PULMICORT RESPULES .25 mg/2mL

Budesonide · SUSPENSION · AstraZeneca Pharmaceuticals LP

3 Recalls on Record

Plain English

PULMICORT RESPULES is a suspension containing budesonide at .25 mg/2mL, taken respiratory (inhalation). Manufactured by AstraZeneca Pharmaceuticals LP.

Key Facts

Brand Name: PULMICORT RESPULES
Generic Name: Budesonide
NDC Code (Product): 0186-1988
Manufacturer: AstraZeneca Pharmaceuticals LP
Strength: .25 mg/2mL
Dosage Form: SUSPENSION
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA020929
Drug Class: Corticosteroid [EPC]
Marketing Start: 09/08/2000

Recall History

3 Recalls on Record

Class II04/03/2018

Kroger Specialty Pharmacy, Inc.

Lack of Processing Controls.

TerminatedVoluntary: Firm initiated

Class III01/11/2013

AstraZeneca LP

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

TerminatedVoluntary: Firm initiated

Class III01/11/2013

AstraZeneca LP

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective4,798 reports

dyspnoea4,691 reports

off label use4,442 reports

asthma3,678 reports

fatigue2,504 reports

condition aggravated2,404 reports

headache2,363 reports

cough2,278 reports

diarrhoea2,265 reports

pneumonia2,200 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PULMICORT RESPULES ® is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use : • PULMICORT RESPULES is NOT indicated for the relief of acute bronchospasm.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table. Previous Therapy Recommended Starting Dose Highest Recommended Dose Bronchodilators alone 0.5 mg total daily dose administered either once daily or twice daily in divided doses 0.5 mg total daily dose Inhaled Corticosteroids 0.5 mg total daily dose administered either once daily or twice daily in divided doses 1 mg total daily dose Oral Corticosteroids 1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once daily 1 mg total daily dose Recommended dosing based on previous therapy ( 2 ). Start with the lowest recommended dose: • Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily • Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily • In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered • If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a d…

Contraindications

4 CONTRAINDICATIONS The use of PULMICORT RESPULES is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. • Hypersensitivity to budesonide or any of the ingredients of PULMICORT RESPULES [see Warnings and Precautions (5.3) , Description (11) , Adverse Reactions (6.2) ] . • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required ( 4 ) • Hypersensitivity to any of the ingredients in PULMICORT RESPULES ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects ( 5.12 , 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 a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the coadministration of PULMICORT RESPULES 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 (5.12) , Clinical Pharmacology (12.3) ] .

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 Reactions 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 (5.7) ] • Growth Effects in Pediatric Patients [see Warnings and Precautions (5.8) , Use in Specific Populations (8.4) ] • Glaucoma, Increased Intraocular Pressure and Cataracts [see Warnings and Precautions (5.9) ] • Eosinophilic Conditions and Churg-Strauss Syndrome [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence > 3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1–800–236–9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted unde…

Frequently Asked Questions

What is PULMICORT RESPULES used for?

PULMICORT RESPULES contains Budesonide. It is a suspension taken respiratory (inhalation). Consult your doctor for specific uses.

Is PULMICORT RESPULES a controlled substance?

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

What is the generic name for PULMICORT RESPULES?

The generic name for PULMICORT RESPULES is Budesonide. There are 11 other brand versions of Budesonide.

What is the NDC code for PULMICORT RESPULES .25 mg/2mL?

The NDC (National Drug Code) for PULMICORT RESPULES .25 mg/2mL is 0186-1988, listed by AstraZeneca Pharmaceuticals LP.

Product NDC

0186-1988

Package NDC

0186-1988-04

Other Budesonide Brands

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

Data from openFDA · Public domain (CC0 1.0)