Cromolyn Sodium
Generic: CROMOLYN SODIUM
Basic Information
Manufacturer
Micro Labs Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRABRONCHIAL
FDA Set ID
aebec664-ed80-447c-9789-0cf47c8b7429
Indications & Usage
INDICATIONS AND USAGE Cromolyn sodium inhalation solution, USP is a prophylactic agent indicated in the management of patients with bronchial asthma.
In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution, USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION ).
The effect of cromolyn sodium inhalation solution is usually evident after several weeks of treatment, although some patients show an almost immediate response.
In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium inhalation solution should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ).
In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution, USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION ).
The effect of cromolyn sodium inhalation solution is usually evident after several weeks of treatment, although some patients show an almost immediate response.
In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium inhalation solution should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ).
Warnings
WARNINGS Cromolyn sodium inhalation solution has no role in the treatment of status asthmaticus.
Anaphylactic reactions with cromolyn sodium administration have been reported rarely.
Anaphylactic reactions with cromolyn sodium administration have been reported rarely.
Adverse Reactions
ADVERSE REACTIONS Clinical experience with the use of cromolyn sodium suggests that adverse reactions are rare events.
The following adverse reactions have been associated with cromolyn sodium: cough, nasal congestion, nausea, sneezing, and wheezing.
Other reactions have been reported in clinical trials; however, a causal relationship could not be established: drowsiness, nasal itching, nose bleed, nose burning, serum sickness, and stomachache.
In addition, adverse reactions have been reported with cromolyn sodium for inhalation capsules.
The most common side effects are associated with inhalation of the powder and include transient cough (1 in 5 patients) and mild wheezing (1 in 25 patients).
These effects rarely require treatment or discontinuation of the drug.
Information on the incidence of adverse reactions to cromolyn sodium for inhalation capsules has been derived from U.S.
postmarketing surveillance experience.
The following adverse reactions attributed to cromolyn sodium, based upon recurrence following readministration, have been reported in less than 1 in 10,000 patients: laryngeal edema, swollen parotid gland, angioedema, bronchospasm, joint swelling and pain, dizziness, dysuria and urinary frequency, nausea, cough, wheezing, headache, nasal congestion, rash, urticaria and lacrimation.
Other adverse reactions have been reported in less than 1 in 100,000 patients, and it is unclear whether these are attributable to the drug: anaphylaxis, nephrosis, periarteritic vasculitis, pericarditis, peripheral neuritis, pulmonary infiltrates with eosinophilia, polymyositis, exfoliative dermatitis, hemoptysis, anemia, myalgia, hoarseness, photodermatitis, and vertigo.
To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc.
at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The following adverse reactions have been associated with cromolyn sodium: cough, nasal congestion, nausea, sneezing, and wheezing.
Other reactions have been reported in clinical trials; however, a causal relationship could not be established: drowsiness, nasal itching, nose bleed, nose burning, serum sickness, and stomachache.
In addition, adverse reactions have been reported with cromolyn sodium for inhalation capsules.
The most common side effects are associated with inhalation of the powder and include transient cough (1 in 5 patients) and mild wheezing (1 in 25 patients).
These effects rarely require treatment or discontinuation of the drug.
Information on the incidence of adverse reactions to cromolyn sodium for inhalation capsules has been derived from U.S.
postmarketing surveillance experience.
The following adverse reactions attributed to cromolyn sodium, based upon recurrence following readministration, have been reported in less than 1 in 10,000 patients: laryngeal edema, swollen parotid gland, angioedema, bronchospasm, joint swelling and pain, dizziness, dysuria and urinary frequency, nausea, cough, wheezing, headache, nasal congestion, rash, urticaria and lacrimation.
Other adverse reactions have been reported in less than 1 in 100,000 patients, and it is unclear whether these are attributable to the drug: anaphylaxis, nephrosis, periarteritic vasculitis, pericarditis, peripheral neuritis, pulmonary infiltrates with eosinophilia, polymyositis, exfoliative dermatitis, hemoptysis, anemia, myalgia, hoarseness, photodermatitis, and vertigo.
To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc.
at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.