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  • CLASSES

    Ocular Anti-Allergics, Mast Cell Stabilizers
    Respiratory Mast Cell Stabilizers
    Systemic Mast Cell Stabilizers
    Topical Nasal Antiallergic Agents

    DEA CLASS

    Rx, OTC

    DESCRIPTION

    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

    COMMON BRAND NAMES

    Crolom, Gastrocrom, Intal, Nasalcrom, Opticrom

    HOW SUPPLIED

    Crolom/Cromolyn/Cromolyn Sodium/Opticrom Ophthalmic Sol: 4%
    Cromolyn/Cromolyn Sodium/Gastrocrom Oral Sol: 5mL, 100mg
    Cromolyn/Cromolyn Sodium/Intal Respiratory (Inhalation) Sol: 2mL, 20mg
    Nasalcrom Nasal Spray Met: 1actuation, 5.2mg

    DOSAGE & INDICATIONS

    For use as an adjunct for asthma maintenance.
    Nebulized Inhalation dosage (solution for nebulization)
    Adults

    Inhale 20 mg via nebulizer 4 times per day at regular intervals. A 4 to 6-week trial may be necessary to determine maximum benefit. Once stabilized, reduce to the lowest effective dose. The usual decrease is from 4 to 3 times per day. Not recommended for routine use in asthma management due to low efficacy.

    Children and Adolescents 2 years and older

    Inhale 20 mg via nebulizer 4 times per day at regular intervals. A 4 to 6-week trial may be necessary to determine maximum benefit. Once stabilized, reduce to the lowest effective dose. The usual decrease is from 4 to 3 times per day. Not recommended for routine use in asthma management due to low efficacy.

    For exercise-induced bronchospasm prophylaxis or the prevention of bronchospasm induced by other known precipitating factors.
    Oral inhalation dosage (nebulized solution)
    Adults

    Inhale 20 mg via nebulization not more than 1 hour before anticipated exercise or exposure to other precipitating factors. Effective prophylaxis lasts approximately 1 to 2 hours. For maximum effect, the interval between administration of cromolyn and exposure to the precipitating factor should be as short as possible. The American Thoracic Society states that a mast cell stabilizing agent such as cromolyn before exercise may be considered in patients who continue to have symptoms despite using an inhaled short-acting beta-2 agonist (SABA) before exercise, or in those who require daily (or more frequent) SABA use. In clinical practice, inhaled corticosteroids or leukotriene receptor antagonists are usually the first-line therapies to be used with SABAs for EIB control.

    Children and Adolescents 2 years and older

    Inhale 20 mg via nebulization not more than 1 hour before anticipated exercise or exposure to other precipitating factors. Effective prophylaxis lasts approximately 1 to 2 hours. For maximum effect, the interval between administration of cromolyn and exposure to the precipitating factor should be as short as possible. The American Thoracic Society states that a mast cell stabilizing agent such as cromolyn before exercise may be considered in patients who continue to have symptoms despite using an inhaled short-acting beta-2 agonist (SABA) before exercise, or in those who require daily (or more frequent) SABA use. In clinical practice, inhaled corticosteroids or leukotriene receptor antagonists are usually the first-line therapies to be used with SABAs for EIB control.

    For the management of symptoms of seasonal allergies and perennial allergies, including allergic rhinitis and allergic rhinitis prophylaxis.
    Nasal dosage (metered spray, e.g., Nasalcrom)
    Adults

    1 spray (5.2 mg/spray) in each nostril 3 to 4 times per day; may be increased to 6 times a day if needed. Best if initiated 1 full week before coming into contact with allergens and used every day while in contact with the cause of the allergies (pollen, molds, pets, and dust).

    Children and Adolescents 2 years and older

    1 spray (5.2 mg/spray) in each nostril 3 to 4 times per day; may be increased to 6 times a day if needed. Best if initiated 1 full week before coming into contact with allergens and used every day while in contact with the cause of the allergies (pollen, molds, pets, and dust).

