Cromolyn Sodium Inhalation
Generic Name: cromolyn sodium inhalation
Brand Names:
Cromolyn Sodium Inhalation Solution
DESCRIPTION The active ingredient of cromolyn sodium inhalation solution USP is cromolyn sodium, USP. It is an inhaled anti-inflammatory agent for the preventive management of asthma. Cromolyn sodium, USP is chemically designated as disodium 5,5'- [(2-hydroxytrimethylene)dioxy] bis [4-oxo-4H-1-benzopyran-2-carboxylate]. The molecular formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Cromolyn sodium, USP is a water-soluble, odorless, white, hydrated crystalline powder.
Overview
DESCRIPTION The active ingredient of cromolyn sodium inhalation solution USP is cromolyn sodium, USP. It is an inhaled anti-inflammatory agent for the preventive management of asthma. Cromolyn sodium, USP is chemically designated as disodium 5,5'- [(2-hydroxytrimethylene)dioxy] bis [4-oxo-4H-1-benzopyran-2-carboxylate]. The molecular formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Cromolyn sodium, USP is a water-soluble, odorless, white, hydrated crystalline powder.
Uses
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 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 should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ).
Dosage
DOSAGE AND ADMINISTRATION For management of bronchial asthma in adults and pediatric patients (two years of age and over), the usual starting dosage is the contents of one vial administered by nebulization four times a day at regular intervals. Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established. Patients with chronic asthma should be advised that the effect of cromolyn sodium inhalation solution therapy is dependent upon its administration at regular intervals, as directed. Cromolyn sodium inhalation solution should be introduced into the patient's therapeutic regimen when the acute episode has been controlled, the airway has been cleared and the patient is able to inhale adequately.
Side Effects
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.
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. CONTRAINDICATIONS Cromolyn sodium inhalation solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Pregnancy
Pregnancy Teratogenic Effects Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg and 164 mg/kg, respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg produced no evidence of fetal malformations. These doses represent approximately 27, 17, and 98 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m 2 basis.
Storage
HOW SUPPLIED Cromolyn Sodium Inhalation Solution Unit-Dose 2 mL Vial is supplied as a colorless solution containing 20 mg cromolyn sodium, USP, in water for injection, USP, with 12 vials per foil pouch containing 5 pouches in a carton NDC: 72162-2307-06: 60 UNIT-DOSE VIALS (12X5 POUCHES) Each vial is made from a low density polyethylene (LDPE) resin.
Frequently Asked Questions
What is Cromolyn Sodium Inhalation used for?▼
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 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 should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ).
What are the side effects of Cromolyn Sodium Inhalation?▼
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.
Can I take Cromolyn Sodium Inhalation during pregnancy?▼
Pregnancy Teratogenic Effects Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg and 164 mg/kg, respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg produced no evidence of fetal malformations. These doses represent approximately 27, 17, and 98 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m 2 basis.
What are the important warnings for Cromolyn Sodium Inhalation?▼
WARNINGS Cromolyn sodium inhalation solution has no role in the treatment of status asthmaticus. Anaphylactic reactions with cromolyn sodium administration have been reported rarely. CONTRAINDICATIONS Cromolyn sodium inhalation solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.