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Cromolyn sodium
(Sodium cromoglycate)
Cromolyn sodium (Intal)
Sodium cromoglycate (Intal)
Cromolyn sodium
(CROH-moh-lin)
Pregnancy Category: B Apo-Cromolyn Gastrocrom Gen-Cromoglycate Sterinebs Intal Nalcrom Nasalcrom Novo-Cromolyn Opticrom PMS-Sodium Chromoglycate Rynacrom Vistacrom (OTC) and (Rx)

Classification: Antiasthmatic, antiallergic drug

Action/Kinetics: Acts locally to inhibit the degranulation of sensitized mast cells that occurs after exposure to certain antigens. Prevents the release of histamine, slow-reacting substance of anaphylaxis, and other endogenous substances causing hypersensitivity reactions. When effective, reduces the number and intensity of asthmatic attacks as well as decreasing allergic reactions in the eye. No antihistaminic, anti-inflammatory, or bronchodilator effects and has no role in terminating an acute attack of asthma. After inhalation, some drug is absorbed systemically. t1/2: 81 min; from lungs: 60 min. About 50% excreted unchanged through the urine and 50% through the bile. When used in the eye, approximately 0.03% is absorbed. Onset, ophthalmic: Several days. Onset, nasal: Less than 1 week. Time to peak effect, nasal: Up to 4 weeks.

Uses: Inhalation: Prophylactic and adjunct in the management of bronchial asthma in clients who have a significant bronchodilator-reversible component to their airway obstruction. Prophylaxis of exercise-induced bronchospasms and bronchospasms due to allergens, cold dry air, or environmental pollutants. Nasal, OTC: Prophylaxis and treatment of allergic rhinitis. PO: Mastocytosis (improves symptoms including diarrhea, flushing, headaches, vomiting, urticaria, nausea, abdominal pain, and itching). Investigational: PO to treat food allergies. Ulcerative colitis, proctitis, urticaria, post-exercise bronchospasm.

Contraindications: Hypersensitivity. Acute attacks and status asthmaticus. For mastocytosis in premature infants. Use of nasal product in children less than 6 years of age.

Special Concerns: Safety and efficacy have not been established for the aerosol in children less than 5 years of age and for the nebulizer in children less than 2 years of age. Reserve use in children less than 2 years of age to severe disease in which potential benefits clearly outweigh potential risks. Due to the propellants in the aerosol, use with caution in coronary artery disease or cardiac arrhythmias. Use with caution for long periods of time, in the presence of renal or hepatic disease, and during lactation.

Side Effects: Respiratory: Bronchospasm (may be severe and associated with a precipitous fall in pulmonary function), laryngeal edema (rare) cough, eosinophilic pneumonia, pharyngeal irritation, nasal congestion, wheezing, nasal stinging or sneezing. CNS: Dizziness, drowsiness, headache. Allergic: Urticaria, rash, angioedema, serum sickness, anaphylaxis. Other: Nausea, urinary frequency, dysuria, joint swelling and pain, lacrimation, swollen parotid gland.
Following nebulization: Sneezing, wheezing, nasal itching, cough, nose bleeds, burning, nasal congestion, nausea, drowsiness, serum sickness, stomach ache. Following aerosol: Lacrimation, swollen parotid gland, dysuria, urinary frequency, dizziness, headache, rash, urticaria, angioedema, joint swelling and pain, nausea, dry or irritated throat, bad taste, cough, wheezing, substernal burning, myopathy (rare). Following nasal solution: Burning, stinging, irritation of nose; sneezing, nose bleeds, headache, bad taste in mouth, postnasal drip, rash.

How Supplied: Oral Concentrate: 100 mg/5 mL; Metered dose inhaler: 0.8 mg/inh; Solution for Nebulization: 10 mg/mL; Nasal spray: 5.2 mg/inh

Dosage
•Nebulizer solution Prophylaxis of bronchial asthma.
Adults and children over 2 years of age, initial: 20 mg inhaled q.i.d. at regular intervals.
Prophylaxis of exercise-induced bronchospasm.
Inhale 20 mg of the nebulizer solution no more than 1 hr (the shorter the interval between the dose and exercise, the better the effect) before anticipated exercise. Repeat as required for protection during prolonged exercise.
•Aerosol Management of bronchial asthma.
Adults and children 5 years and older, initial: 2 metered sprays inhaled q.i.d. at regular intervals. Do not exceed this dose.
Prophylaxis of exercise-induced bronchospasm.
Inhalation of 2 metered dose sprays 10-15 min (but not more than 60 min) before exposure to precipitating factor.
•Nasal Solution Allergic rhinitis.
Adults and children 6 years and older: 1 spray in each nostril 3-6 times/day at regular intervals q 4-6 hr. Maximum effect may not be seen for 1-2 weeks.
•Oral Concentrate Mastocytosis.
Adults and children 13 years and older: 200 mg (i.e., 2 ampules) q.i.d. 30 min before meals and at bedtime. Pediatric, 2-12 years: 100 mg (i.e., 1 ampule) q.i.d. 30 min before meals and at bedtime. If relief is not seen within 2-3 weeks, dose may be increased, but should not exceed 40 mg/kg/day. Maintenance: Reduce dose to minimum amount to maintain client with minimum symptoms.