    For the treatment of allergic ocular disorders such as allergic conjunctivitis, vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
    Ophthalmic dosage
    Adults, Adolescents, and Children 4 years and older

    1 to 2 drops in each eye 4 to 6 times per day at regular intervals. Each drop contains 1.6 mg cromolyn sodium.

    For the treatment of systemic mastocytosis.
    Oral dosage (e.g., Gastrocrom oral solution)
    Adults

    200 mg PO 4 times per day, 30 minutes before meals and at bedtime. If satisfactory control of symptoms is not achieved within 2 to 3 weeks, the dosage may be increased. Max: 40 mg/kg/day PO.

    Adolescents

    200 mg PO 4 times per day, 30 minutes before meals and at bedtime. If satisfactory control of symptoms is not achieved within 2 to 3 weeks, the dosage may be increased. Max: 40 mg/kg/day PO.

    Children 2 to 12 years

    100 mg PO 4 times per day, 30 minutes before meals and at bedtime. If satisfactory control of symptoms is not achieved within 2 to 3 weeks, the dosage may be increased. Max: 40 mg/kg/day PO.

    Infants and Children up to 2 years†

    Safety and efficacy have not been established; some clinical data are available. 20 mg/kg/day PO, given in 4 divided doses. May increase after 2 to 3 weeks if symptoms not controlled. Max for those 6 months and older: 40 mg/kg/day PO. Max for term infants up to 6 months: 20 mg/kg/day PO. Reserve use for those under 2 years of age with severe disease for whom the potential benefit clearly outweighs the risks.

    MAXIMUM DOSAGE

    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.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Oral dosage form: The recommended dosage should be decreased in patients with decreased hepatic function, but no specific recommendations are available.
    Inhaled, nasal, or ophthalmic dosage forms: No dosage adjustments are needed due to minimal systemic absorption.

    Renal Impairment

    Oral dosage form: The recommended dosage should be decreased in patients with decreased renal function, but no specific recommendations are available.
    Inhaled, nasal, or ophthalmic dosage forms: No dosage adjustments are needed due to minimal systemic absorption.

    ADMINISTRATION

    Oral Administration
    Oral Liquid Formulations

    Oral concentrate solution (e.g., Gastrocrom)
    The oral ampules of Gastrocrom are for preparation of an oral solution only. Do not use for inhalation or injection.
    Preparation and Administration
    Empty the appropriate amount of the ampule(s) into a half glass of water. Stir solution. Do not mix the oral concentrate solution with fruit juice, milk, or food.
    Administer the entire dosage immediately after solution preparation.
    Dosages should be administered at regular intervals at least 30 minutes before meals and at bedtime.

    Inhalation Administration
    Oral Inhalation Administration

    Instruct patient on proper inhalation technique.
     
    Inhalation solution for nebulization
    Use a power-operated nebulizer with a flow rate of at least 6 to 8 L/minute and equipped with suitable face mask or mouthpiece. Hand-operated nebulizers are NOT appropriate for administration of cromolyn solution for inhalation.
    The choice of using a mouthpiece versus a face mask must be made based on the skills and understanding of each individual patient.
    Using the 'blow-by' technique (i.e. holding the face mask or open tube near the patient's nose and mouth) is not recommended.
    INCOMPATABILITY: Ipratropium inhalation solutions form a precipitate with cromolyn sodium inhalation solution if mixed in a nebulizer.

    Intranasal Inhalation Administration

    Nasal spray (Nasalcrom):
    Instruct patient on proper inhalation technique.
    Prime inhaler prior to use.
    The nasal spray for intranasal administration delivers 5.2 mg/spray.
    To avoid the spread of infection, do not use the container for more than one person.

    Ophthalmic Administration

    Crolom, Cromoptic, and Opticrom are for ophthalmic use only.
    Instruct patient on appropriate instillation technique.
    Do not to touch the tip of the dropper to the eye, fingertips, or other surface.

    STORAGE

    Crolom:
    - Protect from light
    - Store between 59 to 77 degrees F
    - Store in original container
    Gastrocrom:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    - Store unused product in foil pouch
    Intal:
    - After opening the foil pouch, store unused product in the foil pouch to protect it from light
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Nasalcrom:
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Opticrom:
    - Protect from light
    - Store between 59 to 77 degrees F
    - Store in original container

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Cromolyn sodium products are contraindicated in those patients who have shown hypersensitivity to cromolyn sodium. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium use.

