IMDUR DURULES Isosorbide Mononitrate 30mg Film-Coated Tablet 1's
RXDRUG-DR-XY25446-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Prophylactic treatment of angina pectoris.
Dosage/Direction for Use
60 mg once daily to be taken in the morning. The dose may be increased to 120 mg daily, taken once daily in the morning. The dose can be titrated to minimize the possibility of headache by initiating treatment with 30 mg for the first 2-4 days. The tablets can be taken with or without food.
The 30 mg and 60 mg tablets are scored and dividable. The whole tablets or if needed the divided halves, should not be chewed or crushed and should be swallowed together with half a glass of fluid. Isosorbide-5-mononitrate (IMDUR DURULES) is not indicated for the relief of acute attacks. In these situations sublingual or buccal nitroglycerine tablets or spray formulations should be used.
The matrix of the tablet is insoluble but disintegrates when the active substance is released. Occasionally the matrix may pass through the gastrointestinal tract without disintegrating and may be visible in the stool but this does not indicate that the drug has had a reduced effect.
The 30 mg and 60 mg tablets are scored and dividable. The whole tablets or if needed the divided halves, should not be chewed or crushed and should be swallowed together with half a glass of fluid. Isosorbide-5-mononitrate (IMDUR DURULES) is not indicated for the relief of acute attacks. In these situations sublingual or buccal nitroglycerine tablets or spray formulations should be used.
The matrix of the tablet is insoluble but disintegrates when the active substance is released. Occasionally the matrix may pass through the gastrointestinal tract without disintegrating and may be visible in the stool but this does not indicate that the drug has had a reduced effect.
Overdosage
Symptoms: Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and fall in blood pressure.
Management: Induction of emesis, activated charcoal. In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary intravenous administration of fluid.
Management: Induction of emesis, activated charcoal. In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary intravenous administration of fluid.
Administration
May be taken with or without food: May be divided along the score-line. Whole tabs & divided halves must be swallowed whole, do not chew/crush.
Contraindications
Hypersensitivity to the active substance or to any of the excipients, shock, hypotension, constrictive cardiomyopathy and pericarditis.
Patients treated with Isosorbide-5-mononitrate (IMDUR DURULES) must not be given Phosphodiesterase type 5 Inhibitors (e.g. sildenafil).
Patients treated with Isosorbide-5-mononitrate (IMDUR DURULES) must not be given Phosphodiesterase type 5 Inhibitors (e.g. sildenafil).
Special Precautions
Caution should be observed in patients with severe cerebral arteriosclerosis and hypotension.
Effects on ability to drive and use machines: Patients may develop dizziness when first using Isosorbide-5-mononitrate (IMDUR DURULES). Patients should be advised to determine how they react to Isosorbide-5-mononitrate (IMDUR DURULES) before they drive or operate machinery.
Effects on ability to drive and use machines: Patients may develop dizziness when first using Isosorbide-5-mononitrate (IMDUR DURULES). Patients should be advised to determine how they react to Isosorbide-5-mononitrate (IMDUR DURULES) before they drive or operate machinery.
Use In Pregnancy & Lactation
The safety and efficacy of Isosorbide-5-mononitrate (IMDUR DURULES) during pregnancy or lactation have not been established.
Adverse Reactions
Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Headache may occur when treatment is initiated, but usually disappears during continued treatment. Hypotension, with symptoms such as dizziness and nausea with syncope in isolated cases, has occasionally been reported. These symptoms generally disappear during continued treatment.
The following definitions of frequencies are used: Very common (>10%), common (1 - 9.9%), uncommon (0.1 - 0.9%), rare (0.01 - 0.09%) and very rare (<0.01%).
Cardiovascular system: Common: Hypotension, tachycardia.
Central nervous system: Common: Headache, dizziness. Rare: Fainting.
Gastrointestinal: Common: Nausea. Uncommon: Vomiting, diarrhoea.
Musculoskeletal: Very rare: Myalgia.
Skin: Rare: Rash, pruritus.
Seek medical attention immediately at the first sign of any adverse drug reaction.
The following definitions of frequencies are used: Very common (>10%), common (1 - 9.9%), uncommon (0.1 - 0.9%), rare (0.01 - 0.09%) and very rare (<0.01%).
Cardiovascular system: Common: Hypotension, tachycardia.
Central nervous system: Common: Headache, dizziness. Rare: Fainting.
Gastrointestinal: Common: Nausea. Uncommon: Vomiting, diarrhoea.
