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|Cromolyn Sodium Disodium Cromoglycate

Cromolyn Sodium

Trade Names:
Crolom
- Solution, ophthalmic 4%

Trade Names:
Gastrocrom
- Oral concentrate 100 mg per 5 mL

Trade Names:
Intal
- Solution 20 mg/amp (for nebulizer only)
- Aerosol spray 800 mcg/actuation

Trade Names:
Nasalcrom
- Nasal solution 40 mg/mL (each actuation delivers 5.2 mg)

Mechanism of Action

Pharmacology

Stabilizes mast cells, which release histamine and other mediators of allergic reactions.

Pharmacokinetics

Absorption

8% absorbed from the lungs.

Up to 1% absorbed.

Elimination

After 8% is absorbed from the lung, it is rapidly excreted unchanged in bile and urine. The remainder is either exhaled or swallowed and excreted via the alimentary tract.

0.28% to 0.5% of the dose is excreted in the urine.

Indications and Usage

Prophylaxis of severe bronchial asthma; prevention of exercise-induced asthma; prevention of acute bronchospasm induced by environmental pollutants and known antigens.

Prevention and treatment of allergic rhinitis.

Treatment of mastocytosis.

Treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

Unlabeled Uses

Symptoms of food allergies; eczema; dermatitis; ulceration; urticaria pigmentosa; chronic urticaria; hay fever; and postexercise bronchospasm.

Contraindications

Standard considerations.

Dosage and Administration

Nebulization Initially 20 mg inhaled qid at regular intervals.

Aerosol 2 metered sprays (1600 mcg) inhaled qid at regular intervals.

2 metered dose sprays or 20 mg via inhaled capsule or nebulizer (10 to 15 min but no longer than 60 min) before exposure to precipitating factor.

Nasal solution with spray device Begin treatment prior to contact with allergen and continue throughout exposure period. One spray (5.2 mg) in each nostril 3 to 6 times/day at regular intervals.

PO 200 mg qid 30 min before meals and at bedtime.

PO 100 mg qid 30 min before meals and at bedtime (max, 40 mg/kg/day). Dosage maintenance levels are decreased gradually, except with major complication. Abrupt withdrawal may result in increased asthma symptoms.

PO 20 mg/kg/day in 4 divided doses (max, 20 mg/kg/day).

Not recommended.

Solution 1 or 2 drops in each eye 4 to 6 times/day at regular intervals.

General Advice

• Use spacer (eg, Aero chamber) to enhance delivery of drug.

• Do not administer during acute asthmatic attack.

• Clear patient"s nasal passages before administering spray. Have patient inhale medication through nose.
• Hold container upright. Use pumping motion to force solution mist into nasal passages.

• Instruct patient to close eyes during inhalation to prevent accidental contact with eyes.
• If bronchodilating inhalant is also prescribed, give bronchodilator 5 to 15 min before cromolyn to enhance drug delivery.

• The effectiveness of cromolyn therapy is dependent on its administration at regular intervals, as directed.

• Open and dissolve capsule contents completely in 1/ 2 glass of hot water. While stirring, add equal amount of cold water. Administer all of liquid. Do not mix with juice, milk, or foods.
• Do not use oral capsules for inhalation.

Storage/Stability

Store away from heat and direct sunlight. Protect from freezing. Do not puncture, break or burn container.

Store in tight, light-resistant container. Avoid storing in moist environment (eg, bathroom).

Store in airtight, light-resistant container.

Store in airtight, light-resistant container at room temperature (59° to 86°F).

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Dizziness; headache.

Dermatologic

Rash; urticaria; angioedema.

EENT

Lacrimation; nasal stinging, burning, or irritation; sneezing; nasal congestion; bad taste; swollen parotid gland; dry or irritated throat.

GI

Nausea; substernal burning; diarrhea (oral form).

Genitourinary

Dysuria; urinary frequency.

Ophthalmic

Stinging; burning; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; styes.

Respiratory

Cough; wheezing; bronchospasm.

Miscellaneous

Joint pain and swelling.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established in children less than 5 yr.

Safety and efficacy not established in children less than 2 yr.

Do not use in children less than 2 yr unless directed by health care provider.

In term infants up to 6 mo, data suggest the dose not exceed 20 mg/kg/day. Reserve use in children less than 2 yr for patients with severe disease in which potential benefits clearly outweigh risks.

Hypersensitivity

Severe anaphylactic reactions may occur.

Renal Function

Decreased dose is recommended.

Hepatic Function

Decreased dose is recommended.

Acute asthma

Do not use for acute asthma attack. Effects depend on regular administration.

Aerosol

Use with caution in patients with coronary artery disease or cardiac arrhythmias because of propellants in this preparation.

Bronchospasm

Cough or bronchospasm may follow inhalation.

Eosinophilic pneumonia

If signs of this condition occur, therapy will need to be discontinued.

Patient Information

• Explain that cromolyn is used for prevention, not treatment, of acute asthma attacks.
• Give patient clear instructions about what to do during an acute asthma attack.
• Teach patient correct use of administration device (see instructions in package). Have patient demonstrate its use.
• Emphasize that inhalation capsules are not to be swallowed.
• Explain that oral capsules are oversized to prevent powder from spilling when capsule is opened. Remind patient to dissolve powder in water only and to drink entire contents of solution.
• Advise patient to minimize exposure to known allergens or precipitating factors.
• Instruct patient with cold- or exercise-induced asthma to use medication at least 10 to 15 min before exposure but no longer than 1 hr.
• Advise patient to rinse mouth or gargle after oral inhalation to prevent throat irritation.
• If patient is taking concurrent bronchodilators or corticosteroids, stress importance of not discontinuing abruptly, particularly systemic corticosteroids.
• Advise patient that effectiveness of therapy is dependent on administration at regular intervals. Maximum effectiveness may take 4 wk.
• Caution patient not to discontinue abruptly unless advised by health care provider.
• Instruct patient to report the following symptoms to health care provider: increased difficulty in breathing, increased wheezing, difficulty in swallowing, joint pain or swelling, severe headache.
• Advise patient to not wear contact lenses while using cromolyn ophthalmic solution.