For U.S. Healthcare Professionals
PULMICORT FLEXHALER (budesonide inhalation powder, 90 mcg & 180 mcg)

A Maintenance Treatment Option for Appropriate Patients With Asthma.

PULMICORT FLEXHALER® (budesonide inhalation powder) is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older.

Limitation of Use: Not indicated for the relief of acute bronchospasm.

View Prescribing Information

At a Glance

Key facts for your clinical review

Two Strengths

Available in 90 mcg and 180 mcg dry powder inhaler.

Age 6 and Older

Maintenance treatment of asthma in adult and pediatric patients 6 years of age or older.

Dry Powder Inhaler

A breath-actuated dry powder inhaler delivering budesonide inhalation powder.

Inhaled Maintenance Therapy

Delivered via dry powder inhaler for daily prophylactic use.

Strength

90 mcg

Strength

180 mcg

Product Information

PULMICORT FLEXHALER® (budesonide inhalation powder)

Indication

PULMICORT FLEXHALER® (budesonide inhalation powder) is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older.

Limitation of Use

Not indicated for the relief of acute bronchospasm.

Formulation

Budesonide inhalation powder delivered via a dry powder inhaler, available in 90 mcg and 180 mcg strengths.

For dosing, administration, contraindications, warnings, and full clinical information, please refer to the Full Prescribing Information.
Read Full Prescribing Information

How to Use

Four steps to review with your patients

A high-level summary of key patient-use steps. For the complete procedure, always refer to the official Instructions for Use.

Official Instructions for Use
  1. 01

    Prime before first use

    Prime the inhaler before the first dose as described in the Instructions for Use. Priming is not required for subsequent doses.

  2. 02

    Load the dose

    Hold the inhaler upright and load by twisting the grip until it clicks to prepare the next dose.

  3. 03

    Inhale deeply and forcefully

    Place the mouthpiece between the lips and inhale deeply and forcefully through the mouthpiece.

  4. 04

    Rinse mouth — do not swallow

    After each dose, rinse the mouth with water and spit. Do not swallow the rinse water.

Important Safety Information

PULMICORT FLEXHALER® Safety

Indication

PULMICORT FLEXHALER® (budesonide inhalation powder) is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older.

Limitation of Use

Not indicated for the relief of acute bronchospasm.

This is a summary of Important Safety Information. Please see the Full Prescribing Information for complete details, including additional Warnings and Precautions, Contraindications, and Adverse Reactions.

Ask About Pulmicort

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Responses are limited to approved product information and are not medical advice. To report a suspected adverse reaction, contact Allegis Pharmaceuticals Drug Safety at 1-888-825-3594 or the FDA MedWatch program.

Pulmicort Product Assistant

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Contact

Allegis Pharmaceuticals

For general product inquiries related to PULMICORT FLEXHALER®, please contact Allegis Pharmaceuticals.

Reporting a Suspected Adverse Reaction

Suspected adverse reactions should not be sent to the general sales inbox. Please report them directly to Allegis Pharmaceuticals Drug Safety or the FDA MedWatch program.

Important Safety Information

Key safety topics — summary

  • Not for acute bronchospasm: PULMICORT FLEXHALER is not a bronchodilator and is not indicated for the relief of acute bronchospasm or other acute episodes of asthma. Pat
  • Oropharyngeal candidiasis: Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients treated with inhaled corticosteroids. Adv
  • Hypersensitivity reactions, including anaphylaxis: Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria, and rash have been reported. Discontinue PULMICORT FL
  • Increased risk of infection: Patients on immunosuppressant doses of corticosteroids are more susceptible to infections. Chicken pox and measles can have a more serious o
  • Transferring from systemic corticosteroids: Particular care is needed for patients transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to
  • Hypercorticism and adrenal suppression: PULMICORT FLEXHALER may cause hypercorticism and adrenal suppression, particularly at higher doses. If such changes occur, consider appropri