Product Overview
[Drug Name]
Generic Name: Candesartan Cilexetil Dispersible Tablets
Trade Name: AoBiXin Candesartan Cilexetil Dispersible Tablets 8mg x 14 Tablets
Pinyin Full Code: AoBiXin KanDiShaTanZuoFenSanPian8mg14Pian
[Main Ingredient]
Candesartan Cilexetil
[Properties]
This product is a white tablet.
[Indications/Main Functions]
For the treatment of essential hypertension. This product can be used alone or in combination with other antihypertensive drugs.
[Specifications]
8mg x 14 tablets
[Dosage and Administration]
Oral administration. Can be dissolved in water and taken orally, or can be sucked or swallowed. Generally, adults should take candesartan cilexetil once daily; the dose can be increased to 12mg if necessary. For patients with severe renal impairment, start with 2mg. If blood pressure cannot be controlled with this drug alone, a diuretic may be added, or it may be used in combination with other antihypertensive drugs.
[Adverse Reactions]
1. Serious adverse effects (incidence unknown). 1) Angioedema: Swelling of the face, lips, tongue, pharynx, and larynx may occur as a symptom. Carefully observe the patient. If any abnormality is detected, discontinue the medication and implement appropriate treatment. 2) Syncope and Loss of Consciousness: Excessive blood pressure reduction may cause syncope and temporary loss of consciousness. In such cases, discontinue the medication and implement appropriate treatment. Patients undergoing hemodialysis, those on strict salt restriction, and those recently starting diuretic antihypertensive medications may experience a rapid drop in blood pressure. Therefore, these patients should be started with a lower dose of this medication. If the dose needs to be increased, the patient should be closely monitored and the dosage increased slowly. 3) Acute Renal Failure: Acute renal failure may occur. The patient's condition should be closely monitored. If any abnormality is detected, discontinue the medication and implement appropriate treatment. 5) Deterioration of Liver Function or Jaundice: Given the possibility of liver dysfunction or jaundice, such as elevated ASP (GOT), AL (GPT), and GTP values, the patient's condition should be closely monitored. If any abnormality is detected, discontinue the medication and implement appropriate treatment. 6) Agranulocytosis: Agranulocytosis may occur. Closely monitor the patient's condition. If abnormalities are detected, discontinue the drug and implement appropriate treatment. 7) Rhabdomyolysis: Symptoms such as myalgia, weakness, increased CK, and elevated myosin in the blood and urine may occur. If these symptoms occur, discontinue the drug and implement appropriate treatment. 8) Interstitial Pneumonitis: Interstitial pneumonitis accompanied by fever, cough, dyspnea, and abnormal chest X-rays may occur. If these symptoms occur, discontinue the drug and implement appropriate treatment, such as treatment with corticosteroids. 2. Other Adverse Effects: 1) Allergic Reactions: Rash, eczema, urticaria, and itching (0.1% to 5%). 2) Circulatory System: Dizziness, lightheadedness upon standing, palpitations, and fever (0.1% to 5%); Cardiac disturbances and atrial fibrillation (<0.1%). 3) Neurological: Headache, heaviness of the head, insomnia, drowsiness, tongue numbness (0.1 < 5%); limb numbness (< 0.1%). 4) Digestive: Nausea, vomiting, loss of appetite, stomach discomfort, pain in the chest, diarrhea, stomatitis (0.1 < 5%); abnormal taste (< 0.1%). 5) Liver: Increased GOT, PTA, ALP, and LDH (0.1 < 5%). 6) Blood: Anemia, leukopenia, leukocytosis, eosinophilia, and decreased platelet count (0.1 < 5%). 7) Kidney: Increased BUN and hepatic anhydride, proteinuria (0.1 < 5%). 8) Other: Fatigue, weakness, epistaxis, frequent urination, edema, cough, increased potassium, total cholesterol, CPK, CPR, uric acid, and decreased serum total protein (0.1 < 5%); hyponatremia (< 0.1%). Note 1: Discontinue use in these cases. 2) In such cases, the dose should be reduced or discontinued, and appropriate treatment should be implemented.
[Contraindications]
1. Patients with a history of allergic reactions to any of the ingredients in this product. 2. Pregnant women (see [Use in Pregnant and Lactating Women]).
[Precautions]
1. Use with caution. Use with caution in the following patients: 1) Patients with bilateral or unilateral renal artery stenosis (see 2. Important Precautions). 2) Patients with hyperkalemia may experience worsening liver function. Furthermore, since the clearance of the active metabolite, candesartan, is hypothesized to be low, a low dose should be used initially. Use with caution. See [Pharmacokinetics]). 4) Patients with severe renal impairment: Excessive blood pressure reduction may worsen renal function. Therefore, use with caution, starting with 2 mg once daily. 5) Patients with a history of drug allergies. 6) Elderly patients (see [Use in Elderly Patients]). 2. Important Precautions. 1) Patients with bilateral or unilateral renal artery stenosis who are taking medications that affect the renin-angiotensin-aldosterone system may face increased risks to renal function due to decreased renal blood flow and filtration pressure. Therefore, this medication should be avoided unless it is considered necessary for treatment. 2) Because it may worsen hyperkalemia, this medication should be avoided unless it is considered necessary for treatment. Furthermore, patients with renal impairment and uncontrolled diabetes should closely monitor their blood potassium levels, as these patients are susceptible to developing hyperkalemia. 3) This medication may cause a sudden drop in blood pressure. In particular, the following patients should be treated with a low dose starting point. When increasing the dose, carefully observe the patient's condition and proceed slowly. Patients undergoing hemodialysis. Patients on strict salt restriction. Patients taking diuretic antihypertensive medications, especially those who have recently started taking diuretic antihypertensive medications. 4) Due to the antihypertensive effect, dizziness and staggering may occur. Therefore, caution should be exercised when working at heights or driving a vehicle. 5) It is best to stop taking this medication 24 hours before surgery.
[Pharmacology and Toxicology]
See package insert for details.
