Medically reviewed on Nov 30, 2018
(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
Food allergy: Nalcrom [Canadian product]: Treatment of food allergy in conjunction with restriction of main causative allergens
Systemic mastocytosis: Management of systemic mastocytosis
Hypersensitivity to cromolyn or any component of the formulation
Food allergy: Nalcrom [Canadian product]: Oral: Initial: 200 mg 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum of 40 mg/kg/day. Once the desired effect is achieved, taper to lowest effective dose.
Systemic mastocytosis: Oral: 200 mg 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum of 40 mg/kg/day. Once the desired effect is achieved, taper to lowest effective dose.
Refer to adult dosing.
Food allergy: Nalcrom [Canadian product]: Oral: Initial:
Children ≥2 years of age and Adolescents to ≤14 years of age: 100 mg 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum of 40 mg/kg/day. Once the desired effect is achieved, taper to lowest effective dose.
Adolescents >14 years of age: Refer to adult dosing.
Systemic mastocytosis: Oral:
Infants <6 months of age: Initial: 20 mg/kg/day in 4 divided doses; maximum daily dose: 20 mg/kg/day. Once desired effect is achieved, taper to lowest effective dose. Note: Routine use not recommended; reserve for patients with severe disease in whom potential benefits outweigh risks.
Infants ≥6 months of age and Children <2 years of age: 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 of age: Initial: 100 mg 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum of 40 mg/kg/day. Once the desired effect is achieved, taper to lowest effective dose.
Children >12 years of age 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 capsule: Nalcrom [Canadian product]: Administer as a solution (preferred) by adding 5 mL of very hot water to the capsule contents in a cup and further diluting with 20 mL of cold water. May also swallow capsule whole. Administer 15 to 20 minutes before meals.
Oral solution: Open ampule and squeeze contents into glass of water; stir well; administer entire contents of glass at least 30 minutes before meals and at bedtime.
Store at 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.
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
• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment recommended.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended.
• Appropriate use: Prophylactic drug with no benefit for acute situations.
• Withdrawal: Do not abruptly discontinue therapy; use caution when withdrawing the drug or tapering the dose as symptoms may reoccur.
Pregnancy Risk Factor
Adverse events were not observed in animal reproduction studies. 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, vomiting, insomnia, sneezing, bad taste, joint 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 health care 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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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