READYSHARP BETAMETHASONE- betamethasone sodium phosphate and betamethasone acetate injection, suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Preferred Pharmaceuticals Inc.

Administreringssätt:

INTRALESIONAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 68788-7327-1 SHAKE WELL BEFORE USING. Store at 20°C to 25°C (68°F 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 September 2015 Relabeled By: Preferred Pharmaceuticals Inc.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

READYSHARP BETAMETHASONE- BETAMETHASONE SODIUM PHOSPHATE AND
BETAMETHASONE
ACETATE INJECTION, SUSPENSION
PREFERRED PHARMACEUTICALS INC.
----------
READYSHARP BETAMETHASONE
30 MG/5 ML (6 MG PER ML)
DESCRIPTION
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable
Suspension, USP is a sterile
aqueous suspension containing betamethasone 3 mg per milliliter as
betamethasone sodium phosphate,
and betamethasone acetate 3 mg per milliliter. Inactive ingredients
per mL: dibasic sodium phosphate
7.1 mg; monobasic sodium phosphate 3.4 mg; edetate disodium 0.1 mg;
and benzalkonium chloride 0.2
mg 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
freely soluble in acetone, and is soluble in alcohol and in
chloroform.
22
28
2
8
24
31
6
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
properties, are used as replacement therapy in adrenocortical
deficiency states. Their synthetic analog