Valsartan Hydrochlorothiazide Dispersible Tablets

1. Multiple preclinical safety studies on several animals have found that valsartan, hydrochlorothiazide and valsartan:hydrochlorothiazide do not show systemic or target organ toxicity. High doses of valsartan:hydrochlorothiazide (100:31.25 to 600:187.5 mg/kg body weight) can cause a decrease in red blood cell parameters (erythrocytes, hemoglobin, hematocrit) and renal hemodynamic changes in rats (moderate to severe increases in plasma urea levels, increased plasma potassium and magnesium concentrations, mild increases in urine volume, increased electrolyte levels, mild tubular basophilia and thick afferent arterioles at the highest dose level). In marmoset studies (30:9.375 to 400:125 mg/kg body weight), the changes were similar to those in rat studies but the degree was aggravated, especially at higher dose levels, the effects on the kidneys were more significant, which can cause nephropathy, including increased urea and creatinine levels. 2. Hypertrophy of juxtaglomerular cells was observed in both animal studies. These changes were caused by the pharmacological synergistic effect of valsartan:hydrochlorothiazide (the intensity of which is about 10 times that of valsartan alone), rather than an additive effect. This synergistic effect resulted in a prolonged antihypertensive effect, which was particularly prominent in the marmoset study. In human studies, therapeutic doses of valsartan:hydrochlorothiazide did not seem to be associated with hypertrophy of juxtaglomerular cells. The main finding of the preclinical safety study was the pharmacological synergistic effect of the two drugs, but no evidence of interaction between the two drugs was found. In clinical practice, the effects of the two drugs are additive, and this additive effect has not shown any clinical significance in preclinical studies. 3. Since there is no evidence of any interaction between valsartan and hydrochlorothiazide, the valsartan:hydrochlorothiazide combination preparation has not been tested for mutagenicity, clastogenicity and carcinogenicity, but the mutagenicity, clastogenicity and carcinogenicity tests conducted on valsartan and hydrochlorothiazide respectively showed negative results.

This product is a compound preparation, its components are: each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.

This product is white or off-white tablets.

For the treatment of mild to moderate essential hypertension where blood pressure cannot be adequately controlled with a single drug, valsartan and hydrochlorothiazide are not suitable for the initial treatment of hypertension.

Each tablet of valsartan hydrochlorothiazide contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. When blood pressure cannot be satisfactorily controlled with valsartan monotherapy, or when blood pressure cannot be satisfactorily controlled with 25 mg of hydrochlorothiazide once a day, or when hypokalemia occurs, valsartan hydrochlorothiazide (containing 80 mg of valsartan/12.5 mg of hydrochlorothiazide) can be used instead, one tablet at a time, once a day, to achieve the maximum antihypertensive effect within 2-4 weeks of medication. For patients with mild to moderate renal failure (creatinine clearance ≥ 30 ml/min) or mild to moderate liver failure (non-biliary without cholestasis), no dose adjustment is required.

1. Adverse events with an incidence rate of less than 1% include: abdominal pain, upper abdominal pain, anxiety, arthritis, weakness, bronchitis, acute bronchitis, chest pain, postural dizziness, dyspepsia, dyspnea, dry mouth, erectile dysfunction, gastroenteritis, sweating, hypoesthesia, hypokalemia, hypotension, influenza, insomnia, muscle spasms, muscle tension, nausea, nasal congestion, neck pain, edema, peripheral edema, otitis media, limb pain, palpitations, paresthesia, pharyngitis, frequent urination, fever, rash, sinus congestion, sinusitis, drowsiness, sprains and strains, tachycardia, tinnitus, urinary tract infection, vertigo, viral infection, blurred vision, abnormal vision. It is not known whether these adverse events are related to treatment. 2. Post-marketing data show that the following situations are very rare: angioedema, rash, itching and other hypersensitivity/allergic reactions including serum sickness and vasculitis. 3. There are very rare reports of renal impairment and myalgia. There have been several reports of hydrochlorothiazide-induced pulmonary edema accompanied by granulocyte infiltration and IgG deposition in the alveolar membrane. 4. Non-cardiogenic pulmonary edema may be a rare immune-mediated atopic reaction to hydrochlorothiazide. (See the inner package insert for details)

1. Allergy to valsartan, hydrochlorothiazide, other sulfonamides or any of the ingredients in this product. 2. Pregnancy (see Pregnancy and Lactation). 3. Severe liver damage, biliary cirrhosis or cholestasis. 4. Severe renal failure (creatinine clearance <30ml/min) or anuria. 5. Refractory hypokalemia, hyponatremia or hypercalcemia and symptomatic hyperuricemia.

Precautions for children: There is insufficient research data on the therapeutic application of this product in children. Precautions for pregnancy and lactation: 1. Pregnancy: According to the mechanism of action of angiotensin II receptor antagonists, it is impossible to exclude the damage to the embryo. Exposure to angiotensin converting enzyme inhibitors (a class of drugs that act on the renin-angiotensin aldosterone RRAS system) in the 4th to 6th month and 709th month of pregnancy can cause fetal injury and death. In addition, retrospective data show that patients who use ACE inhibitors in the first three months are at risk of potential birth defects. In utero exposure to thiazide diuretics, including hydrochlorothiazide, can cause thrombocytopenia in the fetus or newborn, and adverse reactions that may occur in adults may occur. There are reports of spontaneous abortion, oligohydramnios, and neonatal renal insufficiency in pregnant women after taking valsartan by mistake, so it is similar to other drugs that directly act on RAAS. Precautions for the elderly: Compared with young volunteers, the concentration of valsartan in some elderly people is slightly increased, but it is not clinically significant. Data show that the systemic clearance of hydrochlorothiazide in the elderly is reduced compared with young healthy volunteers.

1. Combination with other antihypertensive drugs can increase the antihypertensive effect of this product. 2. When used with potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes, or other drugs that can change serum potassium (such as heparin), caution should be exercised and blood potassium levels should be monitored. 3. In the case of combined use of lithium and this product, it is recommended to regularly test serum lithium levels. 4. Thiazides including hydrochlorothiazide can enhance the effects of curare derivatives. 5. Combination with non-steroidal anti-inflammatory drugs (such as salicylic acid derivatives, indomethacin) may weaken the diuretic and antihypertensive activity of the thiazide components in this product. 6. Taking it simultaneously with potassium-excreting diuretics (such as furosemide), corticosteroids, adrenocorticotropic hormone (ACTH), amphotericin B, carbenoxolone, penicillin G or salicylic acid derivatives can aggravate potassium loss.

Keep away from light and store in a sealed container.

Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide

24 months

Shandong Sibang De Pharmaceutical Co., Ltd.

• Founded in:

  2003-10-22

• Address:

  No. 3688, Longhu Road, Longshan Street, Zhangqiu District, Jinan City, Shandong Province

• Tax NO.:

  91370181755424274J

• Registered Funds:

  20 million yuan

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