Product Overview
[Drug Name]
Generic Name: Candesartan Cilexetil Tablets
Trade Name: Dizhiya Candesartan Cilexetil Tablets 8mg*12 Tablets
Pinyin Full Code: Dizhiya KanDiShaTanZuoPian 8mg*12 Tablets
[Main Ingredients]
The main ingredient of this product is candesartan cilexetil.
[Properties]
This product is white tablets.
[Indications/Main Functions]
For the treatment of essential hypertension.
[Specifications]
8mg*12 tablets
[Dosage and Administration]
Oral administration. Generally, adults take 4-8mg once daily. The dose can be increased to 12mg if necessary.
[Adverse Reactions]
1. Angioedema: Angioedema may sometimes present as edema of the face, lips, tongue, pharynx, or larynx. Careful observation is recommended. If any abnormality is observed, discontinue use and administer appropriate treatment. 2. Shock, Syncope, and Loss of Consciousness: Lowering blood pressure may cause shock, syncope, and loss of consciousness. In this case, the patient's condition should be closely observed. If chills, vomiting, loss of consciousness, etc. are observed, appropriate treatment should be immediately implemented. Treatment with this drug should be started at a lower dose. If it is necessary to increase the dose, the patient's condition should be closely observed and the increase should be slow. This is especially true for patients undergoing hemodialysis, patients undergoing strict salt restriction therapy, patients taking diuretics, and patients with heart failure. 3. Acute renal failure: Acute renal failure may occur, and the patient's condition should be closely observed. If abnormalities are found, the medication should be stopped and appropriate treatment should be implemented. 4. Patients with hyperkalemia: Given the possibility of hyperkalemia, the patient's condition should be closely observed. If abnormalities are found, the medication should be stopped and appropriate treatment should be implemented. 5. Deterioration of liver function or jaundice: Given the possibility of liver dysfunction or jaundice, such as elevated AST (GOT), ALT (GPT), and Y-GTP, the patient's condition should be closely monitored. If abnormalities are detected, the drug should be discontinued and appropriate treatment should be implemented. 6. Agranulocytosis: Agranulocytosis may occur, so the patient's condition should be closely monitored. If abnormalities are detected, the drug should be discontinued and appropriate treatment should be implemented. 7. Rhabdomyolysis: Symptoms such as myalgia, weakness, increased CK, and myosin in the blood and urine may occur. If these symptoms occur, the drug should be discontinued. 8. Interstitial pneumonia: Interstitial pneumonia may occur, accompanied by fever, cough, dyspnea, and abnormal chest X-rays. If these symptoms occur, discontinue medication and institute appropriate treatment, such as corticosteroids. 9. Hypoglycemia: Due to the potential for hypoglycemia (which is more common in patients receiving diabetic treatment), closely monitor the patient. If symptoms of weakness or hunger, cold sweats, hand tremors, decreased concentration, convulsions, or impaired consciousness are observed, discontinue medication and institute appropriate treatment.
[Contraindications]
1. Patients with a history of allergies to any of the ingredients in this preparation. 2. Pregnant or potentially pregnant women (see [Use in Pregnant and Lactating Women]). 3. Patients with severe hepatic or renal impairment or cholestasis.
[Drug Interactions]
1. Concomitant use with potassium-sparing diuretics such as spironolactone and triamterene may increase serum potassium levels; caution is advised. This is primarily due to the inhibitory effect of this preparation on aldosterone secretion, combined with the inhibitory effect of potassium-sparing diuretics on potassium excretion. Risk Factors: Particularly in patients with renal impairment. 2. Concomitant use with diuretics such as furosemide and trichlormethiazide; patients receiving diuretic and antihypertensive medications. When patients take this preparation for the first time, it may increase the antihypertensive effect, so they should start with a small dose and use the drug with caution. The main reason is that many patients who receive diuretic antihypertensive drugs have hyperreninemia, and this preparation is more likely to be effective. 3. This product has no obvious interactions with drugs such as glyburide, nimodipine, digoxin, warfarin, and hydrochlorothiazide. There is also no obvious interaction when healthy subjects take oral contraceptives. 4. Since this product is not metabolized by the P450 hepatic enzyme system and has no effect on P450 metabolism, there is no interaction between this product and other drugs that can be metabolized by P450 or affect the metabolic function of P450.
[Precautions]
1. Use with caution (the following patients should use with caution): (1) Patients with bilateral or unilateral renal artery stenosis (see 2. Important Basic Precautions). (2) Patients with hyperkalemia (see 2. Important Basic Precautions). (3) Patients with impaired liver function (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 taken from a low dose and used with caution (see [Pharmacokinetics]). (4) Patients with severe renal dysfunction (due to excessive blood pressure reduction, renal function may worsen, so start taking it from 2 mg once a day and use it with caution). (5) Patients with a history of drug allergy. (6) Elderly patients (see [Medication for Elderly Patients]). 2. Important basic precautions (1) Patients with bilateral or unilateral renal artery stenosis, when taking drugs that affect the renin-angiotensin-aldosterone system, may increase the risk of renal function due to decreased 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 renal dysfunction and uncontrolled diabetes. Since these patients are prone to developing hyperkalemia, blood potassium levels should be closely monitored. (3) Since taking this preparation may sometimes cause a sharp drop in blood pressure, especially for the following patients, it should be started with a small dose. 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). d. Patients with hyponatremia. e. Patients with renal dysfunction. (4) Due to the antihypertensive effect, dizziness and staggering may sometimes occur. Therefore, care should be taken when performing operations such as high-altitude work and driving a vehicle. (5) It is best to stop taking this preparation 24 hours before surgery. (Due to the inhibitory effect on the renin-angiotensin system, patients taking angiotensin receptor antagonists will experience a sharp drop in blood pressure during anesthesia and surgery.) (6) When delivering the drug: the drug packaged in PTP should be Remove from the PTP sheet and consume after use. (There have been reports of accidental ingestion of the hard, sharp corners of the PTP sheet piercing the esophageal mucosa, leading to perforation and serious complications such as mediastinitis.)
[Pediatric Use]
The safety of this medication for pediatric use has not been established (no experience).
[Elderly Use]
It is generally believed that excessive blood pressure reduction in the elderly should not be considered (as it may cause cerebral infarction, etc.). Use with caution while the patient is under observation.
[Overdose]
1. Symptoms: Based on pharmacological considerations, the primary manifestations of overdose may be symptomatic hypotension and dizziness. Case reports have shown that patients who took doses up to 672 mg of candesartan cilexetil recovered normally. 2. Management: If symptomatic hypotension occurs, symptomatic treatment should be initiated and vital signs monitored. The patient should lie supine with legs elevated. If this is ineffective, fluids (such as isotonic saline) should be administered to increase plasma volume. If all other measures are ineffective, sympathomimetic medication may be used. Candesartan cannot be removed through hemodialysis.
[Pharmacology and Toxicology]
Candesartan cilexetil is rapidly hydrolyzed in vivo to its active metabolite, candesartan. Candesartan is an angiotensin II AT1 receptor antagonist. It binds to vascular smooth muscle AT1 receptors to antagonize the vasoconstrictive effects of angiotensin I, thereby reducing peripheral vascular resistance. It is also believed that candesartan exerts a certain antihypertensive effect by inhibiting adrenal aldosterone secretion. Studies in hypertensive patients have shown that repeated use of this drug can increase plasma renin activity, angiotensin I concentrations, 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. In patients with essential hypertension and cerebrovascular disease, cerebral blood flow is not affected.
