RVP

Drug Catalog - Product Detail

MESALAMINE RECTAL SUSPENSION USP, ENEMA KIT KIT 4GM/60ML 7X60ML

NDC Mfr Size Str Form
45802-0923-41 PADAGIS 1 4GM KIT
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Description
DESCRIPTION The active ingredient in Mesalamine Rectal Suspension, USP 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. Structural Formula Image
How Supplied
HOW SUPPLIED Mesalamine Rectal Suspension, USP Enema for rectal administration is an off-white to tan colored suspension. Each disposable enema bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Enema bottles are supplied in boxed, foil-wrapped trays as follows: Carton of 7 Bottles - NDC 45802- 098 -51 Carton of 28 Bottles - NDC 45802- 098 -28 Combo Kit with 7 Bottles and Wipes - NDC 45802- 923 -41 Combo Kit with 28 Bottles and Wipes - NDC 45802- 929 -49 Mesalamine Rectal Suspension Enemas are for rectal use only. KEEP OUT OF REACH OF CHILDREN Patient instructions are included.
Indications & Usage
INDICATIONS AND USAGE Mesalamine Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.
Dosage and Administration
DOSAGE AND ADMINISTRATION The usual dosage of 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 Mesalamine Rectal Suspension Enema may be seen within three to twenty-one days, the usual course of therapy would be from three to six weeks depending on symptoms and sigmoidoscopic findings. Studies available to date have not assessed if Mesalamine Rectal Suspension Enema will modify relapse rates after the 6-week short-term treatment. 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.