Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 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 81665-104-96 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), 100 mg/5 mL Carton Label NDC 81665-104-96 Rx Only Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL FOR ORAL USE ONLY – NOT FOR INHALATION OR INJECTION. Must Be Diluted Marketed by: Omnivium Pharmaceuticals LLC Rahway, NJ 07065 96 Plastic Ampules DESCRIPTION: Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water. NOTE: See package insert for full prescribing information including contraindications, warnings and precautions. 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 to use. Cromolyn Carton
- HOW SUPPLIED: 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 81665-104-96 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), 100 mg/5 mL Carton Label NDC 81665-104-96 Rx Only Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL FOR ORAL USE ONLY – NOT FOR INHALATION OR INJECTION. Must Be Diluted Marketed by: Omnivium Pharmaceuticals LLC Rahway, NJ 07065 96 Plastic Ampules DESCRIPTION: Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water. NOTE: See package insert for full prescribing information including contraindications, warnings and precautions. 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 to use. Cromolyn Carton
Overview
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 C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Its chemical structure is: Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic Cromolyn Structure
Indications & Usage
: 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.
Dosage & 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 Oral Solution (Concentrate) 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 Oral Solution (Concentrate) 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.
Warnings & Precautions
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.
Contraindications
: Cromolyn Sodium Oral Solution (Concentrate) is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Adverse Reactions
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 Omnivium Pharmaceuticals LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm. 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
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