Carvedilol dispersible tablets

Carvedilol is a neurohumoral antagonist with multiple actions, including non-selective beta-blocking, alpha-blocking and antioxidant properties. The vasodilatory effect is a selective alpha1-adrenergic receptor blocking action. Carvedilol reduces peripheral resistance by vasodilation and inhibits the renin-angiotensin-aldosterone system by beta-blockade. Plasma renin activity is reduced and fluid retention rarely occurs. Carvedilol does not have the intrinsic sympathomimetic activity of propranolol and it has membrane stabilizing properties. Carvedilol is a racemic mixture of two stereoisomers. In animal models, both isomers have alpha-adrenergic receptor blocking properties. The beta-adrenergic receptor blocking effect is a non-selective beta1 and beta2 adrenergic receptor blocking effect, and its action is related to the levorotatory form of carvedilol. Carvedilol is a strong antioxidant and a strong reactive oxygen free radical scavenger. The antioxidant properties of carvedilol and its metabolites have been confirmed by in vivo and in vitro animal studies and in vitro various human cell studies.

The main ingredient of this product is carvedilol. Chemical name: (±)-1-(9H-carbazole-4-oxy)-3-[2-(2-methoxyphenoxyethyl)-amino]-2-propanol Chemical structure: Molecular formula: C24H26N2O4 Molecular weight: 406.49

This product is white or off-white tablets.

1. Essential hypertension: It can be used alone or in combination with other antihypertensive drugs, especially thiazide diuretics. 2. Heart failure: Mild or moderate heart failure (NYHA grade II or III), combined with digitalis, diuretics and angiotensin converting enzyme inhibitors (ACEI). It can also be used for patients with heart failure who are intolerant to ACEI and who are treated with or without digitalis, hydralazine or nitrates.

For primary hypertension, it is recommended to take the drug once a day. Adults: The recommended dose for the first two days is 12.5 mg (i.e. 1 tablet) once a day, and then 25 mg (i.e. 2 tablets) once a day. If the condition requires, the dose can be increased to the maximum recommended dose of 50 mg (i.e. 4 tablets) per day after two weeks, taken once a day or in two divided doses. Elderly: An initial dose of 12.5 mg (i.e. 1 tablet) once a day can achieve satisfactory results in some patients. If the effect is not good, the dose can be increased to the maximum recommended dose of 50 mg (i.e. 4 tablets) per day after an interval of at least two weeks, taken once a day or in divided doses. The dose for treating symptomatic congestive heart failure must be individualized, and the doctor needs to observe closely during the dose increase. Patients receiving digoxin, diuretics, and ACEI treatment must stabilize these drug treatments before using carvedilol. The recommended dose for the first two weeks is 3.125 mg (i.e. 1/4 tablet) twice a day. If the tolerance is good, the dose can be increased once after an interval of at least two weeks to 6.25 mg (i.e. 1/2 tablet) twice a day, then 12.5 mg (i.e. 1 tablet) twice a day, and then 25 mg (i.e. 2 tablets) twice a day. The dose must be increased to the maximum limit that the patient can tolerate. For patients weighing less than 85 kg, the maximum recommended dose is 25 mg (i.e. 2 tablets) twice a day; for patients weighing more than 85 kg, the maximum recommended dose is 50 mg (i.e. 4 tablets) twice a day. Before each dose increase, the doctor needs to assess whether the patient has worsening heart failure or symptoms of vasodilation. Transient worsening of heart failure or water and sodium retention must be treated with an increased dose of diuretics. Sometimes it is necessary to reduce the dose of carvedilol or temporarily suspend carvedilol treatment. When carvedilol is discontinued for more than two weeks, the re-administration should start with 3.125 mg (i.e. 1/4 tablet) twice a day, and then increase the dose in the above method. Symptoms of vasodilation can be initially treated by reducing the dose of diuretics. If symptoms persist, the dose of ACEI (if used) needs to be reduced. Then if necessary, the dose of carvedilol should be reduced again. In these cases, the dose of carvedilol should not be increased until heart failure worsens or the symptoms of vasodilation stabilize. Course of treatment: Carvedilol treatment generally requires long-term use. Treatment cannot be stopped abruptly and must be gradually reduced. This is especially important for patients with coronary heart disease. Method of administration: The time of taking the medicine has nothing to do with meals, but carvedilol must be taken with meals for patients with congestive heart failure. To slow down absorption and reduce the occurrence of orthostatic hypotension.

