budesonide rectal (Rx)

Brand and Other Names:Uceris Rectal Foam
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

rectal foam

  • 2mg/metered dose

Ulcerative Colitis

Indicated for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge

1 metered dose (2 mg) PR BID for 2 weeks followed by 1 metered dose PR once daily in evening for 4 weeks

Administration

For rectal administration only; not for oral use

Before administration, use the bathroom to empty your bowels

Each applicator is coated with a lubricant; if additional lubrication is needed, petrolatum or petroleum jelly can also be used

Warm the canister in the hands while shaking it vigorously for 10-15 seconds before use

Can be used in a standing, lying, or sitting position (eg, while using the toilet)

When applied in the evening, use immediately prior to bedtime; try not to empty your bowels again until the next morning

Safety and efficacy not established

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Interactions

Interaction Checker

and budesonide rectal

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • macimorelin

                budesonide rectal, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH growth hormone release before administering prior to administration of macimorelin. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin.

              Monitor Closely (0)

                Minor (0)

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                  Adverse Effects

                  >10%

                  Decreased blood cortisol (17%)

                  1-10%

                  Adrenal insufficiency (4%)

                  Nausea (2%)

                  <1%

                  Insomnia (0.4%)

                  Sleep disorder (0.4%)

                  Acne (0.4%)

                  Depression (0.4%)

                  Hyperglycemia (0.4%)

                  Postmarketing Reports

                  Cardiac disorders: Hypertension

                  Gastrointestinal disorders: Pancreatitis

                  General disorders and administration-site conditions: Pyrexia, peripheral edema

                  Immune system disorders: Anaphylactic reactions

                  Nervous system disorders: Dizziness, benign intracranial hypertension

                  Psychiatric disorders: Mood swings

                  Skin and subcutaneous tissue disorders: Pruritus, maculopapular rash, allergic dermatitis

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                  Warnings

                  Contraindications

                  Hypersensitivity

                  Cautions

                  Long-term use of corticosteroids may cause hypercorticism and adrenal suppression

                  Taper systemic corticosteroids slowly when transitioning from corticosteroids with higher systemic effects to those with lower effects (eg, budesonide rectal); symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop

                  Corticosteroids (prolonged use or high doses) are known to be immunosuppressive; monitor patients with active or quiescent tuberculosis infection, ocular herpes simplex, or untreated fungal, bacterial, systemic viral, or parasitic infections

                  Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, or cataracts; any family history of diabetes or glaucoma; or with any other conditions in which glucocorticosteroids may have unwanted effects

                  Moderate-to-severe hepatic impairment; monitor for increased signs and/or symptoms of hypercorticism

                  Avoid use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, grapefruit juice) during 6-week treatment period; may increase budesonide systemic exposure

                  Rectal foam is flammable; store away from flame or heat sources

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                  Pregnancy & Lactation

                  Pregnancy Category: C

                  Lactation: Rectal foam is likely to result in budesonide in human milk as budesonide delivered by inhalation from a dry-powder inhaler is present in human milk at low concentrations

                  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

                  Elicits glucocorticosteroid activity, including anti-inflammatory effects

                  Absorption

                  AUC: 4.31 ng•hr/mL

                  Distribution

                  Protein bound: 85-90%

                  Vd: 2.2-3.9 L/kg

                  Metabolism

                  Subject to first-pass metabolism

                  Rapidly and extensively biotransformed in liver, mainly by CYP3A4, to its 2 major metabolites, 6-beta-hydroxy budesonide and 16-alpha-hydroxy prednisolone

                  Glucocorticoid activity of these metabolites is negligible (<1/100) in relation to that of the parent compound

                  Elimination

                  Plasma clearance: 0.9-1.8 L/min

                  Excretion: Urine and feces in form of metabolites

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  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.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.