(me SAL a meen)
- 5-Aminosalicylic Acid
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule Delayed Release, Oral:
Delzicol: 400 mg
Capsule Extended Release, Oral:
Pentasa: 250 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow)]
Pentasa: 500 mg [contains brilliant blue fcf (fd&c blue #1)]
Capsule Extended Release 24 Hour, Oral:
Apriso: 0.375 g [contains aspartame]
SfRowasa: 4 g/60 mL (60 mL) [sulfite free; contains edetate disodium, sodium benzoate]
Generic: 4 g (60 mL)
Rowasa: 4 g [contains edetate disodium, potassium metabisulfite, sodium benzoate]
Generic: 4 g
Canasa: 1000 mg (30 ea, 42 ea)
Tablet Delayed Release, Oral:
Asacol HD: 800 mg
Lialda: 1.2 g
Generic: 800 mg, 1.2 g
Brand Names: U.S.
- Asacol HD
- 5-Aminosalicylic Acid Derivative
Mesalamine (5-aminosalicylic acid) is the active component of sulfasalazine; the specific mechanism of action is unknown; however, it is thought that mesalamine modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF); action appears topical rather than systemic
Rectal: Variable and dependent upon retention time, underlying GI disease, and colonic pH; Oral: Tablet: ~20% to 28%, Capsule: ~20% to 43%
Hepatic and via GI tract to N-acetyl-5-aminosalicylic acid
Oral, suppository: Urine (primarily as N-acetyl-5-ASA, ≤12% as unchanged drug); feces (unabsorbed mesalamine)
Enema: Feces (primarily); urine (10% to 30%)
Time to Peak
Capsule: Apriso: ~4 hours; Delzicol: ~10 hours; Pentasa: 3 hours
Rectal: Pentasa, Salofalk [Canadian products]: 2 to 6 hours
Tablet: Asacol HD (formulated with dibutyl phthalate [DBP]): 10 to 16 hours; Asacol HD (formulated without DBP): ~24 hours (mean); Lialda: 9 to 12 hours
Canadian products: Asacol: 7 hours; Asacol 800: 10 hours; Mesasal: ~7 hours; Mezavant [Canadian product]: 8 hours (range: 4 to 34 hours)
5-ASA and N-acetyl-5-ASA: Variable; ~ 25 hours (range: 2 to 296 hours)
Mesalamine (5-ASA): ~43%; N-acetyl-5-ASA: ~78%
Use: Labeled Indications
Apriso: Maintenance of remission of ulcerative colitis in patients ≥18 years
Asacol HD: Treatment of moderately active ulcerative colitis in adults
Delzicol: Treatment of mildly to moderately active ulcerative colitis in patients ≥5 years; maintenance of remission of ulcerative colitis in adults
Lialda, Pentasa: Treatment and maintenance of remission of mildly to moderately active ulcerative colitis
Rectal: Treatment of active mild to moderate distal ulcerative colitis (suspension only), proctosigmoiditis (suspension only), or proctitis (suspension and suppository)
Asacol, Mezavant: Treatment and maintenance of remission of mildly- to moderately-active ulcerative colitis
Asacol 800: Treatment of moderately active ulcerative colitis
Mesasal: Treatment and maintenance of remission of ulcerative colitis
Pentasa: Treatment and maintenance of remission of mildly to moderately active ulcerative colitis; treatment and maintenance of remission of mild to moderate Crohn disease
Rectal: Treatment and maintenance of remission of distal ulcerative colitis (extending to splenic flexure) and as adjunctive therapy in more extensive disease (suspension only); treatment and maintenance of ulcerative proctitis (suppository only)
U.S. labeling: Hypersensitivity to mesalamine, aminosalicylates, salicylates, or any component of the formulation.
