Uceris Rectal Foam (budesonide rectal) dosing, indications, interactions, adverse effects, and more

Sections

Sections budesonide rectal
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

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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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)

>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

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

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.

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

Images

No images available for this drug.

Patient Handout

A Patient Handout is not currently available for this monograph.

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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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