READYSHARP BETAMETHASONE- 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:

Terrain Pharmaceuticals

INN (International Name):

BETAMETHASONE ACETATE

Composition:

BETAMETHASONE ACETATE 3 mg in 1 mL

Administration route:

INTRALESIONAL

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

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

READYSHARP BETAMETHASONE- BETAMETHASONE SODIUM PHOSPHATE AND
BETAMETHASONE ACETATE INJECTION, SUSPENSION
TERRAIN PHARMACEUTICALS
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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:
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 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 analogs ar