you're taking [0.01:<0.001 Significant Rowasa /placebo difference. p> <0.05 N Baseline Day 22 End Point Change Baseline to End Point * Overall DAI Rowasa Placebo 76 77 7.42 7.40 4.05 6.03 3.37 5.83 -55.07% -21.58% Stool Frequency Rowasa Placebo 1.58 1.92 1.11 1.47 1.01 1.50 -0.57 -0.41 Rectal Bleeding Rowasa Placebo 1.82 1.73 0.59 1.21 0.51 1.11 -1.30 -0.61 Mucosal Inflammation Rowasa Placebo 2.17 2.18 1.22 1.74 0.96 1.61 -1.21 -0.56 Physician's Assessment of Disease Severity Rowasa Placebo 1.86 1.87 1.13 1.62 0.88 1.55 -0.97 -0.30 Differences between Rowasa (mesalamine) Rectal Suspension Enema and placebo were also statistically different in subgroups of patients on concurrent sulfasalazine and in those having an upper disease boundary between 5 and 20 or 20 and 40 cm. Significant differences between Rowasa (mesalamine) Rectal Suspension Enema and placebo were not achieved in those subgroups of patients on concurrent prednisone or with an upper disease boundary between 40 and 50 cm. Indications and Usage for Rowasa Rowasa (mesalamine) Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis. Contraindications Rowasa (mesalamine) Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication. Warnings 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. Precautions Mesalamine has been implicated in the production of an acute intolerance syndrome characterized by cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required. The patient's history of sulfasalazine intolerance, if any, should be re-evaluated. If a rechallenge is performed later in order to validate the hypersensitivity it should be carried out under close supervision and only if clearly needed, giving consideration to reduced dosage. In the literature one patient previously sensitive to sulfasalazine was rechallenged with 400 mg oral mesalamine; within eight hours she experienced headache, fever, intensive abdominal colic, profuse diarrhea and was readmitted as an emergency. She responded poorly to steroid therapy and two weeks later a pancolectomy was required. Although renal abnormalities were not noted in the clinical trials with Rowasa (mesalamine) Rectal Suspension Enema, the possibility of increased absorption of mesalamine and concomitant renal tubular damage as noted in the preclinical studies must be kept in mind. Patients on Rowasa (mesalamine) Rectal Suspension Enema, especially those on concurrent oral products which liberate mesalamine and those with preexisting renal disease, should be carefully monitored with urinalysis, BUN (blood urea nitrogen), and creatinine studies. In a clinical trial most patients who were hypersensitive to sulfasalazine were able to take mesalamine enemas without evidence of any allergic reaction. Nevertheless, caution should be exercised when mesalamine is initially used in patients known to be allergic to sulfasalazine. These patients should be instructed to discontinue therapy if signs of rash or fever become apparent. While using Rowasa (mesalamine) Rectal Suspension Enema, some patients have developed pancolitis. However, extension of upper disease boundary and/or flare-ups occurred less often in the Rowasa (mesalamine) Rectal Suspension Enema treated group than in the placebo-treated group. Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, may occur after commencing mesalamine. Rare instances of pericarditis have been reported with mesalamine containing products including sulfasalazine. Cases of pericarditis have also been reported as manifestations of inflammatory bowel disease. In the cases reported with Rowasa (mesalamine) Rectal Suspension Enema, there have been positive rechallenges with mesalamine or mesalamine containing products. In one of these cases, however, a second rechallenge with sulfasalazine was negative throughout a 2-month follow-up. Chest pain or dyspnea in patients treated with Rowasa (mesalamine) Rectal Suspension Enema should be investigated with this information in mind. Discontinuation of Rowasa (mesalamine) Rectal Suspension Enema may be warranted in some cases, but rechallenge with mesalamine can be performed under careful clinical observation should the continued therapeutic need for mesalamine be present. Carcinogenesis, Mutagenesis, Impairment of Fertility Mesalamine caused no increase in the incidence of neoplastic lesions over controls in a 2-year study of Wistar rats fed up to 320 mg/kg/day of mesalamine admixed with diet. Mesalamine is not mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537, TA1538. There were no reverse mutations in an assay using E. coli strain WP2UVRA. There were no effects in an in vivo mouse micronucleus assay at 600 mg/kg and in an in vivo sister chromatid exchange at doses up to 610 mg/kg. No