Drug information of Cromolyn sodium

Mechanism of effect

Inhibits degranulation of sensitized mast cells. Inhibits release of mediators of type I allergic reactions, including histamine and cysteinyl leukotrienes (e.g., slow-reacting substance of anaphylaxis [SRS-A] from sensitized mast cells after exposure to antigens).

Pharmacodynamic

 May block calcium channels in mast cell membranes. No direct antihistamine, anticholinergic, antiserotonin, anti-inflammatory, bronchodilator, or corticosteroid-like properties. Following oral inhalation, acts mainly through a local effect on the lung mucosa.

Pharmacokinetics

 Cromolyn Sodium is poorly absorbed from the gastrointestinal tract. No more than 1% of an administered dose is absorbed by humans after oral administration, the remainder being excreted in the feces. Very little absorption of Cromolyn Sodium was seen after oral administration of 500 mg by mouth to each of 12 volunteers.

From 0.28 to 0.50% of the administered dose was recovered in the first 24 hours of urinary excretion in 3 subjects. The mean urinary excretion of an administered dose over 24 hours in the remaining 9 subjects was 0.45%. Response to treatment with eye drops: May be seen within a few days; treatment for up to 6 weeks is often required.

Dosage

Usual Adult Dose for Asthma - Maintenance

Administer 20 mg (1 vial) via nebulizer 4 times a day at regular intervals.

Prophylaxis of acute bronchospasm due to exercise, exposure to cold dry air, or environmental allergens: 20 mg (1 vial) via nebulizer shortly before anticipated intervals.

Usual Adult Dose for Systemic Mastocytosis

Initial dose: 200 mg (2 ampules) orally one-half hour before meals and at bedtime

-If satisfactory control is not achieved within 2 to 3 weeks, may increase dose.

Maintenance dose: May reduce dose to the minimum required to maintain adequate control once a therapeutic response has been achieved.

Maximum dose: 40 mg/kg/day

Usual Adult Dose for Allergic Conjunctivitis

Instill 1 or 2 drops into both eyes 4 to 6 times a day

Usual Adult Dose for Keratitis

Instill 1 or 2 drops into both eyes 4 to 6 times a day

Usual Adult Dose for Keratoconjunctivitis

Instill 1 or 2 drops into both eyes 4 to 6 times a day

Usual Pediatric Dose for Asthma - Maintenance

Age: 2 years or older:

Administer 20 mg (1 vial) via nebulizer 4 times a day at regular intervals

Prophylaxis of acute bronchospasm due to exercise, exposure to cold dry air, or environmental allergens: 20 mg (1 vial) via nebulizer shortly before anticipated exposure

Usual Pediatric Dose for Systemic Mastocytosis

Age: 2 to 12 years old:

Initial dose: 100 mg (1 ampule) orally one-half hour before meals and at bedtime

Age: 13 years or older:

Initial dose: 200 mg (2 ampules) orally one-half hour before meals and at bedtime

-If satisfactory control is not achieved within 2 to 3 weeks, may increase dose to no more than 40 mg/kg/day.

Maintenance dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain adequate control.

Maximum dose: 40 mg/kg/day

Usual Pediatric Dose for Allergic Conjunctivitis

Age: 4 years or older

Instill 1 or 2 drops into both eyes 4 to 6 times a day

Drug contraindications

hypersensitivity to drug or its components.

Side effects

Anxiety , Migraine , Insomnia , Diarrhea , Frequent urination , Headache , edema , nausea , chest pain , constipation , Tachycardia , Seizures , Angioedema , vertigo , urticaria , myalgia , dysphagia , dry eyes , itching , flatulence , Photosensitivity , hallucinations , stinging , skin rush , Abdominal pain , psychoses

Alerts

Anaphylaxis: Severe anaphylactic reactions may occur rarely.

Use with caution in patients with hepatic or renal impairment; dosage adjustment recommended.

Appropriate use: Prophylactic drug with no benefit for acute situations. 

Withdrawal: Caution should be used when withdrawing the drug or tapering the dose as symptoms may reoccur. 

In corticosteroid-dependent asthmatic patients receiving cromolyn sodium for several weeks, make an attempt to gradually reduce the dosage of corticosteroids even if symptomatic improvement in asthma is not observed.

Points of recommendation

To make sure cromolyn sodium inhalation is safe for you, tell your doctor if you have:

• heart disease or a heart rhythm disorder;
• coronary artery disease;
• kidney disease; or
• liver disease.

Cromolyn sodium inhalation is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether cromolyn sodium inhalation passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Cromolyn sodium inhalation is not approved for use by anyone younger than 2 years old.

Do not swallow this medicine.

To prevent bronchial asthma attacks, cromolyn sodium inhalation is usually given 4 times daily.

To prevent bronchospasm caused by exercise or environmental factors, use the medicine 10 to 15 minutes before exercise or exposure.

Follow your doctor's dosing instructions very carefully. Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of using cromolyn sodium.

You should not stop using this medicine suddenly. Stopping suddenly may make your condition worse.

Do not use cromolyn sodium if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Pregnancy level

B

Related drugs

Ketotifen , Azelastine , Alcaftadine , Lodoxamide , Emedastine , Epinastine , Antazoline