Product Overview
[Drug Name]
Generic Name: Valsartan Dispersible Tablets
Trade Name: Pinxin Pinsartan Dispersible Tablets 80mg*7 tablets
Pinyin Code: ZuXinZuoShaTanFenSanPian 80mg*7 tablets
[Main Ingredient]
ZuXinZuoShaTanFenSanPian 80mg*7 tablets
[Properties]
This product is white tablets.
[Indications/Main Functions]
Treatment of mild to moderate essential hypertension.
[Specifications]
80mg*7 tablets
[Dosage and Administration]
Recommended dose: 80mg once daily. The dose is not affected by race, age, or gender. It can be taken with or without food. It is recommended to take the drug at the same time each day. A definitive antihypertensive effect is achieved within two weeks of treatment, and maximum efficacy is achieved after four 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 insufficiency or non-biliary, non-choledostatic hepatic insufficiency. Valsartan can be used in combination with other antihypertensive drugs.
[Adverse Reactions]
Angioneurotic edema, rash, pruritus, and other hypersensitivity reactions such as serum sickness and vasculitis. Rarely, elevated liver function tests may occur. Other adverse reactions with an incidence of less than 1% include edema, weakness, insomnia, rash, and decreased libido. No specific laboratory parameters need to be monitored in patients with essential hypertension receiving valsartan.
[Contraindications]
Hypersensitivity to any of the ingredients. Pregnancy (see Pregnancy and Lactation). There is no experience with the use of this product in patients with severe renal failure (creatinine clearance <10 m/min).
[Drug Interactions]
Drug interactions may occur if used concomitantly with other medications. Consult your physician or pharmacist for details.
[Precautions]
1. Hyponatremia and/or hypovolemia: In rare cases, patients with severe sodium and/or hypovolemia (e.g., those taking high-dose diuretics) may experience symptomatic hypotension when starting treatment with this product. Prior to medication administration, correct hyponatremia and/or hypovolemia, or reduce the diuretic dose. If hypotension occurs, place the patient in a supine position and administer normal saline intravenously if necessary. Resume treatment with this drug after blood pressure stabilizes. 2. Renal Artery Stenosis: Twelve patients with secondary renovascular hypertension due to unilateral renal artery stenosis took this drug for four days without significant changes in renal hemodynamics, creatinine, or blood urea nitrogen (BUN). Because other drugs that act on the RAAS may increase BUN and creatinine in patients with unilateral or bilateral renal artery stenosis, monitoring is recommended to ensure safety. 3. Renal Impairment: No dose adjustment is required for patients with renal impairment. 4. Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment. The dose of galvansartan should not exceed 80 mg/day in patients with mild to moderate hepatic impairment. Galvansartan is primarily excreted unchanged in the bile, and excretion is reduced in patients with biliary obstruction (see Pharmacokinetics). Caution should be exercised when using this drug in such patients. 5. Early Pregnancy (First Trimester): Pregnancy Category B. Animal studies have shown no harm to the fetus. 6. Second and third trimesters (second and third trimesters): Gestational category D. 7. There is evidence of harm to the human fetus, but the benefits outweigh the risks. Given the mechanism of action of angiotensin II receptor antagonists, fetal harm cannot be ruled out. Drugs that directly act on the RAAS during second and third trimesters can cause fetal harm or death. Renal hypoperfusion begins in the second trimester, and the latter is dependent on the development of the RAAS system. Therefore, the risk is increased with this drug during second and third trimesters. 8. Like other drugs that directly act on the RAAS, this drug is not suitable for use during pregnancy. If pregnancy is discovered during treatment, valsartan should be discontinued as soon as possible. All newborns exposed to the drug in utero should be closely monitored to ensure adequate urine output, prevent hyperkalemia, and monitor blood pressure. If necessary, appropriate treatment measures (such as rehydration) should be implemented to eliminate the drug. Valsartan can be excreted in rabbit milk. However, there are currently no studies in lactating women, so this drug is not suitable for use during lactation. [Pediatric Use]
The efficacy and safety of this drug in children have not been studied. There is no experience with its use in children.
[Elderly Use]
Although systemic exposure to psilocybin is slightly higher in the elderly than in younger patients, this is not clinically significant.
[Overdose]
Although there is no experience with the diagnosis and treatment of an overdose with this drug, the primary symptom may be marked hypotension. If the drug has been taken for a short time, vomiting should be induced; otherwise, standard treatment is intravenous saline infusion. psilocybin cannot be removed by hemodialysis.
[Pharmacology and Toxicology]
Mechanism of Action: Angiotensin I is an activator of the renin-angiotensin-aldosterone system (RAAS). Angiotensin I binds to specific receptors on the cell membranes of various tissues. It has multiple physiological effects, including direct and indirect involvement in blood pressure regulation. Angiotensin I is a potent vasoconstrictor with a direct pressor effect. It also promotes sodium reabsorption and stimulates aldosterone secretion. psilocybin is an orally effective, specific Angiotensin (AT) receptor antagonist, it selectively acts on the AT1 receptor subtype, producing all known effects, and the AT2 receptor subtype is not related to cardiovascular effects. Pinasartan does not have any partial agonist activity on the AT1 receptor. Pinasartan's affinity for the AT1 receptor is 20,000 times stronger than that for the AT2 receptor. ACE converts angiotensin I into angiotensin II and degrades bradykinin. The angiotensin I receptor antagonist - Pinasartan has no inhibitory effect on ACE, does not cause the retention of bradykinin or substance P, and therefore does not cause cough. Cough. Clinical trials comparing pinsartan and ACE inhibitors confirmed that the incidence of dry cough in the pinsartan group (2.6%) was significantly lower than that in the ACE inhibitor group (7.9%) (P<0.05). In a clinical trial conducted on patients who had developed dry cough symptoms after receiving ACE inhibitor treatment, 19.5%, 19.0%, and 68.5% of patients in the pinsartan group, diuretic group, and ACEI group experienced cough, respectively (P<0.05). Pinsartan has no effect on other hormone receptors or ion channels known to play an important role in cardiovascular regulation. Effect. Efficacy: Valsartan lowers elevated blood pressure without affecting heart rate. For most patients, a single oral dose produces a blood pressure lowering effect within 2 hours, reaches peak effect within 4-6 hours, and the blood pressure lowering effect is maintained for more than 24 hours after taking the drug. The maximum antihypertensive effect is achieved after 2-4 weeks of treatment, and the effect is maintained during long-term treatment. Combination with thiazide diuretics can further significantly enhance the antihypertensive effect, and sudden termination of valsartan treatment will not cause hypertension rebound or other side effects. Valsartan does not affect the total cholesterol, triglyceride, blood sugar and uric acid levels of hypertensive patients.
