Product Overview
[Drug Name]
Generic Name: Nifedipine Controlled-Release Tablets
Trade Name: Baixintong
English Name: Nifedipine Controlled-Release Tablets
Chinese Pinyin: Baixintong (Xiaobendipingkongshipian)
[Ingredients]
Each tablet contains 30 mg and 60 mg of nifedipine. Other ingredients: Hydroxypropyl methylcellulose, oxidized polyethylene, magnesium stearate, sodium chloride, red iron oxide (E/72C.1.77491), cellulose acetate, polyethylene glycol 3350, hydroxypropyl cellulose, propylene glycol, titanium dioxide.
[Properties]
Film-coated tablets.
[Indications]
1. Coronary heart disease. Chronic stable angina (exertional angina); 2. Hypertension.
[Dosage and Administration]
Treatment should be tailored to individual patient needs. A different baseline dose should be administered based on the patient's clinical condition. Unless otherwise directed by a physician, the following dosage is recommended for adults: 1. Hypertension: 30mg tablets: 30mg once daily. 60mg tablets: 60mg once daily. 2. Coronary Artery Disease: Chronic Stable Angina (Exertional Angina): 30mg tablets: 30mg once daily. 60mg tablets: 60mg once daily. The usual initial dose for treatment is 30mg daily. Nifedipine dose adjustment or omission may be necessary when coadministered with CYP3A4 inhibitors or inducers (see [Drug Interactions]). Duration of treatment: The duration of medication should be determined by the physician. Dosage: Generally, the tablet should be swallowed whole with a small amount of liquid, regardless of mealtime. Grapefruit juice should be avoided (see [Drug Interactions]). Patients with mild, moderate, or severe hepatic impairment (as measured by the Child-Pugh score) should be carefully monitored and may require dose reduction. The pharmacokinetics of nifedipine have not been studied in patients with severe hepatic impairment (see [Precautions] and [Pharmacokinetics]).
[Adverse Reactions]
1. Common adverse reactions include peripheral edema (dose-proportional) and headache. 2. Adverse reactions of uncertain relationship to this product include dizziness, nausea, constipation, fatigue, facial flushing, and hot sensation. 3.1%-3% adverse reactions include chest pain, leg pain, paresthesia, vertigo, rash, leg cramps, epistaxis, rhinitis, impotence, and frequent urination. 4.1% adverse reactions: cellulitis; chills; facial edema; neck pain; pelvic pain; atrial fibrillation; bradycardia; cardiac arrest; premature beats; hypotension; palpitations; phlebitis; postural hypotension; tachycardia; anxiety; loss of libido; depression; insomnia; drowsiness; pruritus; night sweats; abdominal pain; diarrhea; dry mouth; indigestion; esophagitis; bloating; gastrointestinal bleeding; vomiting; lymphadenopathy; gout; weight loss; arthralgia; arthritis; myalgia; dyspnea; cough; pharyngitis; blurred vision; amblyopia; conjunctivitis; diplopia; kidney stones, etc. 5. Rare adverse reactions: allergic hepatitis; alopecia; anemia; antinuclear antibody-positive arthritis; erythromelalgia; peeling. 6. Exfoliative dermatitis; fever; gingival hyperplasia; gynecomastia in men; leukopenia; mood swings; muscle pain; nervousness; purpura; tremors; sleep disorders; Stevens-Johnson syndrome; syncope; thrombocytopenia; toxic epidermal joint necrosis; transient blindness at peak blood concentration; tremor; urticaria.
[Contraindications]
Baixintong is contraindicated in patients with a known hypersensitivity to nifedipine. Nifedipine is contraindicated in cardiogenic shock. Due to enzyme induction, nifedipine does not achieve effective blood concentrations when used with rifampicin. Therefore, it should not be used in combination with rifampicin.
[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 beta-blockers in combination. Blood pressure should be monitored during this period, especially when taking other antihypertensive medications. 2. Peripheral Edema: Mild to moderate peripheral edema occurs 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 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. These elevations are generally asymptomatic, but 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. Caution should be exercised in patients with hepatic or renal impairment or those currently taking beta-blockers. A low dose should be started to prevent the induction or exacerbation of hypotension, which may increase the incidence of angina, heart failure, and even myocardial infarction. Reversible elevations of blood urea nitrogen and creatinine may occasionally occur with this drug in patients with chronic renal failure, but the relationship to nifedipine is unclear. Please read the package insert carefully and use as directed by your healthcare provider.
