Product Overview
[Drug Name]
Generic Name: Nifedipine Sustained-Release Tablets (I)
Trade Name: Shengtongping
English Name: Nifedipine Sustained-Release Tablets
Chinese Pinyin: Xiao Ben Di Ping Huan Shi Pian
[Ingredients]
Nifedipine
[Properties]
This product is a film-coated tablet that appears yellow after the film coating is removed.
[Indications]
1. Hypertension (used alone or in combination with other antihypertensive drugs). 2. Angina pectoris: especially variant angina.
[Dosage and Administration]
1. Swallow the tablet whole on an empty stomach; do not chew or break it into pieces.
2. Start with a low dose. The initial dose is 20 mg/time, with a maximum dose of 60 mg/time, once daily. The maximum daily dose should not exceed 120 mg.
3. The dose of nifedipine should be adjusted gradually based on the patient's tolerance and control of angina. Monitor the patient's blood pressure before increasing the dose. If the patient's symptoms are significant, the dose adjustment period may be shortened based on the patient's response to the drug. 4. Even if rebound symptoms are not observed upon discontinuation of the drug, the dose should still be gradually reduced, and the patient's condition should be closely monitored.
5. The dose of the standard preparation can be safely substituted for the dose of the extended-release preparation. For example, a 30 mg dose of the standard preparation three times daily can be replaced with a 90 mg dose of the extended-release preparation once daily.
[Adverse Reactions]
1. Liver: Jaundice and elevated glutamate oxaloacetate aminotransferase and glutamate pyruvate aminotransferase levels may occasionally occur. 2. Circulatory System: Chest pain, headache, flushing, dizziness, palpitations, decreased blood pressure, and lower limb edema may occasionally occur. 3. Allergies: Allergic symptoms such as hives and itching may occasionally occur. 4. Digestive System: Abdominal pain, nausea, loss of appetite, and constipation may occasionally occur. 5. Oral: Gingival hypertrophy may occur. 6. Metabolic Abnormalities: Hyperglycemia may occasionally occur.
[Contraindications]
This product is contraindicated in patients allergic to nifedipine.
[Precautions]
1. Hypotension: Most patients experience only mild hypotension after taking nifedipine, but some patients experience severe hypotension. This reaction often occurs during dose adjustment or increase, especially when taking β-blockers concomitantly. Blood pressure should be monitored during this period, especially when taking other antihypertensive drugs. 2. Peripheral Edema: Mild to moderate peripheral edema may occur in patients proportional to the dose and is related to arterial dilation. Edema often initially occurs in the lower extremities and can be treated with diuretics. In patients with congestive heart failure, it is important to determine whether the edema is due to further deterioration of left ventricular function. 3. Diagnostic Interference: Elevations of alkaline phosphatase, creatine phosphokinase, lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase may occasionally occur with this drug. While generally asymptomatic, cholestasis and jaundice have been reported; platelet aggregation is decreased, bleeding time is prolonged, and a positive direct Coomb's test with or without hemolytic anemia has been reported. 4. Use with caution in patients with hepatic or renal impairment or those currently taking beta-blockers. It is advisable to start with a low dose to prevent the induction or exacerbation of hypotension, which may increase the incidence of angina, heart failure, or even myocardial infarction. Patients with chronic renal failure may occasionally experience reversible increases in blood urea nitrogen and creatinine when taking this drug, but the relationship to nifedipine is unclear.
[Use in Special Populations]
Precautions for Children: Safety and efficacy are not yet established.
Precautions for Pregnancy and Lactation: Detailed clinical research data are not available for use in pregnant women. Nifedipine is excreted into breast milk; nursing women should discontinue use or breastfeeding.
Precautions for the Elderly: This drug prolongs its half-life and increases its Cmax and AUC. Start with the lowest dose to minimize the incidence of adverse reactions.
[Drug Interactions]
1. Used in combination with nitrates to control angina attacks, it is well tolerated. 2. When used in combination with beta-blockers, this drug is well tolerated and effective in most patients; however, some patients may experience and aggravate hypotension, heart failure, and angina pectoris. 3. When used in combination with digitalis, blood digoxin concentrations may increase; therefore, digoxin blood concentrations should be monitored during initial use, dose adjustments, or when discontinuing this drug. 4. When used in combination with highly protein-bound drugs, such as dicoumarols, phenytoin, quinidine, quinine, and warfarin, the free concentrations of these drugs often change. 5. When used in combination with cimetidine, peak plasma concentrations of this drug are increased; therefore, dose adjustments should be made accordingly. 6. When grapefruit juice is taken with this drug, the Cmax and AUC of this drug are increased.
[Pharmacological Action]
This product is a calcium influx blocker or slow-channel blocker. It blocks calcium ions from entering cells through channels in the myocardial or vascular smooth muscle membrane. This reduces vascular tone and dilation in systemic blood vessels, including the coronary arteries, thereby lowering blood pressure and increasing coronary blood supply. Furthermore, it inhibits myocardial contraction, reducing myocardial work and oxygen demand, thereby relieving angina pectoris. At therapeutic doses, it has minimal effect on sinus and atrioventricular node function.
[Storage] Store in a dark, sealed container.
[Strength] 10mg
[Packaging Size] Box.
[Expiry Date] 12 months
[Approval Number] National Medicine Standard H44024160
[Manufacturer] Company Name: Sinopharm Group Guangdong Global Pharmaceutical Co., Ltd.
