Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
ANI Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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. Systemic fungal infections (see WARNINGS, Fungal Infections). Dexamethasone tablets are contraindicated in patients who are hypersensitive to any components of this product.
Dexamethasone Tablets, USP are available as follows: 0.5 mg tablets are supplied as a light yellow, round, shallow, biconvex tablet, scored on one side and debossed with “N 398” on the other side. NDC 70954-398-10: Bottle of 100 Tablets 0.75 mg tablets are supplied as a pale blue, round, shallow, biconvex tablet, scored on one side and debossed with “N 399” on the other side. NDC 70954-399-10: Bottle of 100 Tablets 1.5 mg tablets are supplied as a pink, round, shallow, biconvex tablet, scored on one side and debossed with “N 401” on the other side. NDC 70954-401-10: Bottle of 100 Tablets 2 mg tablets are supplied as a white to off white, round, shallow, biconvex tablet, scored on one side and debossed with “N 402” on the other side. NDC 70954-402-10: Bottle of 100 Tablets 4 mg tablets are supplied as a green, round, shallow, biconvex tablet, scored on one side and debossed with “N 403” on the other side. NDC 70954-403-10: Bottle of 100 Tablets NDC 70954-403-30: Unit dose blister packages of 100 (10 cards of 10 Tablets each) 6 mg tablets are supplied as an aqua, round, shallow, biconvex tablet, scored on one side and debossed with “N 404” on the other side. NDC 70954-404-10: Bottle of 100 Tablets Store and Dispense Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight light-resistant, child-resistant container as defined in the USP/NF. All trademarks are the property of their respective owners. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 02/2024 LB4336-02
Abbreviated New Drug Application
DEXAMETHASONE - DEXAMETHASONE TABLET ANI PHARMACEUTICALS, INC. ---------- DEXAMETHASONE TABLETS, USP RX ONLY DESCRIPTION Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 0.5 mg, 0.75 mg, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (0.75 mg, 4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), FD&C Yellow #6 Aluminum Lake (0.5 mg), D&C Yellow #10 Aluminum Lake (0.5 mg, 0.75 mg, 1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9- fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is 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. FDA approved dissolution test specifications differ from USP. 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 & USAGE ALLERGIC STATES Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hyperse Baca dokumen lengkap