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CANASA- mesalamine suppository


  1. Patient Information
  2. Advise Patients:
  3. Do Not Use Canasa If You Are:
  4. Canasa May Cause Serious Side Effects, Including:
  5. The Most Common Side Effects Of Canasa Include:
  6. How Should I Store Canasa?
  7. What Are The Ingredients In Canasa?
  8. Revised: 7/2017document Id:

Patient Information 

Advise patients to read the FDA-approved patient labeling (Patient Information)

Administration

Advise Patients: 

  • Do not cut or break the suppository.
  • Retain the suppository for one to three hours or longer, if possible.
  • If a dose of CANASA is missed, administer as soon as possible, unless it is almost time for next dose. Do not use two CANASA suppositories at the same time to make up for a missed dose.
  • CANASA suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Keep CANASA away from these surfaces to prevent staining.

Renal Impairment

Inform patients that CANASA may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their healthcare provider[
CANASA is a prescription medicine used to treat adults with active ulcerative proctitis (ulcerative rectal colitis).
It is not known if CANASA is safe and effective in children.

Do Not Use Canasa If You Are: 


  • allergic to medicines that contain salicylates, including aspirin.
  • allergic to mesalamine or any of the ingredients in CANASA.
    • Use CANASA exactly as prescribed by your doctor. Your doctor will tell you how long to continue using CANASA.
    • CANASA comes as a suppository that you insert into your rectum.
    • Do notcut or break the suppository.
    • Use CANASA 1 time each day at bedtime, for 3 to 6 weeks. It is not known if CANASA is safe and effective for use for longer than 6 weeks.
    • After you insert CANASA in your rectum, try to keep (retain) the suppository in your rectum for 1 to 3 hours or longer if possible.
    • If you miss a dose of CANASA, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
    • CANASA can stain surfaces including clothing and other fabrics, flooring, painted surfaces, marble, granite, vinyl and enamel. Keep CANASA away from these surfaces to prevent staining.

Canasa May Cause Serious Side Effects, Including: 


  • Kidney problems. Your doctor will do certain tests before you start using CANASA and during your treatment with CANASA.
  • Acute Intolerance Syndrome or Other Allergic Reactions.Some people who use CANASA can have allergic type reactions, including Acute Intolerance Syndrome. Other allergic reactions can cause heart problems including an inflammation of the sac around the heart (pericarditis), blood problems, and problems with other organs in the body including the kidneys, liver and lungs. These problems usually happen in people who have had an allergic reaction to medicines containing sulfasalazine. Stop using CANASA and tell your doctor right away if you get any of these symptoms:
  • cramps
  • stomach (abdominal) pain
  • bloody diarrhea
  • chest pain
  • decrease in the amount of urine
  • fever
  • headache
  • rash
  • shortness of breath
  • fatigue
  • Liver problems.This can happen in people who have a history of liver problems and have taken other medicines that contain mesalamine. Tell your doctor right away if you get any of these symptoms while using CANASA:
  • yellowing of your eyes
  • itchy skin
  • feeling very tired
  • flu-like symptoms
  • nausea or vomiting

The Most Common Side Effects Of Canasa Include: 

  • dizziness
  • acne
  • inflammation of the large intestine (colitis)
  • rectal pain
  • fever
  • rash
These are not all of the possible side effects of CANASA.
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 Canasa? 


  • Store CANASA at room temperature below 77 F (25 C).
  • CANASA may be refrigerated.
  • Keep CANASA away from direct heat, light, or humidity.
Keep CANASA and all medicines out of the reach of children.General information about the safe and effective use of CANASA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CANASA for a condition for which it was not prescribed. Do not give CANASA to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your doctor or pharmacist for information about CANASA that is written for health professionals.

What Are The Ingredients In Canasa? 


Active ingredients: mesalamine
Inactive ingredients: Hard Fat base
Distributed by: Allergan USA, Inc. Irvine, CA 92612
CANASAis a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. 2017 Allergan. All rights reserved.
Patented. Seewww.allergan.com/patents
For more information, go towww.canasa.comor call 1-800- 678-1605.

Principal Display Panel - Canasa Carton Label

NDC 58914-501-56

30 Rectal Suppositories

Canasa

(mesalamine) suppositories,

for rectal use 1000 mg

Rx only

For Rectal Use Only

Principal Display Panel - Canasa Carton Label

Principal Display Panel - Canasa Carton Label

NDC 58914-501-42

For Rectal Use Only

Canasa

(mesalamine) suppositories,

for rectal use 1000mg PAC

Pharmacy Label here

42 Rectal Suppositories

Rx only

Full Course of therapy

Principal Display Panel - Canasa Carton Label

Principal Display Panel - Canasa Carton Label

NDC 58914-501-33

3 Rectal Suppositories

Canasa

(mesalamine) suppositories,

for rectal use 1000 mg

PROFESSIONAL SAMPLE PACKAGE - NOT TO BE SOLD

Rx only

For Rectal Use Only

Principal Display Panel - Canasa Carton Label
CANASA
mesalamine suppository
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58914-501
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mesalamine(UNII: 4Q81I59GXC) (Mesalamine - UNII:4Q81I59GXC)Mesalamine1000 mg
Inactive Ingredients
Ingredient NameStrength
fat, hard(UNII: 8334LX7S21)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58914-501-5630 in 1 BOX; Type 0: Not a Combination Product01/05/2001
2NDC:58914-501-4242 in 1 BOX; Type 0: Not a Combination Product01/05/2001
3NDC:58914-501-333 in 1 BOX; Type 0: Not a Combination Product01/05/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02125201/05/2001
Labeler -Allergan (144796497)
Establishment
NameAddressID/FEIBusiness Operations
EndoCeutics Pharma (MSH) Inc203330217MANUFACTURE(58914-501)

Revised: 7/2017document Id: 

bcb9380c-f7f8-44b4-b453-c4feb7dd416bSet id: 89d91601-152b-4398-bebe-af1c023e9935Version: 16Effective Time: 20170701Allergan



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