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:

Organon LLC

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. Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. The intra-articular or soft tissue administration of CELESTONE SOLUSPAN Injectable Suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. The intralesional administration of CELESTONE SOLUSPAN Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. CELESTONE SOLUSPAN Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). CELESTONE® SOLUSPAN® Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product (see DESCRIPTION ). Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

Product summary:

CELESTONE® SOLUSPAN® Injectable Suspension is supplied as follows: NDC 78206-118-01: 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
ORGANON LLC
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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 (equivalent to 3.95 mg
betamethasone
sodium phosphate USP) 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 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 used as replacement therapy in
adreno