Uses
Asthma
Used as an adjunct in the overall management of mild to moderate bronchial asthma.
For prophylaxis only; not indicated for reversal of acute bronchospasm, including status asthmaticus. (See Acute Bronchospasm under Warnings.)
Dosage and Administration
General
- Initially, administer concurrently with patient’s existing maintenance dosages of β-adrenergic agonists, theophylline, and/or corticosteroids. Once clinical response is observed and asthma adequately controlled, gradual reduction in concomitant therapy may be possible.
Administration
Oral Inhalation
Administer by oral inhalation using an oral aerosol inhaler.
Shake inhaler well before use. Actuate aerosol inhaler 3 times prior to the initial use or if it has not been used for >7 days.
Exhale slowly and completely, invert the inhaler, place the mouthpiece of the inhaler well into the mouth, and close the lips around it. Inhale slowly and deeply through the mouth while actuating the inhaler. Hold breath for 5–10 seconds, withdraw the mouthpiece, and exhale slowly.
Avoid spraying in eyes.
Clean inhaler twice weekly. Remove metal canister and cap and rinse plastic mouthpiece in hot running water. Allow to dry overnight in a warm place.
Optimal therapeutic effect is dependent upon administration at regular intervals, even during symptom-free periods.
Dosage
Available as nedocromil sodium, dosage expressed in terms of the salt.
The dose of nedocromil sodium is expressed as the amount delivered from the actuator of the inhaler per metered spray.
Oral inhalation aerosol delivers 2 mg from the valve and 1.75 mg from the actuator per metered spray. Each aerosol canister delivers ≥104 metered sprays.
Pediatric Patients
Asthma
Oral Inhalation
Children ≥6 years of age: 3.5 mg (2 inhalations) 4 times daily at regular intervals (14 mg/day).
Less frequent administration may be effective if asthma is well controlled at this dose (e.g., patients only need occasional β-agonist therapy and are not experiencing serious exacerbations).
Adults
Asthma
Oral Inhalation
3.5 mg (2 inhalations) 4 times daily at regular intervals (14 mg/day).
Less frequent administration may be effective if asthma is well controlled at this dose (e.g., patients only need occasional β-agonist therapy and are not experiencing serious exacerbations).
Prescribing Limits
Pediatric Patients
Asthma
Oral Inhalation
Children ≥6 years of age: Maximum 3.5 mg (2 inhalations) 4 times daily (14 mg/day).
Adults
Asthma
Oral Inhalation
Maximum 3.5 mg (2 inhalations) 4 times daily (14 mg/day).
Special Populations
No special population dosage recommendations at this time.
Cautions
Contraindications
Known hypersensitivity to nedocromil or any ingredient in the formulation.
Warnings/Precautions
Warnings
Acute Bronchospasm
Nedocromil is not a bronchodilator; do not use for reversal of acute bronchospasm, especially status asthmaticus.
Use should generally be continued during acute exacerbations, unless patient becomes intolerant to use of inhaled dosage forms.
Bronchospasm, possibly life-threatening, may occur immediately after administration. If this occurs, discontinue nedocromil and institute alternative therapy.
General Precautions
Concomitant Corticosteroid Dosage
Role of nedocromil as a corticosteroid-sparing agent in patients receiving oral or inhaled corticosteroids not defined. Monitor patients closely if systemic or inhaled corticosteroids are reduced.
Specific Populations
Pregnancy
Category B.
Lactation
Not known if nedocromil is distributed into milk. Caution is advised if nedocromil is used.
Pediatric Use
Safety and efficacy not established in children <6 years of age.
Common Adverse Effects
Unpleasant taste, coughing, pharyngitis, rhinitis, upper respiratory infection, dyspnea, bronchospasm, sinusitis, nausea, vomiting, headache, chest pain, fever, viral infection.
Drug Interactions
No formal drug interaction studies to date.
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