Valsartan Hydrochlorothiazide Capsules

Valsartan Valsartan is an orally effective specific angiotensin (AT) II receptor antagonist. It selectively acts on the AT1 receptor subtype, and its affinity for the AT1 receptor is 20,000 times stronger than that for the AT2 receptor. The AT1 receptor subtype mediates the physiological response of angiotensin II, and the AT2 receptor subtype is not related to cardiovascular effects. Valsartan has no partial agonist activity on the AT1 receptor. For most patients, a single oral dose produces a hypotensive effect within 2 hours, reaches a peak effect within 4-6 hours, and the hypotensive effect is maintained for more than 24 hours after taking the medicine. In long-term treatment, the maximum hypotensive effect is achieved after 2-4 weeks of treatment and is maintained. Combined use with hydrochlorothiazide significantly enhances the hypotensive effect of valsartan. Sudden termination of valsartan treatment does not cause hypertension "rebound" or other side effects. Valsartan does not affect the fasting total cholesterol, triglyceride, blood sugar or uric acid levels of hypertensive patients. Valsartan has no inhibitory effect on ACE, does not cause retention of bradykinin and substance P, and is therefore not likely to cause cough. Clinical trials comparing valsartan and ACE inhibitors have confirmed that the incidence of dry cough in the valsartan group (2.6%) was significantly lower than that in the ACE inhibitor group (7.9%) (P < 0.05). In a clinical trial of patients who had developed dry cough symptoms after receiving ACE inhibitor treatment, 19.5%, 19.0%, and 68.5% of patients in the valsartan group, diuretic group, and ACEI group, respectively, had cough (P < 0.05). In controlled clinical trials, the incidence of cough in patients treated with valsartan and hydrochlorothiazide was 2.9%. Valsartan has no effect on other hormone receptors or ion channels known to play an important role in cardiovascular regulation. Valsartan reduces elevated blood pressure without affecting heart rate. Hydrochlorothiazide Hydrochlorothiazide acts by inhibiting the co-transport of sodium and chloride ions. Competing for chloride ion sites can affect electrolyte reabsorption, which will directly increase the excretion of sodium and chloride, and indirectly reduce plasma volume, thereby increasing plasma renin activity, aldosterone secretion, and potassium excretion, resulting in lower serum potassium. Because the renin-aldosterone system is angiotensin II-dependent, the combined use of angiotensin II receptor antagonists can reduce the potassium loss associated with thiazide diuretics. In controlled clinical trials, the combined use of valsartan/hydrochlorothiazide has a clear antihypertensive effect that is stronger than the effect of either drug alone.

This product is a compound preparation of valsartan and hydrochlorothiazide.

This product is a capsule, and the contents are white or off-white granules.

Used to treat mild to moderate essential hypertension where blood pressure cannot be adequately controlled by a single drug.

When valsartan monotherapy cannot satisfactorily control blood pressure, hydrochlorothiazide 25mg once a day cannot satisfactorily control blood pressure or hypokalemia occurs, this product (containing valsartan 80mg/hydrochlorothiazide 12.5mg) can be used instead, one tablet each time, once a day, and the maximum antihypertensive effect can be achieved within 2-4 weeks of medication. The use of this product has nothing to do with meal time. For patients with mild to moderate renal failure (creatinine clearance ≥30 ml/min) or mild to moderate liver failure, no dosage adjustment is required.

In two controlled clinical trials involving a total of 1570 patients, 730 of whom received valsartan in combination with hydrochlorothiazide, the following adverse events were reported: Central nervous system Common (>5%): headache (10.8%; placebo 17.2%), dizziness. Infrequent (5-0.1%): fatigue, depression. Upper respiratory tract Infrequent (5-0.1%): cough, rhinitis, sinusitis, pharyngitis, upper respiratory tract infection, epistaxis. Gastrointestinal tract Infrequent (5-0.1%): nausea, diarrhea, dyspepsia, abdominal pain. Lower urinary tract Infrequent (5-0.1%): frequent urination, urinary tract infection. Musculoskeletal system Infrequent (5-0.1%): pain in the arms or legs, arthritis, myalgia, sprains and strains, muscle spasms. Other Infrequent (5-0.1%): weakness, chest pain, asthenia, viral infection, visual disturbances, conjunctivitis. Clinical control trials found that the incidence of neutropenia in the valsartan group and the ACEI group was 1.9% and 1.6%, respectively. The patients with significantly increased serum creatinine, blood potassium, and total bilirubin in the valsartan group were 0.8%, 4.4%, and 6%, respectively, and in the ACEI group, they were 1.6%, 6.4%, and 12.9%, respectively. Occasionally, liver function indicators were elevated. For patients with essential hypertension receiving valsartan treatment, there is no need to specifically monitor laboratory indicators.

Hypersensitivity to any of the ingredients in this product or to sulfonamide derivatives. Pregnancy (see Pregnancy and Lactation). Severe liver failure, biliary cirrhosis or cholestasis. Severe renal failure (creatinine clearance <30ml/min) or anuria. Refractory hypokalemia, hyponatremia or hypercalcemia and symptomatic hyperuricemia (history of gout or uric acid stones).

Precautions for children: There is insufficient research data on the therapeutic use of this product in children. Precautions for pregnancy and lactation: Pregnant women are prohibited from taking this drug. Precautions for the elderly: Compared with young volunteers, some elderly people (>65 years old) have slightly higher valsartan concentrations, but this is of no clinical significance. Compared with young people, the steady-state concentration of hydrochlorothiazide in the elderly is high and the systemic clearance rate is significantly reduced. Therefore, elderly patients receiving hydrochlorothiazide treatment need to be closely monitored.

The antihypertensive effect of this product can be increased by combining it with other antihypertensive drugs. It is necessary to be cautious and monitor the serum potassium level when using it with potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes, or other drugs that can increase serum potassium (such as heparin). It has been reported that the simultaneous use of lithium, ACE inhibitors and/or thiazide diuretics can cause a reversible increase in serum lithium concentration and lithium poisoning. There is no experience of using valsartan and lithium at the same time. Therefore, it is recommended to regularly test serum lithium levels when lithium and this product are used in combination. Because this product contains thiazide diuretics, the following interactions may occur: combined use 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. If hypovolemia exists at the same time, it may lead to acute renal failure. Concomitant administration with potassium-wasting diuretics (e.g., furosemide), corticosteroids, adrenocorticotropic hormone (ACTH), amphotericin B, carbenoxolone, penicillin G, or salicylic acid derivatives may exacerbate potassium and/or magnesium loss. The bioavailability of thiazide diuretics may be increased when anticholinergic drugs (e.g., atropine, biperiden) are given simultaneously, probably as a result of decreased gastrointestinal motility and slower gastric emptying. There are isolated reports of hemolytic anemia with the combined use of hydrochlorothiazide and methyldopa. Cholestyramine and colestipol reduce the absorption of thiazide diuretics. The combined use of thiazide diuretics and vitamin D or calcium salts may enhance the effect of raising serum calcium. The combined use of cyclosporine may increase the risk of hyperuricemia and cause symptoms of gout.

Store at room temperature, tightly closed.

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

24 months

Chongqing Kangke'er Pharmaceutical Co., Ltd.

• Founded in:

  1999-11-30

• Address:

  No. 101, Jinyu Avenue, Economic Development Park, Northern New District, Chongqing

• Tax NO.:

  91500000622044331W

• Registered Funds:

  74.491724 million yuan

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