Mesalamine

• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light.

• Mesalamine is an oral drug used for treating ulcerative colitis.
• Lialda is mesalamine in a form that is slowly released in the intestine so that it can be given just once-a-day.
• Other oral drugs containing mesalamine that are similar to Lialdainclude Asacol, Pentasa, and Apriso.
• Asacol and Pentasa, however, are given as multiple daily doses.
• The exact mechanism of mesalamine is not known but is believed to be by reducing inflammation in the colon.
• Ulcerative colitis and other inflammatory diseases cause excessive production of chemicals (i.e., prostaglandins) that produce inflammation in the colon.
• Prostaglandins are produced by cyclooxygenase and lipoxygenase enzymes.
• These enzymes are over-active in individuals with ulcerative colitis.
• Mesalamine may work by blocking the activity of cyclooxygenase and lipoxygenase, therefore, reducing the production of prostaglandins.
• Reduced prostaglandin production reduces inflammation in the colon and other symptoms associated with ulcerative colitis.
• The FDA approved Lialda in January 2007.

Lialda

The most common side effects are:

• headache,
• flatulence,
• hair loss, and
• itching.

Other less common side effects include:

• increased heart rate,
• acne,
• pancreatitis,
• back pain,
• fatigue,
• tremor,
• ear pain,
• blood disorders, and
• kidney dysfunction.

Possible serious side effects include an acute intolerance syndrome that resembles a flare of inflammatory bowel disease. Symptoms include:

• cramping,
• acute abdominal pain, 
• bloody diarrhea,
• fever,
• headache,
• itching, and
• rash.

These symptoms usually subside once mesalamine is discontinued. Since mesalamine is related chemically to aspirin, individuals who are allergic to aspirin should not take mesalamine.

Common Side Effects

Tell your doctor if any of the following side effects are severe or don't go away:

• Headache
• Nausea or stomach pain
• Infection or inflammation of the nose and throat
• Flare-ups in bowel condition

Serious Side Effects

The following serious side effects require urgent medical attention:

• Kidney disease, inflammation, or failure
• Liver disease or failure
• Infection or inflammation of the muscles or lining of the heart
• Blood abnormalities
• Allergic reactions
• A severe reaction called acute intolerance syndrome, which may involve abdominal pain, fever, and severe or bloody diarrhea

If you experience any symptoms of acute intolerance syndrome, stop taking mesalamine and contact your doctor right away.

Each LIALDA delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5- ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2- hydroxybenzoic acid and its structural formula is:

Molecular formula: C7H7NO3

Molecular weight: 153.14

The tablet is coated with a pH dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine.

The inactive ingredients of LIALDA are sodium carboxymethylcellulose, carnauba wax, stearic acid, silica (colloidal hydrated), sodium starch glycolate (type A), talc, magnesium stearate, methacrylic acid copolymer types A and B, triethylcitrate, titanium dioxide, red ferric oxide and polyethylene glycol 6000.

Mechanism Of Action

The mechanism of action of mesalamine is not fully understood, but appears to have a topical antiinflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

Mesalamine has the potential to inhibit the activation of nuclear factor kappa B (NF?B) and consequently the production of key pro-inflammatory cytokines. It has been proposed that reduced expression of PPAR? nuclear receptors (?-form of peroxisome proliferator-activated receptors) may be implicated in ulcerative colitis. There is evidence that mesalamine produces pharmacodynamic effects through direct activation of PPAR? receptors in the colonic/rectal epithelium.

Pharmacodynamics

The pharmacodynamic actions of mesalamine occur in the colonic/rectal mucosae local to the delivery of drug from LIALDA into the lumen. There is information suggesting that severity of colonic inflammation in ulcerative colitis patients treated with mesalamine is inversely correlated with mucosal concentrations of mesalamine. Plasma concentrations representing systemically absorbed mesalamine are not believed to contribute extensively to efficacy.

Pharmacokinetics

The total absorption of mesalamine from LIALDA 2.4 g or 4.8 g given once daily for 14 days to healthy volunteers was found to be approximately 21-22% of the administered dose.

Gamma-scintigraphy studies have shown that a single dose of LIALDA 1.2 g (one tablet) passed intact through the upper gastrointestinal tract of fasted healthy volunteers. Scintigraphic images showed a trail of radio-labeled tracer in the colon, suggesting that mesalamine had distributed through this region of the gastrointestinal tract.

In a single dose study, LIALDA 1.2 g, 2.4 g and 4.8 g were administered in the fasted state to healthy subjects. Plasma concentrations of mesalamine were detectable after 2 hours and reached a maximum by 9-12 hours on average for the doses studied. The pharmacokinetic parameters are highly variable among subjects (Table 3). Mesalamine systemic exposure in terms of area under the plasma concentration-time curve (AUC) was slightly more than dose proportional between 1.2 g and 4.8 g LIALDA. Maximum plasma concentrations (C ) of mesalamine increased approximately dose proportionately between 1.2 g and 2.4 g and sub-proportionately between 2.4 g and 4.8 g LIALDA, with the dose normalized value at 4.8 g representing, on average, 74% of that at 2.4 g based on geometric means.

