Budesonide (inhalation)

Budesonide (inhalation)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Budesonide (inhalation) is an adrenal cortex hormone that is FDA approved for the treatment of asthma, crohn's disease, allergic and non-allergic rhinitis, active ulcerative colitis (mild to moderate). There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, nausea, arthralgia, headache, epistaxis, nasal stinging/burning, respiratory tract infection, sinusitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Asthma

• Dosing Information

• Initial dose: 360 mcg via oral inhalation twice daily;180 mcg twice daily initially may be sufficient in some patients
• Maximum dose: 720 mcg twice daily

Crohn's disease

• Dosing Information

• Induction of Remission:
• Recommended dose: 9 mg orally once daily in the morning for up to 8 weeks; a repeat 8-week course may be given for recurring episodes; taper off oral prednisolone while concurrently initiating budesonide
• Maintenance of Remission:
• Recommended dose: 6 mg orally once daily for up to 3 months; after 3 months, taper to complete cessation (use beyond 3 months has not shown substantial clinical benefit)

Rhinitis, allergic and non-allergic

• Dosing Information

• Recommended dose: 64 mcg (one 32-mcg spray/nostril) once daily; titrate to minimum effective dose; may be able to reduce dose once symptoms are controlled
• Maximum dose: 256 mcg/day (4 sprays/nostril once daily)

Ulcerative colitis (Mild to Moderate), Active

• Dosing Information

• Recommended dose (Uceris(TM)): 9 mg orally once daily in the morning for up to 8 weeks

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Budesonide in adult patients.

Non–Guideline-Supported Use

Nasal polyp

• Dosing Information

• Dose: 128 mcg intranasally once daily over 8 weeks or 400 mcg/day intranasally in 2 divided doses over 8 to 12 weeks

Ulcerative colitis, distal

• Dosing information

• Effective dose: 100 to 125 mL of a suspension containing 2 mg/100 mL once daily at bedtime (study dosage)or 2 mg (100 mL) as a rectal enema once daily at night for 4 to 8 weeks (Canadian manufacturer dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Asthma

• Dosing Information

• Inhaler:
• Recommended dose, 6 years or older: Initiate at 180 mcg via oral inhalation twice daily; 360 mcg twice daily may be required initially in some patients
• Maximum dose: 360 mcg twice daily
• Nebulization:
• Recommended dose, 1 to 8 years: Based on previous therapy as follows

Rhinitis, allergic and non-allergic

• Dosing information

• Nasal route:
• Recommended dose (6 years or older): 64 mcg (one 32-mcg spray/nostril) once daily; titrate to minimum effective dose; may be able to reduce dose once symptoms are controlled
• Maximum dose: under 12 years, 128 mcg/day (2 sprays/nostril once daily); 12 years or older, 256 mcg/day (4 sprays/nostril once daily)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Budesonide in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Budesonide (inhalation) in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Budesonide (inhalation) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Budesonide (inhalation) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Budesonide (inhalation) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Budesonide (inhalation) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Budesonide (inhalation) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Budesonide (inhalation) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Budesonide (inhalation) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Budesonide (inhalation) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Budesonide (inhalation) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Budesonide (inhalation) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Budesonide (inhalation) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Budesonide (inhalation) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Budesonide (inhalation) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Budesonide (inhalation) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Budesonide (inhalation) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Budesonide (inhalation) in the drug label.

Pharmacology

There is limited information regarding Budesonide (inhalation) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Budesonide (inhalation)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Budesonide (inhalation) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Budesonide (inhalation) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Budesonide (inhalation) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Budesonide (inhalation) in the drug label.

How Supplied

Storage

There is limited information regarding Budesonide (inhalation) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Budesonide (inhalation) in the drug label.

Precautions with Alcohol

• Alcohol-Budesonide (inhalation) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Entocort EC, Pulmicort, Pulmicort Turbuhaler, Rhinocort, Rhinocort Aqua, Pulmicort Flexhaler, Pulmicort Respules, Uceris.

Look-Alike Drug Names

There is limited information regarding Budesonide (inhalation) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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