Drug Facts
Composition & Profile
Identifiers & Packaging
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: Combo Kit with 28 Bottles and Wipes - NDC 63629-8679-1 Mesalamine rectal suspension enemas are for rectal use only. KEEP OUT OF REACH OF CHILDREN Patient instructions are included. Storage Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. 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: 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. For more information call Padagis at 1-866-634-9120. Rx Only; Mesalamine Rectal Suspension, Enema 4g/60 mL Label
- 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: Combo Kit with 28 Bottles and Wipes - NDC 63629-8679-1 Mesalamine rectal suspension enemas are for rectal use only. KEEP OUT OF REACH OF CHILDREN Patient instructions are included. Storage Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. 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: 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. For more information call Padagis at 1-866-634-9120. Rx Only
- Mesalamine Rectal Suspension, Enema 4g/60 mL Label
Overview
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 C 7 H 7 NO 3 , 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
Indications & Usage
Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
Dosage & Administration
The recommended adult 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 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 mesalamine rectal suspension enema will modify relapse rates after the 6-week short-term treatment. Mesalamine rectal suspension enema is for rectal use only. Drink an adequate amount of fluids during treatment. 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.
Warnings & Precautions
WARNINGS Hypersensitivity Reactions Sulfite-Related Reactions 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. Sulfasalazine-Associated Reactions Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to mesalamine rectal suspension enema or to other compounds that contain or are converted to mesalamine. As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue mesalamine rectal suspension enema if an alternative etiology for the signs and symptoms cannot be established. Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure have been reported in patients given products that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity. Evaluate the risks and benefits of using mesalamine rectal suspension enema in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on mesalamine rectal suspension enema therapy. Mesalamine-Induced Acute Intolerance Syndrome Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence cannot be ascertained, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with mesalamine rectal suspension enema.
Contraindications
Mesalamine rectal suspension enema is contraindicated for patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication.
Adverse Reactions
Clinical Adverse Experience - 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 MESALAMINE RECTAL SUSPENSION ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO) MESALAMINE RECTAL SUSPENSION ENEMA PLACEBO SYMPTOM N=815 N % 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, intracranial hypertension and nephrolithiasis. 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. Postmarketing cases of severe cutaneous adverse reactions (SJS/TEN, DRESS, and AGEP) and pleurisy/pleuritis have been reported. Hair Loss Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in seven 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.
Drug Interactions
Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions. Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of mesalamine rectal suspension enema and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
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