Apriso (Mesalamine Extended-Release Capsules)
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Apriso (Mesalamine Extended-Release Capsules)

APRISO
(mesalamine) Extended-Release Capsules

DRUG DESCRIPTION

Each APRISO (mesalamine extended-release capsules) capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an anti-inflammatory drug. The structural formula of mesalamine is:

APRISO™ (mesalamine) Structural Formula Illustration

Molecular Weight: 153.14

Molecular Formula: C7H7NO3

Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above.

The inactive ingredients of APRISO (mesalamine extended-release capsules) capsules are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, simethicone emulsion ethylacrylate/methylmethacrylate copolymer nonoxynol 100 dispersion, hypromellose, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, aspartame, anhydrous citric acid, povidone, vanilla flavor, and edible black ink.

What are the possible side effects of mesalamine oral (Apriso, Asacol, Asacol HD, Lialda, Pentasa)?

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 taking mesalamine and call your doctor at once if you have a serious side effect such as:

  • 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;
  • constipation;
  • headache or...

Read All Potential Side Effects and See Pictures of Apriso »

What are the precautions when taking mesalamine extended-release capsules (Apriso)?

Before taking 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, 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: breathing problems (such as asthma), kidney problems, liver problems, pancreas problems (pancreatitis), swelling of the sac around the heart (pericarditis), stomach/intestinal ulcers, urinary problems (such as blockage).

This medicine may cause stomach bleeding. Daily use of...

Read All Potential Precautions of Apriso »

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

APRISO (mesalamine extended-release capsules) capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.

DOSAGE AND ADMINISTRATION

The recommended dose for maintenance of remission of ulcerative colitis in adult patients is 1.5 g (four APRISO (mesalamine extended-release capsules) capsules) orally once daily in the morning. APRISO (mesalamine extended-release capsules) may be taken without regard to meals. APRISO (mesalamine extended-release capsules) should not be co-administered with antacids. An evaluation of renal function is recommended before initiating therapy with APRISO (mesalamine extended-release capsules) .

HOW SUPPLIED

Dosage Forms And Strengths

Extended-release capsules containing 0.375 g mesalamine.

Storage And Handling

APRISO (mesalamine extended-release capsules) is available as light blue opaque hard gelatin capsules containing 0.375 g mesalamine and with the letters “G” and “M” on either side of a black band imprinted on the capsule.

NDC 65649-103-02 Bottles of 120 capsules

NDC 65649-103-01 Bottles of 4 capsules

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). See USP Controlled Room Temperature.

Manufactured by : Catalent Pharma Solutions for Salix Pharmaceuticals, Inc., Morrisville, NC 27560.

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Studies Experience

The data described below reflect exposure to APRISO (mesalamine extended-release capsules) in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. APRISO (mesalamine extended-release capsules) was studied in two placebo-controlled trials (n = 367 treated with APRISO (mesalamine extended-release capsules) ) and in one open-label, long-term study (n = 190 additional patients). The population consisted of patients with ulcerative colitis; the mean age was 47 years, 54% were female, and 93% were white. Patients received doses of APRISO (mesalamine extended-release capsules) 1.5 g administered orally once per day for six months in the placebo-controlled trials and for up to 24 months in the open-label study.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two placebo-controlled trials, 59% of APRISO (mesalamine extended-release capsules) -treated patients experienced an adverse reaction compared with 64% of placebo patients. Most adverse reactions with APRISO (mesalamine extended-release capsules) were mild or moderate in severity. Severe adverse reactions occurred in 6% of APRISO (mesalamine extended-release capsules) -treated patients and 5% of placebo-treated patients. Discontinuations due to adverse reactions occurred in 11% of APRISO (mesalamine extended-release capsules) -treated patients and 17% of placebo treated patients; the most common adverse reaction resulting in study discontinuation was recurrence of ulcerative colitis (APRISO (mesalamine extended-release capsules) 6%, placebo 14%). The most common reactions reported with APRISO (mesalamine extended-release capsules) ( ≥ 3%) are shown in Table 1 below.