Canadian labeling: Hypersensitivity to mesalamine, salicylates, or any component of the formulation; severe renal impairment (GFR <30 mL/minute/1.73 m2); severe hepatic impairment
Additional contraindications per specific Canadian product labeling: Existing gastric or duodenal ulcer, urinary tract obstruction, use in children <2 years of age (Asacol, Asacol 800, Mesasal, Pentasa, Salofalk); hemorrhagic diathesis (Mesasal); patients unable to swallow intact tablet (Asacol, Asacol 800); renal parenchymal disease (Pentasa)
Crohn disease, mild to moderate (treatment): Oral: Pentasa (Canadian labeling; not in US labeling): Initial: 1 g 4 times daily
Crohn disease, mild to moderate (maintenance of remission): Oral: Pentasa (Canadian labeling; not in US labeling): 1 g 3 times daily
Distal ulcerative colitis or proctosigmoiditis, active mild to moderate (treatment): Rectal: Retention enema: Note: Duration of rectal therapy is 3 to 6 weeks; some patients may require rectal and oral therapy concurrently.
US labeling: 4 g at bedtime, retained overnight, approximately 8 hours
Canadian labeling: Salofalk 4 g or Pentasa 1 to 4 g at bedtime; retained overnight, approximately 8 hours
Distal ulcerative colitis (maintenance of remission): Rectal: Retention enema: Salofalk [Canadian product]: 2 g at bedtime daily or 4 g at bedtime every 2 to 3 days
Ulcerative colitis (treatment): Oral: Usual course of therapy is 6 to 8 weeks:
Asacol HD: 1.6 g 3 times daily for 6 weeks
Delzicol: 800 mg 3 times daily for 6 weeks
Lialda: 2.4 or 4.8 g once daily
Pentasa: 1 g 4 times daily
Asacol: 800 mg to 3.2 g in divided doses daily; for severe active disease may increase to 4.8 g daily
Asacol 800: 1.6 g 3 times daily for 6 weeks
Mesasal: 1.5 to 3 g daily in 3 divided doses
Mezavant: 2.4 to 4.8 g once daily for up to 8 weeks
Pentasa: 500 mg 4 times daily; may increase to 1 g 4 times daily if needed
Ulcerative colitis (maintenance of remission): Oral:
Apriso: 1.5 g once daily in the morning
Delzicol: 1.6 g in 2 to 4 divided doses
Lialda: 2.4 g once daily
Pentasa: 1 g 4 times daily
Asacol: 1.6 g daily in divided doses
Mesasal: 1.5 g daily in 3 divided doses
Mezavant: 2.4 g once daily
Pentasa: 500 mg 4 times daily; may increase to 1 g 4 times daily if needed
Ulcerative proctitis, active:
Retention enema: 4 g at bedtime, retained overnight, approximately 8 hours
Rectal suppository: 1,000 mg (1 suppository) rectally (retain for at least 1 to 3 hours) at bedtime for 3 to 6 weeks.
Canadian labeling: Rectal suppository:
Pentasa: One 1,000 mg suppository in rectum daily at bedtime; retained for at least 1 to 3 hours to achieve maximum benefit
Salofalk: One 500 mg suppository in rectum 2 to 3 times daily or one 1,000 mg suppository in rectum once daily at bedtime; retained for at least 1 to 3 hours to achieve maximum benefit. Usual dose: 1 to 1.5 g daily until significant clinical response or remission. Taper off gradually; avoid abrupt discontinuation.
Refer to adult dosing. Use with caution.
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
Dosing: Renal Impairment
US labeling: There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment may be necessary since mesalamine is renally eliminated. Use with caution.
GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
GFR <30 mL/minute/1.73 m2: Use is contraindicated.
Dosing: Hepatic Impairment
US labeling: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
Severe impairment: Use is contraindicated.
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.
Some products may contain phenylalanine.
Apriso: Do not administer with antacids.
Capsule, tablet: Store between 15°C and 30°C (59°F and 86°F). Protect capsules from moisture.
Asacol HD, Delzicol: Store with desiccant pouch inside bottle with the capsules/tablets
Enema: Store at 20°C to 25°C (68°F to 77°F). Use Rowasa promptly once foil wrap is removed; once the foil wrap is removed from a unit of seven sfRowasa bottles, discard any bottles remaining after 14 days. Contents may darken with time (do not use if dark brown).
Suppository: Store below 25°C (below 77°F). May store under refrigeration. Protect from direct heat, light, and humidity.
