Diltiazem Hydrochloride Sustained Release Capsules (Ⅱ)

This product is a calcium channel blocker. It inhibits the transmembrane influx of calcium ions from the extracellular to the intracellular by acting on the calcium ion channels in the myocardium, coronary vessels, peripheral blood vessels, and atrioventricular node, reducing the concentration of intracellular calcium ions, but does not change the serum calcium concentration. It relieves and prevents the contraction of myocardial and vascular smooth muscle cells, has the effects of dilating coronary arteries and peripheral blood vessels, improving myocardial hypertrophy and prolonging the conduction time of the atrial blockage node, and can effectively treat hypertension, angina pectoris, and arrhythmia. 1. Improvement of angina pectoris: ① This product can effectively dilate the coronary arteries and collateral vessels under the epicardium and endocardium, increase the blood flow of the coronary arteries and collateral vessels, thereby increasing the ischemic myocardium and blood flow, improving myocardial ischemia, and relieving angina pectoris. ② Inhibit the spasm of coronary vessels, and has obvious clinical efficacy on the backlog of angina pectoris caused by coronary artery spasm. ③ Dilate peripheral blood vessels, reduce the afterload of the heart, slow down the heart rate, and reduce the work of the heart, which has a significant improvement effect on angina pectoris caused by increased cardiac oxygen consumption. 2. Improvement of hypertension: ① This product relaxes the smooth muscle of peripheral blood vessels and reduces the resistance of peripheral blood vessels, thereby lowering blood pressure. The extent of blood pressure reduction is related to the degree of hypertension. People with normal blood pressure only show a slight impact. ② This product does not affect the blood supply of important organs such as the heart, brain, and kidneys while lowering blood pressure. ③ This product reduces the afterload of the heart, inhibits myocardial contraction, and has an improvement effect on myocardial hypertrophy caused by hypertension. 3. Effect on the conduction system: This product has an inhibitory effect on the conduction of the atrial node and the atrioventricular node. The clinical manifestations are no increase in heart rate or slowing down of heart rate, prolonged atrioventricular conduction time, etc. Carcinogenic, mutagenic and reproductive toxic effects. There are reports that rats took this product for 24 months and mice took this product for 32 months without carcinogenicity. In vitro bacterial experiments did not find mutagenic effects. Animal experiments have confirmed that this product has no significant effect on fertility.

Its chemical name is: cis-()5-[(2-dimethylamino)ethyl]-2-(4-methoxyphenyl)-3-acetoxy-2,3-dihydro-1,5-benzothiazepine-4(5H)one hydrochloride.

This product is a capsule, and the contents are small white particles.

1. Angina pectoris caused by coronary artery spasm and exertional angina pectoris. 2. Hypertension.

Oral administration, starting dose 60-120 mg/time, twice daily, average dose range 240-360 mg/day. Take in divided doses, but must be taken under the guidance of a doctor.

1. Edema, headache, nausea, dizziness, rash, and weakness may occur. 2. The following conditions may rarely occur (incidence rate less than 1.0%): atrioventricular block, bradycardia, bundle branch block, congestive heart failure, abnormal electrocardiogram, hypotension, palpitations, syncope, tachycardia, premature beats, dreaminess, amnesia, depression, diarrhea, taste disorder, indigestion, thirst, vomiting, mild abnormal liver function, petechiae, photosensitivity, itching, anesthesia, erythema multiforme, exfoliative dermatitis, amblyopia, elevated creatine phosphokinase, dyspnea, nasal congestion, hyperglycemia, hyperuricemia, impotence, muscle spasm, polyuria, tinnitus, osteoarthritis, hair loss, extrapyramidal syndrome, gingival acidemia, gingival hyperplasia, hemolytic anemia, prolonged bleeding time, leukopenia, purpura, retinopathy

1. Patients with sick sinus syndrome without pacemaker. Patients with 211 or 111 degree atrioventricular block without pacemaker. 3. Patients with systolic blood pressure lower than 12kpa (90mmhg) and heart rate lower than 50 beats/min. 4. Patients allergic to this product. 5. Patients with congestive heart failure.

Precautions for children: The safety and effectiveness of this product in children have not been determined. Precautions for pregnancy and lactation: There is a lack of controlled trial data for its use in pregnant women, so pregnant women must weigh the pros and cons when using this product. This product can be excreted through breast milk, and its concentration is close to the blood drug concentration. If it is necessary for a lactating woman to use this product, breastfeeding should be suspended. Precautions for the elderly: No clinical data on the use of this drug in the elderly have been found, but it is recommended that elderly patients can start taking the drug at half the normal dose.

This product is biotransformed in vivo by cytochrome P450 oxidase. When used in combination with other drugs that undergo biotransformation through the same pathway, it can lead to competitive inhibition of metabolism. Therefore, when starting or stopping the combined use of this product, the dosage of drugs in the same metabolic pathway must be adjusted to maintain a reasonable blood concentration. 1. Beta-blockers: This product is well tolerated when used in combination with beta-blockers. However, there is insufficient data in patients with left ventricular dysfunction and conduction dysfunction. This product can increase the bioavailability of propranolol by nearly 50%, so the dose of propranolol needs to be adjusted when starting or stopping the combination of the two drugs. 2. Cimetidine: Due to the inhibition of cytochrome P450 oxidase, it affects the first-pass metabolism of this product, which can significantly increase the peak blood concentration of this product and the area under the drug-time curve. 3. Digoxin: It has been reported that this product can increase the blood concentration of digoxin by 20%. The blood concentration of digoxin should be monitored when starting, adjusting and stopping treatment with this product to avoid excessive or insufficient digoxin. 4. Anesthetics: Anesthetics inhibit myocardial contraction, conduction, and automaticity, and have vasodilation effects, which can produce synergistic effects with this product. Therefore, the dosage must be adjusted when the two drugs are used together. 5. Benzodiazepines: This product can significantly increase the peak plasma concentration of triazolam and midazolam and prolong the elimination half-life. 6. Carbamazepine: In some cases, this product can increase the blood concentration of carbamazepine by 40~72%, resulting in toxicity. 7. Cyclosporine: For heart and kidney transplant patients, when this product is used in combination, the dose of cyclosporine should be reduced by 15~48% to ensure that the drug concentration of cyclosporine is the same as before the combination of this product. The blood concentration of cyclosporine should be monitored when used in combination, especially when starting, adjusting the dose, or stopping the use of this product. The effect of cyclosporine on the plasma drug concentration of this product is still unclear. 8. Rifampicin: It can significantly reduce the plasma drug concentration and efficacy of this product.

Keep in a light-proof and airtight container.

90mg

36 months

Yuanda Pharmaceutical (Tianjin) Co., Ltd.

• Founded in:

  1993-10-15

• Address:

  No. 16, Weisan Road, Microelectronics Industrial Zone, Tianjin Economic and Technological Development Zone

• Tax NO.:

  91120116600576732H

• Registered Funds:

  110.533424 million yuan

• Email:

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