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ALOSETRON HYDROCHLORIDE tablet


  1. A. Alosetron Hydrochloride Is A Medicine Only For Some Women With Severe Chronic Irritable Bowel Syndrome (ibs) Whose:
  2. 1. Serious Complications Of Constipation:
  3. 2. Ischemic Colitis (reduced Blood Flow To The Bowel):
  4. To Lower Your Chances Of Getting Serious Complications Of Ischemic Colitis, Stop Taking Alosetron Hydrochloride And Call Your Doctor Right Away If You Get:
  5. C. Are Alosetron Hydrochloride Right For You?
  6. Of The Following Is True For You:
  7. Alosetron Hydrochloride Is A Medicine Only For Some Women With Severe Chronic Ibs Whose:
  8. 3. Who Should Not Take Alosetron Hydrochloride?
  9. What Is The Most Important Information I Should Know About Alosetron Hydrochloride?
  10. 7. How Should I Store Alosetron Hydrochloride?
  11. Active Ingredient:
  12. Distributed By:
  13. Revised: 12/2018document Id:
  14. Patient Information
  15. Are A Medicine Only For Some Women With Severe Chronic Irritable Bowel Syndrome (ibs) Whose:
  16. Serious Complications Of Constipation:
  17. Inflammation And Injury Of The Intestines Caused By Reduced Blood Flow (ischemic Colitis:
  18. Alosetron Hydrochloride Tablets Are A Prescription Medicine Used Only For Some Women With Severe Chronic Ibs Whose:
  19. Alosetron Hydrochloride Tablets?
  20. Alosetron Hydrochloride Tablets If You:
  21. Talk With Your Doctor:
  22. The Most Common Side Effects Of Alosetron Hydrochloride Tablets Include:
  23. Dist. By:
  24. Mfg. By:
  25. Prescribers Must:
  26. Patients Who Are Prescribed Alosetron Hydrochloride Tablets Should Be Instructed To:
  27. Alosetron Hydrochloride Tablets Are A Medicine Only For Some Women With Severe Chronic Irritable Bowel Syndrome (ibs) Whose:
  28. Inflammation And Injury Of The Intestines Caused By Reduced Blood Flow (ischemic Colitis):
  29. Do Not Take Alosetron Hydrochloride Tablets If You:
  30. How Should I Store Alosetron Hydrochloride Tablets?
  31. Inactive Ingredients:

A. 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.

B. Some patients have developed serious bowel side effects while taking alosetron hydrochloride. Serious bowel (intestine) side effects can happen suddenly, including the following.

1. Serious Complications Of Constipation: 

About 1 out of every 1,000 women who take alosetron hydrochloride may get serious complications of constipation. These complicationsmay 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.

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

  • If you are constipated,do not start taking alosetron hydrochloride.
  • If you get constipated while taking alosetron hydrochloride,stop taking it right away and call your doctor.
  • If your constipation does not get better after stopping alosetron hydrochloride,call your doctor again.
  • If you stopped taking alosetron hydrochloride, do not start taking alosetron hydrochloride againunless your doctor tells you to do so.

2. Ischemic Colitis (reduced Blood Flow To The Bowel): 

About 3 out of every 1,000 women who take alosetron hydrochloride over a 6-month period may get a serious problem where blood flow to parts of the large bowel is reduced. This is called ischemic colitis. The chance of getting ischemic colitis when you take alosetron hydrochloride 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.


To Lower Your Chances Of Getting Serious Complications Of Ischemic Colitis, Stop Taking Alosetron Hydrochloride And Call Your Doctor Right Away If You Get: 

  • new or worse pain in your stomach area (abdomen) or
  • blood in your bowel movements.

C. Are Alosetron Hydrochloride Right For You? 




Alosetron hydrochloride may be right for you ifallof these things are true about you:

  • Your doctor has told you that your symptoms are due to IBS.
  • Your IBS bowel problem is diarrhea.
  • Your IBS has lasted for 6 months or longer.
  • You tried other IBS treatments and they did not give you the relief you need.
  • Your IBS is severe.

You can tell if your IBS is severe ifat least 1

Of The Following Is True For You: 

  • You have lots of painful stomach cramps or bloating.
  • You often cannot control the need to have a bowel movement, or you have accidents where your underwear gets dirty from diarrhea or bowel movements.
  • You cannot lead a normal home or work life because you need to be near a bathroom.

Enough testing has not been done to confirm if alosetron hydrochloride works in men or children under age 18.

Alosetron Hydrochloride Is A Medicine 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 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, your IBS symptoms may return within 1 or 2 weeks to what they were before you started taking alosetron hydrochloride.

Alosetron hydrochloride tablets are not recommended for children.

3. Who Should Not Take Alosetron Hydrochloride? 

Alosetron hydrochloride is not right for everyone.Do not take Alosetron hydrochloride ifanyof the following apply to you:

  • Your main IBS problem is constipation or you are constipated most of the time.
  • You have had a serious problem from constipation.If you are constipated now,do not start taking alosetron hydrochloride tablets.
  • You have had serious bowel blockages.
  • You have had blood flow problems to your bowels, such as ischemic colitis.
  • You have had blood clots.
  • You have had Crohn's disease, ulcerative colitis, diverticulitis, or severe liver disease.
  • You do not understand this Medication Guide or you are not willing to follow it.
  • You are taking fluvoxamine (LUVOX ).