    Acute bronchospasm, status asthmaticus

    The activity of cromolyn sodium acts to prevent asthma symptoms in select patients. It is not a bronchodilator; do not prescribe cromolyn for the treatment of acute bronchospasm; this drug has no role in the treatment of status asthmaticus.

    Hepatic disease, renal failure, renal impairment

    A reduction in the recommended dosage of oral cromolyn sodium should be considered in patients with hepatic disease or renal impairment/renal failure, given the biliary and renal routes of excretion of the drug. However, definitive recommendations for dosage reduction are not provided in the product label.

    Contact lenses

    Patients should not wear contact lenses during treatment with cromolyn sodium ophthalmic solution. In general, users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. Additionally, cromolyn sodium ophthalmic solution contains benzalkonium chloride as a preservative, which can be absorbed by soft contact lenses.

    Pregnancy

    Cromolyn sodium may be used with caution during pregnancy due to low systemic absorption from the various administration routes. Animal studies have not shown adverse effects on the fetus when cromolyn was administered alone. Cromolyn sodium is considered an alternative therapy to inhaled corticosteroids for mild persistent asthma during pregnancy according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group; however, inhaled corticosteroids are the preferred treatment due to greater efficacy.

    Breast-feeding

    It is not known if cromolyn sodium is distributed into breast milk; however, after administration via the oral, nasal, ophthalmic, and inhaled routes only small amounts of drug are absorbed. The manufacturers recommend that the drug be used with caution during breast-feeding. Cromolyn sodium is considered an alternative therapy to inhaled corticosteroids for mild persistent asthma during lactation according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group.

    Children, infants

    There are limited data are available regarding the safe and effective use of cromolyn sodium products in children and infants less than 2 years of age.

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known
    laryngeal edema / Rapid / Incidence not known
    bronchospasm / Rapid / Incidence not known
    seizures / Delayed / Incidence not known
    pancytopenia / Delayed / Incidence not known
    pericarditis / Delayed / Incidence not known
    ventricular tachycardia / Early / Incidence not known
    atrial tachycardia / Early / Incidence not known
    lupus-like symptoms / Delayed / Incidence not known
    exfoliative dermatitis / Delayed / Incidence not known

    Moderate

    dyspnea / Early / Incidence not known
    wheezing / Rapid / Incidence not known
    glossitis / Early / Incidence not known
    constipation / Delayed / Incidence not known
    stomatitis / Delayed / Incidence not known
    dysphagia / Delayed / Incidence not known
    psychosis / Early / Incidence not known
    depression / Delayed / Incidence not known
    hallucinations / Early / Incidence not known
    migraine / Early / Incidence not known
    neuritis / Delayed / Incidence not known
    polycythemia / Delayed / Incidence not known
    anemia / Delayed / Incidence not known
    hemoptysis / Delayed / Incidence not known
    edema / Delayed / Incidence not known
    neutropenia / Delayed / Incidence not known
    dysuria / Early / Incidence not known
    chest pain (unspecified) / Early / Incidence not known
    premature ventricular contractions (PVCs) / Early / Incidence not known
    palpitations / Early / Incidence not known
    erythema / Early / Incidence not known

