Nedocromil Sodium
Pronouncation: (NEH-doe-KROE-mill SO-dee-uhm)Class: Mast cell stabilizer
Trade Names:
Alocril
- Solution, ophthalmic 2% (20 mg/mL)
Trade Names:
Tilade
- Aerosol 1.75 mg/actuation
Pharmacology
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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
Symptomatic adults and children (older than 12 yr of age)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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