Antacids: May diminish the therapeutic effect of Mesalamine. Antacid-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Avoid concurrent administration of antacids with sustained-release mesalamine products. Separating antacid and mesalamine administration, and/or using lower antacid doses may be adequate means of avoiding this interaction. Consider therapy modification
Cardiac Glycosides: 5-Aminosalicylic Acid Derivatives may decrease the serum concentration of Cardiac Glycosides. Monitor therapy
Heparin: 5-Aminosalicylic Acid Derivatives may enhance the adverse/toxic effect of Heparin. Specifically, the risk for bleeding/bruising may be increased. Monitor therapy
Heparins (Low Molecular Weight): 5-Aminosalicylic Acid Derivatives may enhance the adverse/toxic effect of Heparins (Low Molecular Weight). Specifically, the risk for bleeding/bruising may be increased. Monitor therapy
Histamine H2 Receptor Antagonists: May diminish the therapeutic effect of Mesalamine. Histamine H2-Antagonist-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose histamine H2-receptor antagonists with sustained-release mesalamine products. Consider therapy modification
Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of 5-Aminosalicylic Acid Derivatives. Monitor therapy
Proton Pump Inhibitors: May diminish the therapeutic effect of Mesalamine. Proton pump inhibitor-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose proton pump inhibitors (PPIs) with sustained-release mesalamine products. Consider therapy modification
Thiopurine Analogs: 5-Aminosalicylic Acid Derivatives may decrease the metabolism of Thiopurine Analogs. Monitor therapy
Varicella Virus-Containing Vaccines: 5-Aminosalicylic Acid Derivatives may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. The primary concern is the potential development of Reye's Syndrome, a condition that has been associated with the use of salicylates in children with varicella infections. Consider therapy modification
May cause falsely-elevated urinary normetanephrine levels when measured by liquid chromatography with electrochemical detection (due to similarity in the chromatograms of normetanephrine and mesalamine’s main metabolite, N-acetylaminosalicylic acid).
Adverse effects vary depending upon dosage form; frequency similar in adult and pediatric patients unless otherwise noted. Incidence usually on lower end with enema and suppository dosage forms.
Central nervous system: Headache (3% to 14%)
Gastrointestinal: Eructation (≤26%), abdominal pain (oral: 2% to 21%, children & adolescents: 10%; rectal: 5%), constipation (≤11%)
Respiratory: Nasopharyngitis (children and adolescents: 15%; adults: 1% to 4%)
1% to 10%:
Cardiovascular: Hypertension (≤1%)
Central nervous system: Dizziness (≤9%), fatigue (<3%), pain (<3%), vertigo (<3%), nervousness (≥2%), paresthesia (≥2%)
Dermatologic: Skin rash (≤6%), alopecia (<3%), acne vulgaris (≤1%)
Endocrine & metabolic: Increased serum triglycerides (<3%), weight loss (children and adolescents: 2%)
Gastrointestinal: Diarrhea (≤8%), exacerbation of ulcerative colitis (≤6%), flatulence (≤6%), upper abdominal pain (1% to 5%), dyspepsia (≤4%), nausea (≤4%), lower abdominal pain (<3%), gastroenteritis (≥2%), hemorrhoids (≥2%), tenesmus (≥2%), gastrointestinal hemorrhage (<1% to ≥2%), bloody diarrhea (children and adolescents: 2%), pancreatitis (children and adolescents: 2%), sclerosing cholangitis (children and adolescents: 2%), vomiting (≤2%), rectal pain (rectal: 1% to 2%), abdominal distention (≥1%), anorectal pain (rectal: 1%; includes pain on insertion of enema tip), nausea and vomiting (1%), colitis (≤1%)
Genitourinary: Hematuria (<3%), urinary frequency (<1% to ≥2%)
Hematologic & oncologic: Decreased hematocrit (<3%), decreased hemoglobin (<3%), rectal hemorrhage (<3%)
