BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

BETAMETHASONE ACETATE

Composition:

BETAMETHASONE ACETATE 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:

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. NDC: 70518-0506-00 5 in 1 MANUFACTURERS PACKAGING 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 Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 REGENT, INC. SHIRLEY, NY 11967 Revised July 2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE-
BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTION,
SUSPENSION
REMEDYREPACK INC.
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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:
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
165ºC, and remelts at about 200ºC to 220ºC with decomposition. It
is practically insoluble in water, but
22
28
2
8
24
31
6
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 cortisone),
which also have salt-retaining
pr