PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • CLASSES

    Non-steroidal Respiratory Anti-inflammatories, Inhalant
    Non-steroidal Respiratory Anti-inflammatories, Systemic
    Ocular Anti-Allergics, Mast Cell Stabilizers
    Topical Nasal Antiallergic Agents

    DEA CLASS

    Rx, OTC

    DESCRIPTION

    Mast-cell stabilizer; no bronchodilator activity.
    Nasal and respiratory inhalations used for allergic rhinitis or asthma, respectively.
    Ophthalmic solutions used for allergic conjunctivitis.
    Used orally for systemic mastocytosis or ulcerative colitis.

    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 in the management of patients with asthma.
    Oral inhalation dosage (metered dose inhaler)
    Adults, Adolescents, and Children >= 5 years

    Inhale 2 sprays (800 mcg/spray) PO 4 times per day at regular intervals. A 4- to 6-week trial may be necessary to determine maximum benefit. Once asthma is stabilized, reduce the dose to the lowest effective dose.

    Oral inhalation dosage (nebulized solution)
    Adults, Adolescents, and Children >= 2 years

    Inhale 20 mg PO 4 times per day at regular intervals. A 4- to 6-week trial may be necessary to determine maximum benefit. Once asthma is stabilized, reduce the dose to the lowest effective dose.

    Oral inhalation dosage (powder in capsules for use with Spinhaler)
    Adults, Adolescents, and Children > 5 years

    Inhale 20 mg PO 4 times per day at regular intervals. A 4- to 6-week trial may be necessary to determine maximum benefit. Once asthma is stabilized, reduce the dose to the lowest effective dose. NOTE: This product is not available in the United States.

    For exercise-induced bronchospasm prophylaxis or the prevention of bronchospasm induced by other known precipitating factors.
    Oral inhalation dosage (metered dose inhaler)
    Adults, Adolescents, and Children >= 5 years

    Inhale 2 sprays (800 mcg/spray) PO about 10 to 15 minutes, but not more than 1 hour, before exercise or exposure to other precipitating factors. If exercise or exposure to a precipitating factor is prolonged, the dose may be repeated. 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 recommends administration of a mast cell stabilizing agent such as cromolyn as an option before exercise 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, mast cell stabilizing agents typically play a secondary role in the management of exercise-induced bronchospasm in patients needing additional symptom control, with inhaled corticosteroids or leukotriene receptor antagonists typically considered first line therapies to be used with SABAs for control.

    Oral inhalation dosage (nebulized solution)
    Adults, Adolescents, and Children >= 2 years

    Inhale 20 mg PO 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 recommends administration of a mast cell stabilizing agent such as cromolyn before exercise 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, mast cell stabilizing agents typically play a secondary role in the management of exercise-induced bronchospasm in patients needing additional symptom control, with inhaled corticosteroids or leukotriene receptor antagonists typically considered first line therapies to be used with SABAs for control.

    Oral inhalation dosage (powder in capsules for use with Spinhaler)
    Adults, Adolescents, and Children >= 5 years

    Inhale 20 mg PO not more than 1 hour before anticipated exercise or other precipitating factor. Effective prophylaxis lasts approximately 1 to 2 hours. NOTE: This product is not available in the United States.

    For treatment of the nasal symptoms associated with allergic rhinitis including runny/itching nose, sneezing, and allergic nasal congestion; and for allergic rhinitis prophylaxis.
    Nasal inhalation dosage (metered spray)
    Adults, Adolescents, and Children >= 2 years

    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 continued for the duration of allergen exposure. If used for perennial rhinitis, 2 to 4 weeks of therapy may be required to produce relief.

    For the treatment of allergic ocular disorders such as allergic conjunctivitis, allergic keratoconjunctivitis, giant papillary conjunctivitis (GPC), vernal keratitis, vernal keratoconjunctivitis.
    Ophthalmic dosage
    Adults, Adolescents, and Children > 4 years

    1 to 2 drops (1.6 mg per drop) in each eye 4 to 6 times per day at regular intervals.

    For the treatment of systemic mastocytosis.
    Oral dosage (Gastrocrom)
    Adults and Adolescents

    200 mg PO 4 times per day, 30 minutes before meals and at bedtime. In general the maximum recommended dose is 40 mg/kg/day PO.

    Children 2—12 years

    100 mg PO 4 times per day, 30 minutes before meals and at bedtime. Dosage should not exceed 40 mg/kg/day PO.

    Children and Infants 6 to 23 months†

    Initially, 20 mg/kg/day PO given in 4 divided doses. May be increased if benefits are not observed after 2 to 3 weeks up to 30 mg/kg/day PO.

