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Cromolyn (Oral Inhalation)

Pronunciation

Pronunciation

(KROE moe lin)

Index Terms

  • Cromoglicate
  • Cromoglycic Acid
  • Cromolyn Sodium
  • Disodium Cromoglycate
  • DSCG
  • Intal
  • Sodium Cromoglicate
  • Sodium Cromoglycate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Nebulization Solution, Inhalation, as sodium:

Generic: 20 mg/2 mL (2 mL)

Pharmacologic Category

  • Mast Cell Stabilizer

Pharmacology

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

Absorption

Inhalation: ~8% reaches lungs upon inhalation; well absorbed

Excretion

Equally excreted unchanged in urine and feces (via bile); after inhalation, small amounts are exhaled

Time to Peak

Serum: Inhalation: ~15 minutes

Half-Life Elimination

80 to 90 minutes

Use: Labeled Indications

Prophylactic agent used for long-term (chronic) control of asthma; prevention of exercise-induced bronchospasm

Contraindications

Hypersensitivity to cromolyn or any component of the formulation

Dosing: Adult

Asthma: Nebulization solution: Initial: 20 mg 4 times/day; usual dose: 20 mg 3 to 4 times/day

Note: For chronic control of asthma, taper frequency to the lowest effective dose (ie, 4 times/day to 3 times/day to twice daily). Not effective for immediate relief of symptoms in acute asthmatic attacks; must be used at regular intervals for 2 to 4 weeks to be effective.

Prophylaxis of bronchospasm (allergen- or exercise-induced): Nebulization solution: 20 mg (single dose), administer 10 to 15 minutes prior to exercise or allergen exposure

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Asthma: Children >2 years and Adolescents: Refer to adult dosing.

Prevention of allergen- or exercise-induced bronchospasm: Children >2 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Administration

Oral inhalation: Squeeze contents of the unit-dose vial into the solution container of nebulizer. Nebulization should take approximately 5 to 10 minutes.

Compatibility

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.

Storage

Store at room temperature of 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not always defined.

Central nervous system: Drowsiness

Dermatologic: Burning sensation of the nose, pruritus of nose

Gastrointestinal: Nausea, stomach pain

Hypersensitivity: Serum sickness

Respiratory: Cough (20%; transient), wheezing (4%; mild), epistaxis, nasal congestion, sneezing

<1% (Limited to important or life-threatening): Anaphylaxis, anemia, dysuria, exfoliative dermatitis, hemoptysis, hoarseness, lacrimation, laryngeal edema, nephrosis, myalgia, parotid gland enlargement, vasculitis (periarteritis), pericarditis, peripheral neuritis, photodermatitis, polymyositis, pulmonary infiltrates (with eosinophilia), vasculitis (periarteritis)

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Severe anaphylactic reactions may occur rarely

• Bronchospasm: May occur with cough after inhalation; if this occurs, treat with a fast-acting bronchodilator.

Disease-related concerns:

• Asthma: Not to be used in the treatment of status asthmaticus.

Other warnings/precautions:

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

Monitoring Parameters

Periodic pulmonary function tests

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. No data available on whether cromolyn crosses the placenta or clinical effects on the fetus. Available evidence suggests safe use during pregnancy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, headache, sneezing, or bad taste. Have patient report immediately to prescriber difficulty breathing or persistent cough (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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