Rowasa


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mesalamine (5-aminosalicylic acid, 5-ASA, mesalazine, mesalazine (UK))

Apriso, Asacol, Asacol HD, Canasa, Ipocol (UK), Lialda, Mesasal (CA), Mesren (UK), Mezavant (CA), Novo-5-ASA-Ect (CA), Pentasa, Rowasa, Salofalk (CA) (UK)

Pharmacologic class: 5-amino-2-hydroxybenzoic acid

Therapeutic class: GI anti-inflammatory drug

Pregnancy risk category B

Action

Unknown. Thought to act in colon, where it blocks cyclooxygenase and inhibits prostaglandin synthesis.

Availability

Capsules (extended-release): 250 mg, 500 mg, 0.375 g (Apriso)

Rectal suspension: 4 g/60 ml

Suppositories: 1,000 mg

Tablets (delayed-release): 400 mg (Pentasa), 800 mg (Asacol HD), 1.2 g (Lialda)

Indications and dosages

Active ulcerative colitis

Adults: 800 mg P.O. (Asacol delayed-release tablets) t.i.d. for 6 weeks

To induce remission in mildly to moderately active ulcerative colitis

Adults: 1 g P.O. (Pentasa extended-release capsules) q.i.d. for a total dosage of 4 g daily for up to 8 weeks. Or, two to four 1.2 g (Lialda) extended-release tablets P.O. once daily for total daily dose of 2.4 or 4.8 g for up to 8 weeks.

Active distal ulcerative colitis, proctosigmoiditis, or proctitis

Adults: 4-g enema (Rowasa 60 ml) P.R. daily at bedtime, retained for 8 hours. Continue for 3 to 6 weeks.

Active ulcerative proctitis

Adults: 500 mg (Canasa suppository) P.R. b.i.d., increased to t.i.d. if response inadequate after 2 weeks. Or 1,000 mg (suppository) P.R. at bedtime, continued for 3 to 6 weeks.

To maintain remission of ulcerative colitis

Adults: 1.6 g (Asacol) P.O. daily in divided doses. Or, 1.5 g (Apriso) P.O. daily in the morning.

Contraindications

• Hypersensitivity to drug, its components, or salicylates

Precautions

Use cautiously in:
• severe hepatic or renal impairment
• allergy to sulfasalazine
• pyloric stenosis (delayed-release tablets)
• conditions predisposing to development of myocarditis or pericarditis
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).

Administration

• Give Apriso capsules with or without food. Don't give concurrently with antacids.
• Give Lialda tablets with meal.
• Make sure patient swallows tablets whole without crushing or chewing.
• For best effect, have patient retain suppository for 1 to 3 hours.

Adverse reactions

CNS: headache, dizziness, malaise, weakness

CV: chest pain, mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis)

EENT: rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, eructation, flatulence, anal irritation (with rectal use), pancreatitis

GU: interstitial nephritis, renal failure

Musculoskeletal: back pain

Skin: alopecia, rash

Other: fever, acute intolerance syndrome, anaphylaxis, acute intolerance syndrome

Interactions

Drug-drug.Antacids: increased risk of dissolution of coating of Apriso granules

Azathioprine, 6-mercaptopurine: increased potential for blood disorders

Nephrotoxic drugs (including nonsteroidal anti-inflammatory agents): increased risk of renal adverse reactions

Patient monitoring

Monitor carefully for mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis).

Closely monitor patients with history of allergic reactions to sulfasalazine or sulfite sensitivity (if using enema).
• Assess kidney and liver function before and periodically during therapy.
• Monitor for suppository efficacy, which should appear in 3 to 21 days. However, know that treatment usually continues for 3 to 6 weeks.

Watch for signs and symptoms of intolerance syndrome, such as cramping, acute abdominal pain, bloody diarrhea, fever, headache, and rash. If these occur, discontinue drug and notify prescriber.

Watch for signs and symptoms of intolerance syndrome, such as cramping, acute abdominal pain, bloody diarrhea, fever, headache, and rash. If these occur, discontinue drug. Drug may be restarted later only if clearly needed, under close medical supervision and at reduced dosage.

Patient teaching

• Instruct patient to swallow tablets or capsules whole.
• Tell patient to contact prescriber if partially intact tablets repeatedly appear in stools.
• Advise patient using suppository to avoid excessive handling and to retain suppository for 1 to 3 hours or longer for maximum benefit.
• Teach patient about proper enema administration. Tell him to stay in position for at least 30 minutes and, if possible, retain medication overnight.

