STIMATE SUMMARY
Stimate®
(desmopressin acetate)
Nasal Spray, 1.5 mg/mL
Stimate® (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. Stimate® Nasal Spray contains 1.5 mg/mL desmopressin acetate in a pH-adjusted aqueous solution with chlorobutanol and sodium chloride as inactive ingredients. Stimate® Nasal Spray's compression pump delivers 0.1 mL (150 µg) of solution per spray.
Before the initial therapeutic administration of Stimate® Nasal Spray, the physician should establish that the patient shows an appropriate change in the coagulation profile following a test dose of intranasal administration of Stimate® Nasal Spray.2-4
Desmopressin acetate is also available as a solution for injection (DDAVP® Injection) when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness.
Hemophilia A
Stimate® Nasal Spray is indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5%.
Desmopressin acetate will also stop bleeding in patients with hemophilia A with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.2,3
In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate® Nasal Spray provided effective hemostasis 100% of the time in 2 of the 5 patients. For those patients not responding in 100% of bleeding occasions, 45% (14 of 31) of bleeding episodes were effectively controlled with Stimate® Nasal Spray.
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.
von Willebrand's Disease (Type I)
Stimate® Nasal Spray 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 also stop bleeding in mild to moderate von Willebrand's disease patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas, mucosal bleeding or menorrhagia.2,3
In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate® Nasal Spray provided effective hemostasis 100% of the time in 75% of the patients (n=16). For those patients not responding in 100% of bleeding occasions, 78% (64 of 82) of bleeding episodes were effectively controlled with Stimate® Nasal Spray.
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 after initial administration of Stimate® Nasal Spray to ensure that adequate levels have been achieved.
Stimate® Nasal Spray 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.
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Published Studies Related to Stimate (Desmopressin Nasal)
Effects of desmopressin on the sleep of children suffering from enuresis. [2010.07]
AIM: To evaluate the effect of 1-desamino-8-D-Arginine Vasopressin (DDAVP) on sleep architecture and arousal reactions in children with primary monosymptomatic nocturnal enuresis (PME)... CONCLUSION: DDAVP has no effect on the sleep architecture of children with PME when analysed by classical PSG, which is determined by collecting the electric activity of cortical neurons. Taking recent research findings into account, this supports the thesis that the disturbances causing PME occur at brain stem level and do not reach consciousness.
Intranasal desmopressin versus blood transfusion in cirrhotic patients with coagulopathy undergoing dental extraction: a randomized controlled trial. [2010.01]
PURPOSE: Cirrhotic patients waiting for liver transplantation who need dental extractions are given fresh frozen plasma and/or platelets to correct coagulopathy. This is costly and may be associated with transfusion reactions and fluid overload. We evaluated the efficacy of intranasal desmopressin as an alternative to transfusion to correct the coagulopathy of cirrhotic patients undergoing dental extraction... CONCLUSIONS: Intranasal desmopressin was as effective as blood transfusion in achieving hemostasis in cirrhotic patients with moderate coagulopathy undergoing dental extraction. Intranasal desmopressin was much more convenient, less expensive, and well tolerated.
Clinical study shows improved absorption of desmopressin with novel formulation. [2009.07]
PURPOSE: To create improved pharmaceutical formulations for nasal and sublingual administration of desmopressin and investigate their pharmacokinetic profiles in comparison with a commercial nasal liquid spray and finally to evaluate the volunteers' opinions on the different dosage forms... CONCLUSIONS: The nasal powder formulation is a promising new dosage form for the delivery of desmopressin and other compounds. The sublingual tablet has a beneficial means of production and may be further developed by decreasing its disintegration time.
Multisite management study of menorrhagia with abnormal laboratory haemostasis: a prospective crossover study of intranasal desmopressin and oral tranexamic acid. [2009.04]
The optimal management of menorrhagia among women with abnormal laboratory haemostasis is uncertain. In a crossover study, 116 women with menorrhagia [pictorial blood assessment chart (PBAC) score >100], negative gynaecological evaluation and abnormal laboratory haemostasis were randomly assigned to either intranasal desmopressin (IN-DDAVP) or tranexamic acid (TA) therapy for two menstrual cycles...
[Comparison of two sublingual types of desmopressin in 6-year-old and more children with primary nocturnal enuresis. About an international randomized cross-over study.] [2009.02]
OBJECTIVE: Desmopressin (a structural analogue of hormone arginine-vasopressine) is an effective treatment of primary nocturnal enuresis (PNE). A new oral formulation (oral lyophilisate; Minirinmelt((R))) has recently been developed. The principal objective of this study was to compare the preference of patients for the oral lyophilisate versus tablet... CONCLUSIONS: The majority of patients preferred the sublingual lyophilisate. This preference was marked in patients less than 12 years on exploratory analysis. The new formulation of desmopressin requires no water intake and retains similar levels of efficacy and safety than the tablet.
Clinical Trials Related to Stimate (Desmopressin Nasal)
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.
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.
Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo [Recruiting]
Efficacy and Safety of IL-11 in DDAVP Unresponsive [Recruiting]
The purpose of this study is to determine the biologic efficacy and safety of rhIL-11 when
given subcutaneously in adults with moderate or mild hemophilia A or Von Willebrand disease
unresponsive to DDAVP. Biologic efficacy will be measured by the number and percent increase
of VWD coagulation tests (FVIII: C, VWF: Ag, VWF: RCo, closure time, APTT, and VWF multimers)
to the normal range, or at least to 1. 5-3 time baseline, following dosing of rhIL-11 when
given daily for 4 days, and boosted by DDAVP infusion on day 4, in those in whom DDAVP is
not contraindicated. Safety will be measured by the frequency of adverse events, including
fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.
Reports of Suspected Stimate (Desmopressin Nasal) Side Effects
Confusional State (4),
LIP Swelling (4),
Headache (4),
Throat Tightness (4),
Dizziness (4),
Blood Pressure Increased (4),
Chest Discomfort (4),
Anxiety (4),
Malaise (3),
Feeling Abnormal (3), more >>
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Page last updated: 2013-06-14
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