Drugs Details

Drugs Info of Canasa, Canasa Pac, Rowasa
Drugs Details
  • Drugs Type  : FDA
  • Date : 25th Mar 2015 08:09 am
  • Brand Name : Canasa, Canasa Pac, Rowasa
  • Generic Name : mesalamine (rectal) (Pronunciation: me SAL a meen)
Descriptions

The active ingredient in ROWASA® (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 C7H7N03, representing a molecular weight of 153.14. The structural formula is:

ROWASA (mesalamine) structural formula illustration

Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer934P, 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.

What are the possible side effects of mesalamine rectal (Canasa, Canasa Pac, Rowasa)?

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

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

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • rectal pain, constipation;
  • headache or dizziness;
  • tired feeling;...

Read All Potential Side Effects and See Pictures of Rowasa »

What are the precautions when taking mesalamine rectal suspension enema (Rowasa)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications that are broken down into mesalamine (such as sulfasalazine, olsalazine); or to other salicylates (such as aspirin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, kidney problems, pancreas problems (pancreatitis), inflammation of the sac around the heart (pericarditis).

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (such as salicylates) if...

Read All Potential Precautions of Rowasa »

This monograph has been modified to include the generic and brand name in many instances.

Indications

ROWASA® (mesalamine) Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

Dosage 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 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 68220-066-01   ..................   Professional Sample

NDC 68220-066-07   ..................   Carton of 7 Bottles

NDC 68220-066-14   ..................   Carton of 14 Bottles

NDC 68220-066-28   ..................   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); 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: 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.

Rev. 05/08. ALAVEN® Pharmaceutical LLC., 2260 Northwest Parkway, Suite A Marietta, GA 30067. For Medical Inquiries, Call Toll Free: 1-888-317-0001. www.rowasa (mesalamine rectal suspension enema) .com. FDA rev date: 6/20/2008

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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)

  ROWASA® PLACEBO
N =815 N =128
SYMPTOM N % N %
Abdominal Pain/Cramps/Discomforl 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 3 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 and elevated liver enzymes. 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.

Read the Rowasa (mesalamine rectal suspension enema) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

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 (Category B)

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.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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.

ContrainDications

ROWASA® (mesalamine) Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Sulfasalazine is split by bacterial action in the colon into sulfapyridine (SP) and mesalamine (5-ASA). It is thought that the mesalamine component is therapeutically active in ulcerative colitis [A.K. Azad Khan etal, Lancet 2:892-895 (1977)]. The usual oral dose of sulfasalazine for active ulcerative colitis in adults is two to four grams per day in divided doses. Four grams of sulfasalazine provide 1.6 g of free mesalamine to the colon. Each ROWASA® (mesalamine) Rectal Suspension Enema delivers up to 4 g of mesalamine to the left side of the colon.

The mechanism of action of mesalamine (and sulfasalazine) is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes (LTs) and hydroxyeicosatetraenoic acids (HETEs) is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.

Preclinical Toxicology

Preclinical studies have shown the kidney to be the major target organ for mesalamine toxicity. Adverse renal function changes were observed in rats after a single 600 mg/kg oral dose, but not after a 200 mg/kg dose. Gross kidney lesions, including papillary necrosis, were observed after a single oral >900 mg/ kg dose, and after I.V. doses of >214 mg/kg. Mice responded similarly. In a 13-week oral (gavage) dose study in rats, the high dose of 640 mg/kg/day mesalamine caused deaths, probably due to renal failure, and dose-related renal lesions (papillary necrosis and/or multifocal tubular injury) were seen in most rats given the high dose (males and females) as well as in males receiving lower doses 160 mg/kg/day. Renal lesions were not observed in the 160 mg/ kg/day female rats. Minimal tubular epithelial damage was seen in the 40 mg/ kg/day males and was reversible. In a six-month oral study in dogs, the no observable dose level of mesalamine was 40 mg/kg/day and doses of 80 mg/ kg/day and higher caused renal pathology similar to that described for the rat. In a combined 52-week toxicity and 127-week carcinogenicity study in rats, degeneration in kidneys was observed at doses of 100 mg/kg/day and above admixed with diet for 52 weeks, and at 127 weeks increased incidence of kidney degeneration and hyalinization of basement membranes and Bowman's capsule were seen at 100 mg/kg/day and above. In the 12-month eye toxicity study in dogs, Keratoconjunctivitis Sicca (KCS) occurred at oral doses of 40 mg/kg/day and above. The oral preclinical studies were done with a highly bioavailable suspension where absorption throughout the gastrointestinal tract occurred. The human dose of 4 grams represents approximately 80 mg/kg but when mesalamine is given rectally as a suspension, absorption is poor and limited to the distal colon (see Pharmacokinetics). Overt renal toxicity has not been observed (see ADVERSE REACTIONS and PRECAUTIONS), but the potential must be considered.

