Version May 2024
Food allergy: Nalcrom [Canadian product]:
Treatment:
Initial: Oral: 200 mg 4 times daily; dose may be doubled after 2 to 3 weeks if response not adequate to a maximum daily dose of 40 mg/kg/day.
Maintenance: Oral: Once therapeutic response is achieved, the dose may be reduced to the minimum required to maintain symptom control. The optimum dose required to maintain remission is individual, but it is likely not less than 200 mg 4 times daily.
Prevention: Patients unable to avoid allergenic foods under certain circumstances (ie, restaurants, school meals): Oral: Initial: 200 mg administered 15 minutes before the meal. May adjust the dose to optimum dosage specific for each patient (maximum daily dose: 40 mg/kg/day).
Mastocytosis, systemic or cutaneous:
Initial: Oral: 200 mg (further diluted as an oral solution) 4 times daily; dose may be increased after 2 to 3 weeks if response not adequate to a maximum daily dose of 40 mg/kg/day.
Maintenance: Oral: Once therapeutic response is achieved, the dose may be reduced to the minimum required to maintain symptom control. Continue maintenance dosing to prevent relapses.
There are no specific dosage adjustments provided in the manufacturer’s labeling; however, a dose reduction is recommended (although systemic absorption following oral administration is <1%).
There are no specific dosage adjustments provided in the manufacturer’s labeling; however, a dose reduction is recommended (although systemic absorption following oral administration is <1%).
Refer to adult dosing.
(For additional information see "Cromolyn (sodium cromoglicate) (systemic): Pediatric drug information")
Systemic mastocytosis: Oral solution:
Note: In patients <2 years of age, routine use not recommended; in this age group, reserve for patients with severe disease in whom potential benefits outweigh risks.
Infants <6 months: Limited data available: Oral: 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: 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.
Children ≥2 years: Oral: 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.
Adolescents: Oral: Initial: 200 mg 4 times daily; once desired effect is achieved, dose may be tapered to lowest effective maintenance dose.
Food allergy:
Canadian labeling: Nalcrom capsule [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: Note: Recommended only for scenarios where the patient is not able to avoid allergenic foods (eg, school or restaurant meals).
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.
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 with use. In the event of anaphylaxis or an acute life-threatening hypersensitivity event (regardless of the trigger), cromolyn offers no benefit since it is has no antihistaminic, anti-inflammatory, or bronchodilator activity.
Disease-related concerns:
• Hepatic impairment: The manufacturer’s labeling states to use with caution and adjust the dosage in patients with hepatic impairment, although systemic absorption following oral administration is <1%.
• Renal impairment: The manufacturer’s labeling states to use with caution and adjust the dosage in patients with renal impairment, although systemic absorption following oral administration is <1%.
Other warnings/precautions:
• Withdrawal: Do not abruptly discontinue therapy when symptoms have been partially or completely controlled; use caution when withdrawing the drug or tapering the dose as symptoms may reoccur.
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
Concentrate (Cromolyn Sodium Oral)
100 mg/5 mL (per mL): $0.24 - $1.50
Concentrate (Gastrocrom Oral)
100 mg/5 mL (per mL): $2.65
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral, as sodium:
Nalcrom: 100 mg
Oral:
Oral capsule: Nalcrom [Canadian product]: Administer as a solution (preferred) by opening the capsule and adding capsule contents to a cup with 5 mL of very hot water to dissolve, then further dilute with 20 mL of cold water. May also swallow capsule whole. Administer 15 to 20 minutes before meals.
When using as a single preventative dose in situations where patients are unable to avoid allergenic foods (eg, restaurant), administer the dose 15 minutes prior to the meal.
Oral solution: Open ampule(s) and squeeze contents into glass of water; stir well; administer entire contents of glass on an empty stomach at least 30 minutes before meals and at bedtime.
Oral:
Oral concentrate: Open ampul and squeeze contents into a glass of water; stir well; administer entire contents of glass at least 30 minutes before meals and at bedtime.
Oral capsule: Nalcrom [Canadian product]: Administer as a solution (preferred) by opening capsule contents into a cup and adding 5 mL of very hot water to dissolve; further dilute 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.
Mastocytosis: Management of systemic or cutaneous mastocytosis.
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 (mastocytosis): 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).
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