Product Overview
[Drug Name]
Generic Name: Lacidipine Tablets
Trade Name: LeXiPing LaXiDiPing Tablets 4mg*7 Tablets
Pinyin Full Code: LeXiPing LaXiDiPingPian 4mg*7 Tablets
[Main Ingredient]
Chemical Name: (+)-2,6-Dimethyl-4-{2-[(E)-2-(tert-butyloxycarbonyl)-vinyl]phenyl}-1,4-dihydro-3,5-pyridinedicarboxylic acid diethyl ester Molecular Formula: C26H33NO6 Molecular Weight: 455.6
[Properties]
This product is a film-coated tablet that appears off-white after removal of the coating.
[Indications/Main Functions]
For the treatment of hypertension, used alone or in combination with other antihypertensive medications, such as beta-blockers, diuretics, and angiotensin-converting enzyme inhibitors.
[Specifications]
4mg*7 tablets
[Dosage and Administration]
The initial dose is 2 mg once daily. The drug should be taken at the same time each day, preferably in the morning. Treatment for hypertension should be adjusted based on the severity of the condition and individual patient variability. If effective treatment is not achieved within a sufficient period of time after the initial dose, the dose can be increased to 4 mg/day and, if necessary, to 6 mg/day. In practice, dose adjustments should be made no less frequently than every 3-4 weeks unless the condition is severe and rapid dose increases are necessary. This drug should be taken at the same time each day, preferably in the morning, with or without food. Hepatic Impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment. Insufficient data are available to provide a recommended dose for patients with severe hepatic impairment (see [Precautions]). Renal Impairment: Because lacidipine is not excreted by the kidneys, no dose adjustment is required for patients with renal impairment. Elderly Patients: No dose adjustment is required. This drug is suitable for long-term treatment.
[Adverse Reactions]
Data from large-scale clinical studies (both internal and public) have been used to determine the frequency of adverse events, ranging from very common to uncommon. Adverse event rates are defined as: very common (>1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/100), and very rare (<1/10,000). Lacidipine is generally well tolerated. Minor side effects may occur in some cases, related to its known pharmacological effects on peripheral vasodilation. These side effects, indicated by a #, are usually transient and resolve with continued use of the same dose of lacidipine tablets. Psychiatric disturbances: Very rare: Asthenia. Neurological disturbances: Common: Headache #, dizziness #. Very rare: Tremor. Cardiac disturbances: Common: Palpitations #, tachycardia. Uncommon: Worsening of angina, syncope, hypotension. As with other dihydropyridines, worsening of angina has been reported occasionally, particularly at the start of treatment. This is most likely to occur in patients with symptomatic myocardial ischemia. Vascular disorders Common: Skin flushing. Gastrointestinal disorders Common: Gastrointestinal discomfort, nausea. Uncommon: Gingival hyperplasia. Skin and subcutaneous tissue disorders Common: Rash (including erythema and pruritus). Rare: Angioedema, urticaria. Renal and urinary tract disorders Common: Polyuria. Systemic disorders and administration site conditions Common: Asthenia, edema. Laboratory test results Common: Reversible alkaline phosphatase elevation (clinically significant increases are uncommon).
[Contraindications]
This product is contraindicated in patients with hypersensitivity to any component. As with other dihydropyridines, lacidipine is contraindicated in patients with severe aortic stenosis.
[Precautions]
Specific studies have shown that lacidipine does not affect sinus node automaticity or prolong conduction within the atrioventricular node. However, the theoretical effects of calcium antagonists on sinus and atrioventricular node activity should be noted. Therefore, this product should be used with caution in patients with abnormal sinus and atrioventricular node activity. As reported with other dihydropyridine calcium channel blockers, lacidipine should be used with caution in patients with congenital or established acquired QT prolongation. Lacidipine should be used with caution in patients taking concomitant medications known to prolong the QT interval, such as type I and type II antiarrhythmics, tricyclic antidepressants, certain antipsychotics, antibiotics (e.g., erythromycin), and certain antihistamines (e.g., terfenadine). As with other calcium channel blockers, lacidipine should be used with caution in patients with impaired cardiac reserve. As with other dihydropyridine calcium channel blockers, lacidipine should be used with caution in patients with unstable angina. Lacidipine should be used with caution in patients with a recent myocardial infarction. Because the antihypertensive effects of lacidipine may be enhanced in patients with hepatic impairment, lacidipine should be used with caution in patients with hepatic impairment. There is no evidence that lacidipine impairs glucose tolerance or alters diabetic control.
