Nisoldipine Soft Capsules

Pharmacological action: Nisoldipine is a dihydropyridine calcium channel antagonist (calcium ion antagonist or slow channel blocker) that inhibits the influx of calcium ions through the cell membrane into vascular smooth muscle and cardiomyocytes. It can reversibly compete with other dihydropyridine drugs for binding to calcium ion channels. Since the contraction process of vascular smooth muscle depends on the entry of extracellular calcium into muscle cells through specific ion channels, the inhibition of calcium channels will lead to the dilation of arterioles. In vitro experiments have shown that the effect of nisoldipine on the contraction process is selective, and its effect on vascular smooth muscle is stronger than that on the myocardium. Although nisoldipine, like other dihydropyridine calcium channel blockers, has a negative inotropic effect in vitro, studies conducted in anesthetized animals have shown that the dose of nisoldipine that produces vasodilation is lower than that that affects myocardial contractility.

Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrobenzene)-3,5-pyridinedicarboxylate

This product is a capsule containing a yellow clear oily liquid.

It is used to treat primary mild to moderate hypertension and angina pectoris. It is especially suitable for patients with coronary heart disease and hypertension.

Oral administration. Adults take 5-10 mg (1-2 tablets) twice a day. The dosage should be adjusted according to the needs of each patient. Blood pressure should be closely monitored during dosage adjustment.

Circulatory system: sometimes palpitations, low blood pressure, chest pain, flushing, and heat sensation occur. Psychoneural system: sometimes headaches, dizziness, tinnitus, and fatigue occur. Digestive system: sometimes abdominal pain, diarrhea, and nausea occur. Liver: sometimes abnormalities in GOT, GPT, and ALP occur. Kidney: occasionally abnormalities in BNN occur. Allergic reaction: sometimes rash may occur. Other adverse reactions: occasionally frequent urination, gingival hyperplasia, and feminization of male breasts occur.

1. Hypotension: Since nisoldipine reduces peripheral vascular resistance, blood pressure should be monitored during the initial administration and dosage adjustment. Close observation is particularly important for patients who are already taking other antihypertensive drugs. Although nisoldipine has a moderate antihypertensive effect on most patients and is well tolerated, a small number of patients experience excessive and intolerable hypotension. Hypotensive reactions often occur during the initial administration or subsequent dose increases. 2. Congestive heart failure: Although acute hemodynamic studies in patients with NYHA type II-IV heart failure did not show that nisoldipine has the effect of weakening muscle contractility, the safety of this product for patients with heart failure has not yet been definitively determined. Therefore, patients with heart failure or impaired ventricular function should use this product with caution, especially when used with beta-blockers.

Precautions for children: The safety and effectiveness of this product for children have not been established. Precautions for pregnancy and lactation: There have been no adequate and well-controlled studies on pregnant women. This product should only be considered for use if its potential benefits to pregnant women outweigh its potential threat to the fetus. It is currently unknown whether nisoldipine is also excreted from human milk. Since many drugs can be excreted from human milk, the decision to stop breastfeeding or to stop taking this product should be made by considering the importance of the drug to the mother. Precautions for the elderly: Clinical studies of nisoldipine did not include a sufficient number of subjects over the age of 65 to determine whether they respond differently from younger subjects. Other clinical experience cannot determine whether the responses of elderly patients differ from those of young patients. Patients over the age of 65 are considered to have higher blood concentrations of nisoldipine. In general, elderly patients should be cautious when choosing a dose, and the starting dose should be at the lower end of the dosage range, indicating that elderly patients have more cases of decreased liver, kidney, and heart function, as well as concomitant diseases or other drug therapies.

This product can be taken with diuretics, ACE inhibitors and beta-blockers. When taking 400 mg of cimetidine twice a day, the AUC and Cmax values of nisoldipine will increase by 30-40%. When taking 150 mg of ranitidine twice a day, the interaction between nisoldipine and ranitidine is not obvious (the AUC value decreases by 15-20%). The pharmacodynamic effect of histamine H2 receptor antagonists has not been observed. When epileptic patients take phenytoin and 40 mg of this product at the same time, the blood concentration of nisoldipine will be reduced to an undetectable level. Therefore, avoid using this product with phenytoin or any other known CYP3A4 inducers, and use other antihypertensive therapies instead. The pharmacokinetic interactions between nisoldipine and beta-blockers (atenolol, propranolol) are diverse and insignificant. Propranolol can reduce the increase in heart rate after taking immediate-release nisoldipine. For patients taking atenolol, the effect of this product on their blood pressure is greater than that of those who have not used other antihypertensive drugs. Taking quinidine 648 mg twice daily will reduce the bioavailability (AUC) of nisoldipine by 26%, but the peak concentration will not be affected. No significant interaction between nisoldipine and warfarin or digoxin was found.

Keep in a sealed container and shield from light. The validity period is tentatively set at two years.

5mg

Tentative 24 months

Zhejiang Anbao Pharmaceutical Co., Ltd.

• Founded in:

  1996-12-19

• Address:

  Ningbo Economic and Technological Development Zone C1

• Tax NO.:

  9133020625643067X0

• Registered Funds:

  51.78 million yuan

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