Quick Facts

• Intended to help in the induction of remission in patients with active, mild to moderate ulcerative colitis.
• May play a role in managing symptoms of distal ulcerative colitis, extending up to 40 cm from the anal verge.

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Uceris is used to treat patients managing active, mild to moderate ulcerative colitis (UC). This medication is intended to help achieve a period of remission from the disease. UC is a chronic inflammatory condition that affects the lining of the colon and rectum, resulting in symptoms like diarrhea and abdominal discomfort.

The extended-release oral tablet formulation is indicated for the induction of remission in adults with mild to moderate UC generally. The rectal foam formulation is indicated for the induction of remission in patients with active mild to moderate distal UC, which affects the area up to 40 cm from the anal verge. The goal of this treatment may be to help address the inflammation associated with the condition.

Who Can and Cannot Use Uceris (Budesonide Extended-Release)

Eligibility for Uceris use is determined by official regulatory labeling, focusing on specific patient populations and conditions. This information is derived from government health authorities and should not be used as clinical advice.

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Populations That Must Not Use Uceris

Classification	Who is Ineligible?
Absolute Contraindication	Individuals with a known hypersensitivity or allergy to budesonide or any component of the Uceris tablet formulation.
Infection Restriction	Patients with untreated systemic infections, such as active tuberculosis, fungal, bacterial, viral, or parasitic infections, must avoid use or proceed with extreme caution and monitoring.

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Eligibility and Use Limitations

Population/Condition	Regulatory Status
Age (Pediatric)	Use is not established; Uceris is approved for use only in adults (age 18 and older).
Hepatic Function	Caution is required in patients with liver disease. Severe hepatic impairment often leads to a not recommended status due to high systemic exposure risk.
Pregnancy/Lactation	Pregnancy Category C. Use during pregnancy is only advised if the potential benefit outweighs the risk. Use is not recommended in nursing mothers as budesonide is secreted in human milk.

Uceris Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Uceris (budesonide extended-release tablets), as described in government regulatory sources. These interactions primarily involve changes to the active ingredient’s systemic concentration.

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Pharmacokinetic Interactions

Budesonide is extensively metabolized by the CYP3A4 enzyme. Co-administration with strong inhibitors of this enzyme can significantly increase the exposure to budesonide by reducing its systemic clearance. Regulatory information officially recommends avoiding the use of strong CYP3A4 inhibitors with Uceris.

Interaction Type	Interacting Substances (Examples)
Strong CYP3A4 Inhibitors	Ketoconazole, Ritonavir, Itraconazole, Erythromycin

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Food and Population-Specific Considerations

Interactions are also noted for specific dietary products and patient populations:

• Grapefruit Juice: Ingestion of grapefruit and grapefruit juice should be avoided, as it inhibits CYP3A4 and increases the systemic availability of budesonide.
• Hepatic Impairment: The potential for interaction severity is enhanced in patients with moderate to severe hepatic impairment due to their already reduced ability to eliminate budesonide, resulting in increased systemic exposure.

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Drug Release Considerations

Regulatory cautions address medicines that affect the tablet's targeted release mechanism. Agents that elevate gastric pH—such as Antacids or Proton Pump Inhibitors—may alter the pH-dependent dissolution of the extended-release coating, potentially resulting in altered release and uptake of the active compound.

Uceris, containing budesonide, is a corticosteroid with high affinity for the glucocorticoid receptor (GR), acting as an agonist. The extended-release formulation allows for targeted local delivery, concentrating the drug in the colon. Due to extensive first-pass metabolism in the liver by CYP3A4, systemic bioavailability is low, confining its action largely to the intestinal mucosa.

Upon binding to the cytosolic GR, the activated complex translocates to the nucleus. This complex engages in two main genomic mechanisms: transactivation and transrepression. Transactivation upregulates anti-inflammatory genes, such as those encoding lipocortin-1 (which inhibits phospholipase A2). Transrepression directly or indirectly inhibits the activity of pro-inflammatory transcription factors, including Nuclear Factor-kappa B (NF-kappaB) and Activator Protein-1 (AP-1). The resultant intracellular consequence is a profound decrease in the synthesis and release of pro-inflammatory mediators, including cytokines (e.g., interleukins, TNF-alpha), prostaglandins, and leukotrienes. This molecular cascade leads to a system-level physiological consequence of local immunomodulation and attenuation of inflammation within the colonic tissue.

How Uceris is Used: Official Administration Guidelines

Uceris (budesonide) is administered through two distinct routes, depending on the approved dosage form: the oral extended-release tablet or the rectal foam. Both forms are designed for short-term use, primarily for the induction of remission in active, mild to moderate ulcerative colitis.

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Administration Details

The standard protocol for the oral extended-release tablet is a 9 mg dose taken once daily. This tablet must be swallowed whole and should not be chewed, crushed, or broken, as doing so interferes with the drug’s specialized delivery system. It is typically administered in the morning and may be taken with or without food. However, patients must avoid grapefruit and grapefruit juice as they can alter the systemic availability of budesonide. This oral course is generally specified for a duration of up to 8 weeks.

