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.
There are no specific dosage adjustments provided in the manufacturer’s labeling; however, a dose reduction is recommended.
There are no specific dosage adjustments provided in the manufacturer’s labeling; however, a dose reduction is recommended
(For additional information see "Cromolyn (sodium cromoglicate) (systemic): Pediatric drug information")
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 (Gal 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
Children ≥2 years and Adolescents: Consider dose reduction; specific pediatric recommendations not available.
Children ≥2 years and Adolescents: Consider dose reduction; specific pediatric recommendations not available.
Refer to adult dosing.
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)
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral, as sodium:
Nalcrom: 100 mg
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.
Oral:
Oral concentrate: Open ampul and squeeze contents into glass of water; stir well; administer at least 30 minutes before meals and at bedtime; do not mix with juice, milk, or food
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.
Food allergy: Nalcrom [Canadian product]: Treatment of food allergy in conjunction with restriction of main causative allergens
Systemic mastocytosis: Management of systemic mastocytosis
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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
Hypersensitivity to cromolyn or any component of the formulation
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.
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies. Systemic absorption following oral administration is <1%.
It is not known if cromolyn is present in breast milk; however, systemic absorption following oral administration is <1%. The manufacturer recommends that caution be exercised when administering cromolyn to breastfeeding women. The WHO considers cromolyn to be compatible with breastfeeding (WHO 2002).
Prevents the mast cell release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis by inhibiting degranulation after contact with antigens
Onset: Response to treatment: Oral: May occur within 2 to 6 weeks
Absorption: Oral: <1% of dose absorbed
Half-life elimination: 80 to 90 minutes
Excretion: Urine and feces (equal amounts as unchanged drug)
Concentrate (Cromolyn Sodium Oral)
100 mg/5 mL (per mL): $0.24 - $1.30
Concentrate (Gastrocrom Oral)
100 mg/5 mL (per mL): $2.48
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