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CROMOLYN SODIUM
Overview
What is CROMOLYN SODIUM?
Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) 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 Oral Solution (Concentrate) is clear, colorless, and sterile. It is intended for oral use.
Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxy-trimethylene) dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is CHNaO; the molecular weight is 512.34. Its chemical structure is:
Pharmacologic Category: Mast cell stabilizer
Therapeutic Category: Antiallergic
What does CROMOLYN SODIUM look like?
What are the available doses of CROMOLYN SODIUM?
Sorry No records found.
What should I talk to my health care provider before I take CROMOLYN SODIUM?
Sorry No records found
How should I use CROMOLYN SODIUM?
Cromolyn Sodium Oral Solution (Concentrate) 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.
NOT FOR INHALATION OR INJECTION. SEE .
The usual starting dose is as follows:
Adults and Adolescents (13 Years and Older):
Children 2-12 Years:
Pediatric Patients Under 2 Years:
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 Oral Solution (Concentrate) therapy is dependent upon its administration at regular intervals, as directed.
What interacts with CROMOLYN SODIUM?
Sorry No Records found
What are the warnings of CROMOLYN SODIUM?
Sorry No Records found
What are the precautions of CROMOLYN SODIUM?
Sorry No Records found
What are the side effects of CROMOLYN SODIUM?
Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received Cromolyn Sodium Oral Solution (Concentrate) during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded.
To report SUSPECTED ADVERSE REACTIONS, contact Ailex Pharmaceuticals, LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Other Adverse Events:
Other less commonly reported events (the majority representing only a single report) include the following:
| Skin: | pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity |
| Musculoskeletal: | arthralgia, myalgia, stiffness/weakness of legs |
| Neurologic: | headache, dizziness, hypoesthesia, paresthesia, migraine, convulsions, flushing |
| Psychiatric: | psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness |
| Heart Rate: | tachycardia, premature ventricular contractions (PVCs), palpitations |
| Respiratory: | pharyngitis, dyspnea |
| Miscellaneous: | fatigue, edema, unpleasant taste, chest pain, postprandial lightheadedness and lethargy, dysuria, urinary frequency, purpura, hepatic function test abnormal, polycythemia, neutropenia, pancytopenia, tinnitus, lupus erythematosus (LE) syndrome |
What should I look out for while using CROMOLYN SODIUM?
Cromolyn Sodium Oral Solution (Concentrate) is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
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.
What might happen if I take too much CROMOLYN SODIUM?
Sorry No Records found
How should I store and handle CROMOLYN SODIUM?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP. Cromolyn Sodium Oral Solution (Concentrate) is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch.Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.NDC 70556-101-96 96 ampules x 5 mL (12 pouches x 8 ampules)Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature] and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.Store ampules in foil pouch until ready for use. Cromolyn Sodium Oral Solution (Concentrate) is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch.Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.NDC 70556-101-96 96 ampules x 5 mL (12 pouches x 8 ampules)Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature] and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.Store ampules in foil pouch until ready for use. Cromolyn Sodium Oral Solution (Concentrate) is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch.Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.NDC 70556-101-96 96 ampules x 5 mL (12 pouches x 8 ampules)Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature] and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.Store ampules in foil pouch until ready for use. Cromolyn Sodium Oral Solution (Concentrate) is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch.Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.NDC 70556-101-96 96 ampules x 5 mL (12 pouches x 8 ampules)Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature] and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.Store ampules in foil pouch until ready for use. Cromolyn Sodium Oral Solution (Concentrate) is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch.Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.NDC 70556-101-96 96 ampules x 5 mL (12 pouches x 8 ampules)Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature] and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.Store ampules in foil pouch until ready for use.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
In vitro
in vivo
Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity.
Cromolyn sodium is poorly absorbed from the gastrointestinal tract. No more than 1% of an administered dose is absorbed by humans after oral administration, the remainder being excreted in the feces. Very little absorption of cromolyn sodium was seen after oral administration of 500 mg by mouth to each of 12 volunteers. From 0.28 to 0.50% of the administered dose was recovered in the first 24 hours of urinary excretion in 3 subjects. The mean urinary excretion of an administered dose over 24 hours in the remaining 9 subjects was 0.45%.
Non-Clinical Toxicology
Cromolyn Sodium Oral Solution (Concentrate) is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.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.
Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia. Cyclopropane anesthesia may modify oxytocin's cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia.
In view of the biliary and renal routes of excretion of Cromolyn Sodium Oral Solution (Concentrate), consideration should be given to decreasing the dosage of the drug in patients with impaired renal or hepatic function.
Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received Cromolyn Sodium Oral Solution (Concentrate) during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded.
To report SUSPECTED ADVERSE REACTIONS, contact Ailex Pharmaceuticals, LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Other Adverse Events:
Other less commonly reported events (the majority representing only a single report) include the following:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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