DEXAMETHASONE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

AvKARE

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial 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 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 ). Dexamethasone tablets are contraindicated in patients who are hypersensitive to any components of this product.

Produkt oversigt:

Dexamethasone tablets are available as: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP/NF. Product of USA Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 06/21 AV 07/22 (P)

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DEXAMETHASONE- DEXAMETHASONE TABLET
AVKARE
----------
DEXAMETHASONE TABLETS, USP
RX ONLY
RX ONLY
DESCRIPTION
Dexamethasone Tablets 0.5 mg, 0.75 mg, 4 mg and 6 mg are for oral
administration.
Each tablet contains 0.5 mg, 0.75 mg, 4 mg or 6 mg of dexamethasone.
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. It is
designated chemically as 9-fluoro-11β, 17,
21-trihydroxy-16α-methylpregna-1,4-diene-
3,20-dione.
The structural formula is represented below:
C
H
FO
MW 392.47
Each tablet contains anhydrous lactose, croscarmellose sodium,
magnesium stearate,
microcrystalline cellulose and stearic acid. In addition, the 0.5 mg
tablet contains D&C
Yellow #10. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue
#1.
CLINICAL PHARMACOLOGY
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 analogs including dexamethasone are
primarily used
for their anti-inflammatory effects in disorders of many organ
systems.
At equipotent anti-inflammatory doses, dexamethasone almost completely
lacks the
sodium-retaining property of hydrocortisone and closely related
derivatives of
hydrocortisone.
INDICATIONS AND USAGE
22
29
5
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, seasonal or perennial allergic rhinitis
and serum sickness.
DERMATOLOGIC DISEASES
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis
fungoides,
pemphigus, and severe