Advise patient to immediately report breathing difficulties, allergic symptoms, cramping, acute abdominal pain, bloody diarrhea, fever, headache, or rash.
• As appropriate, review all other significant and life-threatening adverse reactions, especially those related to the drugs mentioned above.

mesalamine

(me-sal-a-meen) ,

Apriso

(trade name),

Asacol

(trade name),

Asacol HD

(trade name),

Canasa

(trade name),

Delzicol

(trade name),

Lialda

(trade name),

Pentasa

(trade name),

Rowasa

(trade name)

Classification

Therapeutic: gastroinestinal anti inflammatories
Pregnancy Category: B

Indications

Delzicol, Lialda, and Pentasa—Treatment and maintenance of remission of mildly-to-moderately-active ulcerative colitis.Apriso—Maintenance of remission of ulcerative colitis.Asacol HD—Treatment of moderately-active ulcerative colitis.Canasa—Treatment of active ulcerative proctitis.Rowasa—Treatment of active mild-to-moderate distal ulcerative colitis, proctosigmoiditis, or proctitis.

Action

Locally acting anti-inflammatory action in the colon, where activity is probably due to inhibition of prostaglandin synthesis.

Therapeutic effects

Reduction in the symptoms of ulcerative colitis, proctosigmoiditis, and proctitis.

Pharmacokinetics

Absorption: 28% absorbed following oral administration; 10–30% absorbed from the colon, depending on retention time, following rectal administration.
Distribution: Unknown.
Metabolism and Excretion: Some metabolism occurs, site unknown; mostly eliminated unchanged in the feces.
Half-life: Oral—12 hr (range 2–15 hr); Rectal—0.5–1.5 hr.

Time/action profile (clinical improvement)

ROUTEONSETPEAKDURATION
POunknown unknown6–8 hr
ER2 hr9–12 hr24 hr
Rectal3–21 daysunknown24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity reactions to sulfonamides, salicylates, mesalamine, or sulfasalazine;Cross-sensitivity with furosemide, sulfonylurea hypoglycemic agents, or carbonic anhydrase inhibitors may exist;G6PD deficiency;Hypersensitivity to bisulfites (mesalamine enema only);Urinary tract or intestinal obstruction;Porphyria.
Use Cautiously in: Severe hepatic or renal impairment; Obstetric: Safety not established; use tablets only if potential benefits outweigh risk to fetus (enteric coating contains dibutyl phthalate, which has been shown to cause congenital malformations in animals); Lactation: Has caused side effects in some infants; careful observation required.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • dizziness
  • malaise
  • weakness

Ear, Eye, Nose, Throat

  • pharyngitis
  • rhinitis

Cardiovascular

  • pericarditis

Gastrointestinal

  • diarrhea
  • eructation (PO)
  • flatulence
  • nausea
  • vomiting

Genitourinary

  • interstitial nephritis
  • pancreatitis
  • renal failure

Dermatologic

  • hair loss
  • rash

Local

  • anal irritation (enema, suppository)

Musculoskeletal

  • back pain
  • myalgia

Miscellaneous

  • anaphylaxis (life-threatening)
  • acute intolerance syndrome
  • fever

Interactions

Drug-Drug interaction

May ↓ metabolism and ↑ effects/toxicity of mercaptopurine or thioguanine.

Route/Dosage

One Asacol HD 800-mg tablet is NOT bioequivalent to two Delzicol 400-mg capsules

Treatment of Ulcerative Colitis

Oral (Adults) Delzicol—800 mg (two 400-mg capsules) 3 times daily for 6 wk; Asacol HD—1.6 g (two 800-mg tablets) 3 times daily for 6 wk; Lialda—2.4–4.8 g (two to four 1.2-g tablets) once daily for up to 8 wk; Pentasa—1 g (four 250-mg capsules or two 500-mg capsules) 4 times daily for up to 8 wk.
Rectal (Adults) Rowasa—4-g enema (60 mL) at bedtime, retained for 8 hr for 3–6 wk.

Maintenance of Remission of Ulcerative Colitis

Oral (Adults) Apriso—1.5 g (four 375-mg capsules) once daily in the morning; Delzicol—800 mg (two 400-mg capsules) 2 times daily; Lialda—2.4 g (two 1.2-g tablets) once daily; Pentasa—1 g (four 250-mg capsules or two 500-mg capsules) 4 times daily.

Treatment of Ulcerative Proctosigmoiditis

Rectal (Adults) Rowasa—4-g enema (60 mL) at bedtime, retained for 8 hr (treatment duration = 3–6 wk).

