Candesartan cilexetil capsules

Candesartan cilexetil is rapidly hydrolyzed into active metabolites in the body, candesartan, which is a selective angiotensin II receptor (AT1) antagonist. It antagonizes the vasoconstriction of angiotensin II by binding to the AT1 receptor of vascular smooth muscle, thereby reducing peripheral vascular resistance. It is also believed that candesartan can exert a certain antihypertensive effect by inhibiting the secretion of aldosterone by the adrenal gland. Candesartan does not inhibit kininase II and does not affect the degradation of bradykinin. Tests conducted on hypertensive patients showed that repeated use of this product can increase plasma renin activity, angiotensin I concentration and angiotensin II concentration; continuous use of this product 2-8 mg once a day can reduce systolic and diastolic blood pressure, left ventricular myocardial weight and peripheral vascular resistance, but has no significant effect on cardiac output, ejection fraction, renal vascular resistance, renal blood flow, and glomerular filtration rate; it has no effect on cerebral blood flow in patients with essential hypertension with cerebrovascular disorders. Toxicology study: Mice, rats and dogs were given 2000mg/kg of candesartan cilexetil orally once, and no death occurred. The maximum tolerable dose of this product for NIH mice is up to 6750mg/kg. The non-toxic dose of this product for rats (26 weeks) is 10mg/kg.d, and the non-toxic dose of this product for beagles is 20mg/kg.d. Tests on mutagenicity, carcinogenesis and reproductive damage have proved that candesartan cilexetil has no mutagenic effect through microbial mutagenesis, chromosome aberration and mammalian cell DNA gene mutation tests. Rats and mice were given 300 and 1000mg/kg.d of this product for 2 consecutive years (104 weeks), respectively, and no carcinogenic effect was observed (this dose is 7 and 70 times the maximum daily recommended human dose of 32mg/d, respectively). Female and male rats were given 300mg/kg.d of this product orally (83 times the maximum daily recommended human dose), and there was no effect on their fertility and reproductive capacity. Reproductive and embryotoxicity tests showed that oral administration of 10 mg/kg.d of this product to late-pregnant and lactating rats reduced the number of surviving offspring and increased the incidence of hydronephrosis (2.8 times the recommended maximum human dose). Oral administration of 3 mg/kg.d of this product to pregnant rabbits (approximately 1.7 times the recommended maximum human dose) produced maternal toxicity (weight loss or death), but had no adverse effects on the survival rate, weight, appearance, visceral and skeletal development of surviving mothers and fetuses. Oral administration of this product to pregnant mice up to 1000 mg/kg.d (approximately 138 times the recommended maximum human dose) did not result in maternal toxicity or adverse effects on fetal development.

Candesartan cilexetil.

The content of this product is white or off-white granules or powder.

Used to treat essential hypertension. This product can be used alone or in combination with other antihypertensive drugs.

Oral administration: generally 4-8 mg once a day for adults. The dose can be increased to 12 mg if necessary.

