Learn how to prepare for Severe Allergy Attacks.

Cromolyn Sodium

Pronunciation
( Disodium Cromoglycate )

Pronunciation: KROE-mo-lin SOE-dee-um
Class: Mast cell stabilizer

Trade Names

Cromolyn sodium
- Solution, inhalation 20 mg per 2 mL
- Solution, ophthalmic 4%

Gastrocrom
- Solution, concentrate, oral 100 mg per 5 mL

Nasalcrom
- Solution, intranasal 4%

Apo-Cromolyn (Canada)
Cromolyn (Canada)
Nalcrom (Canada)
Opticrom (Canada)

Pharmacology

Stabilizes mast cells, which release histamine and other mediators of allergic reactions.

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Pharmacokinetics

Absorption

After oral inhalation, approximately 8% is absorbed from the lungs; up to 1% is absorbed from the GI tract after oral administration.

Elimination

After oral inhalation, 8% is absorbed from the lung and rapidly excreted unchanged in bile and urine. The remainder is either exhaled or swallowed and excreted via the alimentary tract. 0.28% to 0.5% of the oral solution dose is excreted in the urine.

Indications and Usage

Management of bronchial asthma or prevention of acute bronchospasm (oral inhalation); prevention and relief of nasal symptoms of hay fever and other nasal allergies, including runny/itchy nose, sneezing, and allergic stuffy nose (intranasal); treatment of mastocytosis (oral solution); treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis (ophthalmic).

Unlabeled Uses

Pruritus (oral solution).

Contraindications

Standard considerations.

Dosage and Administration

Asthma
Adults and Children 2 y of age and older

Oral inhalation 1 vial via nebulizer 4 times daily at regular intervals.

Mastocytosis
Adults and Children 13 y of age and older

PO Initially 200 mg 4 times daily 30 min before meals and at bedtime. If satisfactory control of symptoms is not achieved within 2 to 3 wk, dosage may be increased (max, 40 mg/kg/day). Once a therapeutic response has been achieved, dose may be reduced to the minimum required to maintain a lower degree of symptomatology. To prevent relapses, dosage should be maintained.

Children 2 to 12 y of age

PO Initially, 100 mg 4 times daily 30 min before meals and at bedtime. If satisfactory control of symptoms is not achieved within 2 to 3 wk, dosage may be increased (max, 40 mg/kg/day). Once a therapeutic response has been achieved, dose may be reduced to the minimum required to maintain a lower degree of symptomatology. To prevent relapses, dosage should be maintained.

Renal or Hepatic Function Impairment

PO Reduce dose.

Allergic Rhinitis
Adults and Children 2 y of age and older

Intranasal Spray once into each nostril; repeat 3 to 4 times daily (every 4 to 6 h up to 6 times/day) if needed. For best results, start using up to 1 week before contact.

Prevention of Acute Bronchospasm
Adults and Children 2 y of age and older

Oral inhalation 1 vial via nebulizer shortly before exposure to precipitating factor.

Vernal Keratoconjunctivitis, Vernal Conjunctivitis, and Vernal Keratitis
Adults

Ophthalmic solution 1 to 2 drops in each eye 4 to 6 times/day at regular intervals.

General Advice

  • Clear patient's nasal passages before administering spray. Hold container upright. Have patient inhale medication through nose.
  • Instruct patient to close eyes during inhalation to prevent accidental contact with eyes.
  • Oral inhalation vials are for oral inhalation only; instruct patient not to swallow. Use in a power-driven nebulizer with an adequate airflow rate equipped with a suitable face mask or mouthpiece.
  • If bronchodilating inhalant is also prescribed, give bronchodilator 5 to 15 min before cromolyn to enhance drug delivery.
  • Do not use if product contains particulate matter or becomes discolored.
  • The efficacy of cromolyn therapy is dependent on its administration at regular intervals, as directed.
  • Break open the oral solution ampule and squeeze liquid contents into a glass of water. Stir solution and instruct patient to drink all the contents.
  • Discontinue intranasal use if after 2 weeks symptoms do not improve.

