Product Overview
[Drug Name]
Generic Name: Valsartan and Hydrochlorothiazide Dispersible Tablets
Trade Name: MaiBang
English Name: Valsartan and Hydrochlorothiazide Dispersible Tablets
Chinese Pinyin: XueShaTanQingLvSaiQinFenSanPian (MaiBang)
[Ingredients]
Valsartan and Hydrochlorothiazide is a combination preparation consisting of valsartan and hydrochlorothiazide.
[Properties]
This product is a white or off-white tablet.
[Indications]
For the treatment of mild to moderate essential hypertension where blood pressure cannot be adequately controlled with a single medication. Valsartan and Hydrochlorothiazide is not suitable for the initial treatment of hypertension.
[Dosage and Administration]
Each Valsartan and Hydrochlorothiazide tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. If blood pressure is not satisfactorily controlled with valsartan monotherapy or hydrochlorothiazide 25 mg once daily is insufficient, or if hypokalemia occurs, valsartan-hydrochlorothiazide (containing 80 mg of valsartan/12.5 mg of hydrochlorothiazide) can be used as an alternative, one tablet once daily. Maximum antihypertensive efficacy is achieved within 2-4 weeks of treatment. No dose adjustment is required for patients with mild to moderate renal failure (creatinine clearance ≥ 30 ml/min) or mild to moderate hepatic failure (non-biliary, non-choledochal).
[Adverse Reactions]
1. Adverse events with an incidence of less than 1% include: abdominal pain, upper abdominal pain, anxiety, arthritis, asthenia, bronchitis, acute bronchitis, chest pain, postural dizziness, dyspepsia, dyspnea, dry mouth, erectile dysfunction, gastroenteritis, hyperhidrosis, decreased sensation, hypokalemia, hypotension, influenza, insomnia, muscle cramps, muscle tension, nausea, nasal congestion, neck pain, edema, peripheral edema, otitis media, pain in extremity, palpitations, paresthesia, sore throat, frequent urination, fever, rash, sinus congestion, sinusitis, drowsiness, sprains and strains, tachycardia, tinnitus, urinary tract infection, vertigo, viral infection, blurred vision, and abnormal vision. It is not known whether these adverse events are treatment-related. 2. Post-marketing data indicate that the following have been reported very rarely: angioedema, rash, pruritus, and other hypersensitivity/allergic reactions, including serum sickness and vasculitis. 3. Very rare reports of impaired renal function and myalgia. Several cases of hydrochlorothiazide-induced pulmonary edema with granulocyte infiltration and IgG deposition in the alveolar membranes have been reported. 4. Non-cardiogenic pulmonary edema may be a rare immune-mediated atopic reaction to hydrochlorothiazide. (See inner package insert for details.)
[Contraindications]
1. Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamides, or any of the ingredients in this product. 2. Pregnancy (see Pregnancy and Lactation). 3. Severe hepatic impairment, biliary cirrhosis, or cholestasis. 4. Severe renal failure (creatinine clearance <30 ml/min) or anuria. 5. Refractory hypokalemia, hyponatremia, or hypercalcemia, and symptomatic hyperuricemia.
[Precautions]
1. Serum electrolyte changes: Caution is advised when using this drug with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that increase potassium levels (such as heparin). Hypokalemia has been reported with thiazide diuretics; therefore, serum potassium levels should be monitored regularly. 2. Sodium and/or Volume Depletion: Rarely, symptomatic hypotension may occur when initiating treatment with this drug in patients with severe sodium and/or volume depletion (e.g., those taking high-dose diuretics). Hyponatremia and/or volume depletion should be corrected before initiating treatment with this drug. If hypotension occurs, the patient should be placed in the supine position and, if necessary, given normal saline. Treatment can be resumed after blood pressure stabilizes. 3. Renal Artery Stenosis: There is no experience with the use of this drug in patients with unilateral or bilateral renal artery stenosis or solitary kidney stenosis. 4. Renal Impairment: No dose adjustment is required for patients with renal impairment and a creatinine clearance ≥30 ml/min. 5. Hepatic Impairment: No dose adjustment is required for patients with mild to moderate hepatic impairment that is not cholestatic, but this drug should be used with caution. Liver disease does not significantly affect the pharmacokinetics of hydrochlorothiazide. 6. Systemic lupus erythematosus: There have been reports that thiazide diuretics, including hydrochlorothiazide, can trigger or exacerbate systemic lupus erythematosus. 7. Other metabolic disorders: Thiazide diuretics, including hydrochlorothiazide, can impair glucose tolerance and increase serum cholesterol, triglyceride, and uric acid levels. 8. Effects on the ability to drive and operate machinery: As with other antihypertensive drugs, patients taking this medication should exercise caution when driving or operating machinery. 9. Effects on athletes: This product contains hydrochlorothiazide. Thiazide diuretics can affect the metabolism and excretion of stimulants, potentially reducing the sensitivity of urine tests for stimulants. Therefore, athletes should use this product with caution. Please read the package insert carefully and use as directed by your doctor.
