DEXAMETHASONE 1.5 MG tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Proficient Rx LP

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous: 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. Neoplastic Diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases: 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. Contraindicated in systemic fungal infections (see WARNINGS: Infections: Fungal Infections ) and patients with known hypersensitivity to the product and its consituents.

Přehled produktů:

Dexamethasone Tablets USP, 1.5 mg are supplied as white, round shaped tablets debossed “702” on one side and bisected on the opposite side. The bisect on the tablet provides for a functional scoring of the tablet to ensure accurate breaking. They are available in packages of 21 tablets, with a child resistant closure, (6-Day Dose Pack, NDC 82804-059-21). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a well-closed, light-resistant container as defined in the USP/NF. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 500393-07 Rev. 06/2017

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DEXAMETHASONE 1.5 MG- DEXAMETHASONE 1.5 MG TABLET
PROFICIENT RX LP
----------
DEXAMETHASONE TABLETS USP, 1.5 MG
RX ONLY
DESCRIPTION
Dexamethasone Tablets USP, 1.5 mg
Each tablet contains: Dexamethasone USP … 1.5 mg.
For oral administration.
INACTIVE INGREDIENT
Dexamethasone Tablets USP, 1.5 mg contain lactose monohydrate,
magnesium
stearate, starch and compressible sugar.
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
molecular formula is C
H
FO
. 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:
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.
22
29
5
INDICATIONS AND USAGE
_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 seco