Rowasa

Name: Rowasa

Rowasa Drug Class

Rowasa is part of the drug class:

  • Aminosalicylic acid and similar agents

Other Requirements

  • Store Rowasa at room temperature.
  • Enema suspension: slight darkening of suspension will not affect quality of the medication. However, suspensions with dark brown solid contents should be discarded.
  • Enema suspension can cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.
  • Keep this and all medicines out of the reach of children.

What are some things I need to know or do while I take Rowasa?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Rowasa affects you.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • Some males have had sperm problems while taking Rowasa. This may affect being able to father a child. This may go back to normal after the drug is stopped. Talk with the doctor.
  • Use with care in children. Talk with the doctor.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye's syndrome. Reye's syndrome causes very bad problems to the brain and liver.
  • This medicine may stain fabric, flooring, painted surfaces, marble, granite, vinyl, and enamel.
  • If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Rowasa while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Rowasa Description

The active ingredient in Rowasa® (mesalamine) Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid.

The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is:

Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.

Contraindications

Rowasa® (mesalamine) Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.

Patient instructions

How to Use this Medication.

Best results are achieved if the bowel is emptied immediately before the medication is given.

NOTE: Rowasa® (mesalamine) Rectal Suspension Enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

1. Remove the Bottles a. Remove the bottles from the protective foil pouch by tearing or by using scissors as shown, being careful not to squeeze or puncture bottles. Rowasa® (mesalamine) Rectal Suspension Enema is an off-white to tan colored suspension. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded. 2. Prepare the Medication for Administration a. Shake the bottle well to make sure that the medication is thoroughly mixed.
b. Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the medication to be discharged. 3. Assume the Correct Body Position a. Best results are obtained by lying on the left side with the left leg extended and the right leg flexed forward for balance. b. An alternative to lying on the left side is the "knee-chest" position as shown here. 4. Administer the Medication a. Gently insert the lubricated applicator tip into the rectum to prevent damage to the rectal wall, pointed slightly toward the navel. b. Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back, squeeze slowly to instill the medication. Steady hand pressure will discharge most of the medication. After administering, withdraw and discard the bottle. c. Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the medication all night, if possible.

Rx only

IN-003606-02         Rev. 6/2017

Distributed by:

MEDA
PHARMACEUTICALS®

Somerset, New Jersey 08873-4120

©2017 Meda Pharmaceuticals Inc.

MEDA PHARMACEUTICALS and Rowasa are registered trademarks of
Meda AB or a related entity.

For Medical inquiries, Call Toll Free:
1-866-210-5949

www.Rowasa.com

Package Printed Bottle – Principal Display Panel - 60 mL bottle

60 mL

NDC 0037-0066-06

Rowasa®
(mesalamine) 4.0g/60mL
Rectal Suspension Enema

FOR RECTAL USE ONLY
Rx ONLY

Distributed by:
MEDA
PHARMACEUTICALS®
Somerset, New Jersey 08873-4120

©2013 Meda Pharmaceuticals Inc.

www.Rowasa.com

Rowasa 
mesalamine suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-0066
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 4 g  in 60 mL
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:0037-0066-05 7 BOTTLE, DISPENSING in 1 CARTON
1 NDC:0037-0066-06 60 mL in 1 BOTTLE, DISPENSING
2 NDC:0037-0066-03 28 BOTTLE, DISPENSING in 1 CARTON
2 NDC:0037-0066-06 60 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019618 03/29/2016
Labeler - Meda Pharmaceuticals (051229602)
Revised: 06/2017   Meda Pharmaceuticals
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