Budicort0.5 mg/2 ml

Budicort is a corticosteroid used in different formulations for several distinct conditions:

• Asthma (inhaled form): FDA-approved for maintenance treatment of asthma as prophylactic (preventive) therapy in adults and children. It is not a bronchodilator and must not be used to relieve an acute asthma attack.
• Allergic rhinitis (intranasal form): FDA-approved for relief of symptoms of seasonal and perennial allergic rhinitis (nasal congestion, sneezing, runny nose, itching) in adults and children.
• Crohn's disease (oral controlled-ileal-release capsule): Guideline-supported and FDA-approved for induction of remission in mild-to-moderate active Crohn's disease involving the ileum and/or ascending colon, and for maintenance of remission for up to 3 months.
• Ulcerative colitis (oral extended-release tablet or rectal foam): FDA-approved for induction of remission in patients with active mild-to-moderate ulcerative colitis.
• Microscopic colitis (off-label/guideline-supported use): Commonly used, based on clinical guidelines, for induction and maintenance of remission in collagenous and lymphocytic colitis, though this is not an FDA-labeled indication in all formulations.

The specific formulation (inhaler, nebulizer suspension, nasal spray, oral capsule/tablet, or rectal foam) determines which indication applies; formulations are not interchangeable.

Each formulation contains Budesonide as the active ingredient, micronized for topical/local delivery:

• Inhalation formulations (dry powder inhaler or nebulizer suspension): Budesonide in delivered strengths such as 90 mcg, 180 mcg, 200 mcg, 0.25 mg/2 mL, 0.5 mg/2 mL, or 1 mg/2 mL, depending on the product.
• Nasal spray: Budesonide typically 32 mcg or 64 mcg per metered spray in an aqueous suspension.
• Oral capsules (controlled ileal release): Budesonide 3 mg per capsule.
• Oral extended-release tablets: Budesonide 9 mg per tablet.
• Rectal foam: Budesonide 2 mg per metered dose.

Inactive ingredients vary by manufacturer and formulation (propellants, lactose, polymers for controlled release, preservatives in multidose nasal/nebulizer products).

Budicort is a synthetic, non-halogenated corticosteroid with potent local anti-inflammatory activity and low systemic bioavailability relative to older corticosteroids, largely due to extensive first-pass hepatic metabolism (primarily via CYP3A4) of any absorbed drug.

It is formulated for site-specific delivery: as an inhaled aerosol/powder or nebulized suspension for the lungs, as a nasal spray for the nasal mucosa, and as oral capsules/tablets or rectal foam engineered for targeted release in the distal small bowel and colon in inflammatory bowel disease. This targeted delivery is intended to maximize local anti-inflammatory effect while minimizing the systemic corticosteroid exposure and side effects associated with conventional oral or parenteral steroids.

Corticosteroid (glucocorticoid); Budicort belongs to the class of inhaled/intranasal/gut-targeted-release corticosteroids used for local anti-inflammatory therapy.

Budesonide is a glucocorticoid that binds to the intracellular glucocorticoid receptor, translocates to the nucleus, and modulates gene transcription, resulting in decreased production of pro-inflammatory mediators (cytokines, chemokines, prostaglandins, leukotrienes) and reduced recruitment and activation of inflammatory cells (eosinophils, mast cells, macrophages, lymphocytes).

In the airways, this reduces bronchial hyperresponsiveness and mucosal inflammation over time (it does not provide immediate bronchodilation). In the nasal mucosa, it reduces the inflammatory response responsible for allergic rhinitis symptoms. In the gut-targeted oral formulations, Budesonide is released in the ileum/proximal colon (pH- or time-dependent release systems) to act locally on bowel mucosal inflammation.

Pharmacokinetics: Budesonide undergoes extensive first-pass hepatic metabolism via CYP3A4 (approximately 90% for the oral controlled-release capsule), giving it lower systemic bioavailability than conventional oral corticosteroids such as prednisolone, though systemic absorption and adrenal suppression are still possible, especially with higher doses, prolonged use, or concomitant strong CYP3A4 inhibitors.

Budicort inhaler/nebulizer: for oral inhalation only; rinse mouth after use. Nasal spray: for intranasal use only; prime before first use and after periods of non-use. Oral capsules/tablets: swallow whole, do not crush or chew, generally taken in the morning with or without food as directed. Rectal foam: for rectal administration only, following the manufacturer's applicator instructions. Do not use any Budicort formulation by a route other than that for which it is manufactured.

Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir and other HIV protease inhibitors, clarithromycin) significantly increase systemic exposure to Budicort by inhibiting its hepatic first-pass metabolism, raising the risk of systemic corticosteroid effects including adrenal suppression and Cushingoid features. Concomitant use should generally be avoided; if unavoidable, the interval between administration should be as long as possible and the patient monitored closely.

Grapefruit juice can similarly inhibit CYP3A4 metabolism of oral Budicort and increase systemic exposure; patients on oral Budicort for Crohn's disease/ulcerative colitis should avoid grapefruit and grapefruit juice.

Other corticosteroids or systemic immunosuppressants used concurrently may have additive effects on adrenal suppression and infection risk; concomitant use should be supervised by a physician.

