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Pronunciation |
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(KROE
moe lin SOW dee
um) |
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U.S. Brand
Names |
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Crolom® Ophthalmic Solution;
Gastrocrom® Oral; Intal® Nebulizer Solution; Intal®
Oral Inhaler; Nasalcrom® Nasal Solution
[OTC] |
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Generic
Available |
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No |
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Canadian Brand
Names |
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Novo-Cromolyn; Opticrom®; PMS-Sodium
Cromoglycate; Rynacrom® |
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Synonyms |
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Cromoglycic Acid; Disodium Cromoglycate; DSCG |
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Pharmacological Index |
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Antihistamine, Inhalation; Mast Cell Stabilizer |
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Use |
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Adjunct in the prophylaxis of allergic disorders, including rhinitis, giant
papillary conjunctivitis, and asthma; inhalation product may be used for
prevention of exercise-induced bronchospasm; systemic mastocytosis, food
allergy, and treatment of inflammatory bowel disease; cromolyn is a
prophylactic drug with no benefit for acute situations |
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Pregnancy Risk
Factor |
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B |
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Pregnancy/Breast-Feeding
Implications |
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Clinical effects on the fetus: No data on whether cromolyn crosses the
placenta or clinical effects on the fetus. Available evidence suggests safe use
during pregnancy.
Breast-feeding/lactation: No data on whether cromolyn crosses into breast
milk or clinical effects on the infant |
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Contraindications |
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Hypersensitivity to cromolyn or any component; acute asthma
attacks |
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Warnings/Precautions |
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Severe anaphylactic reactions may occur rarely; cromolyn is a prophylactic
drug with no benefit for acute situations; do not use in patients with severe
renal or hepatic impairment; caution should be used when withdrawing the drug or
tapering the dose as symptoms may reoccur; use with caution in patients with a
history of cardiac arrhythmias |
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Adverse
Reactions |
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>10%:
Gastrointestinal: Unpleasant taste (inhalation aerosol)
Respiratory: Hoarseness, coughing
1% to 10%:
Dermatologic: Angioedema
Gastrointestinal: Xerostomia
Genitourinary: Dysuria
Respiratory: Sneezing, nasal congestion
<1%: Dizziness, headache, rash, urticaria, nausea, vomiting, diarrhea,
arthralgia, ocular stinging, lacrimation, wheezing, throat irritation,
eosinophilic pneumonia, pulmonary infiltrates, nasal burning, anaphylactic
reactions |
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Overdosage/Toxicology |
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Symptoms of overdose include bronchospasm, laryngeal edema,
dysuria |
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Drug
Interactions |
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Isoproterenol |
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Stability |
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Nebulizer solution is compatible with metaproterenol sulfate,
isoproterenol hydrochloride, 0.25% isoetharine hydrochloride, epinephrine
hydrochloride, terbutaline sulfate, and 20% acetylcysteine solution for at least
1 hour after their admixture; store nebulizer solution protected from direct
light |
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Mechanism of
Action |
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Prevents the mast cell release of histamine, leukotrienes and slow-reacting
substance of anaphylaxis by inhibiting degranulation after contact with
antigens |
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Pharmacodynamics/Kinetics |
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Absorption:
Inhalation: ~8% of dose reaches the lungs upon inhalation of the powder and
is well absorbed
Oral: Only 0.5% to 2% of dose absorbed
Half-life: 80-90 minutes
Time to peak serum concentration: Inhalation: Within 15 minutes
Elimination: Absorbed cromolyn is equally excreted unchanged in the urine and
the feces (via bile); small amounts are exhaled |
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Usual Dosage |
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Oral:
Systemic mastocytosis:
Neonates and preterm Infants: Not recommended
Infants and Children <2 years: 20 mg/kg/day in 4 divided doses; may
increase in patients 6 months to 2 years of age if benefits not seen after 2-3
weeks; do not exceed 30 mg/kg/day
Children 2-12 years: 100 mg 4 times/day; not to exceed 40 mg/kg/day
Children >12 years and Adults: 200 mg 4 times/day
Food allergy and inflammatory bowel disease:
Children <2 years: Not recommended
Children 2-12 years: Initial dose: 100 mg 4 times/day; may double the dose if
effect is not satisfactory within 2-3 weeks; not to exceed 40 mg/kg/day
Children >12 years and Adults: Initial dose: 200 mg 4 times/day; may
double the dose if effect is not satisfactory within 2-3 weeks; up to 400 mg 4
times/day
Once desired effect is achieved, dose may be tapered to lowest effective dose
Inhalation:
For chronic control of asthma, taper frequency to the lowest effective dose
(ie, 4 times/day to 3 times/day to twice daily):
Nebulization solution: Children >2 years and Adults: Initial: 20 mg 4
times/day; usual dose: 20 mg 3-4 times/day
Metered spray:
Children 5-12 years: Initial: 2 inhalations 4 times/day; usual dose: 1-2
inhalations 3-4 times/day
Children greater than or equal to 12 years and Adults: Initial: 2 inhalations
4 times/day; usual dose: 2-4 inhalations 3-4 times/day
Prevention of allergen- or exercise-induced bronchospasm: Administer 10-15
minutes prior to exercise or allergen exposure but no longer than 1 hour before:
Nebulization solution: Children >2 years and Adults: Single dose of 20 mg
Metered spray: Children >5 years and Adults: Single dose of 2 inhalations
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Dietary
Considerations |
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Do not mix with food, fruit juice, or milk; should be administered at least
30 minutes before meals |
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Administration |
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For oral use, cromolyn powder is dissolved in water and taken at least 30
minutes before meals |
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Monitoring
Parameters |
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Periodic pulmonary function tests |
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Mental Health: Effects
on Mental Status |
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May cause dizziness |
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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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Oral: Use as directed; do not increase dosage or discontinue abruptly without
consulting prescriber. You may experience dizziness or nervousness (use caution
when driving or engaging in tasks requiring alertness until response to drug is
known); diarrhea (boiled milk, yogurt, or buttermilk may help); or headache or
muscle pain (mild analgesic may offer relief). Report persistent insomnia; skin
rash or irritation; abdominal pain or difficulty swallowing; unusual cough,
bronchospasm, or difficulty breathing; decreased urination; or if condition
worsens or fails to improve.
Nasal: Instill 1 spray into each nostril 3-4 times a day. You may experience
unpleasant taste (rinsing mouth and frequent oral care may help); or headache
(mild analgesic may help). Report increased sneezing, burning, stinging, or
irritation inside of nose; sore throat, hoarseness, nosebleed; anaphylactic
reaction (skin rash, fever, chills, backache, difficulty breathing, chest pain);
or worsening of condition or lack of improvement.
Ophthalmic: For ophthalmic use only. Wash hands before using. Tilt head back
and look upward. Put drops of suspension or apply thin ribbon of ointment inside
lower eyelid. Close eye and roll eyeball in all directions. Do not blink for
1/2
minute. Apply gentle pressure to inner corner of eye for 30 seconds. Do not use
any other eye preparation for at least 10 minutes. Do not let tip of applicator
touch eye or contaminate tip of applicator. Do not share medication with anyone
else. Temporary stinging or blurred vision may occur. Inform prescriber if
condition worsens or fails to improve or if you experience eye pain, redness,
burning, watering, dryness, double vision, puffiness around eye, vision
disturbances, or other adverse eye response; or worsening of condition or lack
of improvement. |
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Nursing
Implications |
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Advise patient to clear as much mucus as possible before inhalation
treatments |
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Dosage Forms |
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Inhalation, oral (Intal®): 800 mcg/spray (8.1 g)
Solution, for nebulization:
10 mg/mL (2 mL)
Intal®: 10 mg/mL (2 mL)
Solution, as sodium (Gastrocrom®): 100 mg/5 mL
Solution, nasal (Nasalcrom®): 40 mg/mL (13 mL)
Solution, ophthalmic (Crolom®): 4% (2.5 mL, 10 mL)
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References |
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Ahmad S, "Cromolyn Sodium and Anaphylaxis," Ann Intern Med, 1983,
99:882.
Expert Panel Report 2,
"Guidelines for the Diagnosis and Management of Asthma," Clinical Practice
Guidelines, National Institutes of Health, National Heart, Lung, and Blood
Institute, NIH Publication No. 94-4051, April, 1997.
Hargreaves MR and Benson MK,
"Inhaled Sodium Cromoglycate in Angiotensin-Converting Enzyme Inhibitor Cough,"
Lancet, 1995, 345(8941):13-6.
Slater EF,
"Cardiac Tamponade and Peripheral Eosinophilia in a Patient Receiving Cromolyn Sodium,"
Chest, 1978, 73:838.
Walter SR, Evans ME, Richard AJ, et al,
"The Fate of Disodium Cromoglycate in Man," J Pharm Pharmacol, 1972,
24:525-31. |
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