Pharmacokinetics

Mesalamine administered rectally as ROWASA® (mesalamine) Rectal Suspension Enema is poorly absorbed from the colon and is excreted principally in the feces during subsequent bowel movements. The extent of absorption is dependent upon the retention time of the drug product, and there is considerable individual variation. At steady state, approximately 10 to 30% of the daily 4-gram dose can be recovered in cumulative 24-hour urine collections. Other than the kidney, the organ distribution and other bioavailability characteristics of absorbed mesalamine in man are not known. It is known that the compound undergoes acetylation but whether this process takes place at colonic or systemic sites has not been elucidated.

Whatever the metabolic site, most of the absorbed mesalamine is excreted in the urine as the N-acetyl-5-ASA metabolite. The poor colonic absorption of rectally administered mesalamine is substantiated by the low serum concentration of 5-ASA and N-acetyl-5-ASA seen in ulcerative colitis patients after dosage with mesalamine. Under clinical conditions patients demonstrated plasma levels 10 to 12 hours post mesalamine administration of 2 pg/mL, about two-thirds of which was the N-acetyl metabolite. While the elimination half-life of mesalamine is short (0.5 to 1.5 h), the acetylated metabolite exhibits a half-life of 5 to 10 hours [U. Klotz, Clin. Pharmacokin. 10:285-302 (1985)]. In addition, steady state plasma levels demonstrated a lack of accumulation of either free or metabolized drug during repeated daily administrations.

Efficacy

In a placebo-controlled, international, multicenter trial of 153 patients with active distal ulcerative colitis, proctosigmoiditis or proctitis, ROWASA® (mesalamine) Rectal Suspension Enema reduced the overall disease activity index (DAI) and individual components as follows:

EFFECT OF TREATMENT ON SEVERITY OF DISEASE
DATA FROM U.S.-CANADA TRIAL
COMBINED RESULTS OF EIGHT CENTERS
Activity Indices, mean

    N Base- line Day 22 End Point Change Baseline to End Point*
Overall DAI ROWASA® 76 7.42 4.05† 3.37‡ -55.07%‡
Placebo 77 7.40 6.03 5.83 -21.58%
Stool Frequency ROWASA®   1.58 1.11§ 1.01† -0.57§
Placebo   1.92 1.47 1.50 -0.41
Rectal Bleeding ROWASA®   1.82 0.59‡ 0.51‡ -1.30‡
Placebo   1.73 1.21 1.11 -0.61
Mucosal Inflammation ROWASA®   2.17 1.22† 0.96‡ -1.21†
Placebo   2.18 1.74 1.61 -0.56
Physician's Assessment of Disease Severity ROWASA®   1.86 1.13‡ 0.88‡ -0.97‡
Placebo   1.87 1.62 1.55 -0.30
Each parameter has a 4-point scale with a numerical rating:
0 = normal, 1 = mild, 2 = moderate, 3 = severe. The four parameters are added together to produce a maximum overall DAI of 12.
* Percent change for overall DAI only (calculated by taking the average of the change for each individual patient).
† Significant ROWASA (mesalamine rectal suspension enema) /placebo difference, p < 0.01
‡ Significant ROWASA (mesalamine rectal suspension enema) /placebo difference, p < 0.001
§ Significant ROWASA (mesalamine rectal suspension enema) /placebo difference, n < 0.05

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.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

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
      1. 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.

 

How to Use this Medication - illustration 1
    1. Prepare the Medication for Administration
      1. Shake the bottle well to make sure that the medication is thoroughly mixed.
      2. 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.

 

How to Use this Medication - illustration 2
  1. Assume the Correct Body Position
      1. Best results are obtained by lying on the left side with the left leg extended and the right leg flexed forward for balance.

     

    How to Use this Medication - illustration 3
      1. An alternative to lying on the left side is the "knee-chest" position as shown here.

     

    How to Use this Medication - illustration 4
  2. Administer theMedication
      1. Gently insert the lubricated applicator tip into the rectum to prevent damage to the rectal wall, pointed slightly toward the navel.
      2. 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.

     

    How to Use this Medication - illustration 5
    1. Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the medication all night, if possible.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MESALAMINE (5-AMINOSALICYLIC ACID) ENEMA - RECTAL

 

(mess-AL-uh-meen)

 

COMMON BRAND NAME(S): Rowasa

 

USES: Mesalamine (also known as 5-aminosalicylic acid) is used to treat certain types of bowel disease (distal ulcerative colitis, proctosigmoiditis, proctitis). It does not cure these conditions, but it may relieve mild-to-moderate pain and decrease the frequency of diarrhea/bloody stools caused by irritation/swelling in the colon/rectum. Mesalamine is an aminosalicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural chemicals that may cause pain and swelling.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat Crohn's disease.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using mesalamine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Use this medication rectally once daily at bedtime, or as directed by your doctor. Dosage is based on your medical condition and response to therapy.

Visually inspect the contents of the bottle before use. The contents should be off-white to tan in color. A slight darkening of the medication is expected, but any enemas that turn dark brown should be discarded.

