Product Overview
[Drug Name]
Generic Name: Nifedipine Sustained-Release Tablets (I)
Trade Name: Sinopharm Nifedipine Sustained-Release Tablets (I) 10mg*30 Tablets
Pinyin Full Code: GuoYaoGongYe XiaoBenDiPingHuanShiPian(I) 10mg*30 Tablets
[Main Ingredients]
The main ingredient of this product is: Nifedipine.
[Properties]
This product is a film-coated tablet. Removal of the film coating reveals a yellow color.
[Indications/Main Functions]
Various types of hypertension and angina pectoris.
[Precautions]
1. When discontinuing calcium channel blockers, the dosage should be gradually reduced. Do not discontinue medication without a doctor's instructions. 2. Use with caution in patients with hypotension. 3. Use with caution in patients with severe aortic valve stenosis, hepatic or renal insufficiency.
[Drug Interactions]
This product is contraindicated for use in pregnant women.
[Pediatric Use]
This product is contraindicated for use in children.
[Use in Elderly Patients]
This study has not been conducted and no reliable references are available.
[Use in Pregnancy and Lactation]
This medication is contraindicated for pregnant women.
[Specifications]
10mg*30 tablets
[Dosage and Administration]
Oral: 10-20mg twice daily. Maximum dose: 40mg once, 0.12g daily.
[Adverse Reactions]
1. Liver: Jaundice and elevated glutamate oxaloacetate aminotransferase and glutamate pyruvate aminotransferase levels may occur occasionally. 2. Circulatory System: Chest pain, headache, flushing, dizziness, palpitations, decreased blood pressure, and lower limb edema may occur occasionally. 3. Allergies: Allergic symptoms such as hives and itching may occur occasionally. 4. Digestive System: Abdominal pain, nausea, loss of appetite, and constipation may occur occasionally. 5. Oral: Gingival hypertrophy may occur. 6. Metabolic Abnormalities: Hyperglycemia may occur occasionally.
[Contraindications]
This medication is contraindicated for pregnant women.
[Overdose]
This study was not conducted and no reliable references are available.
[Pharmacology and Toxicology]
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 areas, 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 can also inhibit myocardial contractility, reduce myocardial metabolism, and decrease 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 animals and humans have not shown that this drug delays atrioventricular conduction, prolongs sinus node recovery time, or slows sinus node rate. Toxicological effects: Carcinogenicity, mutagenicity, and reproductive toxicity: No carcinogenicity. No mutagenicity. High doses can reduce female rat fertility; can cause teratogenicity; and can induce abortion (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 resulted in small placentas and chorionic villus hypoplasia; administration of 3 times the maximum human dose to rats resulted in prolonged gestation.
[Pharmacokinetics]
After oral administration, the drug reaches a plateau approximately 6 hours later, with minimal fluctuations and a duration of action of 24 hours. Under fasting conditions, the sustained-release formulation reduces fluctuations in plasma concentrations. A 90 mg oral dose resulted in an average plasma concentration of 115 ng/mL. High-fat meals increased plasma concentrations by 60%, prolonged the time to peak concentration, and did not significantly change the AUC. The sustained-release formulation has a relative bioavailability of 86% compared to the standard formulation. Within the dose range of 30-180 mg, plasma concentrations are dose-proportional. The drug is converted to inactive metabolites in the liver, 60-80% of which is excreted via the kidneys, and 20% is excreted in the feces. The elimination half-life is approximately 2 hours. Nifedipine is highly bound to plasma proteins, approximately 92-98%. In patients with hepatic and renal insufficiency, the elimination half-life is prolonged, and bioavailability is enhanced.
