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PubMed1995

Acute and subacute effects of nicorandil and isosorbide dinitrate on vessel wall properties of large arteries and hemodynamics in healthy volunteers.

Nicorandil (N) and isosorbide dinitrate (ISDN) are vasodilator drugs used in patients with angina. In 24 healthy male volunteers (18-32 years), the acute effect of a single oral dose (20 mg) of N and ISDN on arterial diameter (D), distensibility, and compliance of the elastic common carotid artery (CCA) and the muscular femoral (FA) and brachial (BA) arteries were investigated. The effects on systolic and diastolic blood pressure (SBP, DBP), heart rate (HR), cardiac index (CI), systemic vascular resistance index (SVRI), and venous hemodynamics were also assessed. In addition, the subacute effects after 8 days of treatment with N (2 x 20 mg/day) and ISDN (3 x 20 mg/day) on these parameters were evaluated. After a 20 mg single oral dose, blood pressure decreased significantly more with ISDN (SBP: 6%; DBP: 14%) than with N (SBP: 2%; DBP: 6%), but after 8 days this decrease in blood pressure was not statistically different between ISDN and N. The diameter of CCA increased more with ISDN (11%) than N (5%) acutely as well as subacutely (ISDN: 12%; N: 9%). Heart rate increased only with ISDN (7% acutely, 3% subacutely). No differences between ISDN and nicorandil were found for acute and subacute effects on SVRI, venous hemodynamics, diameter of muscular arteries (FA, BA), and the distensibility and compliance of elastic (CCA) and muscular (FA, BA) arteries.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1986

Complete atrioventricular block after sublingual isosorbide dinitrate.

A 71-year-old woman, admitted for chest pain, received a 5 mg dose of isosorbide dinitrate sublingually. Within 2 min she became pale and diaphoretic and soon after lost consciousness. A monitor electrocardiographic lead showed sinus bradycardia followed by ventricular asystole. Sinus rhythm was restored by a precordial thump and intravenous administration of atropine. Our patient was receiving lidocaine intravenously because of ventricular premature beats. Its interaction with isosorbide is suspected of having caused the asystole.

Aged↗
PubMed1985

Pharmacokinetics and metabolism of isosorbide-dinitrate after intravenous and oral administration.

The bioavailabilities of a conventional and two slow release 20 mg isosorbide dinitrate (ISDN) formulations were compared after oral administration in a three way cross-over study in 8 male volunteers. In a further group of 6 male volunteers the pharmacokinetics and metabolism of ISDN were investigated after intravenous infusion of a median dose of 14.1 mg for 2.5 h. A new analytical procedure was developed for the determination of isosorbide-5-mononitrate-2-glucuronide (IS-5-MN-2-Glu) and of isosorbide (IS). Kinetic data analysis on a molar basis was performed by the program package KIN-PAK providing model independent parameters. The median elimination half-lives of ISDN, IS-5-MN, IS-2-MN and IS-5-MN-2-Glu were 0.7, 5.1, 3.2 and 2.5 h, respectively. The systemic clearance of ISDN was 3.71/min and the distribution volume 2521 (3.1 l/kg). Apart from IS-5-MN-2-Glu, with a renal clearance of 5.9 l/min which suggested substantial glucuronidation in the kidney, the renal clearances of ISDN, IS-5-MN, IS-2-MN and the corresponding amounts excreted were negligible. 27.8% of the administered ISDN was excreted as IS-5-MN-2-Glu (8.7%) and IS (19.1%). Calculations based on the two mononitrate metabolites formed from ISDN showed an incomplete recovery of 84.1%, leading to the assumption that a simultaneous denitration to IS must have occurred. The rate of denitration at each nitro group in ISDN was almost twice as high as for the same position in the corresponding mononitrate.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1982

NMR determination of isosorbide dinitrate and beta-adrenergic blocking agents in tablets.

An NMR spectroscopic method for the determination of isosorbide dinitrate, alone or together with alprenolol or propranolol, is described. Spectra are determined in dimethyl sulfoxide-d6 containing maleic acid or 1,4-dinitrobenzene as internal standards. Both synthetic mixtures and commercial formulations were assayed, and the results were compared using compendial procedures.

Adrenergic beta-Antagonists↗
PubMed1984

High-performance liquid chromatographic determination of the nitrate esters isosorbide dinitrate, pentaerythritol tetranitrate, and erythrityl tetranitrate in various tablet forms.

