Budesonide 1mg/5mL

Route: Oral suspension swallowed (not spit out) to coat the esophagus.

• Shake well before use. Do not mix with food or liquid prior to administration.
• Swallow slowly, in small sips, to maximize esophageal mucosal contact time.
• Do not eat, drink, or rinse the mouth for at least 30 minutes after administration.
• Spit out any mouth rinsing water rather than swallowing to minimize oral fungal colonization risk.
• Take exactly as prescribed—typically twice daily for the treatment course specified.

Dosing is prescriber-determined, informed by clinical guidelines for EoE. For context:

• The FDA-approved budesonide oral suspension (EOHILIA®) for EoE uses 2 mg twice daily for 12 weeks; the 1 mg/5 mL concentration used here reflects a prescriber-individualized dosing decision.
• Duration of treatment is prescribed; safety and efficacy beyond 12 weeks have not been established in controlled clinical trials.
• Final dosing instructions are established by the prescriber based on the patient's age, weight, and clinical indication.

Budesonide: A glucocorticoid that binds intracellular glucocorticoid receptors in esophageal epithelium and lamina propria; the receptor-ligand complex translocates to the nucleus and suppresses pro-inflammatory gene transcription (IL-5, eotaxin-3, and other eosinophil-recruiting signals). Budesonide has a high first-pass metabolism in the liver (~80–90%), significantly limiting systemic glucocorticoid exposure relative to equivalent doses of systemic corticosteroids. When formulated as a viscous mucoadherent oral suspension, budesonide has prolonged esophageal mucosal contact time, maximizing local anti-inflammatory effect at the site of eosinophilic infiltration.

Budesonide oral suspension is used in the management of eosinophilic esophagitis, a chronic, allergic/immune-mediated condition characterized by eosinophilic infiltration of the esophageal epithelium leading to dysphagia, food impaction, and esophageal remodeling. The primary clinical goal is histologic remission (reduction in peak eosinophil count) and symptomatic improvement.

Prescriber monitoring:

• Reassess histologic response by repeat endoscopy/biopsy at the end of the treatment course.
• Monitor for signs of esophageal or oropharyngeal candidiasis (a recognized adverse effect of topical corticosteroid use in the esophagus).
• Assess for signs of adrenal suppression (fatigue, hypotension) with extended courses, particularly in pediatric patients.
• Avoid concomitant use of strong CYP3A4 inhibitors (ketoconazole, grapefruit juice), which markedly increase systemic budesonide exposure.

Contraindications:

• Known hypersensitivity to budesonide or any formulation excipient
• Severe hepatic impairment (Child-Pugh Class C): use is not recommended due to significantly increased systemic exposure

Warnings & Precautions:

• HPA axis suppression: Although first-pass metabolism limits systemic bioavailability, prolonged use may suppress HPA axis, particularly in pediatric patients or with concurrent CYP3A4 inhibitors.
• Immunosuppression: Topical esophageal corticosteroids may predispose to local opportunistic infections, most commonly Candida esophagitis.
• Erosive esophagitis: Budesonide oral suspension is not indicated for and has not been studied in erosive esophagitis.
• Growth velocity: Monitor growth in pediatric patients during prolonged therapy.
• Pregnancy: Budesonide may cause fetal harm; use only when benefits outweigh risks and prescriber has assessed the situation.

Drug Interactions:

• CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, grapefruit juice): significantly increase systemic budesonide concentrations; avoid concomitant use.

Common Side Effects: Oropharyngeal and esophageal candidiasis (most common, ≥3%), upper respiratory tract infection, headache, gastroenteritis, throat irritation; systemic corticosteroid side effects are uncommon at standard doses due to high first-pass metabolism.

Store at controlled room temperature (20–25°C / 68–77°F) or as specified on the Genesis Compounding label. Protect from excessive heat and light. Shake well before each use. Do not freeze. Use before the beyond-use date assigned by Genesis Compounding per USP compounding standards. Keep out of reach of children.

Why is budesonide given as a swallowed suspension for esophageal disease?

Swallowing budesonide slowly in a viscous suspension maximizes contact time between the drug and the esophageal mucosa, delivering anti-inflammatory corticosteroid activity directly to the site of eosinophilic inflammation. Budesonide's high first-pass hepatic metabolism then minimizes systemic corticosteroid effects.

Can I eat or drink immediately after taking this medication?

No. Wait at least 30 minutes before eating or drinking to allow the suspension to coat and maintain contact with the esophageal mucosa. Eating or drinking immediately after administration washes away the drug before it can exert its local effect.

What is the risk of thrush (oral candidiasis) with this medication?

Topical corticosteroids in the oropharynx and esophagus can promote Candida overgrowth. To minimize risk, spit out (do not swallow) any water used to rinse the mouth after dosing. Report any white patches in the mouth, throat pain, or difficulty swallowing to your prescriber promptly.

Is this product FDA-approved?

This is a 503A compounded preparation from Genesis Compounding for a specific patient. FDA-approved budesonide oral suspension (EOHILIA®) exists at a specific concentration and indication. This compounded preparation may differ in concentration or formulation from the commercial product and is prepared per prescriber order for the specific patient.

How will we know if treatment is working?

Response is typically assessed by symptom improvement (reduction in dysphagia, food impaction episodes) and, more definitively, by repeat upper endoscopy with esophageal biopsies to confirm histologic remission (reduced eosinophil count). Your prescriber will schedule appropriate follow-up.