Table 1: Treatment-Emergent Adverse Reactions during Clinical Trials Occurring in at Least 3% of APRISO (mesalamine extended-release capsules) -Treated Patients and at a Greater Rate than with Placebo

MedDRA Preferred Term APRISO 1.5 g/day
N=367
Placebo
N=185
Headache 11% 8%
Diarrhea 8% 7%
Abdominal Pain Upper 5% 3%
Nausea 4% 3%
Nasopharyngitis 4% 3%
Influenza & Influenza-like Illness 4% 4%
Sinusitis 3% 3%

The following adverse reactions, presented by body system, were reported at a frequency less than 3% in patients treated with APRISO (mesalamine extended-release capsules) for up to 24 months in controlled and open-label trials.

Ear and Labyrinth Disorders: tinnitus, vertigo

Dermatological Disorder: alopecia

Gastrointestinal: abdominal pain lower, rectal hemorrhage

Laboratory Abnormalities: increased triglycerides, decreased hematocrit and hemoglobin

General Disorders and Administration Site Disorders: fatigue

Hepatic: hepatitis cholestatic, transaminases increased

Renal Disorders: creatinine clearance decreased, hematuria

Musculoskeletal: pain, arthralgia

Respiratory: dyspnea

Adverse Reaction Information from Other Sources

The following adverse reactions have been identified during clinical trials of a product similar to APRISO and post approval use of other mesalamine-containing products such as APRISO (mesalamine extended-release capsules) . Because many of these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: lupus-like syndrome, drug fever

Cardiovascular: pericarditis, pericardial effusion, myocarditis

Gastrointestinal: pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer

Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasakilike syndrome including changes in liver enzymes

Hematologic: agranulocytosis, aplastic anemia

Neurological/Psychiatric: peripheral neuropathy, Guillain-Barré syndrome, transverse myelitis

Respiratory/Pulmonary: eosinophilic pneumonia, interstitial pneumonitis

Skin: psoriasis, pyoderma gangrenosum, erythema nodosum

Renal/Urogenital: reversible oligospermia

Read the Apriso (mesalamine extended-release capsules) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Based on in vitro studies, APRISO (mesalamine extended-release capsules) is not expected to inhibit the metabolism of drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.

Antacids

Because the dissolution of the coating of the granules in APRISO (mesalamine extended-release capsules) capsules depends on pH, APRISO (mesalamine extended-release capsules) capsules should not be co-administered with antacids.

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Renal Impairment

Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as APRISO that contain mesalamine or are converted to mesalamine.

It is recommended that patients have an evaluation of renal function prior to initiation of APRISO (mesalamine extended-release capsules) therapy and periodically while on therapy. Exercise caution when using APRISO (mesalamine extended-release capsules) in patients with known renal dysfunction or a history of renal disease.

In animal studies, the kidney was the principal organ for toxicity [See Nonclinical Toxicology]

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 has not been determined, 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. If acute intolerance syndrome is suspected, promptly discontinue treatment with APRISO (mesalamine extended-release capsules) .

Hypersensitivity

Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to APRISO capsules or to other compounds that contain or are converted to mesalamine.

Hepatic Impairment

There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering APRISO (mesalamine extended-release capsules) to patients with liver disease.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dietary mesalamine was not carcinogenic in rats at doses as high as 480 mg/kg/day, or in mice at 2000 mg/kg/day. These doses are about 2.6 and 5.4 times the recommended human dose of granulated mesalamine capsules of 1.5 g/day (30 mg/kg if 50 kg body weight assumed or 1110 mg/m²), respectively, based on body surface area. Mesalamine was negative in the Ames test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, the sister chromatid exchange assay in the Chinese hamster bone marrow test, and the mouse bone marrow micronucleus test. Mesalamine at oral doses up to 320 mg/kg (about 1.7 times the recommended human dose based on body surface area) was found to have no effect on fertility or reproductive performance in rats.