A reliable, sensitive, and specific assay for isosorbide dinitrate pentaerythritol tetranitrate, and erythrityl tetranitrate in sublingual, uncoated, sustained-release, and chewable dosage forms, using high-performance liquid chromatography, is described. The nitrate ester dosage forms were dissolved in methanol, filtered, and injected directly into the liquid chromatograph. A variable-wavelength UV detector, operated at 220 nm, and a reverse-phase C18 microporous silica column were employed. The mobile phase was methanol-water (40:60). The proposed method is quantitative and reproducible.

Chromatography, High Pressure Liquid↗
PubMed1981

The effect of pindolol and isosorbide dinitrate and their combination on exercise tolerance and ECG changes in angina pectoris.

The effect of placebo, isosorbide dinitrate (ISDN) (5 mg orally), pindolol (1.0 mg i.v.) and the combination of ISDN and pindolol was tested in 12 patients with stable, exercise-induced angina pectoris and normal resting ECG. A graded submaximal exercise test was performed on a bicycle ergometer 30 min after medication. All patients had ST depression during and shortly after exercise. ISDN and pindolol increased exercise tolerance to a similar degree but through different mechanisms. Pindolol decreased heart rate and markedly reduced ST depression in the ECG, while ISDN had no effect on ECG changes. The combination of ISDN and pindolol was superior to either drug alone in increasing exercise tolerance in angina pectoris.

Angina Pectoris↗
PubMed1989

Intravenous administration of isosorbide dinitrate attenuates the pressor response to laryngoscopy and tracheal intubation.

In order to evaluate the effect of isosorbide dinitrate (ISDN), administered as a bolus intravenous injection, on the circulatory response to tracheal intubation, mean arterial pressure (MAP), and heart rate (HR) in response to laryngoscopy for 30 s followed by tracheal intubation were compared in patients not receiving ISDN (control) and receiving 40 micrograms/kg or 80 micrograms/kg of ISDN 45 s before starting laryngoscopy. Each group consisted of 10 patients undergoing elective surgery. Forty-five seconds after starting laryngoscopy, MAP was significantly (P less than 0.01) lower in patients receiving 80 micrograms/kg ISDN than in those receiving no or 40 micrograms/kg ISDN. HR increased to a similar extent in the three groups. These results indicate that a bolus injection of ISDN (80 micrograms/kg) is a simple, practical and highly effective means of attenuating the hypertensive response to direct laryngoscopy and tracheal intubation.

Adult↗
PubMed1991

Influence of isosorbide dinitrate concentration on its skin permeability from adhesive matrix devices.

Adhesive matrix devices containing a model drug, isosorbide dinitrate (ISDN), were prepared with three different types of pressure sensitive adhesives (PSAs). ISDN permeation through excised hairless rat skin from the different devices was measured in vitro. For each PSA type, the steady state permeation rate of ISDN increased proportionally with an increase of ISDN concentration in the PSA and reached a maximum level at a certain concentration. Although the concentrations reaching the maximum skin permeation level varied among PSA types, the maximum rate for each PSA type was largely similar to that for ISDN aqueous suspension. The release rate of ISDN from devices was too fast to influence the skin permeation rate for all devices. In the PSA of devices showing maximum skin permeability, ISDN crystalline was observed by polarizing microscopy and differential scanning calorimetry. These results suggest that the skin permeation of ISDN from adhesive matrix devices was controlled by the thermodynamic activity of the drug in the PSAs.

Adhesiveness↗
PubMed1975

[Effect of nitroglycerin in acute myocardial infarction. III. Isosorbide dinitrate in patients with or without left-heart failure (author's transl)].

The oral effectiveness of isosorbide dinitrate (Isoket) was tested in 21 pateints with acute myocardial infarction. Patients were divided into two groups according to thier initial left-ventricular filling pressure (more or less than 20 mm Hg). In both groups there was a highly significant decrease in pulmonary artery pressure. In group I (less than 20 mm Hg) the left-ventricular filling pressure fell from 13.6 +/- 4.0 to 7.1 +/- 2.6 mm Hg, while in group II it fell from 26.9 +/- 4.6 to 19.0 +/- 3.6 mm Hg (P less than 0.001). The cardiac output fell in group I from 5.1 +/- 1.0 to 4.5 +/- 0.9 l/min, while in group II there was a significant rise from a low value (3.5 +/- 0.8 l/min) to 4.1 +/- 0.9 l/min (P less than 0.001). In both groups there was a slight but not significant fall in arterial blood pressure, while heart rate remained constant.

Acute Disease↗
PubMed1997

[Pharmacokinetics of isosorbide dinitrate examined by physiologically-based pharmacokinetic model].