Hepatic: Cholestatic hepatitis (<3%), increased serum transaminases (<3%), hepatic insufficiency (2%)
Infection: Influenza (1% to 5%), infection (≥2%), viral infection (children and adolescents: 2%; adenovirus)
Neuromuscular & skeletal: Back pain (≤6%), arthralgia (<3%), arthropathy (≥2%), leg pain (rectal: ≤2%)
Ophthalmic: Visual disturbance (≥2%)
Otic: Tinnitus (<3%)
Renal: Decreased creatinine clearance (<3%)
Respiratory: Rhinitis (8%), sinusitis (children and adolescents: 7%; adults: <1%), cough (children & adolescents: 5%; adults: <1%), dyspnea (<3%)
Miscellaneous: Intolerance syndrome (3%), fever (≤3%)
<1% (Limited to important or life-threatening): Abdominal cramps (rectal), abnormal stools, abnormal T waves on ECG, acute renal failure, agranulocytosis, albuminuria, amenorrhea, anaphylaxis, anemia, angioedema, anorectal pain (rectal; discomfort), anorexia, anxiety, aplastic anemia, arthritis, blurred vision, bronchitis, chest pain, chills, cholecystitis, cholestatic jaundice, chronic renal failure, confusion, conjunctivitis, decreased libido, depression, diaphoresis, DRESS syndrome, drowsiness, drug fever, duodenal ulcer, dysgeusia, dysmenorrhea, dysphagia, dysuria, ear disease, ecchymoses, eczema, edema, emotional lability, eosinophilia, eosinophilic pneumonitis, epididymitis, erythema, erythema nodosum, esophageal ulcer, Eustachian tube congestion, exacerbation of asthma, eye pain, facial edema, fecal discoloration (rectal), fecal incontinence, frequent bowel movements (rectal), gastritis, gout, granulocytopenia, Guillain-Barré syndrome, hepatic cirrhosis, hepatic failure, hepatic injury, hepatic necrosis, hepatitis, hepatotoxicity, hyperesthesia, hypermenorrhea, hypersensitivity pneumonitis, hypersensitivity reaction, hypertonia, hypomenorrhea, hypotension, idiopathic nephrotic syndrome, increased amylase, increased appetite, increased blood urea nitrogen, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, increased serum creatinine, increased serum lipase, increased thirst, insomnia, interstitial nephritis, interstitial pneumonitis, interstitial pulmonary disease, intracranial hypertension, jaundice, Kawasaki-like syndrome, leg cramps, leukopenia, lichen planus, lupus-like syndrome, lymphadenopathy, malaise, male infertility (rectal), mastalgia, migraine, mucus stools (rectal), myalgia, myocarditis, nail disease, neck pain, nephrogenic diabetes insipidus, nephrotoxicity (rectal), neutropenia (rectal), oligospermia, oral candidiasis, oral mucosa ulcer, otalgia, painful defecation (rectal), palpitations, pancytopenia, perforated peptic ulcer, pericardial effusion, pericarditis, peripheral edema, peripheral neuropathy, pharyngitis, pharyngolaryngeal pain, pleurisy, pneumonitis, prurigo, pruritus, pruritus ani (rectal), psoriasis, pulmonary infiltrates, pulmonary fibrosis, pyoderma gangrenosum, rectal discharge (rectal), rectal polyp, renal disease (including minimal change nephropathy), renal insufficiency, renal failure, rheumatoid arthritis, skin photosensitivity, Stevens-Johnson syndrome, stomach discomfort (rectal), stomatitis, swelling of eye, systemic lupus erythematosus, tachycardia, thrombocythemia, thrombocytopenia, transverse myelitis, tremor, ulcerative colitis (rectal; pancolitis), urinary urgency, urticaria, uterine hemorrhage, vasodilatation, weakness, xeroderma, xerostomia
Concerns related to adverse effects:
• Cardiac hypersensitivity effects: Pericarditis and myocarditis (mesalamine-induced cardiac hypersensitivity reactions) have been reported. Use with caution in patients predisposed to these conditions.
• Hypersensitivity reactions: Mesalamine-induced hypersensitivity reactions have been reported and may include internal organ involvement, such as hepatitis, hematologic abnormalities, and/or pneumonitis. Discontinue treatment for mesalamine-induced hypersensitivity reactions.
