BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE injection, suspension

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

BETAMETHASONE ACETATE (UNII: TI05AO53L7) (BETAMETHASONE - UNII:9842X06Q6M), BETAMETHASONE SODIUM PHOSPHATE (UNII: 7BK02SCL3W) (BETAMETHASONE - UNII:9842X06Q6M)

可用日期:

American Regent, Inc.

INN（国际名称）:

BETAMETHASONE ACETATE

组成:

BETAMETHASONE ACETATE 3 mg in 1 mL

给药途径:

INTRA-ARTICULAR

处方类型:

PRESCRIPTION DRUG

疗效迹象:

When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency.  Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. Gastrointesti

產品總結:

NDC 0517-0720-01: Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, 5 mL multiple dose vial; box of one. Inactive ingredients per mL: 7.1 mg dibasic sodium phosphate anhydrous; 3.4 mg monobasic sodium phosphate monohydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative. SHAKE WELL BEFORE USING. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].  Protect from light. Rx only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Revised July 2018

授权状态:

Abbreviated New Drug Application

产品特点

BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE-
BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTION,
SUSPENSION
AMERICAN REGENT, INC.
----------
BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTABLE
SUSPENSION, USP, 6
MG/ML
30 MG/5 ML (6 MG/ML)
DESCRIPTION
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable
Suspension is a sterile aqueous
suspension containing 3 mg per milliliter betamethasone, as
betamethasone sodium phosphate, and 3 mg
per milliliter betamethasone acetate. Inactive ingredients per mL: 7.1
mg dibasic sodium phosphate
anhydrous; 3.4 mg monobasic sodium phosphate monohydrate; 0.1 mg
edetate disodium; and 0.2 mg
benzalkonium chloride as a preservative. The pH is adjusted to between
6.8 and 7.2.
The formula for betamethasone sodium phosphate is C
H FNa O P and it has a molecular weight of
516.40. Chemically, it is
9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
21-
(disodium phosphate).
The formula for betamethasone acetate is C
H FO and it has a molecular weight of 434.50.
Chemically, it is
9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
21-acetate.
The chemical structures for betamethasone sodium phosphate and
betamethasone acetate are as follows:
STRUCTURAL FORMULA
STRUCTURAL FORMULA
Betamethasone sodium phosphate is a white to practically white,
odorless powder, and is hygroscopic.
It is freely soluble in water and in methanol, but is practically
insoluble in acetone and in chloroform.
Betamethasone acetate is a white to creamy white, odorless powder that
sinters and resolidifies at about
22
28
2
8
24
31
6
165ºC, and remelts at about 200ºC to 220ºC with decomposition. It
is practically insoluble in water, but
freely soluble in acetone, and is soluble in alcohol and in
chloroform.
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are readily absorbed
from the gastrointestinal tract.
Naturally occurring glucocorticoids (hydrocortisone and co