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standards of non-Merck sources.
Pronunciation
(ne doe KROE mil)
U.S. Brand Names
Index Terms
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Aerosol: Maintenance therapy in patients with mild to moderate bronchial asthma
Ophthalmic: Treatment of itching associated with allergic conjunctivitis
Pregnancy Risk Factor
B
Pregnancy Considerations
There are no well-controlled studies in pregnant women. Animal studies show no evidence of teratogenicity or harm to fetus. Additionally, nedocromil has minimal systemic absorption.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to nedocromil or any component of the formulation
Warnings/Precautions
Dosage form specific issues:
• Aerosol: Safety and efficacy have not been established in children <6 years of age; if systemic or inhaled steroid therapy is at all reduced, monitor patients carefully; nedocromil is not a bronchodilator and, therefore, should not be used for reversal of acute bronchospasm
• Ophthalmic solution: Contains benzalkonium chloride, which may be absorbed by contact lenses; users of contact lenses should not wear them during periods of symptomatic allergic conjunctivitis; safety and efficacy have not been established in children <3 years of age.
Adverse Reactions
Inhalation aerosol:
>10%: Gastrointestinal: Unpleasant taste (12%)
1% to 10%:
Central nervous system: Headache (8%), fatigue (1 %)
Gastrointestinal: Nausea (4%), vomiting (3%), dyspepsia (2%), diarrhea (1%), abdominal pain (2%)
Ocular: Conjunctivitis (1%)
Respiratory: Cough (9%), pharyngitis (8%), rhinitis (7%), upper respiratory infection
Ophthalmic solution:
>10%:
Central nervous system: Headache (40%)
Gastrointestinal: Unpleasant taste
Ocular: Burning, irritation, stinging
Respiratory: Nasal congestion
1% to 10%:
Ocular: Conjunctivitis, eye redness, photophobia
Respiratory: Asthma, rhinitis
Drug Interactions
There are no known significant interactions.
Storage
Alocril®: Store at 2°C to 25°C (36°F to 77°F).
Tilade®: Store at 2°C to 30°C (36°F to 86°F); do not freeze.
Mechanism of Action
Inhibits the activation of and mediator release from a variety of inflammatory cell types associated with asthma including eosinophils, neutrophils, macrophages, mast cells, monocytes, and platelets; it inhibits the release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis; it inhibits the development of early and late bronchoconstriction responses to inhaled antigen
Pharmacodynamics/Kinetics
Onset of action: Inhalation: Full therapeutic effect may not occur until ?1 week of therapy
Duration: Therapeutic effect: Inhalation: 2 hours
Absorption: Inhalation: Low; Ophthalmic: Low
Protein binding, plasma: 89%
Bioavailability: Inhalation: 2% to 17%; Ophthalmic: <4%
Half-life elimination: 1.5-3.3 hours
Excretion: Urine 70% (as unchanged drug); feces 30% (as unchanged drug)
Dosage
Inhalation: Children ?6 years and Adults: 2 inhalations 4 times/day; may reduce dosage to 2-3 times/day once desired clinical response to initial dose is observed
Ophthalmic: Children ?3 years and Adults: 1-2 drops in each eye twice daily
Administration: Other
Ophthalmic: Do not allow tip of container to touch eye, surrounding structures, fingers, or other surfaces to avoid bacterial contamination.
Patient Education
Aerosol: Do not use during acute bronchospasm. Use exactly as directed; do not use more often than instructed or discontinue without consulting prescriber. You may experience drowsiness, dizziness, fatigue, especially during early therapy (use caution when driving or engaging in tasks requiring alertness until response to drug is known); dry mouth, nausea, or vomiting (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report persistent runny nose, cough, cold symptoms; unresolved GI effects; skin rash; joint pain or tremor; or if breathing difficulty persists or worsens. Breast-feeding precaution: Consult prescriber if breast-feeding.
Inhaler: Review use with prescriber or follow package insert for directions. Prime with 3 activations prior to first use or if unused more than 7 days. Keep inhaler clean and unobstructed. Always rinse mouth and throat after use of inhaler to prevent advantageous infection. If you are also using a steroid bronchodilator, wait 10 minutes before using this aerosol.
Ophthalmic: Do not wear contact lenses with allergic conjunctivitis. For the eye only. Open eyes, look up, and pull lower lid down. Squeeze medicine into lower eyelid and close eye. Do not touch bottle tip to eye, eyelid, or other skin.
Geriatric Considerations
Elderly may have difficulty using inhaler delivery system, especially if they have physical or medical impairment (eg, Parkinson's disease, stroke). If this prophylactic modality is desired but patient cannot tolerate nedocromil inhalations, consider cromolyn sodium solution for nebulizer use.
Additional Information
Nedocromil has no known therapeutic systemic activity when delivered by inhalation.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Unpleasant taste.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause dizziness or drowsiness
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Not for use during acute bronchospasm. Monitor effectiveness of therapy and adverse reactions at beginning of therapy and periodically with long-term use. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol for oral inhalation, as sodium:
Tilade®: 1.75 mg/activation (16.2 g; at least 104 inhalations) [DSC]
Solution, ophthalmic, as sodium:
Alocril®: 2% (5 mL) [contains benzalkonium chloride]
Pricing: U.S. (www.drugstore.com)
Solution (Alocril)
2% (5): $85.99
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
Content last modified August 2008
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