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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            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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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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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.