Musculoskeletal: Very rare: Myalgia.
Skin: Rare: Rash, pruritus.
Seek medical attention immediately at the first sign of any adverse drug reaction.
Drug Interactions
Concomitant administration of Isosorbide-5-mononitrate (IMDUR DURULES) and Phosphodiesterase type 5 Inhibitors can potentiate the vasodilatory effect of Isosorbide-5-mononitrate (IMDUR DURULES) with the potential result of serious side effects as syncope or myocardial infarction.
Concomitant administration of Isosorbide-5-mononitrate (IMDUR DURULES) and Phosphodiesterase type 5 Inhibitors (e.g. sildenafil) must not be given additionally.
The effect of food on the absorption of Isosorbide-5-mononitrate (IMDUR DURULES) is not clinically significant.
Concomitant administration of Isosorbide-5-mononitrate (IMDUR DURULES) and Phosphodiesterase type 5 Inhibitors (e.g. sildenafil) must not be given additionally.
The effect of food on the absorption of Isosorbide-5-mononitrate (IMDUR DURULES) is not clinically significant.
Storage
Store at a temperature not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: The principal pharmacological action of isosorbide-5-mononitrate an active metabolite of isosorbide dinitrate is relaxation of vascular smooth muscle, producing vasodilatation of both arteries and veins, with the latter effect predominating. The effect of the treatment is dependent of the dose. Low plasma concentrations lead to venous dilatation, resulting in peripheral pooling of blood, decreased venous return and reduction in left ventricular end-diastolic pressure (preload). High plasma concentrations also dilate the arteries reducing systemic vascular resistance and arterial pressure leading to a reduction in cardiac afterload.
Isosorbide-5-mononitrate may also have a direct dilating effect on the coronary arteries. By reducing the end diastolic pressure and volume, the preparation lowers the intramural pressure, thereby leading to an improvement in the sub-endocardial blood flow. The net effect when administering isosorbide-5-mononitrate is therefore a reduced workload of the heart and an improved oxygen supply/demand balance in the myocardium.
In placebo controlled studies, Isosorbide-5-mononitrate (IMDUR DURULES) once daily has been shown effectively to control angina pectoris both in the terms of exercise capacity and symptoms and in reducing signs of myocardial ischaemia. The duration of the effects is at least 12 hours. At this point the plasma concentration is similar to the level 1 hour after dose intake - about 1300 nmol/L.
Isosorbide-5-mononitrate (IMDUR DURULES) has been shown to be effective in monotherapy as well as in combination with beta-blockers and calcium antagonists.
The clinical effects of nitrates may be attenuated during repeated administration owing to high and even plasma levels. This can be avoided by allowing low plasma levels for a certain period of the dosage interval. Isosorbide-5-mononitrate (IMDUR DURULES) when administered once daily in the morning, produce a plasma profile that provides high plasma levels during daytime and low night-time plasma levels. With Isosorbide-5-mononitrate (IMDUR DURULES) 60 mg or 120 mg once daily no development of tolerance with respect to antianginal effect has been observed. Rebound phenomenon between doses as described with intermittent nitrate patch therapy has not been seen with Isosorbide-5-mononitrate (IMDUR DURULES).
Isosorbide-5-mononitrate (IMDUR DURULES) is safe and well tolerated also when used in connection with acute myocardial infarction. The first dose was 30 mg and another 30 mg 12 hours later, thereafter 60 mg once daily. Plasma concentrations in patients with acute myocardial infarction were similar to what is seen in healthy volunteers. Occasionally, protracted absorption may occur possibly due to concomitant morphine administration.
Pharmacokinetics: Isosorbide-5-mononitrate is completely absorbed and is not metabolized during the first passage through the liver. This reduces the intra- and inter-individual variations in plasma levels and leads to predictable and reproducible clinical effects. The elimination half-life of isosorbide-5-mononitrate is around 5 hours. The volume of distribution for isosorbide-5-mononitrate is about 0.6 L/kg and total clearance around 115 mL/minute. Elimination takes place by denitration and conjugation. The metabolites are excreted mainly via the kidneys. Only about 2% of the dose is excreted as unchanged drug via the kidneys.
Impaired liver function or kidney function have no major influence on the pharmacokinetic properties of Isosorbide-5-mononitrate (IMDUR DURULES).
