Budesonide — Membership Pricing

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What Budesonide is approved for (FDA label)

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.

Source: Read the full FDA label on DailyMed. Label effective date: July 16, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Budesonide (FDA label)

Budesonide inhalation suspension is available in two strengths, each containing 2 mL: 0.25 mg/2 mL and 0.5 mg/2 mL. Budesonide inhalation suspension is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose ampules, together with patient instructions for use. There are 30 budesonide inhalation suspension ampules in a carton. Each single-dose budesonide inhalation suspension ampule contains 2 mL of sterile liquid suspension. Inhalation suspension: 0.25 mg/2 mL and 0.5 mg/2 mL. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 3235e2a4-8e12-2d58-e063-6294a90a4936. SPL document ID: 56c0116d-714d-2f59-e063-6294a90a5d10. Label effective date: July 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Budesonide (FDA label)

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) and 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 Rising Pharma Holdings, Inc. at 1-844-874-7464 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 trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: 3235e2a4-8e12-2d58-e063-6294a90a4936. SPL document ID: 56c0116d-714d-2f59-e063-6294a90a5d10. Label effective date: July 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Budesonide (FDA label)

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) and 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 budesonide inhalation suspension ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 3235e2a4-8e12-2d58-e063-6294a90a4936. SPL document ID: 56c0116d-714d-2f59-e063-6294a90a5d10. Label effective date: July 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Budesonide (FDA label)

Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation. ( 5.1 ) Deterioration of disease and acute asthma episodes: Do not use for the relief of acute bronchospasm. ( 5.2 ) Hypersensitivity reactions: anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur. ( 5.3 ) Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.4 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids.

Source: FDA prescribing information (DailyMed). Set ID: 3235e2a4-8e12-2d58-e063-6294a90a4936. SPL document ID: 56c0116d-714d-2f59-e063-6294a90a5d10. Label effective date: July 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Budesonide (FDA label)

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 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) and Clinical Pharmacology(12.3) ].

Source: FDA prescribing information (DailyMed). Set ID: 3235e2a4-8e12-2d58-e063-6294a90a4936. SPL document ID: 56c0116d-714d-2f59-e063-6294a90a5d10. Label effective date: July 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.