Cromolyn Sodium (Disodium Cromoglycate)

( Disodium Cromoglycate ) Pronunciation: (KROE-moe-lin SO-dee-um)Class: Mast cell stabilizer

Trade Names:Crolom- Solution, ophthalmic 4%

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

Trade Names:Gastrocrom- Concentrate, oral 100 mg per 5 mL

Trade Names:Intal- Solution, inhalation 20 mg/amp- Aerosol inhalation 800 mcg/actuation

Trade Names:Nasalcrom- Solution, nasal 40 mg/mL (each actuation delivers 5.2 mg)

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

Pharmacology

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

Pharmacokinetics

Absorption

Aerosol inhalation

8% absorbed from the lungs.

Oral concentrate

Up to 1% absorbed.

Elimination

Aerosol inhalation

After 8% is absorbed from the lung, it is rapidly excreted unchanged in bile and urine. The remainder is either exhaled or swallowed and excreted via the alimentary tract.

Oral concentrate

0.28% to 0.5% of the dose is excreted in the urine.

Indications and Usage

Nebulizer solution/aerosol inhalation

Prophylactic agent for management of bronchial asthma.

Nasal spray

Prevent and relieve nasal symptoms of hay fever and other nasal allergies, including runny/itchy nose, sneezing, and allergic stuffy nose.

Oral concentrate

Treatment of mastocytosis.

Ophthalmic

Treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

Unlabeled Uses

Oral

Symptoms of food allergies; eczema; dermatitis; ulceration; urticaria pigmentosa; chronic urticaria; hay fever; and postexercise bronchospasm.

Contraindications

Standard considerations.

Dosage and Administration

Bronchial AsthmaAdults and Children (2 yr of age and older for solution)

Nebulization Initially 20 mg inhaled 4 times daily at regular intervals.

Adults and Children (older than 5 yr of age)

Aerosol 2 metered sprays (1,600 mcg) inhaled 4 times daily at regular intervals.

MastocytosisAdults and Children 13 yr of age and older

PO 200 mg 4 times daily 30 min before meals and at bedtime. Once a therapeutic response has been achieved, dose may be reduced to minimum needed to maintain a lower degree of symptomatology. To prevent relapses, dosage should be maintained.

Children 2 to 12 yr of age

PO 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 minimum needed to maintain a lower degree of symptomatology. To prevent relapses, dosage should be maintained.

Nasal AllergyAdults and Children 2 yr of age and older

Nasal spray Spray once into each nostril; repeat 3 to 4 times daily (every 4 to 6 h up to 6 times/day) if needed.

Prevention of Acute BronchospasmAdults

Nebulizer solution/aerosol 2 metered dose sprays or 20 mg via inhaled nebulizer (10 to 15 min but no longer than 60 min) before exposure to precipitating factor.

Vernal Keratoconjunctivitis, Vernal Conjunctivitis, and Vernal KeratitisAdults

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

General Advice

Aerosol inhalation

Do not administer during an acute asthmatic attack.

Nasal spray

Clear patient's nasal passages before administering spray. Have patient inhale medication through nose.
Hold container upright. Use pumping motion to force solution mist into nasal passages.

Nebulizer solution

Instruct patient to close eyes during inhalation to prevent accidental contact with eyes.
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.

Ophthalmic solution

The efficacy of cromolyn therapy is dependent on its administration at regular intervals, as directed.

Oral concentrate

Break open ampule and squeeze liquid contents into a glass of water. Stir solution and drink all the contents.
Do not use if product contains particulate matter or becomes discolored.

Storage/Stability

Aerosol inhalation

Store between 59° and 86°F. Do not puncture, incinerate, or place near heat sources.

Nasal spray

Store between 68° and 77°F. Protect from light.

Nebulizer solution

Store between 69° and 77°F. Protect from light.

Ophthalmic solution

Store between 59° and 86°F. Protect from light. Keep tightly closed. Replace cap immediately after use.

Oral concentrate

Store between 59° and 86°F. Protect from light.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Oral concentrate

Palpitations, premature ventricular contractions, tachycardia (postmarketing).

CNS

Aerosol inhalation

Dizziness, headache.

Oral concentrate

Irritability, malaise; anxiety, behavior change, convulsions, depression, fatigue, hallucinations, hypoesthesia, insomnia, migraine, nervousness, paresthesia (postmarketing).

Nebulizer solution

Drowsiness.

Dermatologic

Aerosol inhalation

Rash, urticaria.

Oral concentrate

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

EENT

Aerosol inhalation

Lacrimation, laryngeal edema, nasal congestion, pharyngeal irritation, swollen parotid gland, throat irritation or dryness.

Nebulizer solution

Nasal congestion, nasal itching, nose burning, nosebleed, sneezing.

Ophthalmic solution

Conjunctival injection, dryness around the eye, eye irritation, itchy eyes, ocular burning and stinging upon installation, puffy eyes, styes, watery eyes.

Oral concentrate

Pharyngitis, tinnitus (postmarketing).

GI

Aerosol inhalation

Bad taste, nausea, substernal burning.

Nebulizer solution

Nausea, stomachache.

Oral concentrate

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

Genitourinary

Aerosol inhalation

Dysuria, urinary frequency.

Oral concentrate

Dysuria, urinary frequency (postmarketing).

Hematologic-Lymphatic

Oral concentrate

Neutropenia, pancytopenia, polycythemia (postmarketing).

Hepatic

Oral concentrate

Abnormal LFTs (postmarketing).

Musculoskeletal

Aerosol inhalation

Joint swelling and pain, myopathy.

Oral concentrate

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

Respiratory

Aerosol inhalation

Bronchospasm, cough, pulmonary infiltrates with eosinophilia, wheezing.

Nasal solution

Cough, wheezing.

Oral concentrate

Dyspnea (postmarketing).

Miscellaneous

Aerosol

Anaphylaxis, angioedema.

Nebulizer solution

Serum sickness.

Ophthalmic solution

Immediate hypersensitivity (including edema, dyspnea, and rash)

Oral concentrate

Chest pain, edema, lupus erythematosus syndrome, postprandial lightheadedness and lethargy (postmarketing).

Precautions

Monitor

Instruct patients to notify health care provider of the following: wheezing or coughing after inhalation or stinging effect after nasal instillation, joint pain, severe wheezing, difficulty breathing, chills, sweating, or chest pain, which may indicate eosinophilic pneumonia.

Therapeutic efficacy

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

Pregnancy

Category B .

Lactation

Undetermined.

Children

Aerosol

Safety and efficacy not established in children younger than 5 yr of age.

Nebulizer solution

Safety and efficacy not established in children younger than 2 yr of age.

Nasal spray

Do not use in children younger than 2 yr of age unless directed by health care provider.

Ophthalmic solution

Safety and efficacy not established in children younger than 4 yr of age.

Oral concentrate

Safety and efficacy not established in children younger than 2 yr of age.

Elderly

Oral concentrate

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.

Hypersensitivity

Severe anaphylactic reactions may occur.

Renal Function

Decreased dose is recommended.

Hepatic Function

Decreased dose is recommended.

Acute asthma

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

Aerosol

Use with caution in patients with coronary artery disease or cardiac arrhythmias because of propellants in this preparation.

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.
Inform patient that Intal nebulizer solution should be used in a power-driven nebulizer with an adequate airflow rate equipped with a suitable face mask or mouthpiece.
Advise patient to minimize exposure to known allergens or precipitating factors.
Nasal spray – Instruct patient to use product every day while in contact with the cause of allergies (eg, dust, molds, pets, pollen).
Nasal spray – Inform patient that for best results to begin using 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.