Drug Catalog - Product Detail
CROMOLYN SODIUM ORAL SOLUTION SOL 100MG/5ML 12X8X5ML UD
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 16571-0600-96 | PACK PHARMACEUTICALS, LLC | 5 | 100MG/5ML | LIQUID |
PACKAGE FILES
Generic Name
CROMOLYN SODIUM
Substance Name
CROMOLYN SODIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202583
Description
DESCRIPTION: 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
How Supplied
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 16571-600-96 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.
Indications & Usage
INDICATIONS AND 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 and Administration
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 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.