Product Overview
[Drug Name]
Generic Name: Candesartan Cilexetil Tablets
Trade Name: Norvatan
English Name: Candesartan Cilexetil Tablets
Chinese Pinyin: Kan Di Sha Tan Zhi 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. Serious adverse reactions (incidence unknown): (1) Angioedema: Angioedema with symptoms of edema of the face, lips, tongue, pharynx, larynx, etc. may occur. Careful observation should be conducted. If abnormalities are 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 abnormalities are 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, γ-GTP) and other liver dysfunction or jaundice. If abnormalities are found, the medication should be discontinued and appropriate treatment should be given. (6) Agranulocytosis: Agranulocytosis may occur, and the patient 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 with 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 the ingredients of this preparation. 2. Pregnant or potentially pregnant women. 3. Patients with severe liver or kidney dysfunction or cholestasis. [Precautions] 1. Use with caution (the following patients should use the drug 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 hepatic dysfunction (it may worsen liver function. 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 it should be started with 2 mg once a day and used with caution). (5) Patients with a history of drug allergy. (6) Elderly patients). (7) Kidney transplantation: There is no experience with the use of this product 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 of 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 these patients are prone to hyperkalemia. (3) Since this preparation may sometimes cause a sharp drop in blood pressure, it should be started with a low 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, caution should be exercised when performing high-altitude operations or driving a vehicle. (5) It is best to stop taking the drug 24 hours before surgery. (6) When delivering the drug: The drug 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, which may pierce the esophageal mucosa and cause perforation, resulting in serious complications such as mediastinitis).
[Use in special populations]
Children's precautions: Not yet clear.
Precautions during pregnancy and lactation: Contraindicated for women who are pregnant or may become pregnant.
Precautions for the elderly: Not yet clear.
[Drug Interactions]
Caution: This product has no significant interactions with glyburide, nimodipine, digoxin, warfarin, or hydrochlorothiazide, nor with oral contraceptives in healthy subjects.
[Pharmacological Actions]
Candesartan cilexetil is rapidly hydrolyzed in vivo to its active metabolite, candesartan. Candesartan is a selective angiotensin II receptor (AT1) antagonist. It binds to the AT1 receptors on vascular smooth muscle, antagonizing the vasoconstrictive effects of angiotensin II and 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]
Sealed.
[Strength]
8 mg
[Packaging]
Boxed, 8 mg x 8 sachets/box
[Expiry Date]
24 months
[Approval Number]
National Medicine Standard No. H20080183
[Manufacturer]
Company Name: Shanxi Huangcheng Xiangfu Pharmaceutical Co., Ltd.