This medication works best if you have a bowel movement before using it. Shake the bottle well. Holding the bottle at the neck, remove the cover from the applicator tip. Lie on your left side with your right knee bent. Insert the tip of the bottle into the rectum, pointing toward the navel. Gently and steadily squeeze out the entire contents of the bottle. Remove the bottle. Remain in position for 30 minutes. Throw away the empty bottle. Try to keep the medication in the rectum for 8 hours.

This medication may stain surfaces that it touches (such as clothing, floor, and counter surfaces).

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Rectal pain, pain while inserting the bottle tip, gas, and joint/leg pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor immediately if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, severe/prolonged headache.

Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain, trouble breathing, severe stomach/abdominal pain (especially if spreading to the back), change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Rowasa (mesalamine rectal suspension enema) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications that are broken down into mesalamine (such as sulfasalazine, olsalazine); or to other salicylates (such as aspirin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, kidney problems, pancreas problems (pancreatitis), inflammation of the sac around the heart (pericarditis).

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (such as varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain laboratory tests (including urine normetanephrine levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as kidney and liver function tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Once the foil-wrapped unit of bottles is opened, use all enemas promptly as directed by your physician. Keep all medicines away from children and pets.

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 March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Canasa, Canasa Pac, Rowasa

Generic Name: mesalamine (rectal) (Pronunciation: me SAL a meen)

  • What is mesalamine rectal (Rowasa)?
  • What are the possible side effects of mesalamine rectal (Rowasa)?
  • What is the most important information I should know about mesalamine rectal (Rowasa)?
  • What should I discuss with my health care provider before taking mesalamine rectal (Rowasa)?
  • How should I use mesalamine rectal (Rowasa)?
  • What happens if I miss a dose (Rowasa)?
  • What happens if I overdose (Rowasa)?
  • What should I avoid while taking mesalamine rectal (Rowasa)?
  • What other drugs will affect mesalamine rectal (Rowasa)?
  • Where can I get more information?

What is mesalamine rectal (Rowasa)?

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

Mesalamine rectal is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

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

What are the possible side effects of mesalamine rectal (Rowasa)?

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

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

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • rectal pain, constipation;
  • headache or dizziness;
  • tired feeling; or
  • skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Rowasa (mesalamine rectal suspension enema) Side Effects Center for a complete guide to possible side effects

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What is the most important information I should know about mesalamine rectal (Rowasa)?

Do not take mesalamine rectal by mouth. It is for use only in your rectum.

Tell your doctor if you have any type of kidney or liver disease, or if you are allergic to aspirin. You may not be able to use mesalamine, or you may need a dosage adjustment or special tests during treatment.

This medication comes with patient instructions for using either the rectal suppository or the rectal enema. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Try to empty your bowel and bladder just before using the mesalamine suppository or enema. Try to use the medicine at a time when you can lie down afterward and hold the medicine in. Avoid using the bathroom during this time. It may be best to use this medicine at bedtime.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Shake the rectal enema liquid well just before each use.

The rectal enema liquid may darken in color after it has been removed from the foil pouch. This should not affect the medicine. However, throw away any enema liquid that has turned dark brown.

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

Avoid getting the rectal suppositories or enema liquid on clothing, flooring, painted surfaces, vinyl, marble, granite, and other surfaces. Mesalamine rectal products may stain surfaces.

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Patient Detailed How Take

What should I discuss with my health care provider before taking mesalamine rectal (Rowasa)?

Tell your doctor if you have any type of kidney or liver disease, or if you are allergic to aspirin. You may not be able to use mesalamine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Mesalamine rectal can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use mesalamine rectal (Rowasa)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger or smaller amounts, or use it for longer than recommended by your doctor.

Mesalamine rectal comes with patient instructions for using either the rectal suppository or the rectal enema. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not take mesalamine rectal by mouth. It is for use only in your rectum.

Try to empty your bowel and bladder just before using the mesalamine suppository or enema. It may be best to use this medicine at bedtime.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down after inserting it and hold in the suppository for one to three hours. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom during this time.

Shake the rectal enema liquid well just before each use.

For best results from the enema, stay lying down for at least 30 minutes after using the enema to allow the liquid to distribute throughout your intestines. Try to hold in the enema all night if possible. Avoid using the bathroom during this time.

The rectal enema liquid may darken in color after it has been removed from the foil pouch. This should not affect the medicine. However, throw away any enema liquid that has turned dark brown.

Store the rectal enema at room temperature away from moisture and heat.

Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

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Patient Detailed Avoid Taking

What happens if I miss a dose (Rowasa)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Try to use the medicine at a time when you can lie down afterward and hold the medicine in. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Rowasa)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of mesalamine rectal is not expected to produce life-threatening symptoms.

What should I avoid while taking mesalamine rectal (Rowasa)?

Avoid getting the rectal suppositories or enema liquid on clothing, flooring, painted surfaces, vinyl, marble, granite, and other surfaces. Mesalamine rectal products may stain surfaces.

What other drugs will affect mesalamine rectal (Rowasa)?

There may be other drugs that can interact with mesalamine rectal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about mesalamine rectal.


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.

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