DESCRIPTION
The active ingredient in ROWASA® 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.
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.
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