CROMOLYN SODIUM solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W)

Sẵn có từ:

Wallace Pharmaceuticals Inc.

INN (Tên quốc tế):

CROMOLYN SODIUM

Thành phần:

CROMOLYN SODIUM 20 mg in 1 mL

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

New Drug Application Authorized Generic

Đặc tính sản phẩm

CROMOLYN SODIUM- CROMOLYN SODIUM SOLUTION
WALLACE PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 3D254410-DC83-4EC8-84D2-94EC803F759E
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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,