BETALOAN SUIK- betamethasone sodium phosphate and betamethasone acetate injection, suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Asclemed USA, Inc.

INN (International namn):

Betamethasone Sodium Phosphate

Sammansättning:

Betamethasone 3 mg in 1 mL

Administreringssätt:

INTRA-ARTICULAR

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.

Produktsammanfattning:

Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01 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

Bemyndigande status:

unapproved drug other

Produktens egenskaper

BETALOAN SUIK- BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE
ACETATE INJECTION, SUSPENSION
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 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:
22
28
2
8
24
31
6
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.
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are
readily absorbed