Budesonide Sustained-Release Capsules (Entocort) are an oral corticosteroid medication formulated with delayed-release technology, primarily indicated for the treatment of Crohn's disease affecting the ileum and/or ascending colon.
What Are the Indications for Budesonide Sustained-Release Capsules (Entocort)?
Treatment of Active Crohn's Disease
This medication is indicated for the treatment of mild to moderately active Crohn's disease in patients aged 8 years and above, with lesions confined to the ileum and/or ascending colon.
For adult patients, the recommended dosage is 9 mg orally once daily, with a maximum treatment duration of 8 weeks.
If the disease relapses, this 8-week treatment course may be repeated.
For pediatric patients aged 8 to 17 years who weigh more than 25 kg, the initial 8-week regimen also consists of 9 mg daily, followed by a 2-week continuation at a reduced dosage of 6 mg each morning.
Dosage Form, Strength and Description of Budesonide Sustained-Release Capsules (Entocort)
Dosage Form and Strength
Budesonide Sustained-Release Capsules are delayed-release hard capsules, each containing 3 mg of micronized budesonide as the active ingredient.
Description
The capsule body is opaque light gray, and the cap is opaque pink.
Each capsule is marked with the identification imprint "ENTOCORTEC3mg".
The capsule contents are enteric-coated pellets, which ensure that the drug dissolves and releases only in an environment with a pH value greater than 5.5 (i.e., upon reaching the intestinal tract), thereby exerting a localized effect on the ileum and ascending colon.
Composition
In addition to the active ingredient, the capsule contents contain inactive excipients such as ethyl cellulose, tributyl acetylcitrate, methacrylic acid copolymer type C, triethyl citrate, antifoaming agent M, polysorbate 80, talc and sugar spheres.
The capsule shell is made of gelatin, iron oxide and titanium dioxide.
Storage Methods for Budesonide Sustained-Release Capsules (Entocort)
Storage Conditions
Budesonide Sustained-Release Capsules should be stored at room temperature of 25°C (77°F).
Short-term storage at temperatures ranging from 15°C to 30°C (59°F to 86°F) is permissible.
The medication should be protected from excessive heat, cold or humidity; for example, do not store it in bathrooms or near kitchen sinks.
Packaging and Handling
The medication is usually supplied in bottles (e.g., 100 capsules per bottle).
Ensure the bottle cap is tightly closed immediately after each use to maintain the container's hermetic seal, preventing the drug from absorbing moisture or undergoing compositional changes.
Store the medication in its original packaging container and keep it out of the reach and sight of children and pets for safety purposes.
Precautions
Do not take the medication if it has expired or is no longer needed.
If you have any questions regarding the storage of the drug, or notice any abnormalities in the capsule appearance (such as breakage, discoloration, etc.), consult a pharmacist or healthcare provider.
