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Stimate (Desmopressin Acetate Nasal) - Summary

 
 



STIMATE SUMMARY

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 an aqueous solution at a pH of approximately 5. Stimate ® Nasal Spray's compression pump delivers 0.1 mL (150 mcg) 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.

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.

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.

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 .


See all Stimate indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Stimate (Desmopressin Nasal)

U.S. Deaths From Cervical Cancer May Be Underestimated
Source: MedicineNet Hysterectomy Specialty [2017.01.23]
Title: U.S. Deaths From Cervical Cancer May Be Underestimated
Category: Health News
Created: 1/23/2017 12:00:00 AM
Last Editorial Review: 1/23/2017 12:00:00 AM

more news >>

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.

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Clinical Trials Related to Stimate (Desmopressin Nasal)

The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion [Completed]
There is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no significant difference in renal response parameters was found. This could be interpreted an increased renal sensitivity in females compared to males. The theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. However none of the studies was designed with the purpose of investigate the gender difference. The aim of this study is to investigate possible gender differences in the renal sensitivity to dDAVP and the effect of age on these differences. This will be done by low dose graded infusion of the synthetic AVP analog dDAVP. Participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.

Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia [Completed]
The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults [Completed]
The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

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.

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.

more trials >>

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 >>


Page last updated: 2017-01-23

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