Product Overview
[Drug Name]
Generic Name: Candesartan Cilexetil Tablets
Trade Name: Xijunning
English Name: Candesartan Cilexetil Tablets
Chinese Pinyin: Kandishatanzhi pian
[Ingredients]
The main ingredient of this product is candesartan cilexetil. Chemical Name: (±)-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl-2-ethoxy-1-[[2′-(1H-tetrazol-5-yl)-[1,1′-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylate. Molecular Formula: C33H34N6O6 Molecular Weight: 610.67
[Properties]
This product is a white or off-white tablet.
[Indications]
For the treatment of essential hypertension. This product can be used alone or in combination with other antihypertensive drugs.
[Dosage and Administration]
Oral administration, generally once a day for adults, 4-8 mg per time, the dose can be increased to 12 mg if necessary.
[Adverse Reactions]
(1) Angioedema: Angioedema with symptoms of edema of the face, lips, tongue, pharynx, larynx, etc. may occur. Careful observation should be conducted. If any abnormality is found, the drug should be stopped and appropriate treatment should be given. (2) Syncope and loss of consciousness: Excessive blood pressure reduction may cause syncope and temporary loss of consciousness. In this case, the drug should be stopped and appropriate treatment should be given. In particular, patients undergoing hemodialysis, patients undergoing strict salt restriction therapy, and patients who have recently started taking diuretic antihypertensive drugs may experience a rapid drop in blood pressure. Therefore, these patients should start with a lower dose of this drug. If it is necessary to increase the dose, the patient's condition should be closely observed and the dose should be increased slowly. (3) Acute renal failure: Acute renal failure may occur. The patient's condition should be closely observed. If any abnormality is found, the drug should be stopped and appropriate treatment should be given. (4) Hyperkalemia: Patients should be closely monitored due to the possibility of hyperkalemia. If abnormalities are found, the medication should be discontinued and appropriate treatment should be given. (5) Deterioration of liver function or jaundice: Patients should be closely monitored due to the possibility of elevated AST (GOT), ACT (GPTO, &gamma-GTP) values or jaundice. If abnormalities are found, the medication should be discontinued and appropriate treatment should be given. (6) Agranulocytosis: Agranulocytosis may occur. Patients should be closely monitored. If abnormalities are found, the medication should be discontinued and appropriate treatment should be given. (7) Rhabdomyolysis: Symptoms such as myalgia, weakness, increased CK, and myosin in the blood and urine may occur. If the above symptoms occur, the medication should be discontinued and appropriate treatment should be given. (8) Interstitial pneumonia: Interstitial pneumonia accompanied by fever, cough, dyspnea, and abnormal chest X-ray examination may occur. If the above symptoms occur, the medication should be discontinued and appropriate treatment should be given, such as treatment with corticosteroids.
[Contraindications]
1. Patients with a history of allergy to any of the ingredients in this preparation. 2. Women who are pregnant or may become pregnant. 3. Patients with severe hepatic or renal impairment or cholestasis.
