DESMOPRESSIN SUMMARY
Desmopressin
Acetate
Injection
DESMOPRESSIN ACETATE Injection 4 µg/mL is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation.
Hemophilia A: DESMOPRESSIN ACETATE Injection 4 µg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.
DESMOPRESSIN ACETATE will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.
DESMOPRESSIN ACETATE will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
DESMOPRESSIN ACETATE is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies.
In certain clinical situations, it may be justified to try DESMOPRESSIN ACETATE in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.
von Willebrand's Disease (Type I): DESMOPRESSIN ACETATE Injection 4 µg/mL is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with factor VIII levels greater than 5%. DESMOPRESSIN ACETATE will often maintain hemostasis in patients with mild to moderate von Willebrand's disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.
DESMOPRESSIN ACETATE will usually stop bleeding in mild to moderate von Willebrand's patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
Those von Willebrand's disease patients who are least likely to respond are those with severe homozygous von Willebrand's disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked during administration of DESMOPRESSIN ACETATE to ensure that adequate levels are being achieved.
DESMOPRESSIN ACETATE is not indicated for the treatment of severe classic von Willebrand's disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen. (See WARNINGS.)
Diabetes Insipidus: DESMOPRESSIN ACETATE Injection 4 µg/mL is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. DESMOPRESSIN ACETATE is ineffective for the treatment of nephrogenic diabetes insipidus.
DESMOPRESSIN ACETATE is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy, create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
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NEWS HIGHLIGHTS
Published Studies Related to Desmopressin
Desmopressin and oxybutynin in monosymptomatic nocturnal enuresis: a randomized,
double-blind, placebo-controlled trial and an assessment of predictive factors. [2012]
evaluated... CONCLUSIONS: Our findings highlight that anticholinergic agents may play an
Efficacy and safety of desmopressin for treatment of nocturia: a systematic review and meta-analysis of double-blinded trials. [2011.09.07]
PURPOSE: The purpose of this analysis was to evaluate the efficacy and safety of desmopressin for the treatment of nocturia... CONCLUSIONS: Administered desmopressin was an effective and well-tolerated treatment for nocturia.
Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial. [2011.06]
BACKGROUND: Bleeding complications occur in one-third of percutaneous kidney biopsies and increase costs of the hospital stay. The aim of the study was to evaluate the effect of prebiopsy administration of desmopressin acetate versus placebo in the incidence of postbiopsy bleeding complications... CONCLUSIONS: Prebiopsy desmopressin administration decreases the risk of bleeding and hematoma size in patients undergoing percutaneous kidney biopsy without a cost increase. Copyright (c) 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
Patients with severe aortic valve stenosis and impaired platelet function benefit from preoperative desmopressin infusion. [2011.05]
BACKGROUND: Patients with severe aortic valve stenosis have a markedly reduced platelet function as measured by a prolonged collagen adenosine diphosphate closure time (CADP-CT) determined by the platelet function analyzer PFA-100. We hypothesized that such patients may benefit from desmopressin when they present with prolonged CADP-CT due to the specific action of desmopressin on von Willebrand factor (VWF) and CADP-CT... CONCLUSIONS: Prolonged CADP-CT indicates platelet dysfunction in severe aortic valve stenosis, and can guide the use of desmopressin as an effective prohemostatic agent in patients with severe aortic valve stenosis. Copyright (c) 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
Reducing nocturia in the elderly: a randomized placebo-controlled trial of staggered furosemide and desmopressin. [2011.03]
AIMS: The purpose of this study was to investigate efficacy, safety, and impact on quality of sleep of staggered furosemide and desmopressin in the treatment of nocturia in the elderly... CONCLUSIONS: Staggered furosemide and desmopressin provide an effective and well-tolerated treatment for nocturia in the elderly. Copyright (c) 2011 Wiley-Liss, Inc.
Clinical Trials Related to Desmopressin
Desmopressin Response in the Young [Completed]
The purpose of this study is to determine whether desmopressin administered as a melt tablet
is effective in reducing the number of wet nights in children and adolescents who suffer from
bedwetting.
Effect of Aspirin, Hemodilution and Desmopressin on Platelet Dysfunction [Not yet recruiting]
Study hypothesis: Desmopressin (DDAVP) can improve platelet function under influence of
aspirin, hemodilution and mild hypothermia
Mild hypothermia (34-35oC) is known to cause platelet dysfunction. This could lead to
increased surgical bleeding and increased transfusion requirement during surgery. Although
this hypothermia-induced platelet dysfunction seems to be reversible with warming, this is
not always possible or desirable.
Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in
uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a
recent study, we have found that subcutaneous injection of 1. 5 mcg (1/10th the usual dose)
is already sufficient to fully reverse the platelet dysfunction seen at 32oC. We have
demonstrated in another study that prolongation of the bleeding time in a 20% hemodiluted
sample predicts increased postoperative bleeding after total knee replacement.
We have therefore designed this study as a follow up to our last two studies on DDAVP and
hypothermia, to investigate whether hemodilution affects hypothermia induced platelet
dysfunction and the response to DDAVP. In addition, another common cause of perioperative
platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients.
Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response
to DDAVP, will also be investigated.
Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation [Not yet recruiting]
Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are
considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal
enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal
spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%,
tablet 0. 2%, MELT 0. 5%). There 's insufficient evidence to confirm the actually used
bioequivalent doses ( 10µg spray = 120µg MELT= 0. 2mg tablet).
Although so frequently used, very few pharmacokinetic and - dynamic data on desmopressin are
available for children.
Due to prolonged half life, associated with waterintoxication,the nasal spray has a black
box warning from the FDA and is no longer recommended . For some authors oral formulations
appear to be a safer alternative. However, based on clinical experience of less response
rate with oral formulations, lower biodisponibility is suspected. Adult research confirms
low bioavailability of tablets but also show major influences by food-intake and changes in
gastro-intestinal motility.
To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before
bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never
is 3 hours between evening meal and bedtime.
In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties
for desmopressin Lyophilisate MELT formula.
Since these results implicate superior action of MELT, often a change to MELT is recommended
if there is a suboptimal response with tablet: sublingual absorption would eliminate the
influence of food-intake.
However, for this statement there's no evidence, since these tests were all conducted in
children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT
and tablet.
Hypothesis is that desmopressin MELT formulation has a better bioavailability when
administered together with meal due to its sublingual absorption.
Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic [Recruiting]
In this study we will compare pain intensity and side effects at different time points after
the intranasal administration of desmopressin or placebo in patients with acute renal colic
pain.
Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients [Recruiting]
The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia
in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the
quality of life will be measured.
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