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Mesalamine

Pronunciation

Pronunciation

(me SAL a meen)

Index Terms

  • 5-Aminosalicylic Acid
  • 5-ASA
  • Asacol
  • Fisalamine
  • Mesalazine

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

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]

Enema, Rectal:

SfRowasa: 4 g/60 mL (60 mL) [sulfite free; contains edetate disodium, sodium benzoate]

Generic: 4 g (60 mL)

Kit, Rectal:

Rowasa: 4 g [contains edetate disodium, potassium metabisulfite, sodium benzoate]

Generic: 4 g

Suppository, Rectal:

Canasa: 1000 mg (30 ea, 42 ea)

Tablet Delayed Release, Oral:

Asacol: 400 mg [DSC]

Asacol HD: 800 mg

Lialda: 1.2 g

Generic: 800 mg

Brand Names: U.S.

  • Apriso
  • Asacol HD
  • Asacol [DSC]
  • Canasa
  • Delzicol
  • Lialda
  • Pentasa
  • Rowasa
  • SfRowasa

Pharmacologic Category

  • 5-Aminosalicylic Acid Derivative

Pharmacology

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

Absorption

Rectal: Variable and dependent upon retention time, underlying GI disease, and colonic pH; Oral: Tablet: ~20% to 28%, Capsule: ~20% to 43%

Metabolism

Hepatic and via GI tract to N-acetyl-5-aminosalicylic acid

Excretion

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)

Half-Life Elimination

5-ASA and N-acetyl-5-ASA: Variable; ~ 25 hours (range: 2 to 296 hours)

Protein Binding

Mesalamine (5-ASA): ~43%; N-acetyl-5-ASA: ~78%

Use: Labeled Indications

US labeling:

Oral:

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)

Canadian labeling:

Oral:

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)

Contraindications

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)

Dosing: Adult

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:

US labeling:

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

Canadian labeling:

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:

US labeling:

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

Canadian labeling:

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:

US labeling:

Retention enema: 4 g at bedtime, retained overnight, approximately 8 hours

Rectal suppository: One 1,000 mg suppository rectally at bedtime; retain for at least 1 to 3 hours

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.

Dosing: Geriatric

Refer to adult dosing. Use with caution.

Dosing: Pediatric

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.

Canadian labeling:

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.

Canadian labeling:

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

Severe impairment: Use is contraindicated.

Administration

Oral:

Capsules: Administer with or without food.

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

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

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

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

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

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

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

Lialda: Administer with a meal.

Mesasal [Canadian product]: Administer before meals.

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

Pentasa [Canadian product]: Administer with meals.

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

Suppository: Remove foil wrapper; avoid excessive handling. Insert into rectum. Retain suppository for 1 to 3 hours or longer.

Dietary Considerations

Some products may contain phenylalanine.

Apriso: Do not administer with antacids.

Storage

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; do not freeze. Protect from direct heat, light, and humidity.

Drug Interactions

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-ASA Derivatives may decrease the serum concentration of Cardiac Glycosides. Monitor therapy

H2-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

Heparin: 5-ASA Derivatives may enhance the adverse/toxic effect of Heparin. Specifically, the risk for bleeding/bruising may be increased. Monitor therapy

Heparin (Low Molecular Weight): 5-ASA Derivatives may enhance the adverse/toxic effect of Heparin (Low Molecular Weight). Specifically, the risk for bleeding/bruising may be increased. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of 5-ASA 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-ASA Derivatives may decrease the metabolism of Thiopurine Analogs. Monitor therapy

Varicella Virus-Containing Vaccines: 5-ASA 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

Test Interactions

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 Reactions

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.

>10%:

Central nervous system: Headache (adults: 2% to 14%; children and adolescents: 10%), pain (≤14%)

Gastrointestinal: Eructation (≤26%), abdominal pain (2% to 21%), exacerbation of ulcerative colitis (children and adolescents: 12%; adults: 2% to 3%), constipation (≤11%)

Respiratory: Nasopharyngitis (children and adolescents: 15%; adults: 1% to 4%), pharyngitis (11%)

1% to 10%:

Cardiovascular: Chest pain (3%), peripheral edema (3%), vasodilation (≥2%), syncope (children and adolescents: 2%), hypertension (1%)

Central nervous system: Dizziness (≤9%), hypertonia (5%), chills (3%), fatigue (<3%), vertigo (<3%), anxiety (≥2%), migraine (≥2%), nervousness (≥2%), paresthesia (≥2%), insomnia (≤2%), malaise (≤2%)

Dermatologic: Skin rash (1% to 6%), diaphoresis (≤3%), pruritus (≤3%), alopecia (<3%), acne vulgaris (≤2%)

Endocrine & metabolic: Increased serum triglycerides (<3%), weight loss (children and adolescents: 2%)

