Product Overview
[Drug Name]
Generic Name: Valsartan Capsules
Trade Name: Yifang Valsartan Capsules 80mg*35 Capsules
Pinyin Code: ZuoFang ZuoShaTanJiaoNang 80mg*35Li
[Main Ingredient]
Valsartan
[Properties]
This product consists of white or off-white granules and powder.
[Indications/Main Functions]
It is suitable for all types of mild to moderate hypertension, especially for patients intolerant to ACE inhibitors.
[Specifications]
80mg*35 Capsules
[Dosage and Administration]
Oral administration: one 80mg capsule once daily. The antihypertensive effect usually appears within two weeks of administration, with maximum efficacy achieved after four weeks. For patients with unsatisfactory blood pressure control, the daily dose can be increased to two capsules or a diuretic can be added. No dose adjustment is required for patients with renal insufficiency or non-biliary or cholestatic hepatic insufficiency.
[Adverse Reactions]
1. The overall incidence of adverse reactions with this drug was similar to that observed in the placebo group. The main adverse reactions observed in clinical use include headache, dizziness, viral infection, upper respiratory tract infection, cough, diarrhea, fatigue, rhinitis, back pain, nausea, pharyngitis, and arthralgia. The incidence of adverse reactions was not related to dose or duration of treatment, nor to gender, age, or race. It is unknown whether these reactions are causally related to treatment with this drug. 2. Laboratory Indicators: This drug may occasionally cause decreases in hemoglobin and hematocrit. In controlled clinical trials, patients taking this drug experienced significant decreases in hematocrit and hemoglobin, with the rates being 0.8% and 0.4%, respectively, compared to 0.1% in the placebo group. 3. Neutropenia occurred in 1.9% of patients taking this drug and 1.8% of patients taking ACE inhibitors. 4. In controlled clinical trials, significant elevations in serum creatinine, serum potassium, and total bilirubin occurred in 0.8%, 4.4%, and 6% of patients taking this drug, respectively, compared to 1.6%, 6.4%, and 12.9% of patients taking ACE inhibitors, respectively. 5. Elevated liver function tests were occasionally observed in patients taking this drug. 6. No specific laboratory parameters need to be monitored when treating patients with essential hypertension.
[Contraindications]
1. This drug is contraindicated in patients with allergies. 2. This drug is contraindicated in pregnant and lactating women.
[Drug Interactions]
1. Clinical trials have not demonstrated clinically significant interactions between this drug and the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, and glyburide. 2. This drug generally has no clinically significant interactions with metabolic inducers or inhibitors of the cytochrome P450 enzyme system. In vitro studies have shown no interactions with other drugs with high plasma protein binding, such as dioxyfenac, furosemide, and warfarin. Concomitant use with potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), potassium preparations, or potassium-containing salt substitutes may increase serum potassium. If coadministration is necessary, monitor carefully.
[Precautions]
1. Patients with Hyponatremia or Hypovolemia: Patients with severe sodium deficiency and/or hypovolemia (e.g., due to taking high-dose diuretics) may experience symptomatic hypotension when initiating treatment with valsartan. Therefore, hyponatremia or hypovolemia must be corrected before using this drug. If hypotension occurs, position the patient supine and administer normal saline intravenously if necessary. Transient hypotension does not preclude further treatment; treatment can be continued once blood pressure stabilizes. 2. Patients with Hepatic Impairment: Approximately 70% of valsartan is eliminated unchanged in the bile. Valsartan is not biotransformed, so its systemic effects are unrelated to impaired liver function. Therefore, no dose adjustment is required in patients with non-biliary or non-cholestatic forms of hepatic impairment. However, patients with biliary cirrhosis or biliary obstruction have reduced valsartan clearance (higher AUCs), so caution should be exercised when using valsartan in these patients. 3. Patients with Renal Impairment: Because renal clearance of valsartan accounts for only 30% of total plasma clearance, its systemic effects are unrelated to renal function. No dose adjustment is required in patients with renal impairment. Inhibition of the renin-angiotensin-aldosterone system may alter renal function in sensitive patients. In patients whose renal function is dependent on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers may result in oliguria and/or progressive azotemia and (rarely) acute renal failure and/or death. Therefore, patients with severe renal insufficiency (creatinine clearance <10 ml/min) should use this medication with caution. Short-term use of valsartan in 12 patients with renal hypertension due to unilateral renal artery stenosis showed no significant changes in renal hemodynamics, serum creatinine, or blood urea nitrogen. Long-term use of valsartan has not been studied in patients with unilateral or bilateral renal artery stenosis. Because drugs that affect the renin-angiotensin-aldosterone system may increase serum creatinine or blood urea nitrogen in patients with unilateral or bilateral renal artery stenosis, these parameters should be carefully monitored for safety reasons. 4. No mutagenic, mitogenic, or carcinogenic effects have been identified. 5. Keep this medication out of the reach of children. 6. Used medication packaging should not be discarded carelessly.
[Pediatric Use]
No safety and efficacy data are available for use in pediatric patients.
[Pharmacology and Toxicology]
This product is an angiotensin I (Ang II) receptor AT1 antagonist. It selectively blocks the binding of Angiotensin I to the AT1 receptor, inhibiting vasoconstriction and aldosterone release, resulting in a hypotensive effect.