1. Serious adverse effects (incidence unknown) 1) Angioedema: Angioedema with symptoms of edema of the face, lips, tongue, pharynx, larynx, etc., should be carefully observed. If abnormalities are found, stop taking the drug and take appropriate measures. 2) Syncope and loss of consciousness: Excessive blood pressure reduction may cause syncope and temporary loss of consciousness. In this case, stop taking the drug and take appropriate measures. In particular, patients who are undergoing hemodialysis, patients who are strictly undergoing salt restriction therapy, and patients who have recently started taking diuretic antihypertensive drugs may experience a rapid decrease in blood pressure. Therefore, these patients should start taking this drug at a lower dose. 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, and the patient's condition should be closely observed. If abnormalities are found, stop taking the drug and take appropriate measures. 4) Patients with hyperkalemia: In view of the possibility of hyperkalemia, the patient's condition should be closely observed. If abnormalities are found, stop taking the drug and take appropriate measures. 5) Deterioration of liver function or jaundice: In view of the possibility of liver dysfunction or jaundice with elevated AST (GOT), ALT (GPT), γ-GTP, etc., the patient's condition should be closely observed. If abnormalities are found, the medication should be stopped and appropriate treatment should be carried out. 6) Agranulocytosis: Agranulocytosis 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 carried out. 7) Rhabdomyolysis: Symptoms such as myalgia, weakness, increased CK, and myosin in blood and urine may occur. If the above conditions occur, the medication should be stopped and appropriate treatment should be carried out. 8) Interstitial pneumonia: Interstitial pneumonia accompanied by fever, cough, dyspnea, abnormal chest X-ray examination, etc. may occur. If the above conditions occur, the medication should be stopped and appropriate treatment should be carried out, such as treatment with adrenocortical hormones. 2. Other adverse effects: 5% 1) Allergy: rash, eczema, urticaria, itching, photosensitivity. (Note 1) 2) Circulatory system: dizziness (Note 2), staggering (Note 2), dizziness when standing up (Note 2), palpitations, fever, premature heart beats, atrial fibrillation. Rare adverse reactions include: angina pectoris, myocardial infarction. 3) Nervous system: headache, heaviness of the head, insomnia, drowsiness, numbness of the tongue, numbness of the limbs. 4) Digestive system: nausea, vomiting, loss of appetite, stomach discomfort, pain under the xiphoid, diarrhea, stomatitis, abnormal taste. 5) Liver: increased GOT, GPT, ALP, LDH. 6) Blood: anemia, leukopenia, leukocytosis, eosinophilia, decreased platelet count. 7) Kidney: increased BUN, creatinine, proteinuria, hematuria. 8) Others: fatigue, weakness, epistaxis, frequent urination, edema, cough, potassium, total cholesterol, CPK, CPR, increased uric acid, decreased serum total protein, hyponatremia. Note 1): In this case, the drug should be discontinued. Note 2): In this case, the dose should be reduced or the drug should be discontinued and appropriate treatment should be given.

1. Patients with a history of allergy to the ingredients of this preparation are prohibited from using this product. 2. Women who are pregnant or may become pregnant are prohibited from using this product. 3. Patients with severe liver or kidney dysfunction or cholestasis are prohibited from using this product.

Precautions for children: The safety of the drug for children has not been determined (no experience of use). Precautions for pregnancy and lactation: Pregnant women or women who may become pregnant are prohibited. After oral administration of this preparation to rats during the perinatal and lactation period, it can be seen that the incidence of hydronephrosis in newborns in the group of 10 mg/kg/day or more was increased. In addition, it has been reported that in the middle and late pregnancy, hypertensive patients who were given angiotensin II receptor antagonists or angiotensin converting enzyme inhibitors including candesartan cilexetil developed oligohydramnios, fetal and neonatal death, neonatal hypotension, renal failure, hyperkalemia, head dysplasia, and limb contracture and craniofacial deformity due to oligohydramnios. Therefore, this drug is prohibited for pregnant women or women who may become pregnant. In addition, when this preparation was only given to rats in the late pregnancy or lactation period, hydronephrosis in newborns increased in the group of 300 mg/kg/day. Lactating women should avoid taking the drug, and if they must take the drug, they should stop breastfeeding. Precautions for the elderly: It is generally believed that blood pressure should not be excessively lowered for the elderly (it may cause cerebral infarction, etc.). It should be taken with caution while the patient is under observation. The starting dose for the elderly with normal liver and kidney function is 4 mg, and the recommended starting dose for patients with renal or liver dysfunction is 2 mg. The dose needs to be increased or decreased according to the condition.

Pay attention to combined use (caution should be exercised when using drugs together).

Store in a dry and airtight container.

8mg

24 months

Qingdao Huanghai Pharmaceutical Co., Ltd.

• Founded in:

  1982-02-10

• Address:

  No. 17, Keyuanjingsi Road, Laoshan District, Qingdao

• Tax NO.:

  91370200163567984Y

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  182.18928 million yuan

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