SUMMARY
FLUDROCORTISONE ACETATE TABLETS, USP
0.1 mg
Fludrocortisone Acetate Tablets, USP contains fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects.
Fludrocortisone Acetate Tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.
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NEWS HIGHLIGHTS
Published Studies Related to Fludrocortisone
Nonpharmacological treatment, fludrocortisone, and domperidone for orthostatic hypotension in Parkinson's disease. [2007.08.15]
There is limited evidence for the treatment of orthostatic hypotension in idiopathic Parkinson's disease. The objective of this study was to determine the efficacy of three treatments (nonpharmacological therapy, fludrocortisone, and domperidone)... There was a trend towards reduced blood pressure drop on tilt table testing, with domperidone having a greater effect.
Nonpharmacological treatment, fludrocortisone, and domperidone for orthostatic hypotension in Parkinson's disease. [2007.06.07]
There is limited evidence for the treatment of orthostatic hypotension in idiopathic Parkinson's disease. The objective of this study was to determine the efficacy of three treatments (nonpharmacological therapy, fludrocortisone, and domperidone)... There was a trend towards reduced blood pressure drop on tilt table testing, with domperidone having a greater effect.
The Second Prevention of Syncope Trial (POST II)--a randomized clinical trial of fludrocortisone for the prevention of neurally mediated syncope: rationale and study design. [2006.06]
BACKGROUND: Neurally mediated syncope is a common and frequently distressing problem. It is associated with a poor quality of life, which improves when the frequency of syncope is reduced...
A randomized controlled trial of fludrocortisone for the treatment of hyperkalemia in hemodialysis patients. [2006.05]
BACKGROUND: Previous small uncontrolled studies suggested that fludrocortisone may significantly decrease serum potassium concentrations in hemodialysis patients, possibly through enhancement of colonic potassium secretion. The aim of this study is to evaluate the effect of oral fludrocortisone on serum potassium concentrations in hyperkalemic hemodialysis patients in an open-label randomized controlled trial... CONCLUSION: Administering fludrocortisone to hyperkalemic hemodialysis patients is safe and well tolerated, but does not achieve clinically important decreases in serum potassium levels.
Effectiveness of fludrocortisone and salt in preventing syncope recurrence in children: a double-blind, placebo-controlled, randomized trial. [2005.02.15]
OBJECTIVES: We sought to evaluate the effectiveness of salt and fludrocortisone versus placebo in the prevention of syncope recurrence in children. BACKGROUND: Intravascular volume expansion with fludrocortisone and salt has been reported to be effective in the treatment of syncope in children. However, no pediatric placebo-controlled data are available on the effectiveness of this mode of therapy... CONCLUSIONS: These data, coupled with the reported comparable effect of many medications used in the treatment of syncope, raise the potential of a significant placebo effect with pharmacologic therapy.
Clinical Trials Related to Fludrocortisone
Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression [Recruiting]
Septic shock (associated with relative adrenal insufficiency) is characterized by decreased
arterial responsiveness to catecholamines. The association of hydrocortisone and
fludrocortisone has demonstrated an improvement in survival in septic shock patients. If
hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone
remains to be elucidated. The purpose of our study is to investigate the effect of a
physiological dose of fludrocortisone and/or hydrocortisone on phenylephrine-mean arterial
pressure dose-response relationship in healthy volunteers with aldosterone suppression
induced by intravenous sodium loading.
Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis [Recruiting]
Clinical Trial for the Prevention of Vasovagal Syncope [Recruiting]
The main question in the study is whether people taking fludrocortisone are less likely to
faint than people taking an inactive pill called a placebo.
Fludrocortisone is a drug that stimulates the body to retain salt and water. The
investigators know from some studies that it might prevent people from fainting at home and
in the community, while they are carrying on with their lives. There is some evidence that
salt and water retention help prevent fainting, but no one has a clear idea about whether
this is true. This study will try to determine if that is true.
Activated Protein C and Corticosteroids for Human Septic Shock [Recruiting]
This study aims at comparing the efficacy and safety of recombinant human activated protein
C to that of low dose of corticosteroids and at investigating the interaction between these
drugs in the management of septic shock
Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock [Recruiting]
This study will compare, in adults with septic shock, the safety and efficacy of a
combination of moderate doses of corticosteroids and intensive insulin therapy to that of
moderate doses of corticosteroids. In addition, this study will compare the efficacy and
safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone
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