Budesonide

The label describes budesonide delayed-release capsules for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, in people aged 8 years and older.

It is also described for keeping mild to moderate Crohn's disease in remission for up to 3 months in adults.

• Active mild to moderate Crohn's disease of the ileum and/or ascending colon (age 8 and older)
• Maintenance of remission for up to 3 months in adults

Budesonide is an anti-inflammatory corticosteroid. The label says it has a strong glucocorticoid effect and only a weak mineralocorticoid effect.

Its affinity for glucocorticoid receptors is described as about 200 times that of cortisol and 15 times that of prednisolone.

This page covers the US label for budesonide capsules taken by mouth, with the dosing the label gives for adults and, where the label says so, children.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

For adults with active disease, the label describes 9 mg once daily in the morning for up to 8 weeks. Eight-week courses may be repeated for recurring episodes.

For children aged 8 to 17 years who weigh more than 25 kg, the label describes 9 mg once daily for up to 8 weeks, then 6 mg once daily for 2 weeks.

For maintenance in adults, the label describes 6 mg once daily for up to 3 months, then tapering to stop. For moderate liver impairment, a lower 3 mg daily dose may be considered. The capsules are swallowed whole.

• Take once daily in the morning
• Swallow whole; do not chew or crush
• If unable to swallow, capsule contents may be mixed with applesauce and eaten within 30 minutes
• Avoid grapefruit juice during treatment

The label lists allergy to budesonide or its ingredients as a reason not to use it.

Steroids can raise the risk of infections, including serious chickenpox and measles. The label advises avoiding use with fungal infections, Strongyloides infestation, cerebral malaria and ocular herpes simplex, and screening for hepatitis B.

Children and people with moderate to severe liver impairment may be at higher risk of steroid excess. Severe liver impairment should be avoided. The label also advises caution in high blood pressure and diabetes.

• Do not use if allergic to budesonide
• Infection risk, including chickenpox and measles
• Adrenal suppression and steroid excess
• Liver impairment raises risk
• Caution with high blood pressure or diabetes

• Ketoconazole and itraconazole
• Ritonavir, indinavir, saquinavir
• Erythromycin and cyclosporine
• Grapefruit juice
• The label says to avoid use with CYP3A4 inhibitors, which can raise budesonide levels.
• Ketoconazole caused an eight-fold rise in exposure.
• Examples named include itraconazole, ritonavir, indinavir, saquinavir, erythromycin and cyclosporine.
• Grapefruit juice should also be avoided.

No match in this label text. Ask your pharmacist about any medicine you take.

The label gives a storage range of 20 to 25 degrees C.

The label also says to keep the container tightly closed.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

We did not find budesonide in the Drugs Rules 1945 Schedule H, H1, X or G rows we checked, so we cannot state its Indian prescription status from our lists. Ask your pharmacist or doctor.

Budesonide is on the National List of Essential Medicines 2022. Listed forms include: Nasal Spray 50 mcg/dose (page 93); Nasal Spray 100 mcg/dose (page 93); Inhalation (MDI/DPI) 100mcg/dose (page 104); Inhalation (MDI/DPI) 200mcg/dose (page 104); Respirator solution for use in nebulizer 0.5 mg/mL (page 104).

NPPA lists ceiling prices for scheduled budesonide formulations. The table shows the rows we found. Check NPPA directly for the current list.

The Jan Aushadhi (PMBJP) list we checked has 5 product rows that mention budesonide. We did not capture prices for them.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. They are ceilings, not the price you will always pay.

Jan Aushadhi lists budesonide products including Budesonide Nebuliser Suspension 1mg per 2ml 1mg per 2ml; Budesonide Inhalation IP 100mcg 100mcg; Budesonide Inhalation IP 200mcg 200mcg; Budesonide Powder for Inhalation IP 400mcg (Rotacaps) 400mcg. We have not shown a price for them. Check the pack and the seller for the actual price.