Use In Specific Populations

Pregnancy

Pregnancy Category B. Reproduction studies with mesalamine have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human dose based on a body surface area comparison) and rabbits at doses up to 495 mg/kg/day (about 5.4 times the recommended human dose based on a body surface area comparison) and have revealed no evidence of impaired fertility or harm to the fetus due to mesalamine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Mesalamine is known to cross the placental barrier.

Nursing Mothers

Low concentrations of mesalamine and higher concentrations of its N-acetyl metabolite have been detected in human breast milk. The clinical significance of this has not been determined and there is limited experience of nursing women using mesalamine. Caution should be exercised when APRISO (mesalamine extended-release capsules) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of APRISO (mesalamine extended-release capsules) capsules in pediatric patients have not been established.

Geriatric Use

Clinical studies of APRISO (mesalamine extended-release capsules) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing APRISO (mesalamine extended-release capsules) .

Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias, i.e., neutropenia, pancytopenia, in patients who were 65 years or older who were taking mesalamine-containing products such as APRISO. Caution should be taken to closely monitor blood cell counts during mesalamine therapy.

Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. [see WARNING AND PRECAUTIONS].

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

APRISO (mesalamine extended-release capsules) is an aminosalicylate, and symptoms of salicylate toxicity include hematemesis, tachypnea, hyperpnea, tinnitus, deafness, lethargy, seizures, confusion, or dyspnea. Severe intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement. There is no specific antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. This includes prevention of further gastrointestinal tract absorption by emesis and, if necessary, by gastric lavage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate intravenous therapy. Adequate renal function should be maintained. APRISO (mesalamine extended-release capsules) is a pHdependent delayed-release product and this factor should be considered when treating a suspected overdose.

CONTRAINDICATIONS

APRISO (mesalamine extended-release capsules) is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of APRISO (mesalamine extended-release capsules) capsules.

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism of action of mesalamine (5-ASA) is unknown, but appears to be local to the intestinal mucosa rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites.

Pharmacokinetics

Absorption

The pharmacokinetics of 5-ASA and its metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), were studied after a single and multiple oral doses of 1.5 g APRISO (mesalamine extended-release capsules) in a crossover study in healthy subjects under fasting conditions. In the multiple-dose period, each subject received APRISO (mesalamine extended-release capsules) 1.5 g (4 x 0.375 g capsules) every 24 hours (QD) for 7 consecutive days. Steady state was reached on Day 6 of QD dosing based on trough concentrations.

After single and multiple doses of APRISO (mesalamine extended-release capsules) , peak plasma concentrations were observed at about 4 hours post dose. At steady state, moderate increases (1.5-fold and 1.7-fold) in systemic exposure (AUC0-24) to 5-ASA and N-Ac-5-ASA were observed when compared with a single-dose of APRISO (mesalamine extended-release capsules) .

Pharmacokinetic parameters after a single dose of 1.5 g APRISO (mesalamine extended-release capsules) and at steady state in healthy subjects under fasting condition are shown in Table 2.

Table 2: Single Dose and Multiple Dose Mean ( ± SD) Plasma Pharmacokinetic Parameters of Mesalamine (5-ASA) and N-Ac-5-ASA after 1.5 g APRISO (mesalamine extended-release capsules) Administration in Healthy Subjects

Mesalamine (5-ASA) Single Dose
(n=24)
Multiple Dosec
(n=24)
  AUC0-24 (µg*h/mL) 11 ± 5 17 ± 6
  AUC0-inf (µg*h/mL) 14 ± 5 -
  Cmax (µg/mL) 2.1 ± 1.1 2.7 ± 1.1
  Tmax (h) a 4 (2, 16) 4 (2, 8)
  t½ (h)b 9 ± 7 10 ± 8
N-Ac-5-ASA    
  AUC0-24 (µg*h/mL) 26 ± 6 37 ± 9
  AUC0-inf (µg*h/mL) 51 ± 23 -
  Cmax (µg/mL) 2.8 ± 0.8 3.4 ± 0.9
  Tmax (h)a 4 (4, 12) 5 (2, 8)
  t½(h)b 12 ± 11 14 ± 10
a Median (range);
b Harmonic mean (pseudo SD);
c after 7 days of treatment

In a separate study (n = 30), it was observed that under fasting conditions about 32% ± 11% (mean ± SD) of the administered dose was systemically absorbed based on the combined cumulative urinary excretion of 5-ASA and N-Ac-5-ASA over 96 hours post-dose.

