Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W)
Wallace Pharmaceuticals Inc.
CROMOLYN SODIUM
CROMOLYN SODIUM 20 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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. Cromolyn Sodium, USP is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Cromolyn Sodium, USP Oral 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 51525-0470-8 8 ampules x 5 mL NDC 51525-0470-9 96 ampules x 5 mL Cromolyn Sodium, USP Oral Concentrate should be stored between 15°-30°C (59°-86°F) 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. Distributed by: Wallace Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. Wallace and are trademarks of Wallace Pharmaceuticals Inc., a Viatris Company. © 2023 Viatris Inc. Rev. 6/2023 STW-PRS7096-642R03 IN-0470-04
New Drug Application Authorized Generic
CROMOLYN SODIUM- CROMOLYN SODIUM SOLUTION WALLACE PHARMACEUTICALS INC. REFERENCE LABEL SET ID: 3D254410-DC83-4EC8-84D2-94EC803F759E ---------- CROMOLYN SODIUM, USP FOR ORAL USE ONLY – NOT FOR INHALATION OR INJECTION. 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 C H Na O ; the molecular weight is 512.34. Its chemical structure is: Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic CLINICAL PHARMACOLOGY In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the release of mediators from sensitized mast cells. Cromolyn sodium acts by inhibiting the release of histamine and leukotrienes (SRS-A) from the mast cell. 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%. CLINICAL STUDIES 23 14 2 11 Four randomized, controlled clinical trials were conducted with Cromolyn Sodium, USP in patients with either cutaneous or systemic mastocytosis; two of which utilized a placebo-controlled crossover design, one utilized an active-controlled (chlorpheniramine plus cimetidine) crossover design, Soma hati kamili