Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Lake Erie Medical DBA Quality Care Products LLC
DEXAMETHASONE
DEXAMETHASONE 4 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, perennial or seasonal 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 a
4 mg green, scored tablets (Identified 54 892). NDC# 49999-059-06 6 tab/btl NDC# 49999-059-12 12 TAB/BTL NDC# 49999-059-30 30 tab/btl NDC# 49999-059-60 60 tab/btl NDC# 49999-059-90 90 tab/btl 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.
Abbreviated New Drug Application
DEXAMETHASONE- DEXAMETHASONE TABLET LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- DEXAMETHASONE TABLETS USP, RX ONLY DES CRIPTION Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol™ Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains: Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg Each 5 mL of Oral Solution contains: Dexamethasone....................................................... 0.5 mg Each mL of Intensol ™ Oral Solution (Concentrate) contains: Dexamethasone....................................................... 1 mg Alcohol 30% 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 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 Lestu allt skjalið