    Mild

    diarrhea / Early / 0-5.0
    headache / Early / 0-5.0
    nausea / Early / 0-4.0
    myalgia / Early / 0-4.0
    pruritus / Rapid / 0-4.0
    abdominal pain / Early / 2.0-2.0
    rash / Early / 2.0-2.0
    cough / Delayed / Incidence not known
    nasal irritation / Early / Incidence not known
    throat irritation / Early / Incidence not known
    sneezing / Early / Incidence not known
    hoarseness / Early / Incidence not known
    nasal congestion / Early / Incidence not known
    pharyngitis / Delayed / Incidence not known
    dyspepsia / Early / Incidence not known
    vomiting / Early / Incidence not known
    flatulence / Early / Incidence not known
    tinnitus / Delayed / Incidence not known
    insomnia / Early / Incidence not known
    lethargy / Early / Incidence not known
    fatigue / Early / Incidence not known
    drowsiness / Early / Incidence not known
    dizziness / Early / Incidence not known
    malaise / Early / Incidence not known
    vertigo / Early / Incidence not known
    paresthesias / Delayed / Incidence not known
    hypoesthesia / Delayed / Incidence not known
    anxiety / Delayed / Incidence not known
    arthralgia / Delayed / Incidence not known
    ocular irritation / Rapid / Incidence not known
    lacrimation / Early / Incidence not known
    ocular pruritus / Rapid / Incidence not known
    increased urinary frequency / Early / Incidence not known
    urticaria / Rapid / Incidence not known
    purpura / Delayed / Incidence not known
    photosensitivity / Delayed / Incidence not known
    flushing / Rapid / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Cromolyn Sodium products.

    PREGNANCY AND LACTATION

    Pregnancy

    Cromolyn sodium may be used with caution during pregnancy due to low systemic absorption from the various administration routes. Animal studies have not shown adverse effects on the fetus when cromolyn was administered alone. Cromolyn sodium is considered an alternative therapy to inhaled corticosteroids for mild persistent asthma during pregnancy according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group; however, inhaled corticosteroids are the preferred treatment due to greater efficacy.

    It is not known if cromolyn sodium is distributed into breast milk; however, after administration via the oral, nasal, ophthalmic, and inhaled routes only small amounts of drug are absorbed. The manufacturers recommend that the drug be used with caution during breast-feeding. Cromolyn sodium is considered an alternative therapy to inhaled corticosteroids for mild persistent asthma during lactation according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group.

    MECHANISM OF ACTION

    Cromolyn works at the surface of the mast cell to inhibit its degranulation. In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the release of mediators from sensitized mast cells. Cromolyn sodium acts by inhibiting the release of histamine and leukotrienes (SRS-A) from the mast cell. Studies show that cromolyn sodium indirectly blocks calcium ions from entering the mast cell, thereby preventing mediator release. Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity. Cromolyn's beneficial effects when inhaled or used nasally or in the eye are largely preventative. Continued use is needed to maintain benefits as a controller medication. Inhaled cromolyn can be used before certain exposures to reduce hyperreactivity to exercise, cold air, or antigenic challenge (e.g., allergens, environmental pollutants). When used orally to manage cutaneous or systemic mastocytosis, use results in a clinically significant improvement in gastrointestinal symptoms (diarrhea, abdominal pain) and some improvement for cutaneous manifestations (e.g., urticaria, pruritus, flushing) and cognitive function.

    PHARMACOKINETICS

    Cromolyn sodium is administered orally, via nebulization, intranasally, and via ophthalmic route. Very little of the drug is absorbed systemically by any route of administration.
     
    Affected cytochrome P450 (CYP450) isoenzymes and drug transporters: None

    Oral Route

    Cromolyn sodium is poorly absorbed from the gastrointestinal tract. No more than 1% of an administered dose is absorbed by humans after oral administration, the remainder being excreted in the feces. Very little absorption of cromolyn sodium was seen after oral administration of 500 mg to each of 12 volunteers. From 0.28% to 0.50% of the administered dose was recovered in the first 24 hours of urinary excretion in 3 subjects. The mean urinary excretion of an administered dose over 24 hours in the remaining 9 subjects was 0.45%.

    Inhalation Route

    After administration by inhalation, approximately 8% of the total cromolyn sodium dose administered is absorbed and rapidly excreted unchanged, approximately equally divided between urine and bile. The remainder of the dose is either exhaled or deposited in the oropharynx, swallowed and excreted via the alimentary tract.

    Other Route(s)

    Ophthalmic Route
    Minimal systemic absorption occurs after ophthalmic use. Animal studies indicate trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor and clearance from this chamber is virtually complete within 24 hours after treatment is stopped. In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to the eye.
     
    Intranasal route
    As with inhalational use, minimal systemic absorption occurs after intranasal use.