Conversely, the rectal foam follows a structured, two-phase 6-week course. It is administered via the rectal route only, starting with one metered dose twice daily for the first two weeks, followed by one metered dose once daily for the remaining four weeks. The foam canister must be shaken vigorously for 10 to 15 seconds prior to use, and the evening dose is applied immediately before bedtime for optimal retention.

Use in pediatric patients has not been established. Furthermore, patients with moderate to severe hepatic impairment require close monitoring due to the potential for increased systemic exposure.

Research Evidence / Overview of Studies for Uceris

Evidence for Use in Inducing Remission in Mild to Moderate Ulcerative Colitis

Research exploring this medicine was evaluated in patients with active, mild to moderate ulcerative colitis (UC). The primary evidence is derived from several large, short-term randomized controlled trials (RCTs). These pivotal studies explored differences in measured outcomes between the medicine and a placebo over a specific 8-week period. The trials focused on adult patients enrolled based on the specified severity of UC.

The trials monitored physical discomfort and symptoms linked to inflammatory states in the colon. Researchers used objective scoring tools, such as the Ulcerative Colitis Disease Activity Index (UCDAI), to measure the state of the disease. These tools were used to evaluate specific endpoints, including the frequency of bowel movements, the presence of rectal bleeding, and the visual findings from endoscopic assessment of the colon lining. Studies also monitored plasma cortisol levels, which is a measure used to monitor physiological strain or stress. The research highlights changes measured in patient groups over the short treatment interval.

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Long-Term Studies and Follow-Up Data

The core clinical trials research explored short-term symptom changes, primarily focusing on the initial 8-week induction phase. As a result, data are still emerging and evidence is limited regarding the compound's use for the long-term maintenance of remission.

Observational and extension studies have also explored systemic measurements, such as cortisol levels, over a longer duration. However, there is limited information for long-term outcomes that would fully characterize how symptoms evolved over long time intervals beyond the initial trial periods.

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Evidence in Special Populations

The pivotal trials studies included a population consisting mostly of adults (18 years and older). Data for certain groups remain insufficient or less characterized.

Specifically, efficacy and pharmacokinetic data for pediatric patients (ages 5–17) have been collected in dedicated studies; however, the overall evidence quality varies across studies and the long-term effects for this younger population are not fully established.

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Key Research Gaps and Uncertainties

The evidence landscape highlights several limitations. First, the results apply only to the populations studied—specifically, those with mild to moderate active UC. The evidence base provides limited information for long-term outcomes in individuals with more severe disease, as research focusing on moderate to severe UC is sparse.

Furthermore, comparative evidence is lacking in the primary data set. The core studies research examined the compound mainly against a placebo, and there are not many large-scale, published head-to-head trials directly comparing Uceris to other therapeutic options currently used for UC. Finally, as noted, the follow-up durations were limited in the primary trials, meaning there is ongoing research needed to fully characterize long-term outcomes.

Key Studies & References Budesonide Extended Release for Ulcerative Colitis (Health Technology Assessment / Evidence Review)

Common questions about Uceris (FAQ)

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Q: Does Uceris cause side effects like weight gain?

Official clinical trial data did not list weight gain as a common adverse reaction (incidence 2%). However, Uceris is a type of corticosteroid, and a small amount of the active ingredient, budesonide, can be absorbed systemically. Because other medicines in this class are associated with changes in body fat distribution, if systemic effects like weight change are a concern, a patient's healthcare professional may choose to monitor for these signs.

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Q: Can I stop taking Uceris once my symptoms are gone?

Uceris is typically used for a short-term course, such as up to 8 weeks, to help induce remission. Official product information cautions against suddenly stopping the medication without consulting a healthcare professional. Abruptly stopping corticosteroids carries a risk of adrenal suppression or developing withdrawal symptoms, especially if a patient is transferring from a more potent systemic steroid.

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Q: How long does it take for Uceris to start working for ulcerative colitis?

The key clinical studies that led to the approval of Uceris were conducted over an 8-week treatment period. The primary measures of effectiveness were evaluated after the full 8-week course. Official data does not specify an average time for first noticing an effect, as individual patient response may vary.

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Q: Can Uceris be taken while pregnant or breastfeeding?

Uceris is classified as Pregnancy Category C in the official prescribing information. It should only be used during pregnancy if the potential benefit for the mother is considered to outweigh the potential risks to the fetus. Furthermore, because the active ingredient is secreted in human milk, official information suggests that nursing mothers discuss the decision to either discontinue the drug or avoid breastfeeding while using Uceris.

How to Store and Dispose of Uceris?

The storage and handling of Uceris must adhere strictly to the conditions specified in the official labeling.

Storage Requirements

Dosage Form	Temperature and Container Rules	Special Handling/Restrictions
Extended-Release Tablets	Store at controlled room temperature, 20^circ to 25 C. Keep in the original container, tightly closed, away from excess heat and moisture.	Keep out of the reach of children.
Rectal Foam	Store at controlled room temperature, 20^circ to 25 C. DO NOT REFRIGERATE or expose to heat above 49 C (120 F).	Canister contains a flammable propellant; avoid fire, flame, and smoking. Do not puncture or incinerate.

Disposal

All unused or expired Uceris medication, including the foam canister, must be disposed of properly. Patients are required to ask a healthcare professional or pharmacist how to discard any medicine that is not used. Medicine should not be flushed down the toilet or poured into a drain unless instructed to do so.