effects on fertility were observed in rats receiving up to 320 mg/kg/day. The oligospermia and infertility in men associated with sulfasalazine has very rarely been reported among patients treated with mesalamine. Pregnancy Teratologic studies have been performed in rats and rabbits at oral doses up to five and eight times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus. There are, however, no adequate and well-controlled studies in pregnant women for either sulfasalazine or 5-ASA. Because animal reproduction studies are not always predictive of human response, 5-ASA should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether mesalamine or its metabolite(s) are excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk. Pediatric Use Safety and effectiveness in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-210-5949 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Adverse Reactions Clinical Adverse Experience Rowasa (mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient. ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF Rowasa (MESALAMINE) RECTAL SUSPENSION ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO) SYMPTOM Rowasa N=815 N % PLACEBO N=128 N % Abdominal Pain/Cramps/Discomfort 66 8.10 10 7.81 Headache 53 6.50 16 12.50 Gas/Flatulence 50 6.13 5 3.91 Nausea 47 5.77 12 9.38 Flu 43 5.28 1 0.78 Tired/Weak/Malaise/Fatigue 28 3.44 8 6.25 Fever 26 3.19 0 0.00 Rash/Spots 23 2.82 4 3.12 Cold/Sore Throat 19 2.33 9 7.03 Diarrhea 17 2.09 5 3.91 Leg/Joint Pain 17 2.09 1 0.78 Dizziness 15 1.84 3 2.34 Bloating 12 1.47 2 1.56 Back Pain 11 1.35 1 0.78 Pain on Insertion of Enema Tip 11 1.35 1 0.78 Hemorrhoids 11 1.35 0 0.00 Itching 10 1.23 1 0.78 Rectal Pain 10 1.23 0 0.00 Constipation 8 0.98 4 3.12 Hair Loss 7 0.86 0 0.00 Peripheral Edema 5 0.61 11 8.59 UTI/Urinary Burning 5 0.61 4 3.12 Rectal Pain/Soreness/Burning 5 0.61 3 2.34 Asthenia 1 0.12 4 3.12 Insomnia 1 0.12 3 2.34 In addition, the following adverse events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis, elevated liver enzymes, nephrogenic diabetes insipidus and intracranial hypertension. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease. Hair Loss Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss. Overdosage There have been no documented reports of serious toxicity in man resulting from massive overdosing with mesalamine. Under ordinary circumstances, mesalamine absorption from the colon is limited. Rowasa Dosage and Administration 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. How is Rowasa Supplied Rowasa (mesalamine) Rectal Suspension 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: NDC 0037-0066-01........................... Professional Sample NDC 0037-0066-05........................... Carton of 7 Bottles NDC 0037-0066-14........................... Carton of 14 Bottles NDC 0037-0066-03........................... Carton of 28 Bottles Rowasa (mesalamine) Rectal Suspension Enemas are for rectal use only. KEEP OUT OF REACH OF CHILDREN Patient instructions are included. Storage Store at controlled room temperature 20 to 25 C (68 to 77 F); excursions permitted, please refer to current USP. 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. 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. R x 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 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. R x 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 Next Interactions Print this page Add to My Med List More about Rowasa (mesalamine) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 6 Reviews Add your own review/rating Generic Availability Drug class: 5-aminosalicylates Consumer resources Rowasa rectal Rowasa Rowasa (Advanced Reading) Professional resources Mesalamine (AHFS Monograph) Mesalamine Rectal Suspension (FDA) Other brands: Lialda , Pentasa , Apriso , Asacol , ... +3 more Related treatment guides Ulcerative Proctitis Crohn's Disease Inflammatory Bowel Disease Ulcerative Colitis Ulcerative Colitis, Active> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only Pregnancy Category Risk depends on usage N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Meda Pharmaceuticals Inc. Drug Class 5-aminosalicylates Related Drugs 5-aminosalicylates sulfasalazine , Lialda , mesalamine , Pentasa , Apriso , Asacol Ulcerative Colitis prednisone , Humira , hydrocortisone , budesonide , dexamethasone , More... Crohn's Disease Humira , budesonide , azathioprine , hyoscyamine , Lialda , cyclosporine , More... Ulcerative Proctitis hydrocortisone , Lialda , mesalamine , Pentasa , Apriso , Asacol , More... 2 more conditions... Rowasa Rating 6 User Reviews 7.4 /10 6 User Reviews 7.4 Rate it!} } can be
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