Storage/Stability

Store nasal spray and oral inhalation vial between 68° and 77°F. Store ophthalmic and oral solution between 59° and 86°F. Protect from light. Replace cap on ophthalmic solution immediately after use.

Drug Interactions

None well documented.

Adverse Reactions

Cardiovascular

Palpitations, premature ventricular contractions, tachycardia (postmarketing).

CNS

Drowsiness, headache, irritability, malaise; anxiety, behavior change, convulsions, depression, dizziness, fatigue, hallucinations, hypoesthesia, insomnia, migraine, nervousness, paresthesia, postprandial light-headedness and lethargy, psychosis (postmarketing).

Dermatologic

Pruritus, rash; erythema/burning, flushing, photosensitivity, purpura, urticaria/angioedema (postmarketing).

EENT

Conjunctival injection, dryness around the eye, eye irritation, itchy eyes, nasal congestion, nasal itching, nose burning, nosebleed, ocular burning and stinging upon instillation, puffy eyes, sneezing, styes, watery eyes; pharyngitis, tinnitus (postmarketing).

GI

Abdominal pain, diarrhea, nausea, stomach ache; constipation, dyspepsia, dysphagia, esophagospasm, flatulence, glossitis, stomatitis, unpleasant taste, vomiting (postmarketing).

Genitourinary

Dysuria, urinary frequency (postmarketing).

Hematologic-Lymphatic

Neutropenia, pancytopenia, polycythemia (postmarketing).

Musculoskeletal

Myalgia; arthralgia, stiffness/weakness of legs (postmarketing).

Respiratory

Cough, wheezing; dyspnea (postmarketing).

Miscellaneous

Immediate hypersensitivity (including dyspnea, edema, and rash), serum sickness; abnormal LFTs, chest pain, edema, lupus erythematosus syndrome (postmarketing).

Precautions

Monitor

Evaluate therapeutic efficacy by decrease in frequency or severity of clinical symptoms or decrease in need for cotherapy over a period of 4 wk.


Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 2 y of age (oral inhalation and oral solution); do not use in children younger than 2 y of age unless directed by health care provider (intranasal); safety and efficacy not established in children younger than 4 y of age (ophthalmic).

Elderly

Use with caution, usually starting at low end of dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy (oral solution).

Hypersensitivity

Severe anaphylactic reactions may occur.

Renal Function

Decreased dose is recommended (oral solution).

Hepatic Function

Decreased dose is recommended (oral solution).

Acute asthma

Do not use for acute asthma attack. Effects depend on regular administration.

Bronchospasm

Cough or bronchospasm may follow inhalation.

Eosinophilic pneumonia

If signs of this condition occur, therapy will need to be discontinued.

Patient Information

  • Explain that cromolyn is used for prevention, not treatment, of acute asthma attacks.
  • Give patient clear instructions about what to do during an acute asthma attack.
  • Teach patient correct use of administration device (see instructions in package). Have patient demonstrate its use.
  • Advise patient to minimize exposure to known allergens or precipitating factors.
  • Instruct patient to use the nasal spray product every day while in contact with the cause of allergies (eg, dust, molds, pets, pollen).
  • Inform patient that for best results, begin using the nasal spray product 1 wk before contact with the cause of allergies.
  • Instruct patient with cold- or exercise-induced asthma to use medication shortly before (at least 10 to 15 min but not more than 60 min before) exposure.
  • Advise patient to rinse mouth or gargle after oral inhalation to prevent throat irritation.
  • If patient is taking concurrent bronchodilators or corticosteroids, stress importance of not discontinuing abruptly, particularly systemic corticosteroids.
  • Advise patient that effectiveness of therapy is dependent on administration at regular intervals. Max effectiveness may take 4 wk.
  • Caution patient not to discontinue abruptly unless advised by health care provider.
  • Instruct patient to report the following symptoms to health care provider: increased difficulty in breathing, increased wheezing, difficulty in swallowing, joint pain or swelling, severe headache.
  • Advise patient to not wear contact lenses while using cromolyn ophthalmic solution.

Copyright © 2009 Wolters Kluwer Health.

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