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)
Pharmacology
Mechanism of Action
Prevents the mast cell release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis by inhibiting degranulation after contact with antigens
Pharmacokinetics/Pharmacodynamics
Absorption
Oral: <1% of dose absorbed
Excretion
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
Food allergy: Nalcrom [Canadian product]: Treatment of food allergy in conjunction with restriction of main causative allergens
Systemic mastocytosis: Management of systemic mastocytosis
Contraindications
Hypersensitivity to cromolyn or any component of the formulation
Dosage and Administration
Dosing: Adult
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.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Systemic mastocytosis: Oral:
Infants <6 months: Limited data available: Note: Routine use not recommended; reserve for patients with severe disease in whom potential benefits outweigh risks: Initial: 20 mg/kg/day in 4 divided doses; maximum daily dose: 20 mg/kg/day. Once desired effect is achieved, dose may be tapered to lowest effective maintenance dose.
Infants ≥ 6 months and Children <2 years: Limited data available: Note: Routine use not recommended; reserve for patients with severe disease in whom potential benefits outweigh risks: 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.
Children 2 to 12 years: Initial: 100 mg 4 times daily; Maximum daily dose: 40 mg/kg/day; once desired effect is achieved, dose may be tapered to lowest effective maintenance dose
Children >12 years and Adolescents: Initial: 200 mg 4 times daily; maximum daily dose: 40 mg/kg/day; once desired effect is achieved, dose may be tapered to lowest effective maintenance dose
Food allergy: Limited data available (Kliegman 2007):
Children 2 to 12 years: Initial dose: 100 mg 4 times daily; may double the dose if effect is not satisfactory within 2 to 3 weeks; not to exceed 40 mg/kg/day; once desired effect is achieved, dose may be tapered to lowest effective maintenance dose
Children >12 years and Adolescents: Initial dose: 200 mg 4 times daily; may double the dose if effect is not satisfactory within 2 to 3 weeks; up to 400 mg 4 times daily; once desired effect is achieved, dose may be tapered to lowest effective maintenance dose
Canadian labeling: Nalcrom [Canadian product]:
Treatment:
Children ≥2 years and Adolescents ≤14 years: Oral: Initial: 100 mg 4 times daily; may double the dose if effect is not satisfactory within 2 to 3 weeks; maximum daily dose: 40 mg/kg/day; once the desired effect is achieved, dose may be tapered to lowest effective maintenance dose
Adolescents >14 years: Oral: Initial: 200 mg 4 times daily; may double the dose if effect is not satisfactory within 2 to 3 weeks; maximum daily dose: 40 mg/kg/day; once the desired effect is achieved, dose may be tapered to lowest effective maintenance dose
Prevention:
Children ≥2 years and Adolescents ≤14 years: Oral: 100 mg once; give 15 minutes before the meal
Adolescents >14 years: Oral: 200 mg once; give 15 minutes before the meal
Administration
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.
Storage
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.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
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
Warnings/Precautions
Concerns related to adverse effects:
- Anaphylaxis: Severe anaphylactic reactions may occur rarely
Disease-related concerns:
- 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.
Other warnings/precautions:
- 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
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies. Systemic absorption following oral administration is <1%.
Patient Education
What is this drug used for?
- It is used to treat mastocytosis.
- It is used to treat food allergies.
- It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
- Diarrhea
- Nausea
- Vomiting
- Trouble sleeping
- Sneezing
- Bad taste
- Joint pain
- Headache
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Wheezing
- Cough
- Muscle pain
- Muscle weakness
- Shortness of breath
- Excessive weight gain
- Swelling of arms or legs
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