Side effects of Budicort vary by formulation:

• Inhaled (asthma): oral candidiasis (thrush — reduce risk by rinsing mouth after use), hoarseness/dysphonia, throat irritation, cough. Rarely, paradoxical bronchospasm.
• Intranasal (allergic rhinitis): nasal irritation and dryness, epistaxis (nosebleed), headache, sore throat, and rarely nasal septal perforation with prolonged use.
• Oral (Crohn's disease/ulcerative colitis): headache, nausea, abdominal pain, respiratory infection symptoms, and adrenal suppression — this risk is lower than with conventional systemic corticosteroids owing to the gut-targeted release design, but is not eliminated, particularly with higher doses or prolonged courses. Cushingoid features (weight gain, moon face, striae) can occur with prolonged or high-dose use of any formulation.
• All forms (systemic, uncommon): growth suppression in children with long-term use, increased susceptibility to infection, and rarely, effects on bone mineral density with long-term therapy.

Budicort should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; use the lowest effective dose for the shortest necessary duration and consult a physician. Inhaled and intranasal corticosteroids are generally considered to carry lower systemic risk than conventional oral corticosteroids, but this does not eliminate the need for caution.

Budicort is excreted in breast milk in small amounts. Breastfeeding is generally considered compatible with recommended doses of inhaled or intranasal Budicort, but a physician should be consulted before use during lactation, particularly for oral or higher-dose formulations, and the infant should be monitored for any signs of corticosteroid effect.

Not for acute symptom relief: the inhaled form of Budicort is a maintenance medicine and does not relieve an acute asthma attack; patients must have a separate rescue bronchodilator available.

Infection risk: use with caution in patients with active or latent tuberculosis, untreated fungal/bacterial/viral respiratory infections, or ocular herpes simplex, as corticosteroids can mask or worsen these conditions (see Contraindications for untreated infections).

Adrenal suppression: although designed for local/targeted delivery with lower systemic absorption, Budicort can suppress the hypothalamic-pituitary-adrenal (HPA) axis, particularly at higher doses, with prolonged use, in patients switching from systemic corticosteroids, or with concomitant strong CYP3A4 inhibitors. Do not stop long-term oral Budicort therapy abruptly; dose should be tapered under physician supervision.

Growth monitoring: growth of children and adolescents on long-term corticosteroid therapy of any form should be monitored routinely.

Immunosuppression: patients on Budicort, especially at higher doses, may have reduced ability to fight infections; avoid exposure to chickenpox or measles in non-immune patients and seek medical advice if exposed.

Acute overdose with Budicort is unlikely to cause immediate life-threatening effects given its local delivery and rapid hepatic metabolism, but chronic overuse or excessive dosing can lead to systemic corticosteroid effects including adrenal suppression and Cushingoid features. If an overdose is suspected or a large accidental ingestion occurs (especially in a child), seek immediate medical attention or contact a poison control center/emergency services right away. Do not attempt to manage a suspected overdose at home without professional guidance.

Store at room temperature (below 30°C), away from light and moisture. Do not freeze inhalers or nasal spray. Keep the container tightly closed and out of reach of children.

Hepatic impairment: Budicort undergoes extensive first-pass hepatic metabolism; patients with moderate-to-severe hepatic impairment may have increased systemic exposure and should be monitored for corticosteroid effects, with dose reduction considered.

Renal impairment: no specific dose adjustment is well established; use with routine clinical monitoring.

Elderly: no formulation-specific dose adjustment is established for elderly patients, but they should be monitored for corticosteroid-related adverse effects, including bone density concerns with long-term use.

Pediatric use: see Pediatric Uses section below for approved age ranges and dosing by formulation.

For asthma and allergic rhinitis, Budicort is used as ongoing maintenance therapy for as long as the physician determines it is needed to control symptoms, with periodic reassessment of the lowest effective dose. For Crohn's disease and ulcerative colitis induction, oral Budicort is typically used for up to 8 weeks; maintenance therapy (Crohn's disease) is generally limited to up to 3 months due to diminishing benefit and increasing risk of systemic corticosteroid effects with more prolonged use. Treatment duration should always be determined by the prescribing physician based on response and tolerability.

Corticosteroids; Inhaled corticosteroids (ICS); Intranasal corticosteroids; Gut-targeted-release oral corticosteroids

Budesonide acts as a potent agonist at the glucocorticoid receptor. After binding, the receptor complex translocates to the cell nucleus and alters transcription of genes involved in inflammation — it upregulates anti-inflammatory proteins (e.g., lipocortin-1, which inhibits phospholipase A2 and reduces eicosanoid production) and downregulates pro-inflammatory cytokines, chemokines, and adhesion molecules. This results in reduced recruitment and activity of eosinophils, mast cells, macrophages, and T-lymphocytes at the site of application (airway, nasal mucosa, or gut mucosa), decreasing local inflammation, edema, and mucus hypersecretion.

C (legacy FDA pregnancy category, per original prescribing information; formal letter categories have since been phased out of current US labeling in favor of narrative risk summaries)

Inhaled Budicort (asthma): approved for maintenance treatment in children as young as 6 years for the dry powder inhaler and as young as 12 months (nebulizer suspension) under physician supervision.

Intranasal Budicort (allergic rhinitis): approved for children 6 years of age and older; safety and efficacy in children younger than 6 years have not been established.

Oral Budicort (Crohn's disease/ulcerative colitis): safety and efficacy in pediatric patients have not been established; use in children should be individualized and supervised by a specialist.

Long-term use of any corticosteroid formulation in children warrants monitoring of growth velocity, as corticosteroids may cause a reduction in growth rate.