• Nebulization — Maintenance treatment and prophylactic therapy of asthma.
• Oral inhalation — Chronic control of persistent bronchial asthma. May decrease requirement for or eliminate use of systemic corticosteroids over time in patients with asthma.

Contraindicated in:

• Hypersensitivity to budesonide
• Acute attack of asthma/status asthmaticus.

Use Cautiously in:

• Active untreated infection
• Diabetes
• Glaucoma
• Underlying immunosuppression (from disease or concurrent therapy)
• Systemic corticosteroid therapy (should not be abruptly discontinued when inhaled therapy is started; additional corticosteroids needed during stress or trauma)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Higher than recommended doses in children can lead to suppression of hypothalamic-pituitary-adrenal (HPA) function and suppression of linear growth.

Derm: rash.

EENT: otitis media, dysphonia, epistaxis, oropharyngeal fungal infections, pharyngitis, rhinitis, sinusitis.

Endo: adrenal suppression (high dose, long-term therapy only), ↓ growth (children), weight gain.

GI: abdominal pain, diarrhea, dyspepsia, gastroenteritis, nausea, vomiting.

MS: back pain.

Neuro: headache.

Resp: bronchospasm, cough.
Misc: ANAPHYLAXIS, flu-like syndrome.

Drug-Drug:

• Strong CYP3A4 inhibitors, including ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, and saquinavir↓ metabolism and ↑ levels of budesonide.

(Generic available)

• Inhalation powder (Flexhaler): 90 mcg/metered inhalation (delivers 60 metered inhalations); 100 mcg/metered inhalation (delivers 200 metered inhalations); 180 mcg/metered inhalation (delivers 120 metered inhalations); 200 mcg/metered inhalation (delivers 200 metered inhalations); 400 mcg/metered inhalation (delivers 200 metered inhalations);
• Inhalation suspension (Respules): 0.25 mg/2 mL in single dose ampules (5 ampules/envelope); 0.5 mg/2 mL in single dose ampules (5 ampules/envelope); 1 mg/2 mL in single dose ampules (5 ampules/envelope);
• In combination with: formoterol (Symbicort); formoterol and glycopyrrolate (Breztri Aerosphere); see Appendix [not included in this PDA edition].

Flexhaler

• Inhaln (Adults): — 180–360 mcg twice daily (not to exceed 720 mcg twice daily).
• Inhaln (Children 6 yr): — 180–360 mcg twice daily (not to exceed 360 mcg twice daily).

Respules

• Inhaln (Children 1–8 yr): Previously on bronchodilators alone–0.5 mg once daily or 0.25 mg twice daily (not to exceed 0.5 mg/day); Previously on other inhaled corticosteroids — 0.5 mg once daily or 0.25 mg twice daily (not to exceed 1 mg/day); Previously on oral corticosteroids — 1 mg once daily or 0.5 mg twice daily (not to exceed 1 mg/day).

Pulmicort Respules, Pulmicort Flexhaler

• Potent, locally acting anti-inflammatory and immune modifier.

• Decreases frequency/severity of asthma attacks.
• Improves asthma symptoms.

Therapeutic Classification: corticosteroids

Pharmacologic Classification: corticosteroids

Absorption: Flexhaler — 39%; Respules — 6%. Action is primarily local following inhalation.

Distribution: Crosses placenta; enters breast milk in small amounts.

Protein Binding: 85–90%.

Metabolism/Excretion: Metabolized by the liver (primarily by CYP3A4) following absorption from lungs; 60% excreted in urine, 40% in feces.

Half-life: Adults — 2–3.6 hr; Children 10–14 yrs — 1.5 hr; Children 4–6 yrs — 2.3 hr (after nebulization).

Pulmicort Nebuamp, Pulmicort Turbuhaler

(improvement in symptoms)

†Improvement in pulmonary function; decreased airway responsiveness may take longer.

• Advise patient to take medication as directed. Take missed doses as soon as remembered unless almost time for next dose. Advise patient not to discontinue medication without consulting health care professional; gradual decrease is required. Instruct patient to read the Patient Information and Instructions for Use before using and with each Rx refill, in case of new information.
• Advise patients using inhalation corticosteroids and bronchodilator to use bronchodilator first and to allow 5 min to elapse before administering the corticosteroid, unless otherwise directed by health care professional.
• Advise patient that inhalation corticosteroids should not be used to treat an acute asthma attack but should be continued even if other inhalation agents are used.
• Patients using inhalation corticosteroids to control asthma may require systemic corticosteroids for acute attacks. Advise patient to use regular peak flow monitoring to determine respiratory status.
• Advise patient to rinse mouth with water after treatment to decrease risk of developing local candidiasis.
• Caution patient to avoid smoking, known allergens, and other respiratory irritants.
• Advise patient to notify health care professional if sore throat or mouth or symptoms of anaphylaxis (rash, severe itching, swelling of the face, mouth, and tongue, trouble breathing or swallowing, chest pain, anxiety or feeling of doom) occur.
• Instruct patient whose systemic corticosteroids have been recently reduced or withdrawn to carry a warning card indicating the need for supplemental systemic corticosteroids in the event of stress or severe asthma attack unresponsive to bronchodilators.
• Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Pulmicort Flexhaler: Advise patient to follow instructions supplied. Before first-time use, prime unit by turning cover and lifting off; hold upright with mouthpiece up and twist brown grip fully to right, then fully to left until it clicks. To administer dose, hold upright, twist brown grip fully to right, then fully to left, until it clicks. Turn head away from inhaler and exhale (do not blow into inhaler). Do not shake inhaler. Place mouthpiece between lips and inhale deeply and forcefully. Remove inhaler from mouth and exhale (do not exhale into mouthpiece). Repeat procedure if 2nd dose required. Replace cover.
• Pulmicort Respules: Administer with a jet nebulizer connected to adequate air flow, equipped with a mouthpiece or face mask. Adjust face mask to avoid exposing eyes to nebulized medication. Wash face after use of face mask. Ultrasonic nebulizers are not adequate for administration and not recommended.
  • Instruct parent to read and follow the Patients Instructions for Use included in each package. Do not mix with other medications in the nebulizer.
  • Store respules upright, away from heat and protected from light. Do not refrigerate or freeze. Respules are stable for 2 wk at room temperature after opening aluminum foil envelope. Open respules must be used promptly. Unused respules should be returned to aluminum foil envelope.

byoo-DES-oh-nide