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Cromolyn Sodium
Pronunciation
U.S. Brand Names
Generic Available
Canadian Brand Names
Synonyms
Pharmacological Index
Use
Pregnancy Risk Factor
Pregnancy/Breast-Feeding Implications
Contraindications
Warnings/Precautions
Adverse Reactions
Overdosage/Toxicology
Drug Interactions
Stability
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Dietary Considerations
Administration
Monitoring Parameters
Mental Health: Effects on Mental Status
Mental Health: Effects on Psychiatric Treatment
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Nursing Implications
Dosage Forms
References

Pronunciation
(KROE moe lin SOW dee um)

U.S. Brand Names
Crolom® Ophthalmic Solution; Gastrocrom® Oral; Intal® Nebulizer Solution; Intal® Oral Inhaler; Nasalcrom® Nasal Solution [OTC]

Generic Available

No


Canadian Brand Names
Novo-Cromolyn; Opticrom®; PMS-Sodium Cromoglycate; Rynacrom®

Synonyms
Cromoglycic Acid; Disodium Cromoglycate; DSCG

Pharmacological Index

Antihistamine, Inhalation; Mast Cell Stabilizer


Use

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


Pregnancy Risk Factor

B


Pregnancy/Breast-Feeding Implications

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


Contraindications

Hypersensitivity to cromolyn or any component; acute asthma attacks


Warnings/Precautions

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


Adverse Reactions

>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


Overdosage/Toxicology

Symptoms of overdose include bronchospasm, laryngeal edema, dysuria


Drug Interactions

Isoproterenol


Stability

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


Mechanism of Action

Prevents the mast cell release of histamine, leukotrienes and slow-reacting substance of anaphylaxis by inhibiting degranulation after contact with antigens


Pharmacodynamics/Kinetics

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


Usual Dosage

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


Dietary Considerations

Do not mix with food, fruit juice, or milk; should be administered at least 30 minutes before meals


Administration

For oral use, cromolyn powder is dissolved in water and taken at least 30 minutes before meals


Monitoring Parameters

Periodic pulmonary function tests


Mental Health: Effects on Mental Status

May cause dizziness


Mental Health: Effects on Psychiatric Treatment

None reported


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

No effects or complications reported


Patient Information

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.


Nursing Implications

Advise patient to clear as much mucus as possible before inhalation treatments


Dosage Forms

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)


References

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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