Entocort Ec (budesonide)

No dosing information is available for this tab.

Budesonide is administered orally as delayed-release capsules. For oral inhalation, budesonide is available as an inhalation powder administered via an inhaler device (Flexhaler(R)), as a micronized suspension administered via nebulization, and as an inhalation aerosol containing budesonide in fixed combination with formoterol fumarate (Symbicort(R)) administered via an oral aerosol inhaler with hydrofluoroalkane (HFA) propellant. Patients receiving orally inhaled budesonide should rinse their mouth with water after each dose to remove residual drug in the oropharyngeal area and to minimize the development of fungal overgrowth and/or infection.

No dosing information is available for this tab.

No dosing information is available for this tab.

The following information addresses potential interactions with budesonide. When budesonide is used in fixed combination with formoterol fumarate, interactions associated with formoterol fumarate should be considered. No formal drug interaction studies have been performed to date with the fixed-combination preparation containing budesonide and formoterol fumarate.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to budesonide or any ingredient in the formulation.

Orally inhaled budesonide is contraindicated as primary treatment of acute asthmatic attacks or status asthmaticus when intensive measures (e.g., an orally inhaled beta2adrenergic agonist, an orally inhaled anticholinergic agent, subcutaneous epinephrine, IV aminophylline, and/or an oral/IV glucocorticoid) are required.

Orally inhaled budesonide powder (Pulmicort(R) Flexhaler(R)) is contraindicated in patients with severe hypersensitivity to milk proteins.

Budesonide in fixed combination with formoterol fumarate (Symbicort(R)) is contraindicated as primary treatment of status asthmaticus or other acute episodes of asthma or chronic obstructive pulmonary disease (COPD) when intensive measures are required.

When budesonide is used in fixed combination with formoterol fumarate, contraindications associated with formoterol fumarate should be considered.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in at least 5% of patients receiving budesonide oral capsules include headache, dizziness, nausea, vomiting, dyspepsia, diarrhea, abdominal pain, flatulence, sinusitis, respiratory infection, viral infection, pain (including back pain), arthralgia, and fatigue. Adverse effect profile in long-term treatment was similar to that of short-term treatment.

Adverse effects occurring in 1% or more of patients receiving budesonide by oral inhalation (as a powder using a Flexhaler(R) or a Turbuhaler(R) (no longer commercially available in the US) or as an inhalation suspension, administered via nebulization) include infections (e.g., respiratory infection, ocular infection), nasopharyngitis, pharyngitis, nasal congestion, allergic rhinitis, sinusitis, viral infection (e.g., herpes simplex), cough, voice alteration, stridor, earache, otitis (media or externa), viral infection, flu-like syndrome, moniliasis, oral candidiasis, flu syndrome, fever, headache, migraine, insomnia, dysphonia, hyperkinesia, asthenia, fatigue, emotional lability, pain (e.g., back pain), arthralgia, myalgia, hypertonia, fractures, dyspepsia, gastroenteritis, nausea, vomiting, diarrhea, abdominal pain, dry mouth, taste perversion, weight gain, anorexia, epistaxis, ecchymosis, purpura, cervical lymphadenopathy, conjunctivitis, rash (may be pustular), pruritus, allergic reaction, contact dermatitis, syncope, and chest pain.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of oral budesonide delayed-release capsules have not been established in pediatric patients younger than 18 years of age with Crohn's disease. Oral budesonide (using preparations other than Entecort(R) EC) has been used for the management of mild to moderately active Crohn's disease in a limited number of pediatric patients without unusual adverse effects. Benign intracranial hypertension has been reported in at least one pediatric patient with Crohn's disease receiving the drug.

Safety and efficacy of budesonide inhalation powder have not been established in children younger than 6 years of age. Efficacy of budesonide inhalation suspension has not been established in children younger than 1 year of age, while safety of the suspension has not been established in children younger than 6 months of age. Safety and efficacy of budesonide in fixed combination with formoterol fumarate (Symbicort(R)) inhalation aerosol in patients 12 years of age or older with asthma have been established in studies of up to 12 months' duration; in addition, safety and efficacy of the fixed-combination preparation in children 6 to less than 12 years of age with asthma have been established in studies of up to 12 weeks' duration. The manufacturer states that safety and efficacy of the fixed-combination preparation in children younger than 6 years of age with asthma have not been established. Use of corticosteroids may lead to suppression of growth in children and adolescents. Therefore, children receiving prolonged therapy with orally inhaled budesonide should be monitored periodically for possible adverse effects on growth and development. (See Cautions: Pediatric Precautions, in the Corticosteroids General Statement 68:04.)

Category B (orally inhaled powder and inhalation suspension); category C (oral capsules and the fixed combination of budesonide and formoterol fumarate oral inhalation aerosol). (See Users Guide.) Hypoadrenalism may occur in infants of women receiving corticosteroid therapy during pregnancy. These infants should be carefully monitored.

Like other corticosteroids, budesonide is distributed into milk; however, data are not available on the effects of the drug on the breast-fed child or on milk production. The benefits of breast-feeding and the importance of budesonide to the woman should be considered along with any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition. The manufacturer of budesonide oral inhalation powder (Pulmicort(R) Flexhaler(R)) states that the drug should be used in nursing women only if clinically appropriate and that therapy should be titrated to the lowest effective dosage. In addition, budesonide powder inhaler should be used immediately after nursing to minimize infant exposure to the drug.

Clinical studies of oral budesonide delayed-release capsules or budesonide oral inhalation powder did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger patients. While other clinical experience with budesonide inhalation powder or inhalation suspension or with the inhalation aerosol containing budesonide in fixed combination with formoterol fumarate has not revealed age-related differences in response, oral drug dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. Safety of budesonide inhalation powder in patients 65 years of age or older was similar to that observed in younger adults. No substantial differences in safety and efficacy of budesonide in fixed combination with formoterol fumarate were observed in geriatric patients relative to younger adults. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly also should be considered. (See Dosage and Administration: Special Populations.)