Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
METHYLPREDNISOLONE
PFIZER INDONESIA - Indonesia
METHYLPREDNISOLONE
16 MG
TABLET
DUS, 3 BLISTER @ 10 TABLET
PFIZER ITALIA S.R.L - Italy
2016-01-04
PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Methylprednisolone tablets Trade Name: MEDROL ® CDS Effective Date: June 26, 2019 Supersedes: January 03, 2018 DESCRIPTION MEDROL ® Tablets contain methylprednisolone, which is a glucocorticoid. Glucocorticoids are adrenocortical steroids but naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1, 4-diene-3, 20-dione, 11, 17, 21- trihydroxy-6-methyl-, (6α, 11β) - and the molecular weight is 374.48. The structural formula is represented below: Each MEDROL ® Tablet for oral administrations contains 4 mg and 16 mg of methylprednisolone. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorder of many organ systems. It has greater anti-inflammatory potency than prednisolone and less tendency than prednisolone to induce sodium and water retention. The relative potency of methylprednisolone to hydrocortisone is at least four to one. DISETUJUI OLEH BPOM : 15/02/2022 EREG100241119000329 -330 Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli. PHARMACOKINETIC PROPERTIES Methylprednisolone pharmacokinetics is linear, independent of route of administration. ABSORPTION: Methylprednisolone is rapidly absorbed and the maximum plasma methylprednisolone concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adul Izlasiet visu dokumentu