Product Overview
[Drug Name]
Generic Name: Isosorbide Dinitrate Tablets
Trade Name: Shuangyi
English Name: sosorbide Dinitrate Tablets
Chinese Pinyin: Xiaosuan Yishanlizhi Pian
[Ingredients]
Isosorbide Dinitrate.
[Properties]
This product is a white tablet.
[Indications]
Long-term treatment of coronary heart disease; prevention of angina pectoris; treatment of persistent angina pectoris after myocardial infarction; combined with digitalis and/or diuretics for the treatment of chronic congestive heart failure.
[Dosage and Administration]
Tablets: Oral dose of 10-20 mg 2-3 times daily. In severe cases, 40 mg 2-3 times daily may be used.
[Adverse Reactions]
Vasodilatory headaches caused by nitrates may occur initially, but usually resolve after several days of continuous use. Facial flushing, dizziness, orthostatic hypotension, and reflex tachycardia may also occur. Rarely, a significant decrease in blood pressure, bradycardia, worsening angina pectoris, and syncope may occur.
[Contraindications]
1. Patients with acute circulatory failure (shock, circulatory collapse); 2. Patients with severe hypotension (systolic blood pressure 90 mmHg); 3. Patients with acute myocardial infarction and low filling pressures (unless under continuous hemodynamic monitoring); 4. Patients with hypertrophic obstructive cardiomyopathy; 5. Patients with constrictive pericarditis or cardiac tamponade; 6. Patients with severe anemia; 7. Patients with glaucoma; 8. Patients with increased intracranial pressure; 9. Patients allergic to nitro compounds.
[Precautions] In patients with acute myocardial infarction and low filling pressures, systolic blood pressure should be avoided below 90 mmHg. Use with caution in patients with aortic and/or mitral stenosis, orthostatic hypotension, and renal insufficiency.
[Use in Special Populations]
Precautions for Children:
This drug has been studied in adults. There is no data comparing its use in children and adults. Therefore, it is not recommended for use in children.
Precautions for Pregnancy and Lactation:
No embryotoxic effects have been observed in animal studies, and it is unknown whether ISMN is excreted in breast milk. However, due to a lack of experience with its use in pregnant and lactating women, caution is advised.
Precautions for Elderly Patients:
Elderly patients may be more sensitive to this class of drugs and may be more susceptible to reactions such as dizziness.
[Drug Interactions]
Combination use with other vasodilators, calcium antagonists, beta-blockers, antihypertensive drugs, tricyclic antidepressants, and alcohol may potentiate the blood pressure-lowering effects of this class of drugs.
[Pharmacological Actions]
Isosorbide mononitrate (ISMN) is the primary biologically active metabolite of isosorbide dinitrate. Like other organic nitrates, its primary pharmacological action is to relax vascular smooth muscle. ISMN releases nitric oxide (NO), which, like endothelial relaxing factor, activates guanylate cyclase, increasing cyclic guanosine monophosphate (cGMP) in smooth muscle cells. This relaxes vascular smooth muscle, dilating peripheral arteries and veins and enhancing the venous dilation effect. Venodilation causes blood to accumulate in the periphery, reducing ventricle return and lowering left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arterial dilation reduces peripheral vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Coronary artery dilation increases coronary perfusion. The overall effect is reduced myocardial oxygen consumption, increased oxygen supply, and relief of angina pectoris. No carcinogenic or mutagenic effects were observed in animal studies.
[Storage]
Sealed in a cool, dry place.
[Strength]
5 mg
[Packaging]
100 tablets/bottle.
[Expiration]
36 months
[Approval Number]
National Medicine Standard No. H31021370
[Manufacturer]
Company Name: Shanghai Fudan Fuhua Pharmaceutical Co., Ltd.