Table 3: Mean (SD) PK Parameters for Mesalamine Following Single Dose Administration of LIALDA Under Fasting Conditions

Administration of a single dose of LIALDA 4.8 g with a high fat meal resulted in further delay in absorption, and plasma concentrations of mesalamine were detectable 4 hours following dosing. However, a high fat meal increased systemic exposure of mesalamine (mean C : ↑ 91%; mean AUC: ↑ 16%) compared to results in the fasted state. LIALDA was administered with food in the controlled clinical trials that supported its approval.

In a single and multiple dose pharmacokinetic study of LIALDA, 2.4 g or 4.8 g was administered once daily with standard meals to 28 healthy volunteers per dose group. Plasma concentrations of mesalamine were detectable after 4 hours and were maximal by 8 hours after the single dose. Steady state was achieved generally by 2 days after dosing. Mean AUC at steady state was only modestly greater (1.1- to 1.4-fold) than predictable from single dose pharmacokinetics.

In a single dose pharmacokinetic study of LIALDA, 4.8 g was administered in the fasted state to 71 healthy male and female volunteers (28 young (18-35yrs); 28 elderly (65-75yrs); 15 elderly (>75yrs)). Increased age resulted in increased systemic exposure (approximately 2-fold in C ), to mesalamine and its metabolite N-acetyl-5-aminosalicylic acid. Increased age resulted in a slower apparent elimination of mesalamine, though there was high between-subject variability. Systemic exposures in individual subjects were inversely correlated with renal function as assessed by estimated creatinine clearance.

Table 4: Mean (SD) PK Parameters for Mesalamine Following Single Dose Administration of LIALDA 4.8 g under Fasting Conditions to Young and Elderly Subjects

Mesalamine is approximately 43% bound to plasma proteins at the concentration of 2.5 µg/mL.

The only major metabolite of mesalamine (5-aminosalicylic acid) is N-acetyl-5-aminosalicylic acid. Its formation is brought about by N-acetyltransferase (NAT) activity in the liver and intestinal mucosa cells, principally by NAT-1.

Elimination of mesalamine is mainly via the renal route following metabolism to N-acetyl-5- aminosalicylic acid (acetylation). However, there is also limited excretion of the parent drug in urine. Of the approximately 21-22% of the dose absorbed, less than 8% of the dose was excreted unchanged in the urine after 24 hours, compared with greater than 13% for N-acetyl-5-aminosalicylic acid. The apparent terminal half-lives for mesalamine and its major metabolite after administration of LIALDA 2.4 g and 4.8 g were, on average, 7-9 hours and 8-12 hours, respectively.

Drug Interactions:

The potential effect of Lialda (4.8 g given once daily) on the pharmacokinetics of four commonly used antibiotics were evaluated in healthy subjects. The four antibiotics studied and their dosing regimens were as follows: amoxicillin (single 500 mg dose), ciprofloxacin XR (single 500 mg dose), metronidazole (750 mg twice daily for 3.5 days), and sulfamethoxazole/trimethoprim (800 mg/160 mg twice daily for 3.5 days). Coadministration of Lialda did not result in clinically significant changes in the pharmacokinetics of any of the four antibiotics. The change in Cmax and AUC of amoxicillin, ciprofloxacin and metronidazole when they were co-administered with Lialda were all ≤ 3%. There was an increase of 12% in Cmax and an increase of 15% in AUC of sulfamethoxazole when sulfamethoxazole/trimethoprim was coadministered with Lialda [see DRUG INTERACTIONS].

Animal Toxicology And/Or Pharmacology

In animal studies with mesalamine, a 13-week oral toxicity study in mice and 13-week and 52-week oral toxicity studies in rats and cynomolgus monkeys have shown the kidney to be the major target organ of mesalamine toxicity. Oral daily doses of 2400 mg/kg in mice and 1150 mg/kg in rats produced renal lesions including granular and hyaline casts, tubular degeneration, tubular dilation, renal infarct, papillary necrosis, tubular necrosis, and interstitial nephritis. In cynomolgus monkeys, oral daily doses of 250 mg/kg or higher produced nephrosis, papillary edema, and interstitial fibrosis.

