DEXAMETHASONE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Direct_Rx

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Allergic States 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. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders 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. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, con

Produkt oversigt:

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 NDC 0054-4182-31: Bottle of 1,000 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 a 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 dropper [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 dropper]. 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 dropper provided. Discard opened bottle after 90 days. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 4047401//07 Revised December 2019

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DEXAMETHASONE- DEXAMETHASONE TABLET
DIRECT_RX
----------
DEXAMETHASONE
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 C22H29FO5. The molecular weight is 392.47. It is
designated
chemically as
9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione
and the structural formula is:
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are
readily absorbed from the gastrointestinal tract. Glucocorticoids
cause varied metabolic
effects. In addition, they modify the body's immune responses to
diverse stimuli.
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have
sodium-retaining properties, are used as replacement therapy in
adrenocortical
deficiency states. Their synthetic