Rowasa
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Questions & Answers
Side Effects & Adverse Reactions
ROWASA® (mesalamine) Rectal Suspension Enema contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low. Sulfite sensitivity is seen more frequently in asthmatic or in atopic nonasthmatic persons.
Epinephrine is the preferred treatment for serious allergic or emergency situations even though epinephrine injection contains sodium or potassium metabisulfite with the above-mentioned potential liabilities. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite(s) in epinephrine injection should not deter the administration of the drug for treatment of serious allergic or other emergency situations.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ROWASA® (mesalamine) Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Rowasa Manufacturers
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Alaven Pharmaceutical Llc
![Rowasa (Mesalamine) Enema [Alaven Pharmaceutical Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rowasa | Alaven Pharmaceutical Llc
The usual dosage of ROWASA® (mesalamine) Rectal Suspension Enema in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. While the effect of ROWASA® (mesalamine) Rectal Suspension Enema may be seen within 3 to 21 days, the usual course of therapy would be from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Studies available to date have not assessed if ROWASA® (mesalamine) Rectal Suspension Enema will modify relapse rates after the 6-week short-term treatment. ROWASA® (mesalamine) Rectal Suspension Enema is for rectal use only.
Patients should be instructed to shake the bottle well to make sure the suspension is homogeneous. The patient should remove the protective sheath from the applicator tip. Holding the bottle at the neck will not cause any of the medication to be discharged. The position most often used is obtained by lying on the left side (to facilitate migration into the sigmoid colon); with the lower leg extended and the upper right leg flexed forward for balance. An alternative is the knee-chest position. The applicator tip should be gently inserted in the rectum pointing toward the umbilicus. A steady squeezing of the bottle will discharge most of the preparation. The preparation should be taken at bedtime with the objective of retaining it all night. Patient instructions are included with every seven units.
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