Medicine Information

Budicort ER

Name: Budicort ER
Brand: Budicort ER
Rating: 4.5 (117 reviews)

Extended-release Tablet9 mgCorticosteroidsATC: A07EA06

Generic Name

Budesonide extended-release

Manufacturer

AstraZeneca

Country

Sweden / Global

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
budicort er 9 mg tablet	৳ 30.00	৳ 300.00

Description

Overview of the medicine

Budicort ER 9 mg tablet is an extended-release corticosteroid used to treat ulcerative colitis and Crohn's disease, particularly targeting inflammation in the ileum and ascending colon.

Uses & Indications

Induction and maintenance of clinical and endoscopic remission in patients with mild to moderate active ulcerative colitis.

Treatment of active Crohn's disease involving the ileum and/or ascending colon.

Microscopic colitis (collagenous and lymphocytic colitis).

Dosage

Adults

For Ulcerative Colitis and Crohn's Disease: 9 mg orally once daily in the morning for up to 8 weeks. For maintenance of remission in UC, 6 mg once daily. For Microscopic Colitis: 9 mg once daily, usually for 8 weeks.

Elderly

No specific dose adjustment is generally required, but use with caution due to potential age-related decrease in hepatic function and increased sensitivity to corticosteroids.

Renal_impairment

No dose adjustment is necessary as budesonide is primarily metabolized in the liver and renal excretion of active drug is minimal.

How to Take

Swallow the tablet whole with water in the morning. Do not chew, crush, or break the tablet, as this will affect its extended-release properties. It can be taken with or without food.

Mechanism of Action

Budesonide is a glucocorticoid that exerts potent anti-inflammatory effects primarily within the gastrointestinal tract. It reduces inflammation by inhibiting the release of inflammatory mediators and suppressing immune cell function locally, with minimal systemic absorption due to extensive first-pass metabolism.

Pharmacokinetics

Onset

Clinical improvement typically observed within 2 to 4 weeks, with full effect potentially taking up to 8 weeks.

Excretion

Metabolites are primarily excreted via feces (approximately 60%) and urine (approximately 39%).

Half life

Approximately 2 to 3.6 hours.

Absorption

Well absorbed from the GI tract after oral administration. The extended-release formulation ensures targeted delivery to the ileum and ascending colon.

Metabolism

Extensively metabolized in the liver by the cytochrome P450 3A4 (CYP3A4) isoenzyme to inactive metabolites.

Side Effects

Contraindications

Hypersensitivity to budesonide or any component of the formulation.
Systemic fungal infections.

Drug Interactions

CYP3A4 inducers (e.g., Rifampin, Phenytoin, Phenobarbital, Carbamazepine)

Can decrease systemic exposure to budesonide, potentially reducing its efficacy.

CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin, Grapefruit juice)

Concurrent administration can significantly increase systemic exposure to budesonide, potentially leading to increased corticosteroid-related side effects.

Storage

Store below 30°C (86°F) in a dry place, protected from light and moisture. Keep out of reach of children. Do not freeze.

Overdose

Acute overdose with budesonide is unlikely to lead to severe medical problems due to its low systemic bioavailability. However, chronic overdose, particularly in conjunction with other corticosteroids, may result in signs and symptoms of hypercorticism, such as Cushing's syndrome.

Pregnancy & Lactation

Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is excreted in breast milk; caution advised during lactation due to potential adverse effects on the infant.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 tablets per blister30 tablets per carton

Shelf Life

Typically 24-36 months from the manufacturing date, as indicated on the packaging.

Availability

Pharmacies, hospitals

Approval Status

Approved

Patent Status

Generic available

WHO Essential Medicine

Yes

Clinical Trials

Extensive randomized, placebo-controlled clinical trials have demonstrated the efficacy and safety of budesonide extended-release tablets in inducing and maintaining remission in mild to moderate active ulcerative colitis and active Crohn's disease.

Lab Monitoring

Monitor for signs of adrenal suppression (e.g., ACTH stimulation test) in patients transitioning from systemic corticosteroids or on prolonged high doses.
Bone mineral density assessment with long-term use, especially in patients at risk for osteoporosis.
Ophthalmologic examination for cataracts or glaucoma with long-term use.
Monitor potassium levels in patients at risk of hypokalemia.

Doctor Notes

Emphasize the importance of patient adherence to the full prescribed course and not discontinuing abruptly to avoid adrenal insufficiency.
Educate patients about potential drug interactions, especially with CYP3A4 inhibitors like grapefruit juice, which can significantly increase systemic exposure.
Monitor patients for signs of systemic corticosteroid effects, particularly with prolonged use or in sensitive individuals, despite the drug's low systemic bioavailability.
Consider bone mineral density monitoring in patients at risk for osteoporosis on long-term therapy.

Patient Guidelines

Take the medicine exactly as prescribed by your doctor; do not alter the dose or stop treatment abruptly.
Swallow the tablet whole; do not crush, chew, or break it.
Avoid grapefruit and grapefruit juice while on this medication.
Inform your doctor about all other medications, supplements, and herbal products you are taking.
Report any new or worsening side effects to your doctor.

Missed Dose Advice

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time to make up for a missed dose.

Driving Precautions

Budesonide ER generally does not impair the ability to drive or operate machinery. However, if you experience side effects such as dizziness, blurred vision, or significant fatigue, avoid these activities until you feel well.