PULMICORT FLEXHALER 90 ug/1

Budesonide · AEROSOL, POWDER · H2-Pharma LLC

No Recall History

Plain English

Pulmicort Flexhaler is a corticosteroid inhaler used to control and prevent asthma symptoms. It works by reducing inflammation in the airways to help you breathe more easily.

Key Facts

Brand Name: PULMICORT FLEXHALER
Generic Name: Budesonide
NDC Code (Product): 61269-509
Manufacturer: H2-Pharma LLC
Strength: 90 ug/1
Dosage Form: AEROSOL, POWDER
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA021949
Drug Class: Corticosteroid [EPC]
Marketing Start: 03/19/2007

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea6,003 reports

drug ineffective5,600 reports

off label use5,223 reports

asthma4,596 reports

cough2,996 reports

fatigue2,826 reports

headache2,644 reports

condition aggravated2,605 reports

pneumonia2,488 reports

diarrhoea2,437 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PULMICORT FLEXHALER is a corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Treatment of Asthma PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. Limitations of Use: •PULMICORT FLEXHALER is NOT indicated for the relief of acute bronchospasm.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION PULMICORT FLEXHALER should be administered twice daily by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing [see Patient Counseling Information (17.1) ] . Patients should be instructed to prime PULMICORT FLEXHALER prior to its initial use, and instructed to inhale deeply and forcefully each time the device is used. The safety and efficacy of PULMICORT FLEXHALER when administered in excess of recommended doses have not been established. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with PULMICORT FLEXHALER, increasing the dose may provide additional asthma control. For oral inhalation only. • Patients 18 Years of Age and Older: For patients 18 years of age and older, the recommended starting dosage is 360 mcg twice daily. In some adult patients, a starting dose of 180 mcg twice daily may be adequate. The maximum dosage should not exceed 720 mcg twice daily ( 2.1 ) • Patients 6 to 17 Years of Age: The recomme…

Contraindications

4 CONTRAINDICATIONS The use of PULMICORT FLEXHALER is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. • Severe hypersensitivity to milk proteins or any ingredients of PULMICORT FLEXHALER [see Warnings and Precautions (5.3) , Description (11) ]. • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required ( 4 ) • Severe hypersensitivity to milk proteins and any of the ingredients in PULMICORT FLEXHALER ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects ( 5.7 , 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the co-administration of PULMICORT FLEXHALER with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.7) ] .

Adverse Reactions

6 ADVERSE REACTIONS Systemic and inhaled corticosteroid use may result in the following: • Candida albicans Infection [see Warnings and Precautions (5.1) ] • Hypersensitivity Including Anaphylaxis [see Warnings and Precautions (5.3) ] • Immunosuppression [see Warnings and Precautions (5.4) ] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ] • Reduction in Bone Mineral Density [see Warnings and Precautions (5.8) ] • Growth Effects [see Warnings and Precautions (5.9) , Use in Specific Populations (8.4) ] • Glaucoma and Cataracts [see Warnings and Precautions (5.10) ] • Eosinophilic Conditions and Churg-Strauss [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence ≥1%) are nasopharyngitis, nasal congestion, pharyngitis, rhinitis allergic, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, oral candidiasis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact the Safety Call Center at 1-888-994-8116 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical t…

Frequently Asked Questions

What is PULMICORT FLEXHALER used for?

Pulmicort Flexhaler is a corticosteroid inhaler used to control and prevent asthma symptoms. It works by reducing inflammation in the airways to help you breathe more easily.

Is PULMICORT FLEXHALER a controlled substance?

PULMICORT FLEXHALER is not classified as a controlled substance by the DEA.

What is the generic name for PULMICORT FLEXHALER?

The generic name for PULMICORT FLEXHALER is Budesonide. There are 12 other brand versions of Budesonide.

What is the NDC code for PULMICORT FLEXHALER 90 ug/1?

The NDC (National Drug Code) for PULMICORT FLEXHALER 90 ug/1 is 61269-509, listed by H2-Pharma LLC.

Product NDC

61269-509

Package NDC

61269-509-06

Other Budesonide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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