Budesonide: uses, appearance and warnings

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.

Inhalation suspension: 0.25 mg/2mL, 0.5 mg/2mL, 1 mg/2mL ( 3 ) Budesonide inhalation suspension is available in three strengths, each containing 2 mL: 0.25 mg/2 mL, 0.5 mg/2 mL, and 1 mg/2 mL. Budesonide inhalation suspension is supplied in sealed aluminum foil envelopes containing one plastic strip of either one single-dose ampule or five single-dose ampules together with patient instructions for use. There are 30 ampules in a carton. Each single-dose ampule contains 2 mL of sterile liquid suspension.

Budesonide inhalation suspension is supplied in sealed aluminum foil envelope containing one plastic strip of either one single-dose ampule or five single-dose ampules together with patient instructions for use. There are 30 ampules in a carton. Each single-dose ampule contains 2 mL of sterile liquid suspension Budesonide inhalation suspension is available in three strengths, each containing 2 mL: 1 ampule in foil envelope Budesonide Inhalation Suspension, 0.25 mg/2 mL 1 ampule in foil envelope 30 ampules per carton 69097-318-32 69097-318-53 Budesonide Inhalation Suspension, 0.5 mg/2 mL 1 ampule in foil envelope 30 ampules per carton 69097-319-32 69097-319-53 Budesonide Inhalation Suspension, 1 mg/2 mL 1 ampule in foil envelope 30 ampules per carton 69097-321-32 69097-321-53 5 ampules in foil envelope Budesonide Inhalation Suspension, 0.25 mg/2 mL 5 ampules in foil envelope 30 ampules per carton 69097-318-86 69097-318-87 Budesonide Inhalation Suspension, 0.5 mg/2 mL 5 ampules in foil envelope 30 ampules per carton 69097-319-86 69097-319-87 Budesonide Inhalation Suspension, 1 mg/2 mL 5 ampules in foil envelope 30 ampules per carton 69097-321-86 69097-321-87 Budesonide inhalation suspension should be stored upright at controlled room temperature 20 to 25°C (68 to 77°F) [see USP], and protected from light. When an envelope has been opened, the shelf life of the unused ampules is 2 weeks when protected. After opening the aluminum foil envelope, the unused ampules should be returned to the aluminum foil envelope to protect them from light. Any opened ampule must be used promptly. Gently shake the ampule using a circular motion before use. Keep out of reach of children. Do not freeze.

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 ) ].

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 Therapy : Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to budesonide inhalation suspension ( 5.5 ) Hypercorticism and Adrenal Suppression : May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, reduce budesonide inhalation suspension slowly. ( 5.6 ) Reduction in Bone Mineral Density with Long-Term Administration : Monitor patients with major risk factors for decreased bone mineral content. ( 5.7 ) Effects on Growth : Monitor growth of pediatric patients. ( 5.8 ) Glaucoma and Cataracts : Close monitoring is warranted. ( 5.9 ) Paradoxical Bronchospasm : Discontinue budesonide inhalation suspension and institute alternative therapy if paradoxical bronchospasm occurs. ( 5.10 ) Eosinophilic Conditions and Churg-Strauss Syndrome : Be alert to eosinophilic conditions. ( 5.11 ) 5.1 Local Effects In clinical trials with budesonide inhalation suspension, localized infections with Candida albicans occurred in the mouth and pharynx in some patients. The incidences of localized infections of Candida albicans were similar between the placebo and budesonide inhalation suspension treatment groups. If these infections develop, they may require treatment with appropriate local or systemic antifungal therapy and/or discontinuance of treatment with budesonide inhalation suspension. Patients should rinse the mouth after inhalation of budesonide inhalation suspension. 5.2 Deterioration of Disease and Acute Asthma Episodes Budesonide inhalation suspension is not a bronchodilator and is not indicated for the rapid relief of acute bronchospasm or other acute episodes of asthma. Patients should be instructed to contact their physician immediately if episodes of asthma not responsive to their usual doses of bronchodilators occur during the course of treatment with budesonide inhalation suspension. During such episodes, patients may require therapy with oral corticosteroids. 5.3 Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions including 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 [see Contraindications ( 4 ) ]. 5.4 Immunosuppression Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases, or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents may be considered. The clinical course of chicken pox or measles infection in patients on inhaled corticosteroids has not been studied. However, a clinical study has examined the immune responsiveness of asthma patients 12 months to 8 years of age who were treated with budesonide inhalation suspension. An open-label non-randomized clinical study examined the immune responsiveness of varicella vaccine in 243 asthma patients 12 months to 8 years of age who were treated with budesonide inhalation suspension 0.25 mg to 1 mg daily (n=151) or noncorticosteroid asthma therapy (n=92) (ie, beta 2 -agonists, leukotriene receptor antagonists, cromones). The percentage of patients developing a seroprotective antibody titer of ≥5.0 (gpELISA value) in response to the vaccination was similar in patients treated with budesonide inhalation suspension (85%) compared to patients treated with non-corticosteroid asthma therapy (90%). No patient treated with budesonide inhalation suspension developed chicken pox as a result of vaccination. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. …

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 …

• 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. …