    Infants < 6 months†

    Dosage should not exceed 20 mg/kg/day PO, administered in 4 divided doses.

    For the treatment of chronic inflammatory bowel disease† (e.g., ulcerative colitis†), for initial suppression and for maintenance therapy to prevent relapse.
    Oral dosage (Gastrocrom)
    Adults

    Initially, 200 mg PO 4 times per day given 15 to 20 minutes before meals and at bedtime. If satisfactory results are not seen in 2 to 3 weeks, may double dosage. The maximum recommended dose is 400 mg PO 4 times per day.

    Children and Adolescents 2—14 years

    Initially, 100 mg PO 4 times per day given 15 to 20 minutes before meals and at bedtime. If satisfactory results are not seen in 2 to 3 weeks, may double dosage. The maximum recommended dose is 40 mg/kg/day.

    For the prevention of symptoms associated with food allergy†.
    Oral dosage (Gastrocrom)
    Adults

    Initially, 200 mg PO 4 times per day given 15 to 20 minutes before meals. The same dosage has been used as maintenance therapy to prevent relapse. For patients requiring occasional therapy, 200 mg PO 15 to 20 minutes prior to the precipitating meal may be used, however, the optimal dose should be individualized.

    Children and Adolescents 2—14 years

    Initially, 100 mg PO 4 times per day given 15 to 20 minutes before meals. The same dosage has been used as maintenance therapy to prevent relapse. For patients requiring occasional therapy, 100 mg PO 15 to 20 minutes prior to the precipitating meal may be used, however, the optimal dose should be individualized.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    40 mg/kg/day PO for Gastrocrom.

    Elderly

    40 mg/kg/day PO for Gastrocrom.

    Adolescents

    40 mg/kg/day PO for Gastrocrom.

    Children

    >= 2 years: 40 mg/kg/day PO for Gastrocrom.
    < 2 years: 30 mg/kg/day PO for Gastrocrom.

    Infants

    >= 6 months: 30 mg/kg/day PO for Gastrocrom.
    < 6 months: 20 mg/kg/day PO for Gastrocrom.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    The manufacturer recommends consideration of dosage reduction of Gastrocrom in hepatic impairment, but no quantitative recommendations are available. It appears no dosage adjustments are needed for cromolyn given via inhalation or ophthalmic routes.

    Renal Impairment

    The manufacturer recommends consideration of dosage reduction of Gastrocrom in renal impairment, but no quantitative recommendations are available. It appears no dosage adjustments are needed for cromolyn given via inhalation or ophthalmic routes.

    ADMINISTRATION

    Oral Administration
    Oral Liquid Formulations

    (Oral Concentrate, Gastrocrom):
    The oral ampules of Gastrocrom are for preparation of an oral solution only. Do not use for inhalation or injection.
    Preparation of concentrate for administration: Empty the appropriate amount of the ampule(s) into a half glass of water. Stir solution. Do not mix the 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.
    Following administration, instruct patient to rinse mouth and gargle to minimize dry mouth or throat, throat irritation, and hoarseness.
    To avoid the spread of infection, do not use an inhaler for more than one person.
     
    Aerosol inhalation (metered-dose inhalers):
    NOTE: The metered-dose inhaler for oral inhalation delivers 800 mcg/spray.
    For patients of any age unable to coordinate inhalation and actuation, a spacer or valved holding chamber (VHC) should be used.
    The choice of using a mouthpiece versus a face mask with a spacer/VHC device must be made based on the skills and understanding of each individual patient. However, in general, children < 4 years require administration with a tight fitting face mask and spacer/VHC device to achieve optimal delivery. If a face mask is used, allow 3—5 inhalations per actuation.
     
    Powder for inhalation:
    NOTE: Most children < 4 years of age may not generate sufficient inspiratory flow to activate dry powder inhalers.
    Use only the capsules packaged for inhalation administration.
    Instruct patient on how to load the oral inhaler with an inhalation capsule (see package insert).
     
    Inhalation solution for nebulization:
    NOTE: Administration via nebulization is the delivery method of choice for young children.
    Use a power-operated nebulizer with a flow rate of at least 6—8 liters per 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.
    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 has been shown to produce severe anaphylactoid reactions; it is contraindicated for use in patients with a known hypersensitivity to cromolyn or to other product ingredients.

    Acute bronchospasm, status asthmaticus

    The anti-inflammatory activity of cromolyn sodium acts to prevent asthma symptoms. It is not a bronchodilator; do not prescribe cromolyn for the treatment of acute bronchospasm or status asthmaticus.

