FLORINEF TABLET 0.1 mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

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下载 资料单张 (PIL)
15-05-2014
下载 产品特点 (SPC)
25-03-2024

有效成分:

FLUDROCORTISONE ACETATE

可用日期:

DCH AURIGA SINGAPORE

ATC代码:

H02AA02

剂量:

0.1 mg

药物剂型:

TABLET

组成:

FLUDROCORTISONE ACETATE 0.1 mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Haupt Pharma Amareg GmbH

授权状态:

ACTIVE

授权日期:

1999-01-20

资料单张

                                1 
 
FLORINEF
®
 TABLET 0.1MG  
FLUDROCORTISONE ACETATE
 
 
 
DESCRIPTION  
Round, uniform, biconvex, white
practically odourless tablets. They are free from visible 
impurities. They are scored on one side and engraved on other
side with “SQUIBB” and "429".  
 
FLORINEF
® 
tablet  :  Each tablet contains 0.1mg of
fludrocortisone acetate and the following 
inactive
ingredients :  cornstarch, dicalcium phosphate, lactose,
magnesium stearate, sodium 
benzoate and talc.  
 
 
PHARMACOLOGY  
The active ingredient in FLORINEF
® 
tablets is fludrocortisone (also known as 
fluo(ro)hydrocortisone or fluohydrisone) acetate, a synthetic
adrenocortical steroid with potent 
mineralocorticoid properties and high glucocorticoid activity.
It is used for its mineralocorticoid 
effects.  
 
Corticosteroids are thought to act, at least in part, by
controlling the rate of synthesis of 
proteins at the cellular level. The relationship between this
activity and the metabolic effects is 
not yet totally clear.  
 
The physiologic action of
fludrocortisone acetate is similar to that of hydrocortisone but the 
glucocorticoid effect is 15 times as potent and the
mineralocorticoid effect is 125 times greater. 
Sodium reabsorption in the renal distal tubules and in other
tissues appears to account for the 
physiologic action characteristic of mineralocorticoids. Small
doses of these drugs result in 
marked sodium retention and increased
urinary excretion of potassium and hydrogen. Blood 
pressure is also elevated, apparently because of these effects on
electrolytes. Larger doses 
inhibit endogenous adrenal cortical secretion, thymic activity, and
pituitary corticotropin 
excretion; high doses also promote the deposition of liver
glycogen, and, unless protein intake 
is adequate, induce negative nitrogen balance.  
 
The approximate half-life of fludrocortisone is 18 to
36 hou
                                
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产品特点

                                FLORINEF TABLET 0.1 MG
FLUDROCORTISONE ACETATE
DESCRIPTION
Round, uniform, biconvex, white practically odourless tablets. They
are free from visible impurities.
They are scored on one side and engraved on other side with
“FT01”.
FLORINEF tablet : Each tablet contains 0.1mg of fludrocortisone
acetate and the following inactive
ingredients : cornstarch, dicalcium phosphate, lactose, magnesium
stearate, sodium benzoate and
talc.
PHARMACOLOGY
The active ingredient in FLORINEF tablets is fludrocortisone (also
known as fluo(ro)hydrocortisone or
fluohydrisone) acetate, a synthetic adrenocortical steroid with potent
mineralocorticoid properties
and high glucocorticoid activity. It is used for its mineralocorticoid
effects.
Corticosteroids are thought to act, at least in part, by controlling
the rate of synthesis of proteins at
the cellular level. The relationship between this activity and the
metabolic effects is not yet totally
clear.
The physiologic action of fludrocortisone acetate is similar to that
of hydrocortisone but the
glucocorticoid effect is 15 times as potent and the mineralocorticoid
effect is 125 times greater.
Sodium reabsorption in the renal distal tubules and in other tissues
appears to account for the
physiologic action characteristic of mineralocorticoids. Small doses
of these drugs result in marked
sodium retention and increased urinary excretion of potassium and
hydrogen. Blood pressure is also
elevated, apparently because of these effects on electrolytes. Larger
doses inhibit endogenous
adrenal cortical secretion, thymic activity, and pituitary
corticotropin excretion; high doses also
promote the deposition of liver glycogen, and, unless protein intake
is adequate, induce negative
nitrogen balance.
The approximate half-life of fludrocortisone is 18 to 36 hours. It is
highly protein bound and is
eliminated by the kidneys, mostly as inactive metabolites. Duration of
action is 1 to 2 days.
INDICATIONS AND USAGE
FLORINEF is indicated as partial replacement therapy for primary and
secondary adrenoco
                                
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