REMS
Delzicol, Lialda, and Pentasa:
Apriso:
- Maintenance of remission of ulcerative colitis.
Canasa:
Rowasa:
- Treatment of active mild-to-moderate distal ulcerative colitis, proctosigmoiditis, or proctitis.
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, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).
One 800-mg tablet is NOT bioequivalent to two Delzicol 400-mg capsules
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
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