The effect of a high fat meal intake on absorption of mesalamine granules (the same granules contained in APRISO (mesalamine extended-release capsules) capsules) was evaluated in 30 healthy subjects. Subjects received 1.6 g of mesalamine granules in sachet (2 x 0.8 g) following an overnight fast or a high fat meal in a crossover study. Under fed conditions, tmax for both 5-ASA and N-Ac-5-ASA was prolonged by 4 and 2 hours, respectively. A high fat meal did not affect Cmax for 5-ASA, but a 27% increase in the cumulative urinary excretion of 5-ASA was observed with a high fat meal. The overall extent of absorption of N-Ac-5-ASA was not affected by a high fat meal. As APRISO and mesalamine granules in sachet were bioequivalent, APRISO (mesalamine extended-release capsules) can be taken without regard to food.

Distribution

In an in vitro study, at 2.5 μg/mL, mesalamine and N-Ac-5-ASA are 43 ± 6% and 78 ± 1% bound, respectively, to plasma proteins. Protein binding of N-Ac-5-ASA does not appear to be concentration dependent at concentrations ranging from 1 to 10 μg/mL.

Metabolism

The major metabolite of mesalamine is N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). It is formed by N-acetyltransferase activity in the liver and intestinal mucosa.

Elimination

Following single and multiple doses of APRISO (mesalamine extended-release capsules) , the mean half-lives were 9 to 10 hours for 5-ASA, and 12 to 14 hours for N-Ac-5-ASA. Of the approximately 32% of the dose absorbed, about 2% of the dose was excreted unchanged in the urine, compared with about 30% of the dose excreted as N-Ac-5-ASA.

in vitro Drug-Drug Interaction Study

In an in vitro study using human liver microsomes, 5-ASA and its metabolite, N-Ac-5- ASA, were shown not to inhibit the major CYP enzymes evaluated (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4). Therefore, mesalamine and its metabolite are not expected to inhibit the metabolism of other drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.

Animal Toxicology and/or Pharmacology

Renal Toxicity

Animal studies with mesalamine (13-week and 26-week oral toxicity studies in rats, and 26-week and 52-week oral toxicity studies in dogs) have shown the kidney to be the major target organ of mesalamine toxicity. Oral doses of 40 mg/kg/day (about 0.20 times the human dose, on the basis of body surface area) produced minimal to slight tubular injury, and doses of 160 mg/kg/day (about 0.90 times the human dose, on the basis of body surface area) or higher in rats produced renal lesions including tubular degeneration, tubular mineralization, and papillary necrosis. Oral doses of 60 mg/kg/day (about 1.1 times the human dose, on the basis of body surface area) or higher in dogs also produced renal lesions including tubular atrophy, interstitial cell infiltration, chronic nephritis, and papillary necrosis.

Overdosage

Single oral doses of 800 mg/kg (about 2.2 times the recommended human dose, on the basis of body surface area) and 1800 mg/kg (about 9.7 times the recommended human dose, on the basis of body surface area) of mesalamine were lethal to mice and rats, respectively, and resulted in gastrointestinal and renal toxicity.

Clinical Studies

Ulcerative Colitis

Two similar, randomized, double-blind, placebo-controlled, multi-center studies were conducted in a total of 562 adult patients in remission from ulcerative colitis. The study populations had a mean age of 46 years (11% age 65 years or older), were 53% female, and were primarily white (92%).

Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index1 (DAI), which is a sum of four subscores based on stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician's rating of disease activity. Each subscore can range from 0 to 3, for a total possible DAI score of 12.

