Nedocromil Sodium

Trade Names:Alocril- Solution, ophthalmic 2% (20 mg/mL)

Trade Names:Tilade- Aerosol 1.75 mg/actuation

Pharmacology

Inhibits release of mediators from inflammatory cell types associated with asthma, including histamine from mast cells and betaglucuronidase from macrophages. May also suppress local production of leukotrienes and prostaglandins. Inhibits development of bronchoconstriction responses to inhaled antigen and other challenges such as cold air.

Pharmacokinetics

Absorption

Nedocromil sodium bioavailability is 8% to 17%, C _max is 1.6 to 2.8 ng/mL, and T _max is 5 to 90 min.

Distribution

Plasma protein binding is approximately 89%.

Metabolism

Nedocromil sodium is not metabolized.

Elimination

Nedocromil is eliminated unchanged in urine 64% and feces 36%. The t _½ is 1.5 to 3.3 h.

Indications and Usage

Maintenance of mild to moderate bronchial asthma; treatment of itching caused by allergic conjunctivitis.

Contraindications

Standard considerations.

Dosage and Administration

Aerosol inhalation 2 inhalations 4 times daily at regular intervals to provide 14 mg/day. May attempt lower frequency of doses in well-controlled patients.

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache.

EENT

Ocular burning; irritation and stinging; unpleasant taste; nasal congestion; conjunctivitis; eye redness; photophobia.

GI

Nausea; vomiting; dyspepsia; abdominal pain.

Respiratory

Rhinitis; upper respiratory tract infection; asthma.

Miscellaneous

Unpleasant taste.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 6 yr of age not established (aerosol inhalation). Safety and efficacy in children younger than 3 yr of age not established (ophthalmic).

Acute bronchospasm

Do not use for reversal of acute bronchospasm, particularly status asthmaticus. However, continue to administer during acute exacerbations, unless patient becomes intolerant to inhaled dosage forms.

Cough/Bronchospasm

If cough or bronchospasm follow inhalation, may need to discontinue.

Dosing interval

Optimal effect depends on administration at regular intervals, even during symptom-free periods.

Patient Information

• Ensure appropriate demonstration of how to connect medication and inhalant cartridge. Supply adequate information for home use.
• Provide appropriate demonstration of how to administer inhalant dose.
• Advise patient to increase fluid intake (if not contraindicated) to promote flow of nasal secretions.
• Caution patient to avoid exhaling into mouthpiece to avoid moisture accumulation.
• Tell patient to notify health care provider if coughing and bronchospasm occur with inhalation therapy. Alternative therapy may be needed.
• Explain that therapeutic effect may take about 2 wk.
• Tell patient that nedocromil sodium cannot be substituted for bronchodilator (for acute attacks) or steroids.
• If patient is being tapered from steroids, explain that increased asthmatic symptoms may occur and to notify health care provider if this occurs.
• Demonstrate proper method of cleaning inhaler and remind patient to clean inhaler at least 2 times/wk.
• Tell patient to report any adverse reactions.

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