(KROE moe lin)
- Cromoglycic Acid
- Cromolyn Sodium
- Disodium Cromoglycate
- Sodium Cromoglicate
- Sodium Cromoglycate
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.
- 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
80 to 90 minutes
Use: Labeled Indications
Hypersensitivity to cromolyn or any component of the formulation
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
Refer to adult dosing.
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
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.
There are no known significant interactions.
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
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.
• 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
Adverse events were not observed in animal reproduction studies following oral administration. Systemic absorption following oral administration is <1%.
• 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.
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- Drug class: mast cell stabilizers
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