Dosing & Uses
Dosage Forms & Strengths
oral concentrate
- 100mg/5mL
Mastocytosis
200 mg PO four times daily; 30 minutes prior to meals; may increase to 40 mg/kg/day if control of symptoms not seen within 2-3 weeks
Food Allergy & Inflammatory Bowel Disease (Off-label)
200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily
Administration
Dilute contents of ampule with glass of water; stir well
For systemic mastocytosis administer 30 minutes before meals and bedtime
For food allergy and inflammatory bowel disease administer 15-20 minutes before meals
Dosage Forms & Strengths
oral concentrate
- 100mg/5mL
Mastocytosis
<2 years: Safety and efficacy not established
2-12 years: 100 mg PO four times daily; not to exceed 40 mg/kg/day; give 30 minutes AC and HS
>12 years: As in adults; 200 mg PO four times daily; 30 minutes prior to meals; may increase to <40 mg/kg/day if control of symptoms not seen within 2-3 weeks
Food Allergy & Inflammatory Bowel Disease (Off-label)
<2 years old: Not recommended
2-12 years: 100 mg four times daily initially; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 40 mg/kg/day
>12 years: 200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily
Administration
Dilute the contents of ampule with glass of water
For systemic mastocytosis administer 30 minutes before meals and bedtime
For food allergy and inflammatory bowel disease administer 15-20 minutes before meals
Adverse Effects
Frequency Not Defined
Diarrhea
Headache
Angioedema
Premature ventricular contractions
Hypoesthesia
Lightheadedness
Flushing
Palpitation
Erythema
Postprandial
Photosensitivity
Behavior changes
Psychosis
Esophagospasm
Nausea
Abdominal pain
Pancytopenia
Polycythemia
Stomatitis
Neutropenia
Rash
Pruritus
Warnings
Contraindications
Hypersensitivity
Cautions
Severe anaphylactic reactions may occur (rare)
Excreted through biliary and renal routes; monitor closely patients with hepatic/renal insufficiency; decrease dose in patients with impaired renal or hepatic function
Use caution in patients with history of cardiac arrhythmia and hepatic or renal impairment
Oral concentrated solution should not be used for inhalation or injection
Not beneficial in the acute setting
Symptoms may reoccur when tapering or withdrawing the drug; use caution
Pregnancy & Lactation
Pregnancy Category: B
Lactation: Unknown if excreted in breast milk, use caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Mast cell stabilizer; inhibits release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis from mast cell by inhibiting degranulation following exposure to reactive antigens
Pharmacokinetics
Bioavailability: 0.5-2%
Peak plasma time: 15 min
Peak plasma concentration: 9 ng/mL
Half-life: 80-90 min
Onset: 2-6 weeks (PO)
Duration: 6 hr
Excretion: Feces (98%, unabsorbed drugs); urine (<0.5%)
Images
Patient Handout
Formulary
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