At baseline, approximately 80% of patients had a total DAI score of 0 or 1.0. Patients were randomized 2:1 to receive either APRISO (mesalamine extended-release capsules) 1.5 g or placebo once daily in the morning for six months. Patients were assessed at baseline, 1 month, 3 months, and 6 months in the clinic, with endoscopy performed at baseline, at end of study, or if clinical symptoms developed. Relapse was defined as a rectal bleeding subscale score of 1 or more and a mucosal appearance subscale score of 2 or more using the DAI. The analysis of the intent-to-treat population was a comparison of the proportions of patients who remained relapse-free at the end of six months of treatment. For the table below (Table 3) all patients who prematurely withdrew from the study for any reason were counted as relapses.

In both studies, the proportion of patients who remained relapse-free at six months was greater for APRISO (mesalamine extended-release capsules) than for placebo.

Table 3: Percentage of Patients Relapse-Free* through 6 Months in APRISO (mesalamine extended-release capsules) Maintenance Studies

  APRISO (mesalamine extended-release capsules) 1.5 g/day
% (# no
relapse/N)
Placebo %
(# no relapse/N)
Difference
(95% C.I.)
P-value
Study 1 68%
(143/209)
51%
(49/96)
17%
(5.5, 29.2)
< 0.001
Study 2 71%
(117/164)
59%
(55/93)
12%
(0, 24.5)
0.046
* Relapse counted as rectal bleeding score ≥ 1 and mucosal appearance score ≥ 2, or premature withdrawal from study.

Examination of gender subgroups did not identify difference in response to APRISO (mesalamine extended-release capsules) among these subgroups. There were too few elderly and too few African-American patients to adequately assess difference in effects in those populations.

The use of APRISO (mesalamine extended-release capsules) for treating ulcerative colitis beyond six months has not been evaluated in controlled clinical trials.

REFERENCES

1. Sutherland LR, Martin F, Greer S, Robinson M, Greenberger N, Saibil F, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 1987;92(6):1894-1898.

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients with Phenylketonuria

  • Inform patients with phenylketonuria (PKU) or their caregivers that each APRISO (mesalamine extended-release capsules) capsule contains aspartame equivalent to 0.56 mg of phenylalanine, so that the recommended adult dosing provides an equivalent of 2.24 mg of phenylalanine per day.

General Counseling Information

  • Instruct patients not to take APRISO (mesalamine extended-release capsules) capsules with antacids, because it could affect the way APRISO (mesalamine extended-release capsules) dissolves.
  • Instruct patients to contact a health care provider if they experience a worsening of ulcerative colitis symptoms, because it could be due to a reaction to APRISO (mesalamine extended-release capsules) .

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients with Phenylketonuria

  • Inform patients with phenylketonuria (PKU) or their caregivers that each APRISO (mesalamine extended-release capsules) capsule contains aspartame equivalent to 0.56 mg of phenylalanine, so that the recommended adult dosing provides an equivalent of 2.24 mg of phenylalanine per day.

General Counseling Information

  • Instruct patients not to take APRISO (mesalamine extended-release capsules) capsules with antacids, because it could affect the way APRISO (mesalamine extended-release capsules) dissolves.
  • Instruct patients to contact a health care provider if they experience a worsening of ulcerative colitis symptoms, because it could be due to a reaction to APRISO (mesalamine extended-release capsules) .

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Apriso Consumer

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) EXTENDED-RELEASE CAP - ORAL

(mess-AL-uh-meen)

COMMON BRAND NAME(S): Apriso

USES: Mesalamine (also known as 5-aminosalicylic acid) is used to lessen the signs and severity of ulcerative colitis (remission). It does not cure ulcerative colitis (a bowel disease), but mesalamine may decrease symptoms such as stomach pain, diarrhea, and rectal bleeding caused by irritation/swelling of 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. After an attack has been treated, mesalamine is used to increase the amount of time between attacks of ulcerative colitis.

