দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
PREDNISOLONE (UNII: 9PHQ9Y1OLM) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
PREDNISOLONE Oral Solution is 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: - Psoriatic arthritis - Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) - Ankylosing spondylitis - Acute and subacute bursitis - Acute nonspecific tenosynovitis - Acute gouty arthritis - Post-traumatic osteoarthritis - Synovitis of osteoarthritis - Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: -
Prednisolone Oral Solution containing 15 mg of Prednisolone in each 5 mL (teaspoonful) is a red cherry flavored liquid and is supplied in 240 mL bottles and 480 mL bottles. Pharmacist: Dispense 15 mg/5 mL Prednisolone Oral Solution with suitable calibrated measuring device to assure proper measuring of dose. Dispense in tight, light-resistant and child-resistant container as defined in USP/NF. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT REFRIGERATE. HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev.042:05 01/17
Abbreviated New Drug Application
PREDNISOLONE- PREDNISOLONE SOLUTION REMEDYREPACK INC. ---------- PREDNISOLONE ORAL SOLUTION USP 15 MG PER 5 ML RX ONLY DESCRIPTION PREDNISOLONE ORAL SOLUTION contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol, slightly soluble in chloroform. The chemical name for Prednisolone is Pregna-1,4 -diene -3, 20 - dione, 11, 17, 21- trihydroxy-,(11β). Its molecular weight is 360.45. The molecular formula is C H O and the structural formula is: PREDNISOLONE ORAL SOLUTION contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40. CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs such as prednisolone are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids such as prednisolone cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli. INDICATIONS AND USAGE 21 28 5 PREDNISOLONE ORAL SOLUTION is 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). 1. Congenital adrenal hyperplasia 2. Nonsuppurative thyroiditis 3. Hypercalcem সম্পূর্ণ নথি পড়ুন