দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
PD-Rx Pharmaceuticals, Inc.
METHYLPREDNISOLONE
METHYLPREDNISOLONE 4 mg
ORAL
PRESCRIPTION DRUG
Methylprednisolone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematos
Methylprednisolone tablets, USP are available in the following strengths and package sizes: 4 mg (white, flat faced, oval shaped with a beveled edge. The upper layer is quadrisected and debossed “42/16/V” with the “42/16” above the lengthwise bisect and the “V” in the lower righthand corner. The lower layer is debossed “4”) Dispense in a tight light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Abbreviated New Drug Application
METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET PD-RX PHARMACEUTICALS, INC. ---------- METHYLPREDNISOLONE TABLETS USP RX ONLY DESCRIPTION Methylprednisolone tablets, USP contain methylprednisolone, USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, 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, USP 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 methylprednisolone tablet, USP for oral administration contains 4 mg of methylprednisolone, USP. Inactive ingredients: magnesium stearate, microcrystalline cellulose and sodium starch glycolate. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), 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 disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. INDICATIONS AND USAGE Methylprednisolone tablets are indicated in the following conditions: 1. ENDOCRINE DISORDERS Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. RHEUMATIC DISORDERS As adjunctive therapy for short-term administration (to tide th সম্পূর্ণ নথি পড়ুন