BETALIDO KIT- betamethasone sodium phosphate, betamethasone acetate, lidocaine, povidine iodine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Asclemed USA, Inc.

INN (International Name):

Betamethasone Sodium Phosphate

Composition:

Betamethasone 3 mg in 1 mL

Administration route:

INTRA-ARTICULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 Lidocaine Hydrochloride Injection, USP is supplied as follows: Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) 5 mL Single Dose Vials             NDC 55150-162-05 Sterile, Nonpyrogenic Discard unused portion Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The vial stopper is not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: February 2020

Authorization status:

unapproved drug other

Summary of Product characteristics

BETALIDO KIT- BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE,
LIDOCAINE, POVIDINE
IODINE
ASCLEMED USA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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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.
22
28
2
8
24
31
6
Betamethasone acetate is a white to creamy white, odorless powder that
sinters and resolidifies at about
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