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Pronunciation |
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(ne
doe KROE mil SOW dee
um) |
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U.S. Brand
Names |
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Alocril™; Tilade® Inhalation
Aerosol |
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Generic
Available |
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No |
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Canadian Brand
Names |
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Mireze® |
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Pharmacological Index |
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Antihistamine, Inhalation |
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Use |
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Maintenance therapy in patients with mild to moderate bronchial
asthma |
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Pregnancy Risk
Factor |
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B |
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Contraindications |
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Hypersensitivity to nedocromil or other ingredients in the
preparation |
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Warnings/Precautions |
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Safety and efficacy in children <12 years of age have not been
established; 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 |
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Adverse
Reactions |
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Aerosol: 1% to 10%:
Cardiovascular: Chest pain
Central nervous system: Dizziness, dysphonia, headache, fatigue
Dermatologic: Rash
Gastrointestinal: Nausea, vomiting, dyspepsia, diarrhea, abdominal pain,
xerostomia, unpleasant taste
Hepatic: Increased ALT
Neuromuscular & skeletal: Arthritis, tremor
Respiratory: Cough, pharyngitis, rhinitis, bronchitis, upper respiratory
infection, bronchospasm, increased sputum production
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 |
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Stability |
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Store at 2°C to
30°C/36°F to
86°F; do not freeze |
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Mechanism of
Action |
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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 |
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Pharmacodynamics/Kinetics |
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Duration of therapeutic effect: 2 hours
Protein binding, plasma: 89%
Bioavailability: Systemic: 7% to 9% absorption
Half-life: 1.5-2 hours
Elimination: Excreted unchanged in urine |
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Usual Dosage |
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Inhalation: Children >12 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: 1-2 drops in each eye |
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Mental Health: Effects
on Mental Status |
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May cause dizziness or drowsiness |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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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 gastrointestinal effects; skin rash;
joint pain or tremor; or if breathing difficulty persists or worsens.
Breast-feeding precautions: Consult prescriber if breast-feeding.
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Nursing
Implications |
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Nedocromil is not a bronchodilator and, therefore, should not be used
for reversal of acute bronchospasm; has no known therapeutic systemic activity
when delivered by inhalation |
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Dosage Forms |
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Aerosol: 1.75 mg/activation (16.2 g)
Solution, ophthalmic: 2% (5 mL)
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