What Is The Most Important Information I Should Know About Alosetron Hydrochloride? 

at the beginning of this Medication Guide for information about the serious side effects you may get with alosetron hydrochloride.

This Medication Guide does not tell you about all the possible side effects of alosetron hydrochloride. Your doctor or pharmacist can give you a more complete list.

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

7. How Should I Store Alosetron Hydrochloride? 

Store alosetron hydrochloride between 59 F to 86 F (15 C to 30 C).

Protect alosetron hydrochloride from light and getting wet (moisture).

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

8. General information about the safe and effective use of alosetron hydrochloride

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any questions or concerns about alosetron hydrochloride, ask your doctor. Do not use alosetron hydrochloride for a condition for which it was not prescribed. Do not share your medicine with other people. It may harm them.

Your doctor or pharmacist can give you more information about alosetron hydrochloride that was written for healthcare professionals. You can also contact the company that makes alosetron hydrochloride (toll free) at 1-844-732-3521 or at www.lotronex.com.

Active Ingredient: 

alosetron hydrochloride.

Distributed By: 




Actavis Pharma, Inc.



Parsippany, NJ 07054

Made in CANADA

January October



PI480031016

0.5mg Bottle Label

Principal Display Panel - Bottle Label

actavis

NDC 45963-479-03Rx Only30 tablets

Alosetron Hydrochloride



Tablets 0.5 mg

Each film-coated tablet contains alosetron



hydrochloride equivalent to 0.5 mg alosetron.

0.5mg CartonPrincipal 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 45963-480-03Rx Only30 tablets

Alosetron Hydrochloride



Tablets 1 mg

Each film-coated tablet contains alosetron



hydrochloride equivalent to 1 mg alosetron.

1 mg Bottle Label

1mg Carton

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:45963-479
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALOSETRON HYDROCHLORIDE(UNII: 2F5R1A46YW) (ALOSETRON - UNII:13Z9HTH115)ALOSETRON0.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Colorwhite (white)Scoreno score
ShapeOVAL (OVAL)Size11mm
FlavorImprint CodeGX;EX1
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45963-479-031 in 1 CARTON05/26/2015
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02110705/26/2015
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:45963-480
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALOSETRON HYDROCHLORIDE(UNII: 2F5R1A46YW) (ALOSETRON - UNII:13Z9HTH115)ALOSETRON1 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
Product Characteristics
Colorblue (blue)Scoreno score
ShapeOVAL (OVAL)Size11mm
FlavorImprint CodeGX;CT1
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45963-480-031 in 1 CARTON05/26/2015
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02110705/26/2015
Labeler -Actavis Pharma, Inc. (119723554)
Registrant -Sebela Pharmaceuticals Inc. (079104574)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Inc.240769596manufacture(45963-479, 45963-480)

Revised: 12/2018document Id: 

7d8ab83e-2a7c-3eb1-e053-2a91aa0a723aSet id: 969429cb-60b9-4a9c-be60-dd01994431b2Version: 8Effective Time: 20181221Actavis Pharma, Inc.

Patient Information 

MEDICATION GUIDE

Alosetron Hydrochloride Tablets

(a-LOE-se-tron HYE-droe-KLOR-ide)

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 aboutalosetron 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.

Serious Complications Of Constipation: 

These complicationsmay 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 takingalosetron hydrochloride tablets, stop taking it right away and call your doctor.
  • If your constipation does not get better after stoppingalosetron hydrochloride tablets, call your doctor again.
  • If you stopped takingalosetron hydrochloride tablets, do not start takingalosetron hydrochloride tabletsagainunless 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 takingalosetron hydrochloride tabletsand call your doctoror 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 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 takingalosetron 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

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.
  • any allergies that you have.

    • 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 about when you must stop taking the medicine and when you should call your doctor.

    What are the possible side effects ofalosetron hydrochloride tablets?

    Alosetron hydrochloride tablets

The Most Common Side Effects Of Alosetron Hydrochloride Tablets Include: 

  • constipation
  • stomach (abdominal) discomfort and pain
  • onausea
  • 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 storealosetron hydrochloride tablets?

  • Store alosetron hydrochloride tablets at room temperature between 68 to 77 F (20 to 25 C).
  • Protect alosetron hydrochloride tablets from light and moisture.

Keepalosetron hydrochloride tabletsand all medicines out of the reach of children.

General information about the safe and effective use ofalosetron 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 ofalosetron hydrochloride tablets?

Dist. By: 

ParPharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

Mfg. By: 

Par Formulations Private Limited,

9/215, Pudupakkam, Kelambakkam - 603 103.

Made in India

Mfg.Lic.No:TN00002121

PD819-01-74-02

Revised: 04/2019


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

10006481/03

Revised April 2019

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.

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 doctoror 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.

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 ).

How Should I Store Alosetron Hydrochloride Tablets? 

Store alosetron hydrochloride tablets at 68 to 77 F (20 to 25 C). [

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.

Distr. By:West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10006481/03

Revised April 2019



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