Product Overview
[Drug Name]
Generic Name: Nifedipine Extended-Release Tablets (II)
Trade Name: BeiQiLing Nifedipine Extended-Release Tablets (II) 20mg*30 Tablets
Pinyin Full Code: BeiQiLing XiaoBenDiPingHuanShiPian(II) 20mg*30 Tablets
[Main Ingredient]
The main ingredient of this product is nifedipine.
[Properties]
This product is a film-coated tablet that appears yellow after removal of the coating.
[Indications/Main Functions]
Chronic stable angina (exertional angina); vasospastic angina (Prinzmetal's angina, variant angina); primary hypertension.
[Precautions]
Patients with severe hypotension (systolic blood pressure below 90 mmHg) and decompensated heart failure should only take this product after consulting a physician and under special monitoring conditions. 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 modest and well-tolerated, it can occasionally cause an excessive decrease in blood pressure that is not tolerated. This phenomenon occurs during drug initiation, dose increases, and concomitant beta-blocker use. There have been reports of severe hypotension and/or the need for volume expansion in patients receiving concomitant nifedipine and beta-blockers undergoing 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). Patients receiving nifedipine for hypertension and/or angina may experience an increase in angina and/or myocardial infarction. Rarely, the frequency, duration, and/or severity of these episodes may be increased during drug initiation and/or dose increases, particularly in patients with significant occlusive coronary artery disease. However, the mechanism is unclear. Gradual reduction of beta-blocker dosage is preferable to abrupt discontinuation before nifedipine. Patients who have recently discontinued beta-blockers may experience a discontinuation syndrome with increased angina, possibly related to increased catecholamine sensitivity. Rarely, heart failure may develop after initiation of nifedipine in patients receiving beta-blocker therapy, usually in patients with aortic stenosis. Because nifedipine breakdown is delayed in patients with hepatic impairment, physicians should closely monitor the course of nifedipine. If necessary, the dosage should be reduced. A lower dosage 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 safety responses to medication, this medication may affect the ability of individuals to respond to it, such as those driving vehicles, operating machinery, or those without appropriate safety precautions. This effect may occur primarily during the initial treatment phase, during dose increases, during medication changes, or during concurrent alcohol consumption. Therefore, patients in the above-mentioned occupations should receive regular clinical follow-up while receiving this medication. If the dose is too low or a dose is missed, do not take a double dose at once. Instead, take the next normal dose according to the prescribed dosing interval.
[Drug Interactions]
1. Hypersensitivity to nifedipine or other ingredients in this medication. 2. History of cardiogenic shock. 3. Severe aortic (valvular) stenosis. 4. Unstable angina. 5. Recent myocardial infarction (within the past 4 weeks). 6. Patients currently taking rifampin. 7. Pregnant women.
[Specifications]
20mg x 30 tablets
[Dosage]
Oral. For adults, take 20mg orally twice daily. Adjust dosage based on symptoms.
[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 feeling 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 is rare in patients receiving long-term treatment and resolves spontaneously upon discontinuation of treatment. 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. Rarely, elevated blood sugar levels 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. Temporary loss of consciousness (syncope) due to a decrease in blood pressure has rarely occurred in patients initially receiving 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 impaired renal function 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 the product package insert during treatment, please consult a physician immediately.
[Contraindications]
1. Hypersensitivity to nifedipine or other ingredients in this product. 2. History of cardiogenic shock. 3. Severe aortic (valvular) stenosis. 4. Unstable angina. 5. Recent myocardial infarction (within the past 4 weeks). 6. Patients currently taking rifampicin. 7. Pregnant women.