The adverse events that occur when carvedilol is used to treat hypertension and angina pectoris are consistent with those observed in congestive heart failure, but the incidence of adverse reactions in the former is lower. 1. Central nervous system - Mild dizziness, headache, and fatigue may occur occasionally, especially in the early stages of treatment. - Depression, sleep disorders, and paresthesias are rare. 2. Cardiovascular system - Bradycardia and postural hypotension may occur occasionally in the early stages of treatment, and syncope is rare. - Peripheral circulation disorders (cold limbs) are uncommon and may aggravate symptoms in patients with existing intermittent claudication or Raynaud's phenomenon. - Edema is uncommon. - Angina pectoris is uncommon. - Some patients experience atrioventricular block and worsening of heart failure. - Patients with heart failure may experience dizziness, and occasionally edema of varying degrees in different parts of the body, complete atrioventricular conduction block, and heart failure.

1. It is contraindicated for patients with YHA grade IV decompensated heart failure who require intravenous positive inotropic drugs; 2. It is contraindicated for patients with bronchospasm (2 cases of patients with persistent asthma died after taking a single dose of carvedilol) or related bronchospasm; 3. It is contraindicated for patients with second or third degree atrioventricular block and sick sinus syndrome; 4. It is contraindicated for patients with cardiogenic shock; 5. It is contraindicated for patients with severe bradycardia; 6. It is contraindicated for patients with clinically severe liver dysfunction; 7. It is contraindicated for patients who are allergic to this product; 8. It is contraindicated for patients with diabetic ketoacidosis and metabolic acidosis.

Precautions for children: There is no research data on the safety and efficacy of patients under 18 years old. Precautions for pregnancy and lactation: There is no sufficient clinical experience in the use of carvedilol in pregnant women. Animal reproduction experiments have not found carvedilol to be teratogenic. Beta-blockers reduce placental perfusion, which may lead to intrauterine fetal death, miscarriage and premature birth. In addition, side effects may occur on the fetus and newborn (especially hypoglycemia and bradycardia). It also increases the risk of cardiopulmonary complications in newborns. Pregnant women should not use carvedilol unless the benefits outweigh the risks. Carvedilol and/or its metabolites can be secreted through breast milk, so breastfeeding is not recommended during carvedilol treatment. Precautions for the elderly: See [Usage and Dosage].

1. Like other beta-blockers, carvedilol can also enhance the effects of other antihypertensive drugs (such as alpha-blockers) used in combination, or produce hypotension. When carvedilol is used in combination with diltiazem, some patients experience heart conduction block (the effect on hemodynamics is rare). However, like other drugs with beta-blocking effects, when carvedilol is used in combination with calcium channel blockers such as verapamil and diltiazem, the patient's electrocardiogram and blood pressure should be closely monitored, and intravenous combined use of such drugs is strictly prohibited. 2. When carvedilol is used in combination with digoxin in hypertensive patients, the steady-state blood concentration of digoxin will increase by about 16%. Therefore, the monitoring of digoxin blood concentration should be strengthened at the beginning stage of carvedilol use, the dose adjustment stage and when carvedilol is discontinued. 3. Before the end of the combined use of carvedilol and clonidine, carvedilol should be discontinued a few days before discontinuation of clonidine, and then clonidine should be gradually reduced until it is discontinued. 4. Carvedilol may enhance the effects of insulin or oral hypoglycemic drugs, while the symptoms and signs of hypoglycemia (especially tachycardia) may be masked or weakened and difficult to detect, so it is recommended to monitor blood glucose levels regularly. 5. When carvedilol is used in patients receiving mixed-function oxidase inducers such as rifampicin, the blood concentration of carvedilol may decrease. When it is used in patients receiving mixed-function oxidase inhibitors such as cimetidine, the blood concentration of carvedilol may increase, so attention should be paid. 6. When patients use carvedilol during anesthesia, the negative inotropic effect and hypotension caused by the synergistic effect of carvedilol and anesthetics should be closely observed. 7. The combined use of carvedilol and cardiac glycosides may prolong atrioventricular conduction time. 8. Cyclooxygenase inhibitors (such as acetylsalicylate, corticosteroids) can weaken the antihypertensive effect of carvedilol. 9. The plasma concentration of cyclosporine increases slightly after some renal transplant patients start carvedilol treatment, and the dose that needs to be adjusted for this varies greatly among different patients. Therefore, cyclosporine concentrations should be carefully monitored and the dose individualized in these patients.

Keep in a dark place, sealed and stored at room temperature.

12.5mg

24 months

Zhejiang Jingxin Pharmaceutical Co., Ltd.

• Founded in:

  1999-02-13

• Address:

  No. 800, Xinchang Avenue East Road, Yulin Street, Xinchang County, Zhejiang Province

• Tax NO.:

  91330000704503984N

• Registered Funds:

  861.02914 million yuan

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