Description:

Budesonide Extended Release tablet is an extended-release oral corticosteroid that reduces inflammation in the digestive tract. It is primarily used for the induction of remission in active mild to moderate ulcerative colitis (and sometimes off-label or in related formulations for Crohn’s disease). The extended-release technology helps deliver the drug mainly to the colon while minimizing widespread side effects.

Prescription:

• Yes, it is a prescription-only medication (Rx). It requires a doctor’s prescription and should be used under medical supervision.

Therapeutic Category:

• Corticosteroid (glucocorticoid); Anti-inflammatory agent; Treatment for Inflammatory Bowel Disease (IBD), specifically for ulcerative colitis.

Active Ingredients/Composition:

• Budesonide 9 mg per extended-release tablet (the primary strength for the ER tablet variant).

Variant:

• Budez OD 9 mg Extended Release Tablets (main variant for ulcerative colitis).
• Related: Budez CR 3 mg Controlled Release Capsules (used more for Crohn’s disease or asthma maintenance in some markets).

Consume Type:

• Oral tablets (swallowed whole; do not crush, chew, or break the extended-release tablets).

Directions/Usage:

• For mild to moderate ulcerative colitis: Typically 9 mg once daily in the morning for up to 8 weeks (as directed by the doctor).
• Swallow the tablet whole with water; it can be taken with or without food.
• Do not exceed the prescribed dose or duration. Follow your doctor’s exact instructions, as tapering or maintenance may be needed in some cases.

Common Side Effects:

• Headache, nausea, abdominal pain, bloating, gas, fatigue, acne, mood changes, dizziness, respiratory symptoms (e.g., runny nose, sore throat), or mild weight gain. Because it is extended-release with lower systemic exposure, serious steroid side effects (like adrenal suppression or osteoporosis) are less common than with conventional steroids, but they can still occur with prolonged use.

Package Type:

• Typically available in strips or bottles containing

Storage Advice:

• Store in a cool, dry place at room temperature (below 30°C / 86°F), away from direct sunlight, heat, and moisture. Keep in the original packaging and out of reach of children.

Safety Advice:

• Do not stop suddenly without medical advice (may require gradual tapering).
• Inform your doctor if you have infections, diabetes, osteoporosis, liver problems, or are pregnant/breastfeeding.
• Avoid live vaccines while on this medication. It may suppress the immune system, increasing infection risk.
• Not for use in severe ulcerative colitis or as a cure — it induces remission only.
• Consult a doctor immediately if you experience severe symptoms like persistent vomiting, black stools, or signs of infection.
• Keep out of reach of children.

Product Substitutes:

• Uceris (brand-name budesonide ER 9 mg tablets).
• Generic Budesonide Extended-Release 9 mg tablets (from other manufacturers like Actavis/Mylan).
• Other budesonide formulations: Entocort EC / Budez CR 3 mg capsules (for Crohn’s), or alternatives like mesalamine (e.g., Pentasa, Lialda) or other corticosteroids (e.g., prednisolone) as per doctor’s recommendation.

Manufacturer/Marketer:

• Sun Pharmaceutical Industries Ltd. (Sun Pharma), India. Marketed under the Budez brand (Budez OD for the extended-release tablets).

Country of Origin:

• India.