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: Take this medication by mouth with or without food, usually once daily in the morning or as directed by your doctor.

Swallow the capsules whole. Do not chew or crush the capsules. Do not take with antacids. Doing so can interfere with release of the drug into the colon.

Dosage is based on your medical condition and response to therapy.

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

Tell your doctor if your condition persists or worsens.

Disclaimer

Apriso Consumer (continued)

SIDE EFFECTS: Diarrhea, headache, nausea, runny/stuffy nose, or stomach upset 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: change in the amount of urine, vomit that contains blood or looks like coffee grounds, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the eyes/skin, unusual bleeding/bruising, signs of infection (such as fever, persistent sore throat).

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 Apriso (mesalamine extended-release capsules) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking 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, 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: breathing problems (such as asthma), kidney problems, liver problems, pancreas problems (pancreatitis), swelling of the sac around the heart (pericarditis), stomach/intestinal ulcers, urinary problems (such as blockage).

This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information.

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this medication safely.

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.

Older adults may be more sensitive to the side effects of this drug, especially the effects on the kidneys and decreased blood cell counts.

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.

Disclaimer

Apriso Consumer (continued)

DRUG INTERACTIONS: See also How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some of the products that may interact with this drug include: acetazolamide, "blood thinners" (such as heparin, warfarin), certain diabetes medications (sulfonylureas such as glipizide, tolbutamide; meglitinides such as nateglinide), methotrexate, probenecid.

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: ringing in the ears, hearing loss, extreme tiredness, seizures, fast/difficult breathing, bloody vomit.

NOTES: Do not share this medication with others.

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

MISSED DOSE: If you miss a dose, take 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. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. 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 April 2012. Copyright(c) 2012 First Databank, Inc.

Apriso Patient Information Including Side Effects

Brand Names: Apriso, Asacol, Asacol HD, Lialda, Pentasa

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

What is mesalamine oral (Apriso)?

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

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

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

Asacol 400 mg

oblong, red, imprinted with ASACOLNE

Pentasa 500 mg

blue, imprinted with PENTASA 500 mg, LOGO

What are the possible side effects of mesalamine oral (Apriso)?

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 taking mesalamine and call your doctor at once if you have a serious side effect such as:

  • 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;
  • constipation;
  • headache or dizziness;
  • tired feeling; or
  • skin rash.

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.

Read the Apriso (mesalamine extended-release capsules) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about mesalamine oral (Apriso)?

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.

Side Effects Centers

Apriso Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking mesalamine oral (Apriso)?

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).

To make sure you can safely take mesalamine, tell your doctor if you have any of these other conditions:

  • a stomach condition called pyloric stenosis;
  • a history of allergy to sulfasalazine (Azulfidine);
  • a heart condition such as congestive heart failure;
  • kidney disease; or
  • liver disease.

FDA pregnancy category C. It is not known whether mesalamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Mesalamine 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 take mesalamine oral (Apriso)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take mesalamine with a full glass of water.

Mesalamine can usually be taken with or without food. Follow your doctor's instructions.

Mesalamine extended-release capsules (Lialda) should be taken with a meal.

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.

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

Store at room temperature away from moisture and heat.

Side Effects Centers

Apriso Patient Information including If I Miss a Dose

What happens if I miss a dose (Apriso)?

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.

What happens if I overdose (Apriso)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include ringing in your ears, dizziness, headache, confusion, drowsiness, sweating, shortness of breath, vomiting, and diarrhea.

What should I avoid while taking mesalamine oral (Apriso)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect mesalamine oral (Apriso)?

Tell your doctor about all other medicines you use, especially:

  • azathioprine (Imuran) or mercaptopurine (Purinethol);
  • pentamidine (Nebupent, Pentam);
  • tacrolimus (Prograf);
  • amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
  • antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);
  • antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);
  • cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid); or
  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), diclofenac (Voltaren), etodolac (Lodine), indomethacin, nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with mesalamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

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 1996-2012 Cerner Multum, Inc. Version: 8.01. Revision date: 7/20/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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