Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Hikma Pharmaceuticals USA, Inc.
DEXAMETHASONE
DEXAMETHASONE 0.5 mg
ORAL
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
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 Soma hati kamili