Product Overview
[Drug Name]
Generic Name: Nifedipine Sustained-Release Tablets (II)
Trade Name: Parachute Nifedipine Sustained-Release Tablets (II) 48 Tablets
Pinyin Full Code: JiangLuoSan XiaoBenDiPingHuanShiPian(II) 16Pian*3Ban
[Main Ingredient]
The main ingredient of this product is nifedipine. Its chemical name is: 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylic acid dimethyl ester. Molecular Formula: C₁₇H₁₈N₂O₆. Molecular Weight: 346.34
[Properties]
This product is a yellow tablet.
[Indications/Main Functions]
- Chronic stable angina (exertional angina); - Vasospastic angina (Prinzmetal's angina, variant angina); - Essential hypertension
[Precautions]
Patients with severe hypotension (systolic blood pressure below 90 mmHg) and decompensated heart failure should only take this medication after consulting a physician and under specialized monitoring. This should be done even if the patient has only experienced these conditions in the past. Although nifedipine-induced hypotension in patients with angina is generally moderate and well-tolerated, it can occasionally cause an excessive drop in blood pressure that the patient cannot tolerate. This phenomenon often occurs during drug initiation, dose increases, and concomitant use of beta-blockers. There have been reports of patients receiving concomitant nifedipine and beta-blockers experiencing severe hypotension and/or the need for intravenous volume expansion when high-dose fentanyl is administered during coronary artery bypass surgery. This drug interaction may occur with the combined use of nifedipine and beta-blockers, or with nifedipine alone, low-dose fentanyl, other surgical procedures, or anesthetics. Physicians should be aware of this issue when high-dose fentanyl is required in patients receiving nifedipine. Nifedipine should be washed out of the system before surgery (at least 36 hours), if possible. Patients taking nifedipine for hypertension and/or angina may experience increased angina and/or myocardial infarction. Rarely, patients with severe occlusive coronary artery disease may experience an increase in the frequency, duration, and/or severity of angina attacks when initiating and/or increasing the dose. However, the mechanism is unclear. A gradual reduction in the beta-blocker dose is preferable to abrupt discontinuation before nifedipine administration. Patients who have recently discontinued beta-blockers may experience a discontinuation syndrome with increased angina, possibly related to increased sensitivity to catecholamines. Rarely, heart failure may develop after initiating nifedipine therapy, usually in patients receiving beta-blocker therapy. Patients with aortic stenosis are at greater risk. Because nifedipine breakdown is delayed in patients with impaired liver function, physicians should closely monitor nifedipine use. If necessary, the dose should be reduced. A lower dose should be used in patients with severe cerebral circulation (cerebrovascular disease). Dialysis patients with malignant hypertension and hypovolemia should be aware of the potential for a significant decrease in blood pressure due to vasodilation. Due to individual differences in drug response, this medication may affect the ability of individuals who drive vehicles, operate machinery, or who lack appropriate safety precautions. This effect primarily occurs during the initial treatment phase, during dose increases, during medication changes, or during concomitant alcohol consumption. Therefore, patients in these occupations require regular clinical follow-up while receiving this medication. If a dose of this medication is too low or a dose is missed, do not take a double dose at once. The next normal dose should be taken at the prescribed dosing interval.
[Drug Interactions]
- Hypersensitivity to nifedipine or other ingredients in this medication. - Previous cardiogenic shock. - Severe aortic stenosis (aortic (valve) stenosis). - Unstable angina. - Recent myocardial infarction (within the past 4 weeks). - Patients currently taking rifampin. - Pregnant women.
[Specifications]
48 tablets
[Dosage and Administration]
Please take this product as prescribed by your doctor; otherwise, optimal therapeutic effect may be difficult to achieve. Dosage should be individualized based on the severity of the disease and the patient's response to the drug. A standardized dosing regimen should be established gradually based on the patient's clinical symptoms. Patients with impaired liver function should have their liver function closely monitored and the dose reduced. Patients with severe cerebrovascular disease should receive a lower dose. Unless otherwise prescribed, the recommended dosage of this product is as follows: Adults: Chronic stable angina (exertional angina): Standard dose: One tablet twice daily (equivalent to 40 mg of nifedipine daily). Adults: Vasospastic angina (Prinzmetal's angina, variant angina): Standard dose: One tablet twice daily (equivalent to 40 mg of nifedipine daily). The standard dose is 20 mg twice daily; the dose can be increased to 40 mg twice daily. Adults: Primary hypertension: Standard dose: One tablet twice daily (equivalent to 40 mg of nifedipine daily). The standard dose is 20 mg twice daily; the dose can be increased to 40 mg twice daily. Administration: This product should be taken whole with water after meals. Taking it with food may delay, but not reduce, the absorption of this product. The interval between doses should be at least 4 hours. This drug should be discontinued gradually, especially at higher doses.
[Adverse Reactions]
The following symptoms are common, especially at the beginning of treatment, but are usually transient: headache, flushing of the face and/or skin accompanied by a sensation of warmth (erythema), and redness, swelling, and pain in the arms and legs (erythema limbis). Rarely, there may be a rapid pulse (tachycardia), palpitations, and lower extremity edema due to vasodilation. Dizziness and fatigue are rare. Numbness and tingling in the arms and legs and a drop in blood pressure below normal (hypotension) have also been reported. Gastrointestinal disturbances (such as nausea, abdominal distension, and diarrhea) are rare. Skin allergic reactions (such as itching, hives, and rash) are rare. Rare abnormalities in blood counts (such as decreased red blood cell, white blood cell, and platelet counts, and skin and mucous membrane bleeding due to thrombocytopenia) are rare. Gingival hyperplasia has rarely occurred in patients receiving long-term treatment and resolves spontaneously upon discontinuation of the drug. Very rare cases of liver dysfunction (intrahepatic cholestasis, elevated transaminases), low blood counts (agranulocytosis), petechial hemorrhages on the skin and mucous membranes (purpura), exfoliative dermatitis, photodermatitis, and acute systemic allergic reactions (e.g., swelling of the skin and mucous membranes, laryngeal edema, bronchomus spasm, including fatal respiratory distress) have been reported; these reactions resolve after discontinuation of treatment. Breast swelling (gynecomastia) has rarely occurred, particularly in elderly men treated with this drug for a long time; this symptom resolves spontaneously after discontinuation of treatment. Rare cases of elevated blood sugar have been reported, typically in patients with diabetes. Muscle pain, finger tremors, and mild, transient visual changes have occasionally occurred in patients taking high doses. Rarely, patients have experienced brief loss of consciousness (syncope) due to a decrease in blood pressure at the beginning of treatment. At the beginning of treatment, rare cases of angina have occurred; the frequency, duration, and severity of these episodes may be increased in patients with a history of angina. Patients with renal impairment may experience transient worsening of renal function during treatment with this drug. Particular attention should be paid to dialysis patients with hypertension and hypovolemia, as vasodilation may significantly lower blood pressure. Urine output may increase during the first week of treatment. If patients experience any adverse reactions not listed in this package insert during treatment, please consult a physician immediately.
[Contraindications]
- Hypersensitivity to nifedipine or other ingredients in this product. - Previous cardiogenic shock. - Severe aortic stenosis (aortic (valve) stenosis). - Unstable angina. - Recent myocardial infarction (within the past 4 weeks). - Patients currently taking rifampin. - Pregnant women.