To make a physiologically-based pharmacokinetic model of isosorbide dinitrate (ISDN), the author infused ISDN at 1, 10, 30 micrograms.kg-1.min-1 into anesthetized rabbits and measured concentrations of ISDN and its metabolites (2-ISMN and 5-ISMN) in plasma and in the brain, liver as well as fat tissue. There was the accumulation of ISDN in the brain and fat tissue. There was no significant difference in concentrations of ISDN between the plasma and liver, or in concentrations of its metabolites among plasma, and the tissues of the brain, liver and fat. Using these informations, the author constructed a physiologically-based pharmacokinetic model to human and estimated values were compared with observed values to determine the validity of the model. There was no remarkable differences between the estimated values and observed values. This suggests the validity of the model. The plasma concentrations of ISDN estimated by this model, showed a linear increase (Y = 25 X) with the infusion rate less than 6.0 micrograms.kg-1.min-1. The accumulation of ISDN, especially in the brain was suggested by this model.

Adipose Tissue↗
PubMed1975

Hemodynamic and metabolic effects of isosorbide dinitrate in chronic congestive heart failure.

To assess the potential beneficial effects of a nonparenteral vasodilator, sublingual isosorbide dinitrate (5 to 15 mg.) was administered in 12 patients with chronic congestive heart failure refractory to conventional therapy. Hemodynamic measurements were performed before and at 15 minute intervals after drug administration for 90 minutes. Venous capacitance was measured at 5 minute intervals. Myocardial metabolism was also studied in five patients before and after drug administration. Hemodynamic effects were characterized by a modest decrease in mean arterial pressure (85 +/- 3 to 78 +/- 2 [S.E.M.] mm. Hg) and substantial decrease in right atrial (10 +/- 1 to 6 +/- 1), pulmonary arterial (39 +/- 4 to 30 +/- 4) and pulmonary capillary wedge pressures (28 +/- 2 to 21 +h- 2). These changes were accompanied by an increase in venous capacitance (2.46 +/- 0.16 to 3.99 +/- 0.24 c.c./100 c.c. of tissue). Along with a decrease in left ventricular filling pressure, cardiac index increased (1.99 +/- 0.13 to 2.37 +/- 0.15 L./min/M.2). No significant effect on heart rate was seen. Delta P/delta t, an index related to left ventricular dp/dt, increased in all but one patient (253 +/- 31 to 298 +/- 39 mm. Hg/sec.) (p less than 0.02 for all changes) in the face of decreased preload and afterload and unchanged heart rate, suggesting improved contractile state. A decrease in coronary blood flow (165 +/- 13 to 131 +/- 15 c.c./min.) and myocardial oxygen consumption (18.1 +/- 1.6 to 14.5 +/- 1.6 c.c./min.) was noted (p less than 0.02). No change in arterial-coronary sinus oxygen difference or lactate extraction was observed. These data demonstrate that the objectives of therapy in congestive heart failure, namely improved forward output and decreased ventricular filling pressures, can be achieved without metabolic deterioration by using sublingual isosorbide. The mechanisms responsible are related to diminished impedence to ventricular ejection and peripheral pooling of blood. Since the duration of action does not usually exceed 90 minutes, frequent drug administration may be a source of patient inconvience.

Administration, Oral↗
PubMed1992

[Acute hemodynamic effects of intravenous bolus injection of isosorbide dinitrate in aged patients with congestive heart failure].

In order to investigate whether intravenous bolus injection of isosorbide dinitrate (ISDN) is a safe and efficient therapy in aged patients with congestive heart failure, we studied acute hemodynamic effects in 11 patients. Peak effects on preload were observed after 5 to 10 minutes of bolus injection and unloading effects continued effectively for 60 minutes. At peak effect, pulmonary systolic pressure decreased from 50.2 +/- 2.6 to 36.2 +/- 2.6 mmHg (-28.5%, p less than 0.01) and pulmonary end diastolic pressure decreased from 25.0 +/- 2.2 to 18.5 +/- 2.1 mmHg (-26.0%, p less than 0.01). Mean pulmonary artery wedge pressure decreased from 23.4 +/- 2.2 to 16.0 +/- 2.1 mmHg (-31.6%, p less than 0.01). Mean right atrial pressure decreased from 10.5 +/- 1.8 to 7.4 +/- 2.0 mmHg (-29.5%, p less than 0.01). Blood pressure, heart rate, cardiac index, systemic and pulmonary vascular resistance showed no significant changes. Thus, intravenous bolus injection of ISDN showed a potent vasodilator effects on preload, and may be a safe and useful treatment for aged patients with acute congestive heart failure.

Aged↗
PubMed1984

Determination of the two mononitrate metabolites of isosorbide dinitrate in human plasma and urine by gas chromatography with electron-capture detection.

