Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Blenheim Pharmacal, Inc.
DEXAMETHASONE
DEXAMETHASONE 1.5 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, seasonal or perennial allergic rhinitis and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycisis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first 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 (Diamon-Blackfan anemia), idiopathic thrombocytopenic purpura in adult
Dexamethasone tablets are available as: 1.5 mg tablets scored (pink), debossed “Par-086” and supplied in bottles of 10, NDC 10544-211-10. 4 mg tablets scored (white), debossed “Par-087” and supplied in bottles of 6, NDC 10544-212-06. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP/NF. Manufactured by: Par Pharmaceutical Companies, Inc. Spring Valley, N.Y. 10977 Marketed/ Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131, (USA) Revised: 07/2010
Abbreviated New Drug Application
DEXAMETHASONE- DEXAMETHASONE TABLET BLENHEIM PHARMACAL, INC. ---------- DEXAMETHASONE TABLETS, USP DESCRIPTION Dexamethasone Tablets 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 1.5 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 and FD&C Yellow #5. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1. The 1.5 mg tablet contains FD&C Red #40. The 6 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6. 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 ALLERGIC STATES 22 29 5 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 allerg Izlasiet visu dokumentu