Isosorbide-5-mononitrate (IMDUR DURULES) is a prolonged release formulation (Durules) of isosorbide-5-mononitrate. The active substance is released independently of pH, over a 10-hour period. Compared to ordinary tablets the absorption phase of Isosorbide-5-mononitrate (IMDUR DURULES) is prolonged and the duration of effect is extended. The extent of bioavailability of Isosorbide-5-mononitrate (IMDUR DURULES) is about 90% compared to immediate release tablets. Absorption is not significantly affected by food intake. After repeated peroral administration of 60 mg once daily, a maximal plasma concentration (around 3,000 nmol/L) is achieved after around 4 hours. The plasma concentrations then gradually fall to around 500 nmol/L at the end of the dosage interval (24 hours after dose intake).
Toxicology: Preclinical safety data: Not applicable.
Isosorbide-5-mononitrate may also have a direct dilating effect on the coronary arteries. By reducing the end diastolic pressure and volume, the preparation lowers the intramural pressure, thereby leading to an improvement in the sub-endocardial blood flow. The net effect when administering isosorbide-5-mononitrate is therefore a reduced workload of the heart and an improved oxygen supply/demand balance in the myocardium.
In placebo controlled studies, Isosorbide-5-mononitrate (IMDUR DURULES) once daily has been shown effectively to control angina pectoris both in the terms of exercise capacity and symptoms and in reducing signs of myocardial ischaemia. The duration of the effects is at least 12 hours. At this point the plasma concentration is similar to the level 1 hour after dose intake - about 1300 nmol/L.
Isosorbide-5-mononitrate (IMDUR DURULES) has been shown to be effective in monotherapy as well as in combination with beta-blockers and calcium antagonists.
The clinical effects of nitrates may be attenuated during repeated administration owing to high and even plasma levels. This can be avoided by allowing low plasma levels for a certain period of the dosage interval. Isosorbide-5-mononitrate (IMDUR DURULES) when administered once daily in the morning, produce a plasma profile that provides high plasma levels during daytime and low night-time plasma levels. With Isosorbide-5-mononitrate (IMDUR DURULES) 60 mg or 120 mg once daily no development of tolerance with respect to antianginal effect has been observed. Rebound phenomenon between doses as described with intermittent nitrate patch therapy has not been seen with Isosorbide-5-mononitrate (IMDUR DURULES).
Isosorbide-5-mononitrate (IMDUR DURULES) is safe and well tolerated also when used in connection with acute myocardial infarction. The first dose was 30 mg and another 30 mg 12 hours later, thereafter 60 mg once daily. Plasma concentrations in patients with acute myocardial infarction were similar to what is seen in healthy volunteers. Occasionally, protracted absorption may occur possibly due to concomitant morphine administration.
Pharmacokinetics: Isosorbide-5-mononitrate is completely absorbed and is not metabolized during the first passage through the liver. This reduces the intra- and inter-individual variations in plasma levels and leads to predictable and reproducible clinical effects. The elimination half-life of isosorbide-5-mononitrate is around 5 hours. The volume of distribution for isosorbide-5-mononitrate is about 0.6 L/kg and total clearance around 115 mL/minute. Elimination takes place by denitration and conjugation. The metabolites are excreted mainly via the kidneys. Only about 2% of the dose is excreted as unchanged drug via the kidneys.
Impaired liver function or kidney function have no major influence on the pharmacokinetic properties of Isosorbide-5-mononitrate (IMDUR DURULES).
Isosorbide-5-mononitrate (IMDUR DURULES) is a prolonged release formulation (Durules) of isosorbide-5-mononitrate. The active substance is released independently of pH, over a 10-hour period. Compared to ordinary tablets the absorption phase of Isosorbide-5-mononitrate (IMDUR DURULES) is prolonged and the duration of effect is extended. The extent of bioavailability of Isosorbide-5-mononitrate (IMDUR DURULES) is about 90% compared to immediate release tablets. Absorption is not significantly affected by food intake. After repeated peroral administration of 60 mg once daily, a maximal plasma concentration (around 3,000 nmol/L) is achieved after around 4 hours. The plasma concentrations then gradually fall to around 500 nmol/L at the end of the dosage interval (24 hours after dose intake).
Toxicology: Preclinical safety data: Not applicable.
MedsGo Class
Anti-Anginal Drugs
Features
Brand
Imdur Durules
Full Details
Dosage Strength
30 mg
Drug Ingredients
- Isosorbide
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Isosorbide Mononitrate
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY25446
Drug Classification
Prescription Drug (RX)
Please sign in so that we can notify you about a reply