Product Overview
[Drug Name]
Generic Name: Isosorbide Mononitrate Extended-Release Tablets
Trade Name: Imodo Isosorbide Mononitrate Extended-Release Tablets 30mg x 7 tablets
[Main Ingredient]
This product contains isosorbide mononitrate.
[Properties]
This product is a film-coated tablet. The 30mg tablet is pink and the 60mg tablet is yellow. After removing the coating, it appears white or off-white.
[Indications/Main Functions]
For the long-term treatment of coronary artery disease, prevention of vasospastic and mixed angina pectoris, and is also suitable for post-myocardial infarction treatment and long-term treatment of chronic heart failure.
[Specifications]
30mg x 7 tablets
[Dosage and Administration]
Oral. The dosage should be individualized and adjusted based on clinical response. Take the tablet in the morning. To avoid headaches, start with 30mg once daily for the first 2-4 days. The normal dose is 60mg once daily, which can be increased to 120mg once daily if necessary. The tablet can be split along the notch and taken in half. Whole or half tablets should be kept intact before use and swallowed with half a glass of water. Do not chew or crush.
[Adverse Reactions]
Headache may occur at the beginning of treatment but disappears after 1-2 weeks of continued treatment. The likelihood of headache can be minimized by starting with 30 mg (for the first 2-4 days) and then gradually increasing the dose. A decrease in blood pressure may lead to reflex tachycardia, dizziness, and syncope. Severe hypotension, including nausea, vomiting, restlessness, pallor, and diaphoresis, has been reported with the use of organic nitrates. Rarely, severe hypotension leading to exacerbation of angina symptoms has been reported. There have been a few reports of heartburn caused by nitrate-induced sphincter relaxation. Common: Headache, hypotension, tachycardia, nausea. Uncommon: Vomiting, diarrhea. Rare: Collapse (often accompanied by bradycardia and syncope), rash, pruritus, and exfoliative dermatitis. Very rare: Myalgia.
[Contraindications]
Hypersensitivity to any component of this product; hypertrophic obstructive cardiomyopathy; constrictive pericarditis; restrictive cardiomyopathy; cardiac tamponade; acute circulatory failure (shock, vascular collapse); cardiogenic shock (except when appropriate measures are taken to ensure adequate end-diastolic pressure); severe hypotension (systolic blood pressure below 90 mmHg); increased intracranial pressure; severe anemia; glaucoma; concomitant use of type 5 phosphodiesterase inhibitors, such as sildenafil, during nitrate therapy; acute myocardial infarction with low filling pressure (unless used in an intensive care unit with continuous hemodynamic monitoring).
[Drug Interactions]
1. Concomitant use of antihypertensive drugs, such as beta-blockers, calcium channel blockers, vasodilators, and/or alcohol, neuroleptics, and tricyclic antidepressants, may enhance the antihypertensive effect of this product.
2. The combined use of this product with phosphodiesterase type 5 inhibitors (such as sildenafil) for the treatment of erectile dysfunction will increase the antihypertensive effect of this product and may cause fatal cardiovascular complications. Therefore, phosphodiesterase type 5 inhibitors such as sildenafil should not be used when using this product.
[Precautions]
1. The following patients require special medical supervision: those with low filling pressures, such as acute myocardial infarction, impaired left ventricular function (left ventricular failure); aortic and/or mitral valve stenosis; diseases associated with increased intracranial pressure; and orthostatic circulatory disorders.
2. This product is not indicated for use in patients with acute angina attacks.
3. Nitrate therapy carries the risk of drug tolerance. Therefore, for Imdole, once-daily dosing to achieve a low blood concentration interval is crucial to reduce the risk of drug tolerance.
4. Patients with severe cerebral arteriosclerosis should be observed with caution.
5. Patients who continue to use this product should be advised not to use products containing phosphodiesterase type 5 inhibitors (such as sildenafil). Treatment with this product should not be interrupted due to the use of products containing phosphodiesterase type 5 inhibitors (such as sildenafil), as this can increase the risk of angina attacks.
6. Because dizziness may occur during treatment with this product, it should be used with caution when concentration is required, such as when driving or operating machinery.
7. During use, this drug may increase blood flow to poorly ventilated alveoli (forming a pulmonary "bypass"), leading to transient hypoxemia. This can particularly lead to myocardial hypoxia in patients with coronary artery disease.
[Pediatric Use]
The safety and efficacy of this drug in children have not been established.
[Elderly Use]
There is no evidence that daily dosage adjustments are necessary for elderly patients, but those with increased sensitivity to hypotension may require special attention.
[Overdose]
Overdose may cause a throbbing headache. More severe symptoms include excitement, flushing, cold sweats, vomiting, dizziness, syncope, tachycardia, palpitations, and a decrease in blood pressure. High doses may cause methemoglobinemia (very rare). Treatment: 1. Discontinue the drug. 2. Treatment of nitrate-induced hypotension: - Place the patient in a supine position with the head lowered and the legs elevated. - Provide oxygen. - Increase blood volume. - Specific treatment for shock (admit the patient to an intensive care unit). 3. If blood pressure is too low, administer sympathomimetics such as epinephrine hydrochloride or norepinephrine hydrochloride to raise blood pressure. 4. Treatment of methemoglobinemia: Use vitamin C, methylene blue, or toluidine blue. - Oxygen inhalation (if necessary). - Initiation of artificial ventilation. - Hemodialysis (if necessary). 5. Resuscitation: Immediate resuscitation is necessary if there are signs of respiratory or circulatory arrest.
[Pharmacology and Toxicology]
The primary pharmacological action of isosorbide mononitrate is relaxation of vascular smooth muscle and dilation of arteries and veins, with venous dilation being the primary effect. The drug's effects are dose-dependent. Low blood concentrations cause venous dilation, leading to peripheral pooling of blood, decreased venous return, and reduced left ventricular end-diastolic pressure (preload). High blood concentrations can also dilate arteries, reducing systemic vascular resistance and arterial pressure, and reducing cardiac afterload. Isosorbide mononitrate may also have a direct effect on coronary artery dilation. By reducing end-diastolic pressure and volume, this drug reduces intramural pressure, thereby improving subendocardial blood flow. Therefore, the combined effects of isosorbide mononitrate administration are to reduce cardiac workload and improve myocardial oxygen supply/demand balance. In placebo-controlled studies, once-daily administration of this drug effectively controlled angina, improved exercise capacity and symptoms, and reduced signs of myocardial ischemia. The duration of action was at least 12 hours, with plasma concentrations at this time similar to those observed one hour after dosing, approximately 1300 nmol/L. This drug has been shown to be effective as monotherapy or in combination with beta-blockers and calcium antagonists. The clinical effects of nitrates may diminish after repeated dosing to achieve high and stable plasma concentrations; this can be avoided by maintaining low plasma concentrations for a period of time between dosing. This drug, administered once daily in the morning, exhibits high daytime concentrations and low evening concentrations. No tolerance to its anti-anginal effects has been observed with 60 mg and 120 mg of this drug administered once daily. The rebound phenomenon observed with intermittent nitrate therapy was not observed with this medication. Emdole is also safe and well-tolerated in the setting of acute myocardial infarction. The initial dose is 30 mg, followed by another 30 mg 12 hours later, and thereafter, 60 mg once daily. Plasma concentrations in patients with acute myocardial infarction are similar to those in healthy volunteers. Prolonged absorption may occasionally occur, possibly due to concomitant morphine use. Emdole is composed of an insoluble matrix that typically disintegrates through intestinal peristalsis. Occasionally, the tablet may remain intact while passing through the gastrointestinal tract, but the active ingredient has already been released.