Treatment of Ulcerative Proctitis

Rectal (Adults) Rowasa—4-g enema (60 mL) at bedtime, retained for 8 hr (treatment duration = 3–6 wk); Canasa—Insert a 1–g suppository at bedtime, retain for at least 1–3 hr (treatment duration = 3–6 wk).

Availability (generic available)

Delayed-release tablets: 500 mg, 800 mg (Asacol HD), 1.2 g (Lialda)
Controlled-release capsules (Pentasa): 250 mg, 500 mg
Delayed-release capsules (Delzicol): 400 mg
Extended-release capsules (Apriso): 375 mg
Suppositories (Canasa): 1 g
Rectal suspension (Rowasa): 4 g/60 mL

Nursing implications

Nursing assessment

  • Assess for allergy to sulfonamides and salicylates. Patients allergic to sulfasalazine may take mesalamine or olsalazine without difficulty, but therapy should be discontinued if rash or fever occurs.
  • Monitor intake and output ratios. Fluid intake should be sufficient to maintain a urine output of at least 1200–1500 mL daily to prevent crystalluria and stone formation.
  • Inflammatory Bowel Disease: Assess abdominal pain and frequency, quantity, and consistency of stools at the beginning of and during therapy.
  • Lab Test Considerations: Monitor urinalysis, BUN, and serum creatinine prior to and periodically during therapy. Mesalamine may cause renal toxicity.
    • Mesalamine may cause ↑ AST and ALT levels, serum alkaline phosphatase, GGTP, LDH, amylase, and lipase.

Potential Nursing Diagnoses

Acute pain (Indications)
Diarrhea (Indications)

Implementation

  • Do not confuse Asacol (mesalamine) with Os-Cal (calcium carbonate).
  • Oral: Administer with a full glass of water. Tablets should be swallowed whole; do not break the outer coating, which is designed to remain intact. Take Lialda tablets with a meal. Take Apriso capsules in the morning without regard to meals. Do not co-administer with antacids; may effect dissolution of the coating of the granules in Apriso capsules. Intact or partially intact tablets may occasionally be found in the stool. If this occurs repeatedly, advise patient to notify health care professional. Swallow Delzicol capsules whole; do not break, crush, or chew. Administer 1 hr before or 2 hr after a meal. Two Delzicol 400 mg capsules are not equal to one Asacol HD (mesalamine) delayed-release 800 mg tablet.
  • Rectal: Patient should empty bowel prior to administration of rectal dose forms.
    • Avoid excessive handling of suppository. Remove foil wrapper and insert pointed end first into rectum with gentle pressure. Suppository should be retained for 1–3 hr or more for maximum benefit.
    • Administer 60-mL retention enema once daily at bedtime. Solution should be retained for approximately 8 hr. Prior to administration of rectal suspension, shake bottle well and remove the protective cap. Have patient lie on left side with the lower leg extended and the upper leg flexed for support or place the patient in knee-chest position. Gently insert the applicator tip into the rectum, pointing toward the umbilicus. Squeeze the bottle steadily to discharge most of the preparation.

Patient/Family Teaching

  • Instruct patient on the correct method of administration. Advise patient to take medication as directed, even if feeling better. Take missed doses as soon as remembered unless almost time for next dose.
  • May cause dizziness. Caution patient to avoid driving or other activities that require alertness until response to medication is known.
  • Advise patient to notify health care professional if skin rash, sore throat, fever, mouth sores, unusual bleeding or bruising, wheezing, fever, or hives occur.
  • Instruct patient to notify health care professional if symptoms do not improve after 1–2 mo of therapy.
  • Instruct patient to notify health care professional if symptoms worsen or do not improve. If symptoms of acute intolerance (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) occur, discontinue therapy and notify health care professional immediately.
  • Inform patient that proctoscopy and sigmoidoscopy may be required periodically during treatment to determine response.
  • Rectal: Instruct patient to use rectal suspension at bedtime and retain suspension all night for best results.
  • Advise patient not to change brands of mesalamine without consulting health care professional.

Evaluation/Desired Outcomes

  • Decrease in diarrhea and abdominal pain.
  • Return to normal bowel pattern in patients with inflammatory bowel disease. Effects may be seen within 3–21 days. The usual course of therapy is 3–6 wk.
  • Maintenance of remission in patients with inflammatory bowel disease.

Rowasa

(rō-ā′sə)
A trademark for the drug mesalamine.
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