Diltiazem Hydrochloride Controlled Release Capsules

1 Pharmacology This product is a calcium channel blocker, and its action is related to the inhibition of calcium ion influx during myocardial and vascular smooth muscle depolarization. This product can effectively dilate the epicardial and subendocardial coronary arteries, relieve spontaneous angina pectoris or angina pectoris caused by coronary artery spasm induced by ergonovine; by slowing down the heart rate and lowering blood pressure, it reduces myocardial oxygen demand, increases exercise tolerance and relieves exertional angina pectoris. This product can relax vascular smooth muscle, reduce peripheral vascular resistance and lower blood pressure; the extent of its blood pressure reduction is related to the degree of hypertension, and only slightly reduces blood pressure in people with normal blood pressure. This product has a negative inotropic effect and can slow down the conduction of the sinoatrial node and atrioventricular node. 2 Toxicology Carcinogenic, mutagenic and reproductive toxic effects have been reported. No carcinogenic effect was found in rats taking this product for 24 months and in mice taking this product for 21 months. No mutagenic effect was found in in vitro bacterial experiments. Animal experiments have confirmed that this product has no significant effect on fertility.

The main ingredient of this product and its chemical name are: cis-()-5-[(2-dimethylamino)ethyl]-2-(4-methoxyphenyl)-3-acetoxy-2,3-dihydro-1,5-benzothiazepine-4(5H)-one hydrochloride.

This product is a white hard capsule, which appears white after removing the film coating.

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

Oral administration: the initial dose is 60-120 mg/time, twice a day (2-4 tablets at a time, twice a day), and the average dose range is 240-360 mg/day.

Common adverse reactions: edema, headache, nausea, dizziness, rash, weakness. Rare adverse reactions (1%): Cardiovascular system: angina pectoris, arrhythmia, atrioventricular block, bradycardia, bundle branch block, congestive heart failure, abnormal electrocardiogram, hypotension, palpitations, syncope, tachycardia, ventricular premature beats. Nervous system: dreaminess, amnesia, depression, abnormal gait, hallucinations, insomnia, nervousness, paresthesia, personality changes, drowsiness, tremor. Digestive system: anorexia, constipation, diarrhea, taste disorder, indigestion, thirst, vomiting, weight gain, mild increase in alkaline phosphatase, lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase. Skin: petechiae, photosensitivity, itching, urticaria. Others: amblyopia, increased CPK, dry mouth, dyspnea, epistaxis, irritability, hyperglycemia, hyperuricemia, impotence, muscle spasm, nasal congestion, polyuria, increased nocturia, tinnitus, bone and joint pain, hair loss, erythema multiforme, extrapyramidal syndrome, gingival hyperplasia, hemolytic anemia, prolonged bleeding time, leukopenia, purpura, retinopathy, thrombocytopenia, and exfoliative dermatitis.

1. Patients with sick sinus syndrome without pacemaker. 2. Patients with II or III degree atrioventricular block without pacemaker. 3. Patients with systolic blood pressure lower than 12kPa (90mmHg). 4. Patients allergic to this product. 5. Patients with acute myocardial infarction or pulmonary congestion.

This product is biotransformed by cytochrome P450 oxidase in the body. 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. 1β-receptor blockers: This product is well tolerated when used in combination with beta-receptor 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. 2Cimetidine: 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. 3Digoxin: 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% and cause 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.

90 mg

Guangdong Baiao Pharmaceutical Co., Ltd.

• Founded in:

  2002-06-05

• Address:

  No. 4-1, Biaohai Industrial Zone, Shatang Town, Kaiping City

• Tax NO.:

  91440783737598158B

• Registered Funds:

  10 million yuan

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