BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE SODIUM PHOSPHATE (UNII: 7BK02SCL3W) (BETAMETHASONE - UNII:9842X06Q6M), BETAMETHASONE ACETATE (UNII: TI05AO53L7) (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 Betamethasone Sodium Phosphate and Betamethasone Acetate 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 r

Product summary:

Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is supplied as follows: NDC: 70518-2952-00 PACKAGING: 1 in 1 BOX , 5 mL in 1 VIAL MULTI DOSE, TYPE 0 Betamethasone Sodium Phosphate and Betamethasone Acetate 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. Rx only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

New Drug Application Authorized Generic

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
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: 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:
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 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