HOW SUPPLIED Mesalamine Rectal Suspension Enema for rectal administration is an offwhite 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:. NDC 43386-510-87; for 7 bottles Mesalamine Rectal Suspension Enemas are for rectal use only. KEEP OUT OF REACH OF CHILDREN Patient instructions are included. Storage and Handling Store at controlled room temperature 20° to 25°C (68° to 77°F); excusions permitted, please refer to current USP. Once the foilwrapped 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. NOTE: 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. Rx only Mfd. For: GAVIS Pharmaceuticals, LLC 400 Campus Drive, Somerset, NJ 08873 For Medical Inquiries, Call Toll Free: 1-866-403-7592 GIN-510-00 Rev. 08/09 PATIENT INSTRUCTIONS How to Use this Medication. Best results are achieved if the bowel is emptied immediately before the medication is given. NOTE: 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. 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. Cut Seal Grasp seam and tear down 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 Mfd. For: GAVIS Pharmaceuticals, LLC 400 Campus Drive, Somerset, NJ 08873 For Medical Inquiries, Call Toll Free: 1-866-403-7592 Rev. 08/09 cd11492c-figure-02 cd11492c-figure-03 cd11492c-figure-04 cd11492c-figure-05 cd11492c-figure-06