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ALOSETRON HYDROCHLORIDE tablet, film coated


  1. Patient Information
  2. Revised: 9/2019document Id:
  3. Prescribers Must:
  4. Should Be Instructed To:
  5. For The First Time, You Should:
  6. 1. What Is The Most Important Information I Should Know About Alosetron Hydrochloride Tablets?
  7. A Medicine Only For Some Women With Severe Chronic Irritable Bowel Syndrome (ibs) Whose:
  8. 1. Serious Complications Of Constipation:
  9. 2. Ischemic Colitis (reduced Blood Flow To The Bowel):
  10. And Call Your Doctor Right Away If You Get:
  11. Right For You?
  12. Of The Following Is True For You:
  13. Alosetron Hydrochloride Tablets Are A Medicine Only For Some Women With Severe Chronic Ibs Whose:
  14. 3. Who Should Not Take Alosetron Hydrochloride Tablets?
  15. Talk With Your Doctor:
  16. What Is The Most Important Information I Should Know About Alosetron Hydrochloride Tablets?
  17. 7. How Should I Store Alosetron Hydrochloride Tablets?
  18. Active Ingredient:
  19. Inactive Ingredients:

Patient Information 

2

AVKARE
NDC 42291-124-30

Alosetron Hydrochloride Tablets
1 mg*
PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE.
30 Tablets Rx Only

*Each film-coated tablet contains alosetron
hydrochloride equivalent to 1 mg alosetron.
See prescribing information for Dosage and
Administration.
Store at 20 to 25 C (68 to 77 F); [See USP
Controlled Room Temperature]. Protect from
light and moisture.
Dispense in a tight, light-resistant container as
defined in the USP.
Keep out of the reach of children.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 01-2017-01 AV 02/17 (P)
N3 42291 123430 1

ALOSETRON HYDROCHLORIDE
alosetron hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42291-123(NDC:65162-248)
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 MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize11mm
FlavorImprint CodeAN248
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42291-123-3030 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20664702/23/2017
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42291-124(NDC:65162-249)
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 MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Product Characteristics
Colorblue (light blue)Scoreno score
ShapeOVALSize11mm
FlavorImprint CodeAN249
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42291-124-3030 in 1 BOTTLE; Type 0: Not a Combination Product02/23/201708/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20664702/23/201708/31/2019
Labeler -AvKARE, Inc. (796560394)

Revised: 9/2019document Id: 

91c0dde8-6242-1f38-e053-2995a90adfeaSet id: c0b3bb8c-ce68-4388-ac8d-9de70bce5fb1Version: 5Effective Time: 20190904AvKARE, Inc.

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.
  • 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.

Additional copies of the Medication Guide are available by contacting AvKARE, Inc. at 1-855-361-3993 or email:drugsafety@avkare.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.
  • 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.
  • 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.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 04-2016-00 AV 02/17 (P)

For The First Time, You Should: 

  • Understand that alosetron hydrochloride tablets have serious risks for some people.
  • Read and follow the directions in this Medication Guide.

Carefully 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.

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

A. 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.

1. Serious Complications Of Constipation: 

About 1 out of every 1,000 women who take alosetron hydrochloride tablets 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 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 tablets, do not start taking alosetron hydrochloride tablets 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 tablets 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 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.

To lower your chances of getting serious complications of ischemic colitis, stop taking alosetron hydrochloride tablets

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 tablets

Right For You? 

Alosetron hydrochloride tabletsmay 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 tablets works in men or children under age 18.

Alosetron Hydrochloride Tablets Are 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 tablets do 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.

Alosetron hydrochloride tablets are not recommended for children.

3. Who Should Not Take Alosetron Hydrochloride Tablets? 

Alosetron hydrochloride tablets are not right for everyone.Do not take alosetron hydrochloride tabletsifanyof 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).

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.

    • 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.
    • If you

      Constipation is the most common side effect among women with IBS who take alosetron hydrochloride tablets.Some patients have developed serious bowel side effects while taking alosetron hydrochloride tablets.Read the section

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

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

This Medication Guide does not tell you about all the possible side effects of alosetron hydrochloride tablets. 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 Tablets? 

  • Store alosetron hydrochloride tablets between 59 F to 86 F (15 C to 30 C).
  • Protect alosetron hydrochloride tablets from light and getting wet (moisture).

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

8. 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. If you have any questions or concerns about alosetron hydrochloride tablets, ask your doctor. Do not use alosetron hydrochloride tablets 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 tablets that was written for healthcare professionals. For more information you can contact AvKARE, Inc. at 1-855-361-3993 or email:drugsafety@avkare.com

Active Ingredient: 

alosetron hydrochloride.

Inactive Ingredients: 

lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film-coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film-coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide.

*Trademarks are the property of their respective owners.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

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

Mfg. Rev. 04-2016-00 AV 02/17 (P)



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