Product Overview
[Drug Name]
Generic Name: Valsartan Capsules
Trade Name: Valsartan
English Name: Triprolidine Hydrochloride Tablets
Chinese Pinyin: Xiashatan Jiaonang
[Ingredients]
Chemical name: (S)-N-valeryl-N-{[2-(1H-tetrazol-5-)biphenyl-4-]methyl}valine; (S)-N-oxopentyl-N-{[2-(1H-5-tetrazolyl)biphenyl-4-]methyl}valine, Molecular Formula: C24H29N5O3, Molecular Weight: 435.5
[Properties]
This product is a hard capsule containing a white powder.
[Indications]
Valsartan is indicated for all types of mild to moderate hypertension, especially for patients intolerant to ACE inhibitors.
[Dosage and Administration]
Oral administration: 1 capsule once daily.
[Adverse Reactions]
Adverse reactions are rare, mild, and transient: 1. Mild headache, dizziness, fatigue, abdominal pain, dry cough, and postural blood pressure changes are rare. 2. Increased serum potassium, neutropenia, decreased hemoglobin and hematocrit, and increased serum creatinine and transaminases have been reported. 3. Diarrhea, rhinitis, pharyngitis, arthralgia, and nausea have been reported.
[Contraindications]
This product is contraindicated in patients with allergies. It is contraindicated in pregnant women.
[Precautions]
1. Patients with Hyponatremia or Hypovolemia: Patients with severe sodium deficiency and/or hypovolemia (e.g., due to high-dose diuretics) may experience symptomatic hypotension when initiating valsartan treatment. Therefore, hyponatremia or hypovolemia must be corrected before starting valsartan. If hypotension occurs, the patient should be placed in a supine position and, if necessary, administered intravenously with normal saline. 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 drug with caution. Short-term use of valsartan in 12 patients with renal hypertension due to unilateral renal artery stenosis did not show 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 drug out of the reach of children. 6. Used drug packaging should not be discarded carelessly.
[Use in Special Populations]
Precautions for Children:
The efficacy and safety of this product in children and adolescents (under 18 years of age) have not been studied. Precautions for Pregnancy and Lactation:
Contraindicated for pregnant women.
Precautions for the Elderly:
Although systemic exposure to valsartan in the elderly is slightly higher than in younger individuals, this effect is not clinically significant.
[Drug Interactions]
This product has no significant interactions with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The combined antihypertensive effect of this product with atenolol is greater than either alone, but it does not further reduce heart rate compared to atenolol alone. The pharmacokinetics of this product are not altered when it is coadministered with warfarin, and the anticoagulant effect of warfarin is not affected by this product. Concomitant use with potassium-sparing diuretics, potassium preparations, or potassium-containing salt substitutes may increase serum potassium.
[Pharmacological Actions]
This product is an angiotensin II receptor antagonist. This product selectively targets the AT1 receptor subtype known to be involved in the action of angiotensin II, selectively blocking the binding of angiotensin II to AT1 receptors on tissues such as the adrenal glands and vascular smooth muscle, inhibiting vasoconstriction and aldosterone secretion, resulting in a hypotensive effect. Its affinity for AT1 receptors is approximately 20,000 times higher than for AT2 receptors. It does not affect the action of bradykinin or ion channel function, nor does it bind to the receptors of other hormones that play an important role in regulating cardiovascular function. It is non-carcinogenic, non-teratogenic, non-mutagenic, and non-reproductive.
[Storage] Store in a sealed container away from light.
[Strength] 40 mg
[Packaging Size] 40 mg x 14 tablets
[Expiry Date] 24 months
[Approval Number] National Medicine Standard H20010811
[Manufacturer] Company Name: Changzhou Siyao Pharmaceutical Co., Ltd.
