Budesonide Inhalation Suspension .5 mg/2mL
Budesonide · INHALANT · Exelan Pharmaceuticals, Inc.
Budesonide Inhalation Suspension is a inhalant containing budesonide at .5 mg/2mL, taken oral. Manufactured by Exelan Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Budesonide Inhalation Suspension
- Generic Name
- Budesonide
- NDC Code (Product)
76282-641- Manufacturer
- Exelan Pharmaceuticals, Inc.
- Strength
- .5 mg/2mL
- Dosage Form
- INHALANT
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205710
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 04/17/2019
Recall History
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Cipla USA, Inc.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
AstraZeneca LP
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
CIPLA
Lack of Assurance of Sterility
AstraZeneca LP
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Budesonide inhalation suspension 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 Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use : Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 dailydose should be increased and/or administered as a divided dose. Once asthma stability is achieved, titrate the dose downwards. For inhalation use via compressed air driven jet nebulizers only (not for use with ultrasonic devices). Not for injection. ( 2.2 ) The recommended starting dose and highest recommended dose of budesonide inhalation suspension, 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 adm…
Contraindications
4 CONTRAINDICATIONS Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ( 4 ) Hypersensitivity to any of the ingredients in budesonide inhalation suspension ( 4 ) The use of budesonide inhalation suspension 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 budesonide inhalation suspension [see Warnings and Precautions ( 5.3 ), Description ( 11 ),Adverse Reactions( 6.2 ) ].
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 P4503A4 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 budesonide inhalation suspension 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 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 Cipla Ltd 1-866-604-3268 or FDA at 1-800-FDA-1088 or FDA or www.fda.gov/medwatch . 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 )] 6.1 Clinical Trials Experience Because clinical trials a…
Frequently Asked Questions
What is Budesonide Inhalation Suspension used for?
Budesonide Inhalation Suspension contains Budesonide. It is a inhalant taken oral. Consult your doctor for specific uses.
Is Budesonide Inhalation Suspension a controlled substance?
Budesonide Inhalation Suspension is not classified as a controlled substance by the DEA.
What is the generic name for Budesonide Inhalation Suspension?
The generic name for Budesonide Inhalation Suspension is Budesonide. There are 11 other brand versions of Budesonide.
What is the NDC code for Budesonide Inhalation Suspension .5 mg/2mL?
The NDC (National Drug Code) for Budesonide Inhalation Suspension .5 mg/2mL is 76282-641, listed by Exelan Pharmaceuticals, Inc..
Other Budesonide Inhalation Suspension Dosages
Other Budesonide Brands
See all →- Budesonide and formoterol fumarate dihydrate80 ug/10480-3080
- Budesonide32 ug/10536-1112
- budesonide3 mg/10574-9855
- Budesonide.25 mg/2mL47335-631
- SYMBICORT160 ug/150090-4509
- BREYNA160 ug/10378-7503
- budesonide3 mg/170771-1075
- Budesonide Inhalation.5 mg/2mL0115-1689
- PULMICORT RESPULES.25 mg/2mL0186-1988
- Budesonide32 ug/149035-703
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)