Product Overview
[Drug Name]
Generic Name: Nifedipine Extended-Release Tablets
Trade Name: Jiubaoping
English Name: Nifedipine Extended-Release Tablets
Chinese Pinyin: Nifedipine Extended-Release Tablets
[Ingredients]
Chemical Name: 2,6-Dimethyl-4-(2-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylic acid dimethyl ester Molecular Weight: C17H18N2O6
[Properties]
This product is a yellow tablet.
[Indications]
1. Hypertension; 2. Coronary heart disease, chronic stable angina (exertional angina).
[Dosage and Administration]
Oral: 30 mg once daily. This tablet should be swallowed whole and should not be chewed.
[Adverse Reactions] 1. Short-lived reactions, most commonly swelling of the ankles, feet, and calves, which can be relieved with diuretics. 2. Occasionally, chest pain, headache, flushing, dizziness, palpitations, and decreased blood pressure may occur. 3. Occasional abdominal pain, nausea, loss of appetite, and constipation may occur. 4. Gingival hypertrophy may occur.
[Contraindications]
1. This product is contraindicated in patients with known hypersensitivity to nifedipine or any of its ingredients. 2. Nifedipine is contraindicated in cardiogenic shock. 3. Due to enzyme induction, effective plasma concentrations of nifedipine cannot be achieved when used in combination with rifampicin. Therefore, it should not be used in combination with rifampicin. 4. Nifedipine is contraindicated in women under 20 weeks of pregnancy and during lactation.
[Precautions]
1. Patients with heart failure and severe aortic stenosis should use this product with extreme caution when their blood pressure is very low (severe hypotension with a systolic blood pressure of 90 mmHg).
2. Excessive hypotension: Although the blood pressure-lowering effect of nifedipine is moderate and tolerable in most patients, a few patients may experience excessive and unbearable hypotension. Hypotension often occurs with the initial administration of nifedipine or subsequent dose increases, particularly in patients taking beta-blockers. 3. Although nifedipine-induced hypotension in patients with angina is generally moderate and tolerable, it can occasionally cause an excessive drop in blood pressure that the patient cannot tolerate. This phenomenon often occurs during initial administration, dose increases, and concomitant beta-blocker use. 4. There have been reports of patients receiving nifedipine and beta-blockers experiencing severe hypotension and/or requiring intravenous volume expansion during coronary artery bypass surgery when high-dose fentanyl is administered. This drug interaction may occur with the combined use of nifedipine and beta-blockers, as well as with nifedipine alone, low-dose fentanyl, other surgical procedures, or anesthetics. Physicians should be aware of this concern when high-dose fentanyl is administered to patients receiving nifedipine. If possible, nifedipine should be washed out of the system before surgery (at least 36 hours).
[Use in Special Populations]
Precautions for Children:
Contraindicated in children.
Precautions for Pregnancy and Lactation:
Pregnant women should not use this product. Clinical studies in nursing mothers are insufficient; it is recommended that patients taking this product refrain from breastfeeding.
Precautions for Elderly Patients:
This product may prolong its half-life and increase its Cmax and AUC. Be sure to start at the lowest dose to minimize the incidence of adverse reactions.
[Drug Interactions]
1. It is well tolerated when used in combination with nitrates to control angina attacks. 2. The Cmax and AUC of this product may be increased when grapefruit juice is taken with this product. 3. It may increase blood digoxin concentrations when used with digitalis. Therefore, digoxin blood levels should be monitored during initial use, dose adjustments, or discontinuation of this product. 4. Concomitant use with highly protein-bound drugs, such as dicoumarols, phenytoin, quinidine, quinine, and warfarin, may alter the free concentrations of these drugs. 5. Concomitant use with cimetidine may increase peak plasma concentrations of this product; therefore, dose adjustments should be made.
[Pharmacological Action] Nifedipine is a dihydropyridine calcium antagonist that selectively inhibits transmembrane calcium transport into myocardial and smooth muscle cells and inhibits calcium release from intracellular stores without altering plasma calcium concentration. Pharmacological Action: This drug can dilate coronary arteries in both normal and ischemic territories, antagonizing spontaneous or ergonovine-induced coronary artery spasm, increasing myocardial oxygen delivery in patients with coronary artery spasm, and relieving and preventing coronary artery spasm. It also inhibits myocardial contractility, reduces myocardial metabolism, and decreases myocardial oxygen consumption. Furthermore, it can dilate peripheral resistance vessels, lower peripheral resistance, reduce systolic and diastolic blood pressure, and reduce cardiac afterload. This drug can delay sinus node function and atrioventricular conduction in isolated hearts; electrophysiological studies in whole animals and humans have not shown that this drug delays atrioventricular conduction, prolongs sinus node recovery time, or slows sinus node reversal rate. Toxicological Effects: Carcinogenicity, Mutagenicity, and Reproductive Toxicity: No carcinogenicity. Non-mutagenic. High doses can reduce female mouse fertility; cause teratogenesis; and induce miscarriage (increased fetal drug absorption, increased fetal mortality, and decreased neonatal survival). Administration of 2/3 to 2 times the maximum human dose to pregnant monkeys can result in small placentas and chorionic villus hypoplasia; administration of 3 times the maximum human dose to rats can cause prolonged pregnancy.
Storage: Store in a dark, airtight container.
Specifications: 30mg x 10 tablets
Packaging: Box
Expiration Period: 24 months
Approval Number: National Medicine Standard H20103238
Manufacturer: Beijing Honglin Pharmaceutical Co., Ltd.