    Cardiac arrhythmias, cardiac disease, coronary artery disease

    Use cromolyn sodium inhalation aerosol products with caution in patients with cardiac disease, such as coronary artery disease and/or cardiac arrhythmias because the aerosol contains fluorocarbon propellant.

    Contact lenses

    Cromolyn sodium for ophthalmic use contains benzalkonium chloride as a preservative, and wearers of soft contact lenses should be advised against wearing the lenses during therapy.

    Lactase deficiency

    Oral preparations of cromolyn are not for administration by inhalation or injection. Oral preparations of cromolyn contain lactose; patients with lactase deficiency should take appropriate precautions with use.

    Hepatic disease, renal disease, renal failure, renal impairment

    According to the manufacturer, a reduction in the dosage of oral cromolyn sodium should be considered in patients with hepatic disease or renal impairment/renal failure or renal disease, given the biliary and renal routes of excretion of the drug. However, definitive recommendations are not provided.

    Pregnancy

    Cromolyn sodium is classified as pregnancy category B. Animal studies have not shown adverse effects on the fetus when cromolyn was administered alone. However, when administered to mice (at doses similar to the maximum recommended adult oral dose on a mg/m2 basis) with isoproterenol via SC injection the incidence of major malformations (primarily cleft palate) was increased; no such reaction was observed with coadministration of the 2 drugs in rats or rabbits. 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. It should be noted that inhaled corticosteroids are the preferred treatment due to greater efficacy. However, maintaining a previously established treatment regimen may be more beneficial to the patient. Therefore, selection of any pharmacologic treatment for asthma control during pregnancy should include the specific needs of the patient, based on an individual evaluation, and consideration of the potential benefits or risks to the fetus.

    Breast-feeding

    It is not known if cromolyn sodium is distributed into breast milk; however, after administration via the oral and inhaled routes only small amounts of drug are absorbed. The manufacturer recommends 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 pregnancy and lactation according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Children, infants

    Children as young as 2 years of age have received cromolyn safely. Limited data are available regarding the use of cromolyn in infants 6 months and older.

    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 (unspecified) / 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 is classified as pregnancy category B. Animal studies have not shown adverse effects on the fetus when cromolyn was administered alone. However, when administered to mice (at doses similar to the maximum recommended adult oral dose on a mg/m2 basis) with isoproterenol via SC injection the incidence of major malformations (primarily cleft palate) was increased; no such reaction was observed with coadministration of the 2 drugs in rats or rabbits. 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. It should be noted that inhaled corticosteroids are the preferred treatment due to greater efficacy. However, maintaining a previously established treatment regimen may be more beneficial to the patient. Therefore, selection of any pharmacologic treatment for asthma control during pregnancy should include the specific needs of the patient, based on an individual evaluation, and consideration of the potential benefits or risks to the fetus.

    It is not known if cromolyn sodium is distributed into breast milk; however, after administration via the oral and inhaled routes only small amounts of drug are absorbed. The manufacturer recommends 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 pregnancy and lactation according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Cromolyn works at the surface of the mast cell to inhibit its degranulation. This, in turn, prevents the release of histamine and slow-reacting substance of anaphylaxis (SRS-A), mediators of type I allergic reactions. Cromolyn also may reduce the release of inflammatory leukotrienes. It has been postulated that cromolyn produces these effects by inhibiting calcium influx, but its exact mechanism of action is unclear. Cromolyn does not interfere with the binding of IgE to the mast cell or with the binding of antigen to IgE. Because cromolyn is not a bronchodilator, an antihistamine, or a vasoconstrictor, its beneficial effects in the treatment of asthma are largely prophylactic. Cromolyn can reduce hyperreactivity of the bronchi, inhibiting asthmatic responses to antigenic challenge (e.g., cold air, allergens, environmental pollutants) or to exercise. Cromolyn also has been administered orally to treat inflammatory bowel disease.

    PHARMACOKINETICS

    Cromolyn sodium is administered orally, intranasally and via ophthalmic route. Cromolyn does not traverse cell membrane walls well because it is highly lipid-insoluble and mainly ionized. Several weeks of therapy may be required before improvement is apparent. The drug does not significantly cross the placenta or distribute into breast milk. Roughly 98% of the dose is eliminated unchanged in the feces.

    Oral Route

    Systemic bioavailability of oral cromolyn is approximately 1%. Nevertheless, cromolyn is administered orally to treat systemic mastocytosis and inflammatory bowel disease.

    Other Route(s)

    Ophthalmic Route
    Minimal systemic absorption occurs after ophthalmic use.
     
    Intranasal route
    Minimal systemic absorption occurs after intranasal use. Roughly 5—10% of an inhaled dose reaches the lungs. The amount reaching the lungs after inhalation is affected by the degree of bronchoconstriction present.