Product Overview
[Drug Name]
Generic Name: Lacidipine Tablets
Trade Name: Sanjing/Seleping
English Name: Lacidipine Tablets
Chinese Pinyin: Lɑ xi di pinɡ Piɑn
[Ingredients]
Lacidipine. The chemical name of lacidipine is (±)-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 white, odorless, and photolabile tablet.
[Indications]
Hypertension.
[Dosage and Administration]
The starting dose for adults is 4 mg once daily, preferably in the morning. It can be taken before or after meals. If necessary over 3-4 weeks, the dose can be increased to 6 mg or 8 mg once daily, unless more urgent clinical need warrants pre-emptive administration. The initial dose for patients with liver disease is 2 mg once daily.
[Adverse Reactions]
The most common reactions are headache, flushing, edema, dizziness, and palpitations. Less common reactions include weakness, rash (including erythema and pruritus), poor appetite, nausea, and polyuria. Chest pain and gingival hyperplasia are rare.
[Contraindications]
Allergies to the ingredients in this product.
[Precautions]
1. Patients with impaired liver function should reduce the dose or use with caution, as bioavailability may increase, potentially enhancing the hypotensive effect. 2. This product is not excreted by the kidneys; no dose adjustment is required in patients with renal disease. 3. Laboratory tests or hematological tests generally do not significantly affect this product. However, there has been a report of a reversible increase in alkaline phosphatase. 4. Although this product does not affect the conduction system or myocardial contractility, calcium antagonists theoretically may affect sinus node activity and myocardial reserve, which should be considered. Patients with abnormal sinus node activity should be particularly concerned, and patients with impaired cardiac reserve should also exercise caution.
[Use in Special Populations]
Precautions for Pediatric Use:
This product has no experience with pediatric use.
Precautions for Pregnancy and Lactation:
1. There is no data confirming the safety of this product in human pregnancy. Pregnant women should carefully weigh the risks and benefits of its use.
2. This product and its metabolites are excreted in breast milk. It is best not to breastfeed or discontinue use of this product.
3. This product may cause uterine muscle relaxation and should be used with caution in women about to give birth.
Precautions for Elderly Patients:
The initial dose for elderly patients is 2 mg once daily, which can be increased to 4 mg or 6 mg once daily if necessary. Long-term continuous use is acceptable.
[Drug Interactions]
1. Concomitant use with beta-blockers and diuretics may enhance the antihypertensive effect.
2. Concomitant use with cimetidine may increase the blood concentration of this product.
3. Concomitant use with digoxin may increase peak digoxin levels by 17%, with no effect on the 24-hour average digoxin level. 4. When used in combination with propranolol, it may slightly increase the area under the curve (AUC) of both drugs.
5. It has no specific cross-reactivity with warfarin, tolbutamide, diclofenac, cyclosporine, and antipyrine.
[Pharmacological Actions]
1. Pharmacological Action: This product is a dihydropyridine calcium ion antagonist with high selectivity for calcium channels in smooth muscle. It primarily dilates peripheral arteries, reduces peripheral resistance, and has a strong and sustained antihypertensive effect. It has no significant effects on the cardiac conduction system or myocardial contractile function. It may also improve diastolic function in damaged and hypertrophic left ventricles and have anti-atherosclerotic effects. It increases renal blood flow without affecting glomerular filtration rate, and produces transient but insignificant diuretic and natriuretic effects, thereby preventing cyclosporine A-induced renal hypoperfusion in transplant patients. This product is highly lipid-soluble, deposited in the lipid compartment, and continuously released to binding sites during the clearance phase. This characteristic distinguishes this product from other calcium antagonists, which have low lipid solubility and a shorter duration of action.
2. Toxicological Effects: 78-week acute, subacute, and chronic toxicology studies in Sparague-Dawley rats and Beagle dogs demonstrated that the maximum repeated doses were 32 mg/kg (1 month) or 20 mg/kg (6 months) in rats and 8.5 mg/kg (1 month) or 5 mg/kg (6 months) in dogs. Changes associated with the drug's efficacy include tachycardia and constipation. A 60-week oral toxicity study in dogs demonstrated gingival hyperplasia at the highest doses (1 mg/kg and 5 mg/kg). Carcinogenicity, Teratogenicity, and Mutagenicity: Studies have shown that this drug is not carcinogenic, teratogenic, or mutagenic.
[Storage] Store in a sealed container away from light.
[Specification] 4mg x 15 tablets
[Packaging] Box
[Validity Period] 24 months
[Approval Number] National Medicine Standard H10980180
[Manufacturer] Harbin Pharmaceutical Group Sanjingmingshui Pharmaceutical Co., Ltd.
