DEXAMETHASONE tablet DEXAMETHASONE INTENSOL solution, concentrate DEXAMETHASONE solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Sẵn có từ:

Hikma Pharmaceuticals USA, Inc.

INN (Tên quốc tế):

DEXAMETHASONE

Thành phần:

DEXAMETHASONE 0.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a 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. 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. Systemic fungal infections (see WARNINGS: Fungal Infections ) and in patients who are hypersensitive to any components of these products.

Tóm tắt sản phẩm:

Dexamethasone Tablets, USP 0.5 mg tablets are supplied as a light yellow, flat tablet with beveled edges, scored on one side and product identification “54 299” debossed on the other side. NDC 0054-8179-25: 10x10 Unit-Dose NDC 0054-4179-25: Bottle of 100 Tablets 0.75 mg tablets are supplied as a pale blue, flat tablet with beveled edges, scored on one side and product identification “54 960” debossed on the other side. NDC 0054-8180-25: 10x10 Unit-Dose NDC 0054-4180-25: Bottle of 100 Tablets 1 mg tablets are supplied as a yellow, flat tablet with beveled edges, scored on one side and product identification “54 489” debossed on the other side. NDC 0054-8174-25: 10x10 Unit-Dose NDC 0054-4181-25: Bottle of 100 Tablets 1.5 mg tablets are supplied as a pink, flat tablet with beveled edges, scored on one side and product identification “54 943” debossed on the other side. NDC 0054-8181-25: 10x10 Unit-Dose NDC 0054-4182-25: Bottle of 100 Tablets 2 mg tablets are supplied as a white, flat tablet with beveled edges, scored on one side and product identification “54 662” debossed on the other side. NDC 0054-8176-25: 10x10 Unit-Dose NDC 0054-4183-25: Bottle of 100 Tablets 4 mg tablets are supplied as a green, flat tablet with beveled edges, scored on one side and product identification “54 892” debossed on the other side. NDC 0054-8175-25: 10x10 Unit-Dose NDC 0054-4184-25: Bottle of 100 Tablets 6 mg tablets are supplied as an aqua, flat tablet with beveled edges, scored on one side and product identification “54 769” debossed on the other side. NDC 0054-8183-25: 10x10 Unit-Dose NDC 0054-4186-25: Bottle of 100 Tablets Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight light-resistant, child-resistant container as defined in the USP/NF. Dexamethasone Oral Solution, USP 0.5 mg per 5 mL oral solution is supplied as a (cherry brandy flavored) clear colorless solution. NDC 0054-3177-57: Bottle of 240 mL NDC 0054-3177-63: Bottle of 500 mL Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight light-resistant, child-resistant container as defined in the USP/NF. Dexamethasone Oral Solution, USP Intensol ™ (Concentrate) 1 mg per mL oral solution is supplied as a clear colorless solution. NDC 0054-3176-44: Bottle of 30 mL with calibrated oral syringe [graduation of 0.25 mL (0.25 mg), 0.5 mL (0.5 mg), 0.75 mL (0.75 mg) and 1 mL (1 mg) on the oral syringe]. Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Do not use if solution contains a precipitate. Dispense only in this bottle and only with the calibrated oral syringe provided. Discard opened bottle after 90 days. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C5000comb/02/k01 Revised February 2024

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DEXAMETHASONE- DEXAMETHASONE TABLET
DEXAMETHASONE INTENSOL- DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE
DEXAMETHASONE- DEXAMETHASONE SOLUTION
HIKMA PHARMACEUTICALS USA, INC.
----------
DEXAMETHASONE TABLETS, USP
DEXAMETHASONE ORAL SOLUTION, USP AND
DEXAMETHASONE ORAL SOLUTION, USP _INTENSOL_™ (CONCENTRATE)
DESCRIPTION
Dexamethasone Tablets, USP are available for oral administration
containing either 0.5
mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone, USP.
Each tablet
contains the following inactive ingredients: lactose monohydrate,
magnesium stearate,
starch, sugar, D&C Yellow #10 (0.5 mg and 4 mg), FD&C Blue #1 (0.75 mg
and 1.5
mg), FD&C Green #3 (4 mg and 6 mg), FD&C Red #3 (1.5 mg), FD&C Red #40
(1.5
mg), FD&C Yellow #6 (0.5 mg and 4 mg) and Yellow Iron Oxide (1 mg).
Dexamethasone Oral Solution, USP is formulated for oral administration
containing 0.5
mg per 5 mL of dexamethasone, USP. The cherry brandy flavored oral
solution contains
the following inactive ingredients: anhydrous citric acid, cherry
brandy flavor, disodium
edetate, glycerin, methylparaben, propylene glycol, propylparaben,
sorbitol solution and
water.
Dexamethasone Oral Solution, USP _Intensol_™ (Concentrate) is
formulated for oral
administration containing 1 mg per mL of dexamethasone, USP. In
addition, the oral
solution contains the following inactive ingredients: alcohol 30% v/v,
anhydrous citric
acid, benzoic acid, disodium edetate, propylene glycol and water.
Dexamethasone, a synthetic adrenocortical steroid, is a white to
practically white,
odorless, crystalline powder. It is stable in air. It is practically
insoluble in water. The
empirical formula is C
H
FO . The molecular weight is 392.46. It is designated
chemically as
9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione
and the structural formula is:
CLINICAL PHARMACOLOGY
22
29
5
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are
readily absorbed from the gastrointestinal tract. Glucocorticoids
cause varied m