This paper describes a sensitive method for the determination of 2-isosorbide mononitrate and 5-isosorbide mononitrate as metabolites of isosorbide dinitrate at concentrations down to 2 ng/ml of 2-isosorbide mononitrate in both plasma and urine, and 5 ng/ml and 10 ng/ml of 5-isosorbide mononitrate in plasma and urine, respectively. The two mononitrate metabolites are extracted at basic pH into ethyl acetate, which is then evaporated to dryness. The residue is dissolved in a basic aqueous solution, which is washed with heptane and then re-extracted into ethyl acetate. The metabolites are quantitated by gas chromatography, using a 63Ni electron-capture detector. Conjugates of 2- and 5-isosorbide mononitrate are determined in urine after enzymatic hydrolysis.

Chemical Phenomena↗
PubMed1991

Vascular effects of isosorbide dinitrate on the common carotid artery in human volunteers.

The effects of 20 mg of orally administered isosorbide dinitrate (ISDN, Isocoronal R; CAS 87-33-2) on cerebral hemodynamics were investigated in 14 normal healthy volunteers (average age 32.6 years). The common carotid artery hemodynamics in the right supraclavicular region were measured using an ultrasonic quantitative flow measurement system. 2 h after drug administration, systolic blood pressure (15.5 mmHg, p less than 0.001) and mean blood pressure (7.2 mmHg, p less than 0.02) decreased significantly, but diastolic blood pressure did not change. A decrease in blood flow volume (2.85 ml/s, p less than 0.001) and blood flow velocity (7.00 cm/s, p less than 0.001), and an increase in mean vessel diameter (0.19 mm, p less than 0.05), and volume elasticity (0.68 x 10(5) dyn/cm2, p less than 0.02) were observed with ISDN. Mean vessel diameter increased gradually and reached its maximum at 4 h. However, the other maximal effects of ISDN were exerted at about 2 h. The ultrasonic quantitative flow measurement system was found to be useful in the case of repetitive measurements of the common carotid artery hemodynamics. It has been demonstrated that ISDN (20 mg/subject, p.o.) increases the diameter of the common carotid artery, although it decreases the blood flow in the common carotid artery.

Adult↗
PubMed1984

Fate of orally given isosorbide dinitrate in cirrhotic patients.

In 5 out of 7 patients with cirrhosis and extensive shunting, plasma concentrations of isosorbide dinitrate after oral administration of 10 mg of the substance were markedly higher than those found in subjects without hepatic disease. The explanation could be a higher bioavailability and/or a lower systemic clearance, due to shunting and hepatic cell dysfunction. The difference was confirmed by the calculation of the areas under the concentration-time curves.

Administration, Oral↗
PubMed1991

Transient pulsus alternans induced by isosorbide dinitrate: echocardiographic and hemodynamic evidence of reduced venous return--a case report.

Transient pulsus alternans was induced by isosorbide dinitrate (ISDN) in a patient with postmyocarditis congestive heart failure under diuretic therapy. The severity and duration of pulsus alternans depended on the dose of ISDN. According to the echocardiographic and hemodynamic examinations, the superimposed preload reduction caused by ISDN combined with decreased blood volume owing to diuretic therapy most likely contributed to the development of pulsus alternans.

Adult↗
PubMed1988

Effects of isosorbide dinitrates intravenously in high doses over a short period in anterior acute myocardial infarction.

The effects of intravenous isosorbide dinitrate administered in high doses over a short period of time in 17 patients (14 men, 3 women, mean age 67 years) with anterior wall acute myocardial infarction were evaluated. Patients were classified into 2 groups based on the electrocardiographic pattern of acute ischemia. Patients presented with anterior acute myocardial infarction; an electrocardiographic pattern of third-degree ischemia demonstrated a more favorable electrocardiographic and radionuclear angiographic evolution than similar patients who presented with an electrocardiographic pattern of second-degree ischemia.

Adult↗
PubMed1977

Blood and tissue levels of [14C]isosorbide dinitrate after oral and intravenous administration to rat.

Rat blood and various tissues were analyzed for levels of isosorbide dinitrate (ISDN), an antianginal drug, after the administration of 14C-labeled compound. Unaltered [14C]ISDN was found in all tissues analyzed and in the circulating blood for up to 4 hours after p.o. or i.v. administration. These results clearly show that ISDN is not completely degraded in a single pass through the liver after either route of administration. ISDN concentration (nanograms of ISDN per gram wet weight of tissue) in vascular tissue were significantly greater than other tissues or the blood.

Administration, Oral↗