Cromolyn sodium

Dosage Forms & Strengths

oral concentrate

• 100mg/5mL

Mastocytosis

200 mg PO four times daily; 30 minutes prior to meals; may increase to 40 mg/kg/day if control of symptoms not seen within 2-3 weeks 

Food Allergy & Inflammatory Bowel Disease (Off-label)

200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily

Administration

Dilute contents of ampule with glass of water; stir well

For systemic mastocytosis administer 30 minutes before meals and bedtime

For food allergy and inflammatory bowel disease administer 15-20 minutes before meals

Dosage Forms & Strengths

oral concentrate

• 100mg/5mL

Mastocytosis

<2 years: Safety and efficacy not established

2-12 years: 100 mg PO four times daily; not to exceed 40 mg/kg/day; give 30 minutes AC and HS 

>12 years: As in adults; 200 mg PO four times daily; 30 minutes prior to meals; may increase to <40 mg/kg/day if control of symptoms not seen within 2-3 weeks

Food Allergy & Inflammatory Bowel Disease (Off-label)

<2 years old: Not recommended

2-12 years: 100 mg four times daily initially; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 40 mg/kg/day 

>12 years: 200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily

Administration

Dilute the contents of ampule with glass of water

For systemic mastocytosis administer 30 minutes before meals and bedtime

For food allergy and inflammatory bowel disease administer 15-20 minutes before meals

You should not use this medication if you are allergic to cromolyn sodium.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you use cromolyn sodium nasal, tell your doctor if you have:

• asthma;
• drug allergies; or
• polyps in your nose.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cromolyn sodium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Avoid getting this medication in your eyes. If this does happen, rinse with water.

• Allergy (Allergies)
• Allergy Drugs: Prescription and OTC
• Chronic Rhinitis and Post-Nasal Drip
• Eye Allergy
• Hay Fever (Allergic Rhinitis)

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• white patches or sores inside your mouth or on your lips;

• swelling of your tongue;

• trouble swallowing; or

• tight feeling in the chest.

Common side effects may include:

• headache, feeling irritable;

• nausea, diarrhea, stomach pain;

• rash, itching; or

• muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 exposure

Comments:
-This drug is a prophylactic agent to be used in patients whose symptoms are sufficiently frequent to require a continuous regimen of medications; the effect is usually evident after several weeks, although some patients show an almost immediate response.
-This drug should not be added to a therapeutic regimen during an acute episode; therapy should be started once asthma is controlled, the airway is cleared, and the patient is able to inhale adequately.

Use: For the management of bronchial asthma

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

Comment:
-Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

Use: For the management of patients with mastocytosis.

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

Comments:
-This drug is a prophylactic agent to be used in patients whose symptoms are sufficiently frequent to require a continuous regimen of medications; the effect is usually evident after several weeks, although some patients show an almost immediate response.
-This drug should not be added to a therapeutic regimen during an acute episode; therapy should be started once asthma is controlled, the airway is cleared, and the patient is able to inhale adequately.

Use: For the management of bronchial asthma

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

Comment:
-Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
-Not recommended for patients less than 2 years of age unless the potential benefits clearly outweigh the risks.

Use: For the management of patients with mastocytosis.

Mast-cell stabilizer.c

General

Asthma

• Initiate oral inhalation therapy after acute asthma has been controlled, the airway is clear, and the patient is able to inhale adequately.206 b

• When oral inhalation is added to existing therapy, initially do not change dosage of concurrent antiasthmatic agents (e.g., inhaled β2-adrenergic agonist or inhaled corticosteroid).206 b When a response to therapy is evident, gradually reduce the dosage of concurrent agents.206 b (See Concomitant Corticosteroid Therapy under Cautions.)

Administration

Administer orally or via oral inhalation.b c e Do not inject oral concentrate or use for oral inhalation therapy.c d

Administer at regular intervals.205 206 d

Oral Administration

Dilute just prior to administration; empty the contents of the ampul(s) into a glass of water and stir.203 d

Administer as a diluted solution; patient should drink all of the resultant solution.203 d

Do not mix solution with fruit juice, milk, or food.a

Administer 30 minutes before meals and at bedtime.c d

Oral Inhalation

Prime aerosol inhaler (aerosol preparation for oral inhalation no longer commercially available in US226 ) prior to first use and after a period of nonuse by pressing once (i.e., actuating) on the top of the metal canister.f

Canister should be at room temperature prior to use;205 f shake well prior to actuation.f

Patient should exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed around it.f Tilt inhaler upward and head backward and then inhale deeply through the mouth while actuating the inhaler.f Remove inhaler from the mouth, hold breath for a few seconds, and then exhale slowly.f Repeat if a second inhalation is necessary.f

Avoid spraying into the eyes.205 f

Clean inhaler by removing the canister from the inhaler and cleaning the plastic mouthpiece with warm water.f

Discard canister after the labeled number of actuations.205 f

Prevention of bronchospasm: Administer 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to another precipitating factor.205

Administer oral inhalation solution by nebulization using a power-operated nebulizer with an adequate flow rate and suitable face mask.206 g Do not use hand-operated nebulizers.a

Administer by nebulization for young children who have difficulty using the oral aerosol inhaler (no longer commercially available in US226 ).205

Safety and stability of oral inhalation solution when mixed with other drugs in the nebulizer not established.206 g