• Intolerance syndrome: May cause an acute intolerance syndrome (cramping, abdominal pain, bloody diarrhea; sometimes fever, headache, malaise, pruritus, rash, conjunctivitis); may be hard to discern from an exacerbation; discontinue immediately if syndrome occurs or is suspected. Symptoms usually abate if drug is discontinued. If rechallenge is performed to validate the hypersensitivity, use a reduced dose and only if clearly needed.
• Oligospermia: In males, oligospermia (rare, reversible) has been reported.
• Renal effects: Renal impairment (including minimal change nephropathy, acute and chronic interstitial nephritis, nephrotic syndrome, and rarely renal failure) has been reported. A renal function evaluation is recommended prior to initiation of therapy and periodically during treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal impairment during treatment.
• Sulfasalazine hypersensitivity: Patients with hypersensitivity to sulfasalazine may react to mesalamine.
• Hepatic impairment: Use caution in patients with hepatic impairment; hepatic failure has been reported.
• Renal impairment: Use with caution in patients with renal impairment, a history of renal disease, or those on nephrotoxic medications.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Elderly: Use with caution in the elderly; uncontrolled studies and postmarketing reports suggest an increased incidence of blood dyscrasias (ie, agranulocytosis, neutropenia, pancytopenia) in patients >65 years of age.
Dosage form specific issues:
• Apriso: Contains phenylalanine.
• Asacol HD (formulated without dibutyl phthalate [DBP]), Delzicol: Intact, partially intact, and/or tablet shells have been reported in the stool.
• Canasa suppositories: Contain saturated vegetable fatty acid esters (contraindicated in patients with allergy to these components). May stain surfaces including clothing, other fabrics, flooring, painted surfaces, enamel, granite, marble and vinyl. Avoid contact with these surfaces.
• Rowasa enema: Contain metabisulfite salts that may cause severe hypersensitivity reactions (ie, anaphylaxis) in patients with sulfite allergies.
• Rowasa, sfRowasa: May stain direct contact surfaces including clothing, other fabrics, flooring, painted surfaces, enamel, granite, marble and vinyl. Choose a suitable location for product administration.
• Tablets: Patients with pyloric stenosis or other organic or functional upper gastrointestinal obstructive disorders may have prolonged gastric retention of tablets, delaying the release of mesalamine in the colon.
• Appropriate use: Asacol HD: Safety and effectiveness beyond 6 weeks have not been determined.
• Bioequivalence: The Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Delzicol 400 mg capsules. Two Delzicol 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine 800 mg delayed-release tablet.
Renal function (prior to and periodically during therapy); CBC (particularly in elderly patients); hepatic function; signs/symptoms of worsening acute intolerance syndrome
Pregnancy Risk Factor
Adverse events have not been observed in animal reproduction studies. Mesalamine is known to cross the placenta. An increased rate of congenital malformations has not been observed in human studies. Preterm birth, still birth and decreased birth weight have been observed; however, these events may also be due to maternal disease.
Dibutyl phthalate (DBP) may be an inactive ingredient in the enteric coating of some products (eg Asacol, Asacol HD); adverse effects in male rats were noted at doses greater than the recommended human dose. Refer to product labeling for current formulation.
When treatment for inflammatory bowel disease is needed during pregnancy, mesalamine may be used, although products with DBP should be avoided (Habal 2012; Mottet 2009).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
•Patient may experience abdominal pain, heartburn, pharyngitis, constipation, diarrhea, flatulence, rhinorrhea, rhinitis, muscle pain, joint pain, nausea, vomiting, or rectal irritation. Have patient report immediately to prescriber signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, or weight gain), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), angina, vomiting blood, burning or numbness feeling, confusion, tachycardia, arrhythmia, chills, severe headache, severe dizziness, severe back pain, shortness of breath, excessive weight gain, swelling of arms or legs, bruising, bleeding, severe loss of strength and energy, or signs of ulcerative colitis (severe abdominal pain or cramps; bloody stools; fever; headache; or rash) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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