NEODOSE

INDICATIONS

• Bronchodilator
• Hyperkalemia in preterm neonates: Published data using the nebulized formulation of albuterol for the treatment of hyperkalemia in preterm neonates are limited to one randomized, placebo-controlled trial (n=19). Following administration every 2 hours until serum potassium dropped below 5 mmol/L (or a maximum of 12 doses), nebulized albuterol (n=8) was effective in lowering potassium levels at 4 and 8 hours when compared with placebo (saline via nebulization; n=11).
• Bronchiolitis: Albuterol is not recommended for the routine treatment of bronchiolitis in infants and children. Consistent benefits have not been demonstrated. There are a lack of data in those with severe disease or with respiratory failure.

CONTRAINDICATIONS

Proair® Respiclick™ and Proair® Digihaler™ are contraindicated in patients with history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins.

PRECAUTIONS

• Cardiovascular:
  • Use sympathomimetic amines with caution in patients with preexisting cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; possibility for cardiovascular events seen in heart rate, blood pressure and ECG changes . Discontinuation may be required.
• Endocrine & Metabolic:
  • Use caution in patients with preexisting diabetes mellitus as large doses of IV albuterol have been reported to aggravate condition.
  • Use caution in patients with preexisting ketoacidosis as large doses of IV albuterol have been reported to aggravate condition.
  • Use caution in patients with preexisting hyperthyroidism.
  • Hypokalemia has occurred but considered transient and not requiring supplementation, but has potential to lead to other cardiovascular side effects.
• Higher doses:
  • Fatalities have been reported upon exceeding recommended doses or excessive use. The cause of death is unknown, but severe acute asthmatic crisis and subsequent hypoxia suspected
• Immunologic:
  • Rare immediate hypersensitivity can occur and manifest as symptoms of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Consider not reinitiating if immediate hypersensitivity occurs.
  • Lactose, used as an inactive ingredient in some inhalers, could lead to immediate hypersensitivity reactions to milk proteins, including anaphylaxis, angioedema, pruritus, and rash.
• Neurologic:
  • Use caution in patients with preexisting convulsive disorders.
• Respiratory:
  • Beta adrenergic agonist therapy alone may be insufficient to control asthma in many patients; consider adding anti-inflammatory agents (eg, corticosteroids) to therapeutic regimen.
  • Benzalkonium chloride preservative, in the multi-dose bottle for nebulization, may induce bronchoconstriction; use only single-use preservative-free, albuterol, particularly when using continuous nebulized albuterol (off-label use).
  • Asthma deterioration may occur suddenly over a few hours or chronically over a few days; use of more albuterol than usual may indicate asthma deterioration, consider alternative therapy and reevaluation of treatment regimen, giving special consideration to possible need for anti-inflammatory treatment.
  • Potentially life-threatening paradoxical bronchospasm has been reported and often occurs with first use of new canister. Discontinue immediately if this occurs and consider alternative treatments.

ADVERSE EFFECTS

Tachycardia, arrhythmias, tremor, hypokalemia, and irritable behavior.

ADMINISTRATION

• Inhalation
  • (ProAir® HFA, Proventil® HFA, Ventolin® HFA) Metered-dose inhaler: Shake well before each spray; canister should be at room temperature before use. Prime before using for the first time, or if the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped; prime the inhaler by spraying it 4 times for Proventil® HFA or Ventolin® HFA or 3 times for ProAir® HFA into the air, away from the face . Use a spacer or a valve holding chamber in younger patients (less than 5 years of age) or patients with poor inhaler technique. A mask should be added for children less than 4 years of age.
  • (Proair® Respiclick™, Proair® Digihaler™) Metered-dose inhaler: Does not require priming. Do not use with spacer or volume holding chamber. Keep inhaler clean and dry by wiping with dry cloth or tissue as needed; never wash or put any part of inhaler in water.
• Nebulization
  • Solution for inhalation: Use the entire contents of pre-diluted vials for inhalation via nebulizer immediately after opening. The dose withdrawn from the 0.5% 20-mL multidose bottle must be further diluted with sterile normal saline to a total volume of 3 mL prior to administration . Preservative-free solutions are recommended, particularly with continuous nebulization; benzalkonium chloride in 20-mL multidose bottles may cause bronchoconstriction. There are no data in neonates, however, no significant differences in response were observed between albuterol solutions with and without benzalkonium chloride in a retrospective study of 128 hospitalized pediatric patients (4 to 17 years of age) administered continuous nebulized albuterol. Administer via nebulizer over 5 to 15 minutes at a gas flow of 6 to 8 L/minute. A tight-fitting face mask should be used in patients who cannot use a mouthpiece.

MONITORING

Assess degree of bronchospasm. Continuous EKG monitoring. Consider not administering when heart rate is greater than 180 beats per minute. Serum potassium