Adult Dosing

Mastocytosis

• 200 mg PO qid, give 30 minutes before meals and at bedtime; may increase if insufficient response within 2-3 wks
• Max 40 mg/kg/day; maintain at lowest effective dose

Food allergy [Non FDA Approved]

• 200 mg PO qid, give 15-20 minutes before meals; if satisfactory control of symptoms is not achieved within 2-3 wks, the dose may be doubled

Inflammatory Bowel Disease [Non FDA Approved]

• 200 mg PO qid; give 15-20 minutes before meals
• Maintenance: 200 mg PO qid; maintain at lowest effective dose

Note:

• Mix contents of amp in water and drink

Pediatric Dosing

Mastocytosis

Children 2-12 yrs

• 100 mg PO qid, give 30 minutes before meals and at bedtime; may increase if insufficient response within 2-3 wks
• Max 40 mg/kg/day; maintain at lowest effective dose

Children 13 yrs

• 200 mg PO qid, give 30 minutes before meals and at bedtime; may increase if insufficient response within 2-3 wks
• Max 40 mg/kg/day; maintain at lowest effective dose

Food allergy [Non FDA Approved]

Children 2-14 yrs

• 100 mg PO qid, give 15-20 minutes before meals. If satisfactory control of symptoms is not achieved within 2-3 wks, the dose may be doubled
• MAX: 40 mg/kg/day; maintain at lowest effective dose

Inflammatory Bowel Disease [Non FDA Approved]

Children 2-14 yrs

• 100 mg qid, give 15-20 minutes before meals
• Maintenance: 100 mg PO qid; maintain at lowest effective dose

Note:

• Mix contents of amp in water and drink
• Safety and effectiveness in pediatric patients <2 yrs of age have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of patients with mastocytosis

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Decrease dose; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Decrease dose; dose adjustments not defined

See Supplemental Patient Information

• Dose should be reduced in patients with renal or hepatic dysfunction
• Severe anaphylactic reactions may occur with cromolyn sodium administration

Cautions: Use with caution in

• Renal impairment
• Hepatic impairment
• Arrhythmias

Supplemental Patient Information

• Do not mix cromolyn with fruit juice, milk, or food

Pregnancy Category:B

Breastfeeding: Safety unknown. Although no published data exist on the use of cromolyn during lactation, maternal milk levels are likely to be very low and it is expected to be poorly absorbed from the infant's GIT. An expert panel considers use of cromolyn to be acceptable during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 January 2010). Manufacturer advises caution when administering to a nursing woman.

• CNS: Headache
• GI: Diarrhea, nausea, abdominal pain, bitter taste
• DERM: Pruritus, rash
• MUSC: Myalgia
• RESP: Bronchospasm, wheezing, cough
• EENT: Dry throat, throat irritation
• MISC: Irritability, malaise
• HYPERSENSITIVITY: Anaphylaxis

• Mast cell stabilizer; inhibits the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from sensitized mast cells
• Absorption: <1% systemic absorption on oral administration
• Excretion: Primarily feces; urine <1%
• Half-life: Unknown

US Trade Name(s)

• Gastrocrom

US Availability

cromolyn (generic)

• CONC: 100 mg/5 mL

Gastrocrom

• CONC: 100 mg/5 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Pulmonary

Mast Cell Stabilizers

Allergy & Immunology

Mast Cell Stabilizers

Pricing data from www.DrugStore.com in U.S.A.

• Gastrocrom 100 MG/5ML CONC [Ampule] (AZUR PHARMA)
  5 5ml = $22.49
  10 5ml = $28.71

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.