Product Overview
[Drug Name]
Generic Name: Nitrendipine Tablets
Trade Name: Huanan Brand
English Name: Nitrendipine Tablets
Chinese Pinyin: Niqundiping Pian
[Ingredients]
Main ingredient: The main ingredient and its chemical name are: 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylic acid methyl ethyl ester. Molecular formula: C₁₈H₂₀N₂O₆. Molecular weight: 360.37.
[Properties]
This product is a pale yellow tablet.
[Indications]
Hypertension.
[Dosage and Administration]
Usual adult dosage: Initially, take 10 mg orally once daily, which can be increased to 20 mg twice daily as needed.
[Adverse Reactions]
Less common reactions include headache and facial flushing. Less common reactions include dizziness, nausea, hypotension, ankle edema, angina attacks, and transient hypotension. Allergic reactions to this drug may result in allergic hepatitis, rash, or even exfoliative dermatitis.
[Contraindications]
This drug is contraindicated in patients with allergies or severe aortic valve stenosis.
[Precautions]
1. Elevated blood alkaline phosphatase levels may occur in a minority of cases. 2. Blood concentrations may increase in patients with hepatic impairment, but the pharmacokinetics are minimally affected in patients with renal insufficiency. Use this drug with caution in these situations. 3. While most patients experience only mild, tolerable hypotension after taking this drug, some may experience severe systemic hypotension. This reaction often occurs during initial dose adjustments or increases, particularly when taking beta-blockers. Therefore, blood pressure should be monitored regularly while taking this drug. 4. In a very small number of patients, particularly those with severe coronary artery stenosis, the incidence of angina or myocardial infarction has been shown to increase while taking this drug or during dose increases. The mechanism is unclear. Therefore, regular electrocardiograms should be performed while taking this drug. 5. A small number of patients receiving beta-blockers may develop heart failure after starting this medication. This risk is greater in patients with aortic stenosis.
[Use in Special Populations]
Precautions for Children:
Not yet established.
Precautions for Pregnancy and Lactation:
The use of this product in pregnant women has not been adequately studied. Existing clinical use has not resulted in problems, but adverse reactions should be noted.
Precautions for the Elderly:
Serum concentrations are higher in the elderly, but the half-life is not prolonged, so the dose should be appropriately reduced. Patients currently taking beta-blockers should use this product with caution. Combination therapy should start with a low dose to prevent inducing or exacerbating systemic hypotension, which could increase the risk of angina, heart failure, or even myocardial infarction. The recommended initial dose for elderly patients is 10 mg (1 tablet) daily.
[Drug Interactions]
1. In most patients, the concomitant use of γ-blockers enhances the antihypertensive effect and can reduce the tachycardia that occurs after nitrendipine administration; however, in some patients, it may induce and worsen systemic hypotension, heart failure, and angina. 2. Coadministration with angiotensin-converting enzyme inhibitors is well tolerated and enhances the antihypertensive effect. 3. Coadministration with long-acting nitrates is well tolerated, but there is a lack of literature evaluating the effectiveness of this combination for controlling angina. 4. Some studies suggest that the use of digitalis may increase the plasma concentration of the concomitant digoxin, by an average of 45%. Some studies suggest that it does not increase digoxin plasma concentration or toxicity. This suggests that digoxin plasma concentrations should be monitored during initial use, dose adjustment, or discontinuation of nitrendipine to prevent digoxin overdose or underdose. 5. There are no reports of coadministration of dicoagulants with nitrendipine increasing the prothrombin time of coumarin anticoagulants. Currently, there is no definitive interaction between these drugs. 6. Cimetidine can mediate inhibition of hepatic cytochrome P450 enzymes, altering the first-pass effect of nitrendipine. Therefore, it is recommended that patients taking cimetidine concurrently with nitrendipine adjust their dosage.
[Pharmacological Actions]
1. This product is a dihydropyridine calcium channel blocker. 2. This product inhibits transmembrane calcium influx in vascular smooth muscle and myocardium, primarily targeting the blood vessels, resulting in a strong vascular selectivity. 3. This product causes dilation of systemic blood vessels, including coronary arteries and renal arterioles, resulting in a hypotensive effect.
[Storage] Store in a dark, sealed container.
[Strength] 10mg
[Packaging Size] 100s
[Expiry Life] 24 months.
[Approval Number] National Medicine Standard H44023983
[Manufacturer] Company Name: Guangdong Huanan Pharmaceutical Group Co., Ltd.
