Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
METHYLPREDNISOLONE ACETATE (UNII: 43502P7F0P) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
Sandoz Inc
METHYLPREDNISOLONE ACETATE
METHYLPREDNISOLONE ACETATE 40 mg in 1 mL
INTRA-ARTICULAR
PRESCRIPTION DRUG
When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of methylprednisolone acetate injectable suspension, USP is indicated as follows: 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, serum sickness, transfusion reactions. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance) congenital adrenal hyperplasia, hypercalcemia associated with c
Methylprednisolone acetate injectable suspension, USP is available in the following strengths and package sizes: 40 mg per mL NDC 0781-3131-71 single-dose vial of 1 mL in boxes of 1 NDC 0781-3131-95 single-dose vial of 1 mL in boxes of 10 80 mg per mL NDC 0781-3132-71 single-dose vial of 1 mL in boxes of 1 NDC 0781-3132-95 single-dose vial of 1 mL in boxes of 10 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION SANDOZ INC ---------- METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP NOT FOR INTRAVENOUS USE DESCRIPTION Methylprednisolone acetate injectable suspension, USP is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue or intralesional injection. It is available as single dose vials in two strengths: 40 mg/mL; 80 mg/mL. Each mL of these preparations contains: METHYLPREDNISOLONE ACETATE 40 MG 80 MG Polyethylene glycol 3350 29 mg 28 mg Myristyl gamma picolinium chloride 0.19 mg 0.19 mg Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range; e.g., 3.0 to 7.0. The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)- 11,17-dihydroxy-6-methyl-, (6α, 11β)- and the molecular weight is 416.51. The structural formula is represented below: Methylprednisolone acetate sterile injectable suspension, USP contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, in alcohol, in chloroform, and in methanol, and slightly soluble in ether. It is practically insoluble in water. CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic are adrenocortical steroids. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt retaining properties, are used in replacement therapy in adrenocortical deficiency states. Their synthetic analogs are used primarily for their anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune response to diverse stimuli. INDICATIONS AND USAGE A. Baca dokumen lengkap