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Cromolyn (Systemic)



(KROE moe lin)

Index Terms

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

Dosage Forms

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

Concentrate, Oral, as sodium:

Gastrocrom: 100 mg/5 mL (5 mL)

Generic: 100 mg/5 mL (5 mL)

Concentrate, Oral, as sodium [preservative free]:

Generic: 100 mg/5 mL (5 mL)

Brand Names: U.S.

  • Gastrocrom

Pharmacologic Category

  • Mast Cell Stabilizer


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


Oral: <1% of dose absorbed


Urine and feces (equal amounts as unchanged drug)

Onset of Action

Response to treatment: Oral: May occur within 2 to 6 weeks

Half-Life Elimination

80 to 90 minutes

Use: Labeled Indications

Systemic mastocytosis


Hypersensitivity to cromolyn or any component of the formulation

Dosing: Adult

Systemic mastocytosis: Oral: 200 mg 4 times/day. If control of symptoms is not seen within 2 to 3 weeks, dose may be increased to a maximum 40 mg/kg/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Systemic mastocytosis: Oral:

Infants ≥6 months and Children <2 years: Oral: Initial: 20 mg/kg/day in 4 divided doses; maximum dose: 100 mg/dose; if control of symptoms is not observed within 2 to 3 weeks, may increase dose; maximum daily dose: 40 mg/kg/day. Once desired effect is achieved, dose may be tapered to lowest effective maintenance dose Note: Routine use not recommended; reserve for patients with severe disease in whom potential benefits outweigh risks.

Children 2 to 12 years: Oral: 100 mg 4 times/day; not to exceed 40 mg/kg/day

Children >12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

Decrease dose in patients with renal impairment.

Dosing: Hepatic Impairment

Decrease dose in patients with hepatic impairment.


Oral solution: Open ampul and squeeze contents into glass of water; stir well; administer at least 30 minutes before meals and at bedtime

Dietary Considerations

Oral: Should be taken at least 30 minutes before meals.


Store at room temperature of 15°C to 30°C (59°F to 86°F). Protect from light. Do not use oral solution if solution becomes discolored or forms a precipitate.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Cardiovascular: Chest pain, edema, flushing, palpitations, tachycardia, ventricular premature contractions

Central nervous system: Headache (5%), irritability (2%), malaise (1%), anxiety, behavioral changes, burning sensation, convulsions, depression, dizziness, dizziness (postprandial), fatigue, hallucination, hypoesthesia, insomnia, lethargy, migraine, nervousness, paresthesia, psychosis

Dermatologic: Pruritus (3%), skin rash (2%), erythema, skin photosensitivity, urticaria

Gastrointestinal: Diarrhea (5%), nausea (3%), abdominal pain (2%), constipation, dyspepsia, dysphagia, esophageal spasm, flatulence, glossitis, stomatitis, unpleasant taste, vomiting

Genitourinary: Dysuria, urinary frequency

Hematologic & oncologic: Neutropenia, pancytopenia, polycythemia, purpura

Hepatic: Abnormal hepatic function tests

Hypersensitivity: Anaphylaxis, angioedema

Neuromuscular & skeletal: Myalgia (3%), arthralgia, lower extremity weakness, lupus erythematosus, stiffness of legs

Otic: Tinnitus

Respiratory: Dyspnea, pharyngitis


Concerns related to adverse effects:

• Anaphylaxis: Severe anaphylactic reactions may occur rarely

Dosage form specific issues:

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

Other warnings/precautions:

• 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.

Pregnancy Risk Factor


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, nausea, abdominal pain, or headache. Have patient report immediately to prescriber wheezing, cough, muscle pain, muscle weakness, shortness of breath, excessive weight gain, or swelling of arms or legs (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.