IMDUR SUMMARY
IMDUR®
(isosorbide mononitrate)
Extended Release Tablets
Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. IMDUR® Tablets contain 30 mg, 60 mg, or 120 mg of isosorbide mononitrate in an extended-release formulation.
IMDUR Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
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NEWS HIGHLIGHTS
Published Studies Related to Imdur (Isosorbide Mononitrate)
Addition of propranolol and isosorbide mononitrate to endoscopic variceal ligation does not reduce variceal rebleeding incidence. [2009.09]
BACKGROUND & AIMS: Endoscopic variceal ligation (EVL) and propranolol are standard secondary prophylaxis therapies for variceal bleeding. Addition of isosorbide mononitrate (ISMN) to propranolol improves its hemodynamic efficacy; we investigated whether a combination of EVL and propranolol/ISMN was more effective than EVL alone for secondary prophylaxis... CONCLUSIONS: EVL alone is sufficient to prevent variceal rebleeding in cirrhotic and noncirrhotic patients with history of variceal bleeding. Addition of propranolol and ISMN to EVL does not reduce the incidence of variceal rebleeding but increases severe adverse effects. Risk factors for rebleeding include ascites, low serum albumin, and high hepatic venous pressure gradients.
Randomised placebo-controlled trial of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour--clinical trial with analyses of efficacy and acceptability. The IMOP study. [2009.08]
OBJECTIVE: To determine whether isosorbide mononitrate (IMN), self-administered vaginally by women at home, improves the process of induction of labour. DESIGN: Randomised double blind placebo-controlled trial. SETTING: Large UK maternity hospital. POPULATION OR SAMPLE: Nulliparous women with a singleton pregnancy, cephalic presentation > or = 37 weeks gestation, requiring cervical ripening prior to induction of labour... CONCLUSIONS: IMN self-administered vaginally at home does not shorten admission to delivery interval despite a significant effect on cervical ripeness assessed using the Bishop score. However, women report positive views on cervical ripening at home, and the setting deserves further investigation.
The cost-effectiveness of outpatient (at home) cervical ripening with isosorbide mononitrate prior to induction of labour. [2009.08]
OBJECTIVES: To assess the cost-effectiveness of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour... CONCLUSIONS: Although the probability that IMN is cost-effective approaches 0.7 at seemingly low willingness to pay thresholds for an hour prevented from hospital admission to delivery, our results should be viewed in the light of the clinical findings from the IMOP trial.
Nadolol plus isosorbide mononitrate alone or associated with band ligation in the prevention of recurrent bleeding: a multicentre randomised controlled trial. [2009.08]
CONCLUSIONS: Adding EBL to pharmacological treatment did not reduce recurrent bleeding, the need for rescue therapy, or mortality, and was associated with more adverse events. Furthermore, associating EBL to drug therapy did not reduce the high rebleeding risk of HVPG non-responders. ISRCTN26221020.
Efficacy of beta-adrenergic blocker plus 5-isosorbide mononitrate and endoscopic band ligation for prophylaxis of esophageal variceal rebleeding: a meta-analysis. [2009.05.07]
AIM: To systematically assess the efficacy and safety of beta-adrenergic blocker plus 5-isosorbide mononitrate (BB + ISMN) and endoscopic band ligation (EBL) on prophylaxis of esophageal variceal rebleeding... CONCLUSION:In the prevention of esophageal variceal rebleeding, BB + ISMN are as effective as EBL. There are few complications with the two treatment modalities. Both BB + ISMN and EBL would be considered as the first-line therapy in the prevention of esophageal variceal rebleeding.
Clinical Trials Related to Imdur (Isosorbide Mononitrate)
Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients [Recruiting]
This is a randomized, double blind, placebo-controlled study, clinical trail designed to
evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate
for the relief of acute anginal pain episodes in acute coronary syndrome patients in
comparison with the usual manner of S/L isosorbide dinitrate .
Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate [Active, not recruiting]
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis [Recruiting]
This study will measure and compare changes in insulin production and sensitivity using the
hyperglycemic clamp technique in obese patients with impaired glucose tolerance and
hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide
(HCTZ).
Renin-Angiotensin Aldosterone System and Fibrinolysis Interaction in Humans-Specific Aim 3 [Recruiting]
Secondary Prophylaxis After Variceal Bleeding in Non-Responders [Completed]
Controlled and randomized study comparing combined treatment (nadolol and endoscopic
ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to
hemodynamic response, in the prevention of esofagic verices rebleeding.
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