[Use in Pregnant and Lactating Women]
This medication is contraindicated in pregnant women and women of reproductive age up to 20 weeks of gestation. There are insufficient studies in pregnant women.Animal studies have shown embryotoxicity, fetotoxicity, and teratogenicity. Although there have been reports of increased perinatal asphyxia, cesarean section, premature birth, and intrauterine growth retardation, available clinical evidence does not indicate a specific prenatal risk. It is unclear whether these reports are due to underlying hypertension and its treatment, or specific medication effects. Available information is insufficient to exclude adverse effects on the fetus and neonate. Therefore, the use of this medication in women older than 20 weeks of gestation should be carefully weighed against the risks and benefits, and should only be considered when other treatment options are inadequate or ineffective. When nifedipine is administered concurrently with intravenous magnesium sulfate to pregnant women, blood pressure should be closely monitored due to the potential for hypotension, which could affect both the mother and the fetus. In some cases of in vitro fertilization, calcium antagonists like nifedipine have been associated with reversible biochemical changes in the sperm head, impairing sperm function. For men who have repeatedly failed in vitro fertilization (IVF) and have no other causative factors, nifedipine-type calcium channel blockers should be considered as a possible cause. Nifedipine can enter breast milk during lactation. Because there are no reports of potential effects on infants, if nifedipine is taken during breastfeeding, breastfeeding must be discontinued.
[Pediatric Use]
No safety and efficacy data are available for pediatric use.
[Elderly Use]
No data are available for the use of this drug in elderly patients.
[Drug Interactions]
1. This drug is well tolerated when used in combination with nitrates to control angina attacks. 2. This drug is well tolerated and effective when used in combination with beta-blockers in most patients, but may induce and aggravate hypotension, heart failure, and angina in some patients. 3. This drug may increase blood digoxin concentrations when used in combination with digitalis, urinary digoxin concentrations should be monitored when first using this drug, adjusting the dose, or discontinuing it. 4. Concomitant use with highly protein-bound drugs, such as dicoumarols, phenytoin, quinidine, quinine, and warfarin, often results in altered free concentrations of these drugs. 5. Concomitant use with cimetidine increases peak plasma concentrations of this drug; therefore, adjust the dose carefully. 6. When grapefruit juice is taken with this drug, the Cmax and AUC of this drug increase.
[Pharmacological Actions]
1. Nifedipine is a 1,4-dihydropyridine calcium antagonist. Calcium antagonists reduce the entry of calcium ions into cells via slow calcium channels. Nifedipine specifically targets smooth muscle cells of myocardial cells, coronary arteries, and peripheral resistance vessels. 2. Nifedipine dilates coronary arteries, particularly large vessels, and can even dilate healthy vessels in areas of incomplete occlusion. Nifedipine also reduces coronary artery smooth muscle tone, preventing vasospasm. Ultimately, this increases blood flow and oxygen delivery to narrowed vessels. Furthermore, by reducing peripheral resistance (afterload), nifedipine reduces oxygen demand. Long-term use of nifedipine can prevent the development of new coronary atherosclerotic lesions. 3. Nifedipine can reduce increased peripheral resistance and blood pressure by reducing arterial smooth muscle tone. Initial nifedipine treatment may cause a temporary reflex increase in heart rate, leading to an increase in cardiac output. However, this increase is insufficient to compensate for vasodilation. Furthermore, both short-term and long-term nifedipine use can increase sodium and water excretion. Nifedipine's antihypertensive effect is particularly significant in patients with hypertension. 4. A multinational, randomized, double-blind, prospective study, conducted over 3-4.8 years and involving 6,321 hypertensive patients with at least one additional risk factor, showed that nifedipine controlled-release tablets reduced the incidence of cardiovascular and cerebrovascular events, comparable to standard diuretic combination therapy.
[Storage]
Sealed.
[Specifications]
30mg x 14s (Bainxintong)
[Expiry Date]
36 months
[Approval Number]
National Medicine Standard No. J20180025
[Manufacturer]
Company Name: Bayer HealthCare Co., Ltd.