Clinical Studies

Two similarly designed, randomized, double blind, placebo-controlled trials were conducted in 517 adult patients with active, mild to moderate ulcerative colitis. The study population was primarily Caucasian (80%), had a mean age of 42 years (6% age 65 years or older), and was approximately 50% male. Both studies used LIALDA doses of 2.4 g/day and 4.8 g/day administered once daily for 8 weeks except for the 2.4 g/day group in Study 1, which was given in two divided doses (1.2 g twice daily). The primary efficacy end-point in both trials was to compare the percentage of patients in remission after 8 weeks of treatment for the LIALDA treatment groups versus placebo. Remission was defined as an Ulcerative Colitis Disease Activity Index (UC-DAI) of ≤ 1, with scores of zero for rectal bleeding and for stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline.

In both studies, the LIALDA doses of 2.4 g/day and 4.8 g/day demonstrated superiority over placebo in the primary efficacy endpoint (Table 5). Both LIALDA doses also provided consistent benefit in secondary efficacy parameters, including clinical improvement, treatment failure, clinical remission, and sigmoidoscopic improvement. LIALDA 2.4 g/day and 4.8 g/day had similar efficacy profiles.

Table 5: Patients in Remission at Week 8

A multicenter, randomized, double-blind, active comparator study was conducted in a total of 826 adult patients in remission from ulcerative colitis. The study population had a mean age of 45 years (8% age 65 years or older), were 52% male, and were primarily Caucasian (64%).

Maintenance of remission was assessed using a modified Ulcerative Colitis Disease Activity Index (UC-DAI). For this trial, maintenance of remission was based on maintaining endoscopic remission defined as a modified UC-DAI endoscopy subscore of ≤1. An endoscopy subscore of 0 represented normal mucosal appearance with intact vascular pattern and no friability or granulation. For this trial the endoscopy score definition of 1 (mild disease) was modified such that it could include erythema, decreased vascular pattern, and minimal granularity; however, it could not include friability.

Subjects were randomized in a 1:1 ratio to receive either LIALDA 2.4 g/day administered once daily or mesalamine delayed release 1.6 g/day administered as 0.8 g twice daily. The proportion of patients who maintained remission at Month 6 in this study using LIALDA 2.4 g once daily (83.7%) was similar to that seen using the comparator (mesalamine delayed release) 1.6 g/day (81.5%).

No Information Provided

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before you take mesalamine, tell your doctor if you have kidney or liver disease, a stomach condition called pyloric stenosis, a heart condition such as congestive heart failure, or a history of allergy to sulfasalazine (Azulfidine).

Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole. It is specially formulated to release the medicine after it has passed through your stomach into your intestines.

Call your doctor if you find undissolved tablets in your stool.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines that can damage the kidneys, including non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and aspirin (Ecotrin)
• azathioprine (Imuran)
• 6-mercaptopurine (Purinethol)
• antacids such as Maalox, Mylanta, Mag-Ox, Caltrate, Tums, or Rolaids

This is not a complete list of mesalamine drug interactions.  Ask your doctor or pharmacist for more information.

Oral/Topical:

Serious side effects have been reported with mesalamine including:

• Kidney problems. Tell your doctor if you take non-steroidal anti-inflammatory drugs or have kidney disease. Your doctor will check your kidney function with a simple blood test before you start taking mesalamine.
• Mesalamine may worsen ulcerative colitis. Tell your doctor if you experience the following symptoms:
  • cramping
  • acute abdominal pain
  • bloody diarrhea
  • fever
  • headache
  • rash
• Hypersensitivity reaction. An allergic reaction is possible with mesalamine. Tell your doctor if you are allergic to sulfasalazine (Azulfidine) or mesalamine. Serious reactions can lead to heart problems, like myocarditis or pericarditis.
• Liver failure is possible with mesalamine. Tell your doctor if you have liver disease.
• Upper GI tract obstruction. Pyloric stenosis or an obstruction in the digestive tract could prevent mesalamine from reaching the colon and treating ulcerative colitis.
• Pericarditis (inflammation of the lining around the heart). Tell your doctor if you experience symtoms of pericarditis including chest pain, rapid heartbeat, difficulty breathing, and fever. Your doctor may want to temporarily stop use of mesalamine.

Do not take mesalamine if you:

• have kidney disease
• are allergic to mesalamine or any ingredients in mesalamine
• are allergic to salicylates (including aspirin)

Oral:

• Intact, partially intact, and/or capsule shells have been reported in the stool. Contact your doctor if this occurs repeatedly.

Tell your doctor if you are pregnant or plan to become pregnant.  

The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Mesalamine falls into category B. Studies in animals have failed to demonstrate a risk to the unborn baby and there are no well-controlled studies in pregnant women.

• Store mesalamine at room temperature.
• Protect delayed-release capsules from moisture.
  • Close the container tightly and to leave any desiccant pouches present in the bottle along with the capsules.
• Enema suspension: slight darkening of suspension will not affect quality of the medication. However, suspensions with dark brown solid contents should be discarded.
  • Enema suspension can cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.
• Rectal suppositories: these can cause stains on things it touches. Therefore keep it away from clothing and other fabrics, flooring, painted surfaces, marble, granite, plastics, andenamel. Be careful since the suppository may stain clothing.
• Keep this and all medicines out of the reach of children.