[Use in Special Populations]
Precautions for use in children:
Insufficient research data are available regarding the therapeutic use of this product in children.
Precautions during pregnancy and lactation:
1. Pregnancy: Based on the mechanism of action of angiotensin II receptor antagonists, the risk of embryonic damage cannot be ruled out. In utero exposure to angiotensin-converting enzyme inhibitors (a class of drugs that act on the renin-angiotensin-aldosterone system) during the 4th to 6th and 7th to 9th months of gestation can cause fetal harm and death. Furthermore, retrospective data suggest a potential risk of birth defects in patients who use ACE inhibitors during the first trimester. In utero exposure to thiazide diuretics, including hydrochlorothiazide, can cause fetal or neonatal thrombocytopenia, and adverse reactions similar to those seen in adults. There have been reports of spontaneous abortion, oligohydramnios, and neonatal renal insufficiency following maternal ingestion of valsartan, similar to other drugs that directly act on the RAAS.
Precautions for Elderly Patients:
Some elderly individuals have slightly elevated valsartan concentrations compared to younger volunteers, but these are not clinically significant. Data suggest that systemic clearance of hydrochlorothiazide is decreased in the elderly compared to young, healthy volunteers.
[Drug Interactions]
1. Concomitant use with other antihypertensive drugs may enhance the antihypertensive efficacy of this drug. 2. Caution is advised when coadministering with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other medications that may alter serum potassium (e.g., heparin). Serum potassium levels should be monitored regularly. 3. When lithium is coadministered with this product, regular monitoring of serum lithium levels is recommended. 4. Thiazides, including hydrochlorothiazide, may enhance the effects of curare derivatives. 5. Coadministration with nonsteroidal anti-inflammatory drugs (e.g., salicylic acid derivatives, indomethacin) may attenuate the diuretic and antihypertensive activity of the thiazide component of this product. 6. 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 loss.
[Pharmacological Actions]
1. Multiple preclinical safety studies in several animal models have shown that valsartan, hydrochlorothiazide, and valsartan:hydrochlorothiazide exhibit no systemic or target organ toxicity. High-dose valsartan:hydrochlorothiazide (100:31.25 to 600:187.5 mg/kg body weight) can cause decreases in red blood cell parameters (erythrocytes, hemoglobin, and hematocrit) and alterations in renal hemodynamics in rats (moderate to severe increases in plasma urea, plasma potassium and magnesium concentrations, mild increases in urine volume, elevated electrolyte levels, mild tubular basophilia, and thickened afferent arterioles at the highest dose levels). In studies in marmosets (30:9.375 to 400:125 mg/kg body weight), these changes were similar to those in rats but more severe, with the higher doses having more pronounced renal effects, which can lead to nephropathy, including increases in urea and creatinine levels. 2. Juxtaglomerular cell hypertrophy was observed in both animal models. These changes were attributed to a pharmacological synergistic effect of valsartan and hydrochlorothiazide (approximately 10 times greater than that of valsartan alone), rather than an additive effect. This synergistic effect resulted in a prolonged antihypertensive effect, particularly in marmoset studies. In human studies, therapeutic doses of valsartan and hydrochlorothiazide do not appear to be associated with juxtaglomerular cell hypertrophy. Preclinical safety studies primarily demonstrated pharmacological synergy between the two drugs, but no evidence of an interaction was found. In clinical practice, the effects of the two drugs appear additive, and this additive effect has not been shown to be clinically significant in preclinical studies. 3. Because there is no evidence of an interaction between valsartan and hydrochlorothiazide, the valsartan-hydrochlorothiazide combination was not tested for mutagenicity, clastogenicity, and carcinogenicity. However, separate studies of valsartan and hydrochlorothiazide for mutagenicity and clastogenicity have yielded negative results. [Storage] Protect from light and store tightly closed.
[Specifications] Each tablet contains 80mg of valsartan and 12.5mg of hydrochlorothiazide.
[Packaging] 7 tablets/box.
[Expiry Date] 24 months.
[Approval Number] National Medicine Standard H20110092
[Manufacturer] Shandong Sibonde Pharmaceutical Co., Ltd.
