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Cromolyn Sodium (Cromoglycate)

    Brands

    DEA Class; Rx

    Common Brand Names; Gastrocrom, Crolom, NasalCrom

    • Mast Cell Stabilizers; 
    • Mast Cell Stabilizers, Ophthalmic

    Mast-cell stabilizer; used in adult and pediatric patients 2 years and older
    Nasal spray is used for allergic rhinitis; ophthalmic solution used for allergic conjunctivitis; used orall for systemic mastocytosis
    Nebulizer solution used for asthma control or exercise-induced bronchospasm, but is not a preferred treatment

    Indicated for use as an adjunct for asthma maintenance.

    For exercise-induced bronchospasm prophylaxis or the prevention of bronchospasm induced by other known precipitating factors.
    For the management of symptoms of seasonal allergies and perennial allergies, including allergic rhinitis and allergic rhinitis prophylaxis.
    For the treatment of allergic ocular disorders such as allergic conjunctivitis, vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
    For the treatment of systemic mastocytosis.

    Hypersensitivity

    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

    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 Category: B

    Lactation: Unknown if excreted in breast milk, use caution

    Adults

    40 mg/kg/day PO; 20 mg inhaled via nebulization 4 times per day.

    Geriatric

    40 mg/kg/day PO; 20 mg inhaled via nebulization 4 times per day.

    Adolescents

    40 mg/kg/day PO; 20 mg inhaled via nebulization 4 times per day.

    Children

    2 to 12 years: 40 mg/kg/day PO; 20 mg inhaled via nebulization 4 times per day.
    1 year: Safety and efficacy have not been established; 40 mg/kg/day PO is suggested. Safety and efficacy of other routes have not been established.

    Infants

    6 to 11 months: Safety and efficacy have not been established; 40 mg/kg/day PO is suggested. Safety and efficacy of other routes have not been established.
    1 to 5 months: Safety and efficacy have not been established; 20 mg/kg/day PO is suggested. Safety and efficacy of other routes have not been established.

    Neonates

    Safety and efficacy have not been established.

    Cromolyn sodium

    oral concentrate

    • 100mg/5mL

    ophthalmic solution

    • 4% (10mL)

    nebulization solution

    • 10mg/mL (2mL/vial)

    intranasal spray

    • 5.2mg/spray