Prevention of bronchospasm: Administer 10–15 minutes before anticipated exercise or exposure to another precipitating factor.e g

Dosage

Available as cromolyn sodium; dosage expressed in terms of the salt.203 205

Unless otherwise stated, the dosage of cromolyn sodium via aerosol inhalation (aerosol preparation for oral inhalation no longer commercially available in US226 ) is expressed as the amount delivered from the mouthpiece of the inhaler per metered spray.b The oral aerosol inhaler delivers approximately 1 mg from the valve and 800 mcg per metered spray from the mouthpiece.b The 8.1- or 14.2-g canister delivers at least 112 or 200 metered sprays, respectively.b f

Pediatric Patients

Full-term neonates and infants <2 years of age†: Initially, 20 mg/kg daily in 4 divided doses.a (See Pediatric Use under Cautions.)

Children 2–12 years of age: Initially, 100 mg 4 times daily.203 d

Children ≥13 years of age: Initially, 200 mg 4 times daily.203 d

Dosage may be increased after 2–3 weeks, according to clinical response.203

Reduce dosage to minimum effective level when an adequate response is achieved.203

Children 2–14 years of age: Initially, 100 mg 4 times daily 15–20 minutes before meals has been used.a If satisfactory control of symptoms is not achieved within 2–3 weeks, may double dosage but should not exceed 40 mg/kg daily.a

Reduce dosage to minimum effective level when an adequate response is achieved.a

Children 2–14 years of age requiring occasional therapy (e.g., when avoidance of allergenic foods cannot be assured): 100 mg about 15 minutes before meal suggested.a Optimal dosage must be individualized.a

Aerosol inhalation (no longer commercially available in US226 ) in children ≥5 years of age: 1.6 mg (2 inhalations) 4 times daily.205 f Lower dosage may be effective, especially in younger patients.205 f Following stabilization, gradually reduce the frequency of administration from 4 to 3 and then 3 to 2 times (2 inhalations per dose) daily.b

Inhalation solution for nebulization in children ≥2 years of age: 20 mg 4 times daily at regular intervals.206 Following stabilization, gradually reduce the frequency of administration from 4 to 3 times daily.206

If control deteriorates at a reduced dosage (<4 doses daily), with or without concurrent agents at a reduced dosage, may need to increase the dosage of cromolyn sodium and reinitiate or increase the dosage of concurrent agent.205 206

Aerosol inhalation (no longer commercially available in US226 ) in children ≥5 years of age: 1.6 mg (2 inhalations) 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to precipitating factor.205 f

Inhalation solution for nebulization in children ≥2 years of age: 20 mg 10–15 minutes before anticipated exercise or exposure to precipitating factor.206 e g

Adults

Initially, 200 mg 4 times daily.203 Dosage may be increased after 2–3 weeks, according to clinical response.203 Reduce dosage to minimum effective level when an adequate response is achieved.203

Initially, 200 mg 4 times daily given 15–20 minutes before meals has been used.a If satisfactory control of symptoms not achieved within 2–3 weeks, may double dosage.a

Reduce dosage to minimum effective level when an adequate response is achieved.a

Adults requiring occasional therapy (e.g., when avoidance of allergenic foods cannot be assured): 200 mg about 15 minutes before meal suggested.a Optimal dosage must be individualized.a

Aerosol inhalation (no longer commercially available in US226 ): 1.6 mg (2 inhalations) 4 times daily.205 Following stabilization, gradually reduce the frequency of administration from 4 to 3 and then 3 to 2 times daily.b

Inhalation solution for nebulization: 20 mg 4 times daily.206 e Following stabilization, gradually reduce the frequency of administration from 4 to 3 times daily.206

Aerosol inhalation (no longer commercially available in US226 ): 1.6 mg (2 inhalations) 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to precipitating factor.205 b

Inhalation solution for nebulization: 20 mg 10–15 minutes before anticipated exercise or exposure to precipitating factor.206 e g

Prescribing Limits

Pediatric Patients

Infants <6 months age†: Maximum 20 mg/kg daily.203

Children ≥2 years of age: Maximum 40 mg/kg daily.203

Children ≥5 years of age: Maximum 1.6 mg 4 times daily via metered-dose aerosol (no longer commercially available in US226 ).205

Adults

Maximum 1.6 mg 4 times daily via metered-dose aerosol (no longer commercially available in US226 ).205

Special Populations

Hepatic Impairment

Reduce oral dosage.203

Reduce aerosol inhalation (no longer commercially available in US226 ) dosage.205

Renal Impairment

Reduce oral dosage.203

Reduce aerosol inhalation (no longer commercially available in US226 ) dosage.205

Geriatric Patients

Oral concentrate: Initiate dosage at the low end of the dosing range.203 (See Geriatric Use under Cautions.)

Storage

Oral

15–30°C; protect from light.203 d Store ampules in foil pouch until ready for use.203 d Do not use solution if a precipitate is present or solution becomes discolored.c d

Oral Inhalation

Aerosol (no longer commercially available in US226 ): 15–30°C.205 b Do not puncture aerosol canisters, use or store near heat or open flame, expose to temperatures >42°C, or place into fire or incinerator for disposal.b

Inhalation solution: 20–25 or 15–30°C, depending on manufacturer.206 e