[Precautions]
1. Use with caution (the following patients should be used with caution) (1) Patients with bilateral or unilateral renal arteries (see 2 Important basic precautions).(2) Patients with hyperkalemia (see 2 Important basic precautions).(3) Patients with liver dysfunction (liver function may worsen. In addition, it is speculated that the clearance rate of the active metabolite candesartan is reduced, so it should be started at a low dose and used with caution.) (4) Patients with severe renal dysfunction (due to excessive blood pressure reduction, renal function may worsen, so start with 2 mg once a day and use with caution).(5) Patients with a history of drug allergy.(6) Elderly patients: It is generally believed that excessive blood pressure reduction should not be applied to the elderly (it may cause cerebral infarction, etc.). It should be used with caution while the patient is under observation. The starting dose for elderly people with normal liver and kidney function is 4 mg. The recommended starting dose for patients with renal or hepatic insufficiency is 2 mg. The dose needs to be increased or decreased according to the condition. (7) Kidney transplantation: There is no experience with the use of this drug in patients who have recently undergone kidney transplantation. (8) Stenosis of the great arteries and left atrioventricular valves (obstructive cardiomyopathy): Patients using other vasodilators, patients with hemodynamically relevant stenosis of the great arteries or left atrioventricular valves or obstructive cardiomyopathy should use this drug with caution. (9) Mild to moderate hyperadrenocorticism: Patients with mild to moderate hyperadrenocorticism usually do not respond to antihypertensive drugs that inhibit the renin-angiotensin and aldosterone systems, so it is not recommended to take this drug. 2 Important basic precautions (1) Patients with bilateral or unilateral renal artery stenosis who take drugs that affect the renin-angiotensin-aldosterone system may increase the risk of renal function due to the reduction in renal blood flow and filtration pressure. Unless it is considered necessary for treatment, this drug should be avoided as much as possible. (2) Because it may aggravate hyperkalemia, patients with hyperkalemia should avoid taking this drug as much as possible unless it is considered necessary for treatment. In addition, patients with uncontrolled diabetes and renal dysfunction should pay close attention to their blood potassium levels because they are prone to developing hyperkalemia. (3) Since this preparation may cause a sharp drop in blood pressure, it should be started with a small dose, especially for the following patients. When increasing the dose, the patient's condition should be carefully observed and the dosage should be increased slowly. A. Patients undergoing hemodialysis. B. Patients undergoing strict salt restriction therapy. C. Patients taking diuretic antihypertensive drugs (especially those who have recently started taking diuretic antihypertensive drugs). (4) Due to the antihypertensive effect, dizziness and staggering may occur. Therefore, care should be taken when performing high-altitude operations or driving vehicles. (5) It is best to stop taking this medicine 24 hours before surgery. (6) When delivering the medicine: The medicine packaged in the PTP should be taken after it is removed from the PTP sheet (there have been reports of accidental ingestion of the hard sharp corners of the PTP sheet piercing the esophageal mucosa, resulting in perforation and serious complications such as mediastinitis).
[Special population medication]
Precautions for children: The safety of this medicine for children has not been determined (no experience). Precautions for Pregnancy and Lactation:
Women who are pregnant or may become pregnant.
Precautions for the Elderly:
It is generally believed that excessive blood pressure reduction in the elderly should not be used (it may cause cerebral infarction, etc.). Caution should be exercised when using this medication under observation.
[Drug Interactions]
This product has no significant interactions with medications such as glyburide, nimodipine, digoxin, warfarin, and hydrochlorothiazide. It also has no significant interactions with oral contraceptives in healthy subjects. Because this product is not metabolized by the P450 hepatic enzyme system and has no effect on P450 metabolism, it does not interact with other drugs that are metabolized by or affect P450 metabolism.
[Pharmacological Actions]
Candesartan cilexetil is rapidly hydrolyzed in vivo to its active metabolite, candesartan. Candesartan is a selective angiotensin II receptor (AT1) antagonist. It antagonizes the vasoconstrictive effects of angiotensin II by binding to the AT1 receptor on vascular smooth muscle, thereby reducing peripheral vascular resistance. It is also believed that candesartan may exert a certain antihypertensive effect by inhibiting adrenal aldosterone secretion. Candesartan does not inhibit kininase II and does not affect bradykinin degradation. Experiments in patients with hypertension have shown that repeated use of this drug can increase plasma renin activity, angiotensin I, and angiotensin II concentrations. Continuous daily administration of 2-8 mg of this drug can reduce systolic and diastolic blood pressure, left ventricular myocardial mass, and peripheral vascular resistance, while having no significant effect on cardiac output, ejection fraction, renal vascular resistance, renal blood flow, or glomerular filtration rate. It also has no effect on cerebral blood flow in patients with primary hypertension and cerebrovascular disease.
[Storage] Store in a sealed container away from light.
[Strength] 4 mg
[Packaging Size] 4 mg x 14 s
[Expiry Life] 36 months
[Approval Number] National Medicine Standard H20051217
[Manufacturer] Company Name: Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd.