Gastrointestinal: Diarrhea (2% to 8%), flatulence (≤6%), vomiting (≤5%), dyspepsia (≤4%), nausea (≤4%), abnormal stools (≥2%), gastroenteritis (≥2%), gastrointestinal hemorrhage (<1% to ≥2%), tenesmus (≥2%), hemorrhoids (≥2%), bloody diarrhea (children and adolescents: 2%), pancreatitis (children and adolescents: 2%), rectal pain (2%), sclerosing cholangitis (children and adolescents: 2%), abdominal distention (≥1%), anorectal pain (1%; on insertion of enema tip), nausea and vomiting (1%)

Genitourinary: Hematuria (<3%), urinary frequency (<1% to ≥2%)

Hematologic & oncologic: Decreased hemoglobin (<3%), decreased hematocrit (<3%), rectal hemorrhage (<1% to ≥2%), anemia (children and adolescents: 2%)

Hepatic: Cholestatic hepatitis (<3%), increased serum transaminases (<3%), abnormal hepatic function tests (2%), increased serum ALT (1%)

Hypersensitivity: Anaphylaxis (2%)

Infection: Infection (≥2%), viral infection (children and adolescents: 2%; adenovirus)

Neuromuscular & skeletal: Back pain (6%), arthralgia (≤5%), myalgia (≤3%), weakness (<1% to ≥2%), arthritis (2%), musculoskeletal pain (2%; leg/joint)

Ophthalmic: Visual disturbance (≥2%), conjunctivitis (≤2%)

Otic: Tinnitus (<3%), otalgia (≥2%)

Renal: Decreased creatinine clearance (<3%), polyuria (≥2%)

Respiratory: Rhinitis (8%), sinusitis (children and adolescents: 7%; adults: ≥2%), flu-like symptoms (1% to ≥5%), cough (≤5%), dyspnea (<3%), bronchitis (≥2%)

Miscellaneous: Fever (≤1% to ≥5%), intolerance syndrome (3%)

<1% (Limited to important or life-threatening): Abdominal distention, abnormal T waves on ECG, abnormal uterine bleeding, agranulocytosis, albuminuria, alopecia, aplastic anemia, cholecystitis, cholestatic jaundice, DRESS syndrome, drug fever, duodenal ulcer, dysuria, ecchymoses, eczema, edema, eosinophilia, eosinophilic pneumonitis, erythema nodosum, esophageal ulcer, fecal discoloration, granulocytopenia, Guillain-Barré syndrome, hepatic cirrhosis, hepatic failure, hepatic injury, hepatic necrosis, hepatitis, hepatotoxicity, hypersensitivity pneumonitis, hypersensitivity reaction, hypomenorrhea, idiopathic nephrotic syndrome, increased blood urea nitrogen, increased serum amylase, increased serum bilirubin, increased serum creatinine, increased serum lipase, increased thirst, interstitial nephritis, interstitial pneumonitis, jaundice, Kawasaki-like syndrome, leg cramps, leukopenia, lupus-like syndrome, lymphadenopathy, mastalgia, mucus stools, myocarditis, nail disease, nephrotoxicity, neutropenia, oligospermia, palpitations, pancytopenia, paresthesia, perforated peptic ulcer, perianal skin irritation, pericardial effusion, pericarditis, peripheral neuropathy, pharyngolaryngeal pain, pleurisy, pneumonitis, pruritus, pulmonary infiltrates, pulmonary interstitial fibrosis, pyoderma gangrenosum, rectal discharge, rectal polyp, renal failure, skin photosensitivity, Stevens-Johnson syndrome, systemic lupus erythematosus, tachycardia, tenesmus, thrombocythemia, thrombocytopenia, transverse myelitis, vasodilation

Warnings/Precautions

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.

Disease-related concerns:

• Hepatic impairment: Use caution in patients with hepatic impairment; hepatic failure has been reported. Canadian labeling contraindicates use in severe impairment.

• Renal impairment: Use with caution in patients with renal impairment, a history of renal disease, or those on nephrotoxic medications. Canadian labeling contraindicates use in patients with severe impairment (GFR <30 mL/minute/1.73 m2); urinary tract obstruction and renal parenchymal disease are also included as contraindications in specific Canadian labels (refer to Contraindications).

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.

Special populations:

• Elderly: Use with caution in the elderly; postmarketing reports suggest an increased incidence of blood dyscrasias 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, Salofalk [Canadian product] and Pentasa [Canadian product] 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.

Other warnings/precautions:

• 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 Asacol 400 mg tablets [Canadian product] or 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.

Monitoring Parameters

Renal function (prior to and periodically during therapy); CBC (particularly in elderly patients); hepatic function

Pregnancy Risk Factor

B

Pregnancy Considerations

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, Mesasal [Canadian product]); 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).

Patient Education

• 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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