Therapeutic Classification: gastrointestinal anti-inflammatories
Pharmacologic Classification: corticosteroids
Absorption: Well absorbed following oral administration (9–21% bioavailability).
Distribution: Widely distributed to extravascular tissues; enters breast milk.
Protein Binding: 85–90%.
Metabolism/Excretion: Rapidly and extensively metabolized during first pass hepatic metabolism by the CYP3A4 enzyme system to inactive metabolites which are excreted in urine and feces.
Half-life: 2.0–3.6 hr; Tarpeyo — 5–6.8 hr.
(improvement in symptoms of Crohn’s disease or induction of remission of ulcerative colitis)
CV: edema, hypertension, palpitations, tachycardia.
Derm: acne, easy bruising, hirsutism, alopecia, dermatitis, eczema, flushing, striae, sweating.
EENT: abnormal vision, conjunctivitis.
Endo: ADRENAL SUPPRESSION, hypokalemia.
GI: nausea, abdominal pain, dyspepsia, flatulence, vomiting.
GU: dysuria, irregular menses, nocturia, urinary frequency.
Hemat: leukocytosis.
Metab: weight gain.
MS: back pain, cramps, myalgia.
Neuro: hyperkinesia, paresthesia, tremor, headache, agitation, confusion, dizziness, drowsiness, fatigue, ↑ appetite, insomnia, malaise, nervousness, vertigo.
Resp: bronchitis, dyspnea.
Misc: infection, cushingoid appearance, flu-like syndrome.
Treatment of Active Crohn's Disease (Entocort EC and Ortikos)
- PO (Adults): 9 mg once daily in the morning for up to 8 wk; recurring episodes of active disease can be treated with a repeat 8–wk course of therapy.
- PO (Children
8 yr and >25 kg): 9 mg once daily in the morning for up to 8 wk, then 6 mg once daily in the morning for 2 wk.
Hepatic Impairment
- (Adults): Moderate hepatic impairment (Child-Pugh Class B) — Entocort EC: 3 mg once daily in the morning.
Maintenance of Remission of Crohn's Disease (Entocort EC and Ortikos)
- PO (Adults): Following treatment of active disease and once patient's symptoms controlled, continue treatment with 6 mg once daily for up to 3 mo. If symptom control maintained at 3 mo, dose should be tapered to complete discontinuation. Continuing treatment for > 3 mo does not produce significant clinical benefit.
Hepatic Impairment
- (Adults): Moderate hepatic impairment (Child-Pugh Class B) — Entocort EC: 3 mg once daily in the morning.
Induction of Remission of Ulcerative Colitis (Uceris)
- PO (Adults): 9 mg once daily in the morning for up to 8 wk.
Reduction in Proteinuria Associated with Primary Immunoglobulin A Nephropathy (Tarpeyo)
- PO (Adults): 16 mg once daily in the morning for 9 mo, then 8 mg once daily in the morning for 2 wk.
Entocort EC, Ortikos, Tarpeyo, Uceris
Cortiment, Entocort, Jorveza