budesonide (Rx)Brand and Other Names:Entocort EC, Uceris

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule, enteric-coated and extended-release (Entocort EC)

  • 3mg

tablet, enteric-coated and extended-release (Uceris)

  • 9mg
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Ulcerative Colitis

Induction of remission of active mild-to-moderate ulcerative colitis

Uceris: 9 mg PO qAM for up to 8 weeks

Crohn Disease

Treatment of active mild-to-moderate Crohn disease involving ileum or ascending colon; maintenance of clinical remission of mild-to-moderate Crohn disease for up to 3 months

Entocort EC: 9 mg PO qAM for up to 8 weeks; for recurring episodes of active disease, 8-week courses may be repeated

Once symptoms are controlled, may be tapered to 6 mg PO qAM for maintenance

Crohn disease maintenance

  • Entocort EC: 6 mg PO qAM for up to 3 months
  • If symptom control is maintained at 3 months, tapering to complete cessation may be attempted (recommended)

Immunoglobulin A Nephropathy (Orphan)

Slowing of progression of immunoglobulin A nephropathy; delaying of onset of kidney failure in patients affected by this disease

Orphan indication sponsor

  • Pharmalink AB; Engelbrekts kyrkogata 7b; Stockholm, Sweden

Ulcerative Colitis (Orphan)

Orphan designation (budesonide [Uceris]) for treatment ulcerative colitis in pediatric patients aged 0 through 16 years

Orphan sponsor

  • Santarus, Inc.; 3611 Valley Centre Drive, Suite 400; San Diego, CA 92130
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Interactions

Interaction Checker

budesonide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (21%)

            Acne (<5-15%)

            Nausea (11%)

            Respiratory infection (11%)

            1-10%

            Back pain (7%)

            Dizziness (7%)

            Abdominal pain (6%)

            Dyspepsia (6%)

            Vomiting (6%)

            Fatigue (5%)

            Frequency Not Defined

            Adrenal suppression

            Amnesia

            Anaphylactic reactions

            Benign intracranial hypertension

            Diarrhea

            Facial edema

            Fever

            Flu syndrome

            GI irritation

            Hypokalemia

            Increased appetite

            Insomnia

            Migraine

            Nervousness

            Pharyngitis

            Rash

            Xerostomia

            Weight gain

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            Warnings

            Contraindications

            Documented hypersensitivity

            Cautions

            High-fat meal delays absorption

            May increase risk of serious or fatal infection in individuals exposed to viral illnesses such as chickenpox or measles

            Use with caution in patients with diabetes mellitus, hypertension, hypothyroidism, electrolyte abnormalities, sodium and water retention, infections, immunizations, ocular herpes simplex, myasthenia gravis, peptic ulcer disease, psychosis, or renal insufficiency

            Thromboembolic disorders and myopathy may occur

            Delayed wound healing is possible

            Patients receiving corticosteroids should avoid chickenpox- or measles-infected persons if unvaccinated

            Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)

            Some suggestion (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy

            Prolonged corticosteroid use may result in elevated intraocular pressure, glaucoma, or cataracts and has been associated with development of Karposi sarcoma

            Myopathy has been reported

            Secreted in human milk; no data from controlled trials on potential serious adverse reactions in nursing infants; use with caution

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Use with caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Anti-inflammatory corticosteroid; potent glucocorticoid activity but weak mineralocorticoid activity; controls rate of protein synthesis; decreases inflammation by suppressing migration of polymorphonuclear leukocytes (PMNs) and reducing capillary permeability; stabilizes cell and lysosomal membranes, increases surfactant synthesis, increases serum vitamin A concentration, and inhibits prostaglandin and proinflammatory cytokines; suppresses lymphocyte proliferation through direct cytolysis, inhibits mitosis, and breaks down granulocyte aggregates

            Absorption

            Bioavailability: Capsule, 9-21%

            Peak plasma time: Capsule, 5-10 hr

            Distribution

            Protein bound: 85-90%

            Vd: 2.2-3.9 L/kg

            Metabolism

            Extensive 1st-pass metabolism by CYP3A4 in liver

            Metabolites: 6-Beta-hydroxybudesonide, 16-alpha-hydroxyprednisolone (inactive)

            Elimination

            Half-life: 2-3.6 hr

            Excretion: Urine (60%), feces (minimal)

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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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