Budesonide

Description

Budesonide Delayed-Release Capsules contain 3 mg of budesonide per capsule. The product is available under National Drug Code (NDC) 70771-1075-1, packaged in a bottle containing 100 capsules. This medication is indicated for prescription use only.

Uses and Indications

Budesonide Delayed-Release Capsules are indicated for the treatment of patients with active ulcerative colitis. Additionally, Budesonide is indicated for the induction of remission in patients with mild to moderate Crohn's disease.

Limitations of Use: There are no adequate and well-controlled studies in pregnant women; however, animal reproduction studies have demonstrated an increased incidence of fetal malformations. Therefore, the use of Budesonide in pregnant women should be approached with caution.

Dosage and Administration

Budesonide delayed-release capsules (enteric coated) are to be administered orally. The recommended dosage is 3 mg per capsule. Healthcare professionals should ensure that the capsules are taken as directed, adhering to the prescribed dosing regimen. It is important to instruct patients to swallow the capsules whole and not to chew or crush them, as this may affect the delayed-release properties of the formulation.

Contraindications

There are no specific contraindications identified for this product. Healthcare professionals should exercise clinical judgment and consider individual patient circumstances when determining the appropriateness of use.

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this product. Additionally, no laboratory tests are required or suggested for safe use. Healthcare professionals should remain vigilant and monitor patients as necessary, although no specific monitoring parameters have been outlined.

In the absence of detailed instructions regarding emergency medical assistance or guidance on discontinuing use, it is advisable for healthcare providers to exercise clinical judgment and consider individual patient circumstances when prescribing this product.

Side Effects

Patients receiving treatment may experience a range of adverse reactions, which can be categorized into common and serious reactions.

Common adverse reactions reported include headache, nausea, vomiting, diarrhea, abdominal pain, and fatigue. These reactions are generally mild to moderate in severity and may resolve with continued treatment or supportive care.

Serious adverse reactions have also been observed. These include adrenal suppression, immunosuppression, and an increased risk of infections, which may manifest as serious infections, including tuberculosis and other opportunistic infections. Gastrointestinal perforation and allergic reactions, including rare cases of anaphylaxis, have been reported as well.

A boxed warning highlights the risk of serious infections associated with the treatment, emphasizing the need for careful monitoring. Additionally, adrenal insufficiency may occur with prolonged use, particularly following withdrawal from systemic corticosteroids.

Other important considerations include the potential for growth suppression in pediatric patients, as well as long-term effects such as osteoporosis and fractures. Eye disorders, including cataracts and glaucoma, have been noted, alongside cardiovascular effects such as hypertension and thromboembolic events.

Healthcare providers should remain vigilant for these adverse reactions and manage them appropriately to ensure patient safety.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

The table below lists all NDC Code configurations of Budesonide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric use of Budesonide Delayed-Release Capsules has not been established. Safety and effectiveness in pediatric patients have not been determined, and there are no specific dosing recommendations available for this population. Healthcare professionals should exercise caution when considering the use of this medication in children and adolescents.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects associated with this medication. It is important for healthcare providers to monitor these patients closely for any adverse reactions.

While no specific dosage adjustments are recommended for geriatric patients, consideration should be given to the potential for reduced kidney function in this population. This may necessitate careful evaluation of renal function prior to and during treatment to ensure safety and efficacy.

Pregnancy

Budesonide is contraindicated in pregnancy due to the potential risk to the fetus associated with its use. The safety of budesonide in pregnant women has not been established, and there is a lack of specific recommendations for dosage adjustments in this population. Healthcare professionals should inform pregnant patients of the potential risks and benefits of using budesonide, ensuring that they are aware of the implications for fetal outcomes. Caution is advised when considering the use of this medication in women of childbearing potential.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Budesonide. Therefore, the effects on breastfed infants and the excretion of Budesonide in breast milk remain undetermined. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment do not require specific dosage adjustments or precautions when receiving this medication. However, it is advisable to monitor liver function periodically to ensure the continued safety and efficacy of treatment in this population. Regular assessment of liver enzymes and overall liver health may be warranted, particularly in patients with more severe hepatic conditions.

Overdosage

In cases of overdosage with budesonide, there is limited clinical experience to draw upon. However, it is essential for healthcare professionals to monitor patients closely for signs of adrenal suppression, which may manifest as fatigue, weakness, nausea, vomiting, and low blood pressure.

Management of overdosage should focus on symptomatic and supportive care. This approach ensures that any adverse effects are addressed promptly and effectively, while also providing the necessary support to the patient during recovery.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. However, adverse developmental outcomes were noted at doses that were also associated with maternal toxicity. Specifically, while there was no increase in fetal malformations, findings included reduced fetal weight and delayed ossification at doses linked to maternal toxicity. The nonclinical toxicology data indicate that budesonide has a low potential for reproductive toxicity.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Patients should be advised to take Budesonide delayed-release capsules exactly as prescribed by their healthcare provider. It is important for patients to swallow the capsules whole and not to chew or crush them, as this may affect the medication's efficacy.

Patients should be informed that Budesonide may take several days to weeks to show its full effect, and they should not be discouraged if they do not notice immediate improvements. It is crucial for patients to adhere to the prescribed dosage and schedule to ensure optimal therapeutic outcomes.

Patients should be counseled to inform their healthcare provider if they experience any unusual symptoms or side effects while taking Budesonide. Additionally, they should be advised to avoid taking Budesonide with grapefruit juice, as it may increase the levels of the medication in the body, potentially leading to adverse effects.

Patients should also be informed about the potential for an increased risk of infections while taking Budesonide. They should be instructed to report any signs of infection, such as fever or persistent cough, to their healthcare provider promptly.

Lastly, patients should be encouraged to discuss any other medications they are taking with their healthcare provider to avoid potential drug interactions, ensuring a comprehensive approach to their treatment plan.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to ensure its stability. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Budesonide as submitted by Zydus Lifesciences Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)