CELESTONE SOLUSPAN- betamethasone acetate and betamethasone sodium phosphate 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.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

When oral therapy is not feasible, the intramuscular use of CELESTONE ® SOLUSPAN ® Injectable Suspension is indicated as follows: 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. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). 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. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acq

Product summary:

CELESTONE ® SOLUSPAN ® Injectable Suspension is supplied as follows: NDC 0085-4320-01: CELESTONE SOLUSPAN Injectable Suspension, 5-mL multiple-dose vial; box of one. Inactive ingredients per mL: 8.9 mg dibasic sodium phosphate dihydrate; 3.8 mg monobasic sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative. SHAKE WELL BEFORE USING. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

CELESTONE SOLUSPAN- BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM
PHOSPHATE INJECTION, SUSPENSION
REMEDYREPACK INC.
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CELESTONE SOLUSPAN
(BETAMETHASONE SODIUM PHOSPHATE
AND BETAMETHASONE ACETATE) INJECTABLE SUSPENSION, USP
30 MG/5 ML (6 MG/ML)
DESCRIPTION
CELESTONE
SOLUSPAN
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: 8.9 mg dibasic sodium phosphate
dihydrate; 3.8 mg monobasic
sodium phosphate dihydrate; 0.1 mg edetate disodium; and 0.2 mg
benzalkonium chloride as
preservative. The pH is adjusted to between 6.8 and 7.2.
The formula for betamethasone sodium phosphate is C
H
FNa
0
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.
®
®
®
®
22
28
2
8
24
31
6
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
165°C, and remelts at about 200°C-220°C 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