Your pharmacist can provide more information about mesalamine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 8.01. Revision date: 7/20/2011.

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Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine is used to treat mild to moderate ulcerative colitis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Some brands of mesalamine are for use only in adults, and some brands are for use in children who are at least 5 years old.

Mesalamine may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take mesalamine with a full glass of water.

Take Asacol HD on an empty stomach, at least 1 hour before or 2 hours after a meal.

Lialda should be taken with a meal.

Other brands of mesalamine can be taken with or without food. Follow your doctor's instructions or the directions on your medicine label.

Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole.

The extended-release capsule is specially formulated to release the medicine after it has passed through your stomach into your intestines. Breaking the pill may cause the drug to be released too early in the digestive tract.

The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.

Tell your doctor if you find undissolved tablets in your stool.

Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are taking mesalamine.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb mesalamine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using mesalamine and call your doctor at once if you have:

• severe stomach pain, cramping, bloody diarrhea;

• fever, headache, skin rash;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or

• liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, stomach pain, diarrhea, constipation;

• runny or stuffy nose, sinus pain, sore throat;

• flu-like symptoms;

• headache, back pain;

• rash; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The 5-amino derivative of salicylic acid; a GI anti-inflammatory agent.1 3 4 6 15

Storage

Oral

25°C (may be exposed to 15–30°C).229

400-mg tablets: 20–25°C.228

1.2-g tablets: 15–25°C (may be exposed to 30°C).448

Rectal

<25°C.230 Do not freeze; keep out of reach of children.230

20–25°C (may be exposed to 15–30°C); keep out of reach of children.1 6 May darken with time once the container has been removed from the foil wrap;1 dark brown suspensions should be discarded.1 199

The active ingredient in Mesalamine 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. 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.

Mesalamine Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.

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 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.

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.

Ulcerative colitis (treatment): Children ≥5 years and Adolescents: Oral: Delzicol:

17 to 32 kg: 800 mg in the morning and 400 mg in the evening for 6 weeks; maximum dose: 1,200 mg/day

33 to 53 kg: 1,200 mg in the morning and 800 mg in the evening for 6 weeks; maximum dose: 2,000 mg/day

54 to 90 kg: 1,200 mg in the morning and 1,200 mg in the evening for 6 weeks; maximum dose: 2,400 mg/day

US labeling: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Canadian labeling:

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Severe impairment: Use is contraindicated.

Oral:

Capsules: Administer with or without food.

Apriso: Do not administer with antacids. Opening the capsule and placing the contents (delayed-release granules) on food with a pH <6 is not expected to affect the release of mesalamine once ingested (data on file, Salix Pharmaceuticals Medical Information). There is no safety/efficacy information regarding this practice.

Delzicol: Swallow capsule whole with water; do not break, chew, crush, or cut. If a patient is unable to swallow the capsule, may open capsule and swallow capsule contents whole (do not cut, chew, break, or crush, or cut the contents).

Pentasa: Swallow capsule whole; do not crush or chew; if a patient is unable to swallow the capsule, may open capsule and sprinkle the entire contents (controlled-release beads) onto yogurt or applesauce.

Tablets: Swallow whole; do not break, chew, or crush.

Asacol [Canadian product]: Administer with or without food.

Asacol HD (product formulated without dibutyl phthalate [DBP]): Administer on an empty stomach (at least 1 hour before or 2 hours after a meal).

Asacol HD (product formulated with DBP), Asacol 800 [Canadian product]: Administer with or without food.

Lialda: Administer with a meal.

Mesasal [Canadian product]: Administer before meals.

Mezavant [Canadian product]: Administer once daily with a meal.

Pentasa [Canadian product]: Administer with meals.

Rectal enema: Shake bottle well. Instruct patient to lie on left side with left leg extended and right leg flexed forward for balance, or in “knee-chest” position. Insert lubricated applicator tip into the rectum and point slightly toward the navel. Grasp bottle firmly and tilt so nozzle is aimed toward the back; squeeze slowly to instill medication. After administration, withdraw and discard bottle. Retain enemas for 8 hours or as long as practical.

Suppository: Remove foil wrapper; avoid excessive handling. Insert into rectum. Retain suppository for 1 to 3 hours or longer. Do not cut or break suppository.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Commonly reported side effects of mesalamine include: headache. Other side effects include: abdominal cramps, abdominal distress, abdominal pain, headache, influenza, nausea, constipation, dyspepsia, skin rash, vomiting, and flatulence. See below for a comprehensive list of adverse effects.