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Side Effects & Adverse Reactions
WARNINGS: The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE: Cromolyn Sodium, USP is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: Each 5 mL ampule of Cromolyn Sodium, USP contains 100 mg Cromolyn Sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium, USP Oral Concentrate is clear, colorless, and sterile. It is intended for oral use.
Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is:
Pharmacologic Category: Mast cell stabilizer
Therapeutic Category: Antiallergic
Sources
Sun Therape Face Spf-35 Manufacturers
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Pharmagel International Inc
Sun Therape Face Spf-35 | Wallace Pharmaceuticals Inc.
DOSAGE AND ADMINISTRATION: NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE.
The usual starting dose is as follows:
Adults and Adolescents (13 Years and Older): Two ampules four times daily, taken one-half hour before meals and at bedtime.
Children 2-12 Years: One ampule four times daily, taken one-half hour before meals and at bedtime.
Pediatric Patients Under 2 Years: Not recommended.
If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day.
Patients should be advised that the effect of Cromolyn Sodium, USP therapy is dependent upon its administration at regular intervals, as directed.
Maintenance Dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained.
Administration: Cromolyn Sodium, USP should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions:
Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. Stir solution. Drink all of the liquid.
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