 1 mg alosetron.

1 mg Bottle Label
(click image for full-size original)

1mg Carton
(click image for full-size original)

Principal Display Panel — Carton Label

actavis

NDC 45963- 480 -03

Rx only

Alosetron
Hydrochloride
Tablets

1 mg

Each film-coated tablet contains alosetron hydrochloride equivalent to 1 mg alosetron.

30 tablets

ALOSETRON HYDROCHLORIDE alosetron hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-479
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALOSETRON HYDROCHLORIDE (ALOSETRON) ALOSETRON 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
HYPROMELLOSES
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white (white) Score no score
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code GX;EX1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-479-03 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (45963-479-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021107 05/26/2015
ALOSETRON HYDROCHLORIDE alosetron hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-480
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALOSETRON HYDROCHLORIDE (ALOSETRON) ALOSETRON 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
HYPROMELLOSES
TITANIUM DIOXIDE
TRIACETIN
INDIGOTINDISULFONATE SODIUM
Product Characteristics
Color blue (blue) Score no score
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code GX;CT1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-480-03 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (45963-480-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021107 05/26/2015
Labeler — Actavis Pharma, Inc. (119723554)
Registrant — Sebela Pharmaceuticals Inc. (079104574)
Establishment
Name Address ID/FEI Operations
Patheon Inc. 240769596 manufacture (45963-479), manufacture (45963-480)

Revised: 10/2019 Actavis Pharma, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.