Delzicol, Lialda, and Pentasa:

• Treatment and maintenance of remission of mildly-to-moderately-active ulcerative colitis.

Apriso:

• Maintenance of remission of ulcerative colitis.

Canasa:

• Treatment of active ulcerative proctitis.

Rowasa:

• Treatment of active mild-to-moderate distal ulcerative colitis, proctosigmoiditis, or proctitis.

Contraindicated in:

• Hypersensitivity reactions to sulfonamides, salicylates, mesalamine, or sulfasalazine
• Cross-sensitivity with furosemide, sulfonylureas, or carbonic anhydrase inhibitors may exist
• Hypersensitivity to bisulfites (mesalamine enema only)
• Urinary tract or intestinal obstruction
• Porphyria.

Use Cautiously in:

• Renal impairment
• Hepatic impairment
• Atopic dermatitis or atopic eczema (↑ risk of photosensitivity)
• Phenylketonuria (Apriso contains phenylalanine)
• OB: Use tablets only if potential benefits justify potential fetal risks (enteric coating contains dibutyl phthalate, which has been shown to cause congenital malformations in animals)
• Lactation: Use while breast feeding only if potential maternal benefits justify potential risk to infant
• Geri: Older adults may have ↑ risk of agranulocytosis, neutropenia, and pancytopenia.

CV: pericarditis.

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMATIC SYMPTOMS (DRESS), hair loss, photosensitivity, rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

EENT: pharyngitis, rhinitis.

GI: diarrhea, eructation (PO), flatulence, HEPATOTOXICITY, nausea, pancreatitis, vomiting.

GU: interstitial nephritis, nephrolithiasis, renal impairment.

Local: anal irritation (enema, suppository).

MS: back pain, myalgia.

Neuro: headache, dizziness, malaise, weakness.
Misc: acute intolerance syndrome, fever, (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)HYPERSENSITIVITY REACTIONS .

Drug-Drug:

• May ↑ myelosuppressive effects of mercaptopurine or azathioprine; avoid concurrent use, if possible.
• Concurrent use with NSAIDs may ↑ risk of nephrotoxicity.

(Generic available)

• Delayed-release tablets: 400 mg; 500 mg; 800 mg; 1 g; 1.2 g (Lialda);
• Delayed-release capsules (Delzicol): 400 mg;
• Extended-release capsules (Apriso) (contain phenylalanine): 375 mg;
• Extended-release capsules (Pentasa): 250 mg; 500 mg;
• Rectal enema (Rowasa): 1 g/100 mL; 2 g/60 mL; 4 g/60 mL; 4 g/100 mL;
• Rectal foam: 1 g/actuation;
• Rectal suppository (Canasa): 500 mg; 1 g;

Treatment of Ulcerative Colitis

• PO (Adults): 1.6 g (two 800-mg tablets) 3 times daily for 6 wk; Delzicol: 800 mg (two 400-mg capsules) 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.
• Rect (Adults): Rowasa: 4-g enema (60 mL) at bedtime, retained for 8 hr for 3–6 wk.
• PO (Children ≥12 yr and 54–90 kg): Delzicol: 27–44 mg/kg/day in 2 divided doses (max dose = 2.4 g/day) for 6 wk.
• PO (Children ≥12 yr and 33–53 kg): Delzicol: 37–61 mg/kg/day in 2 divided doses (max dose = 2 g/day) for 6 wk.
• PO (Children ≥12 yr and 17–32 kg): Delzicol: 36–71 mg/kg/day in 2 divided doses (max dose = 1.2 g/day) for 6 wk.
• PO (Children >50 kg): Lialda: 4.8 g (four 1.2-g tablets) once daily for 8 wk, then 2.4 g (two 1.2–g tablets) once daily.
• PO (Children 36–50 kg): Lialda: 3.6 g (three 1.2-g tablets) once daily for 8 wk, then 2.4 g (two 1.2–g tablets) once daily.
• PO (Children 24–35 kg): Lialda: 2.4 g (two 1.2-g tablets) once daily for 8 wk, then 1.2 g once daily.

Maintenance of Remission of Ulcerative Colitis

• PO (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

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

Treatment of Ulcerative Proctitis

• Rect (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).

Apriso, Asacol, Asacol HD, Canasa, Delzicol, Lialda, Pentasa, Rowasa

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

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

Therapeutic Classification: gastrointestinal anti-inflammatories

Absorption: 28% absorbed following oral administration; 10–30% absorbed from the colon, depending on retention time, following rectal administration.

Distribution: Unknown.

Metabolism/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.

Mezavant, Mezera, Octasa, Salofalk, Teva 5–ASA

(clinical improvement)

• 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. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient not to change brands of mesalamine without consulting health care professional.
• Encourage patient to drink an adequate amount of fluids to minimize risk of kidney stones and to notify health care professional if signs and symptoms of kidney stones (severe side or back pain, blood in urine) occur.
• 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.
• Advise patient to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors to decrease risk of photosensitivity.
• 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.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Monitor breast-fed infants for diarrhea.
• Rect: Instruct patient to use rectal suspension at bedtime and retain suspension all night for best results.

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