Product Overview
[Drug Name]
Generic Name: Valsartan Capsules
Trade Name: Daiwen Valsartan Capsules 80mg*7 capsules
Pinyin Code: xieshatanjiaonang
[Main Ingredient]
Active ingredient: Valsartan.
[Properties]
This product is a hard capsule containing a white powder.
[Indications/Main Function]
Treatment of mild to moderate essential hypertension.
[Precautions]
1. Hyponatremia and/or Hypovolemia: In rare cases, patients with severe sodium deficiency and/or hypovolemia (e.g., those taking high-dose diuretics) may experience symptomatic hypotension when starting treatment with this product. Hyponatremia and/or hypovolemia should be corrected before starting treatment, for example, by reducing the diuretic dose. If hypotension occurs, the patient should be placed in a supine position and, if necessary, given an intravenous infusion of normal saline. Treatment with this product can be continued after blood pressure stabilizes. 2. Renal Artery Stenosis: Short-term use of this drug in 12 patients with secondary renovascular hypertension due to unilateral renal artery stenosis did not cause significant changes in renal hemodynamics, creatinine, or blood urea nitrogen (BUN). Since other drugs that act on the renin-angiotensin-aldosterone system (RAAS) may increase BUN and creatinine in patients with unilateral or bilateral renal artery stenosis, monitoring BUN and creatinine is recommended as a safety measure. 3. Renal Impairment: Dose adjustment is required for patients with renal impairment, but since there are no data on severe cases (creatinine clearance <10 ml/min), caution is advised when using this drug. 4. Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment. Valsartan is primarily excreted unchanged in the bile, and excretion is reduced in patients with biliary obstruction. Therefore, caution should be exercised when using this drug in such patients. The effects on driving and operating machinery are similar to those of other antihypertensive drugs; patients taking this drug should exercise caution when driving or operating machinery.
[Drug Interactions]
1. Hypersensitivity to valsartan or any other excipients in this product.
2. Pregnancy (see Pregnant and Lactating Women).
[Pediatric Use]
The efficacy and safety of this product in children and adolescents (under 18 years of age) have not been studied.
[Elderly Use]
Although systemic exposure to valsartan is slightly higher in the elderly than in younger adults, this is not clinically significant.
[Pregnant and Lactating Women Use]
1. Pregnancy: Given the mechanism of action of angiotensin II antagonists, fetal harm cannot be ruled out. There have been reports of harm or death to the developing fetus when angiotensin-converting enzyme inhibitors (an adjunctive drug class that acts on the RAAS) are administered intrauterine during the second and third trimesters of pregnancy. Furthermore, retrospective data suggest a potential risk of birth defects with the use of angiotensin-converting enzyme inhibitors during the first to third trimesters of pregnancy. There have been reports of spontaneous abortion, oligohydramnios, and neonatal renal insufficiency when pregnant women inadvertently take valsartan. Similar to other drugs that directly act on the RAAS, this product should not be used by pregnant women (see Contraindications). When prescribing drugs that act on the RAAS, women of childbearing potential should be informed of the potential risks of these drugs during pregnancy. If pregnancy is discovered during treatment, valsartan should be discontinued as soon as possible. 2. Breastfeeding: It is unknown whether valsartan is excreted in human milk. Valsartan is excreted in the milk of lactating rats, so this product is not suitable for use during lactation.
[Specifications]
80mg x 7 tablets (Diovan)
[Dosage and Administration]
Recommended dose: 80mg of this product, once daily. The dose is not affected by race, age, or sex. It can be taken with or without food (see Absorption). It is recommended to take the drug at the same time each day (e.g., in the morning). A definitive antihypertensive effect is achieved within 2 weeks of treatment, and maximal efficacy is achieved after 4 weeks. If the antihypertensive effect is unsatisfactory, the daily dose can be increased to 160mg, or a diuretic can be added. No dose adjustment is required for patients with renal impairment (see Precautions for severe renal failure) and non-biliary, non-cholestatic hepatic insufficiency. Valsartan can be used in combination with other antihypertensive medications.
[Adverse Reactions]
In a placebo- and Diovan-controlled trial in 2316 hypertensive patients, the overall adverse event (AE) rate in the Diovan group was similar to that observed in the placebo group. In a 6-month open-label extension trial of 642 hypertensive patients treated with 320 mg of valsartan, the overall AE rate was similar to that observed in the placebo-controlled trials. The table below shows the adverse event rates reported in 10 placebo-controlled trials in which patients received 10 to 320 mg of valsartan daily for up to 12 weeks. Of the 2316 patients, 1281 received 80 mg and 660 received 160 mg, respectively. The adverse event rate was not related to dose or duration of treatment; therefore, adverse events occurring at all doses were combined. The adverse event rate was not related to gender, age, or race. Incidence is defined as follows: Very rare (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); Rare (≥1/10,000, <1/1000); Very rare (<1/10,000). Elevated liver function tests may occur occasionally. No specific laboratory monitoring is required for patients with essential hypertension receiving valsartan.
[Contraindications]
1. Hypersensitivity to valsartan or any other excipients in this product. 2. Pregnancy (see pregnant and lactating women).
[Overdose]
Not yet established.
[Pharmacology and Toxicology]
This product is an angiotensin II receptor antagonist. It selectively targets the AT1 receptor subtype known to be involved in the action of angiotensin II, selectively blocking the binding of angiotensin II to the AT1 receptor on tissue cells such as the adrenal glands and vascular smooth muscle, inhibiting vasoconstriction and aldosterone secretion, resulting in a hypotensive effect. This drug has an affinity for AT1 receptors that is approximately 20,000 times higher than for AT2 receptors. It does not affect the effects of bradykinin or ion channel function, nor does it bind to the receptors of other hormones that play an important regulatory role in cardiovascular function. It is not carcinogenic, teratogenic, or mutagenic, and has no reproductive toxicity.
[Pharmacokinetics]
Not yet established.
