Product Overview
[Drug Name]
Generic Name: Losartan Potassium Tablets
Trade Name: Huanning
English Name: Losartan Potassium Tablets
Chinese Pinyin: Losartan Potassium Tablets
[Ingredients]
Losartan Potassium.
[Appearance]
White, oval film-coated tablets. The core appears white or off-white after the film is removed.
[Indications]
This product is indicated for the treatment of essential hypertension.
[Dosage and Administration]
For most patients, the usual starting and maintenance dose is 50 mg once daily. Maximum antihypertensive effect is achieved after 3 to 6 weeks of treatment. In some patients, increasing the dose to 100 mg once daily may produce further antihypertensive effects. For patients with insufficient vascular volume (e.g., those receiving high-dose diuretics), a starting dose of 25 mg once daily may be considered (see Precautions). No adjustment to the starting dose is necessary for elderly patients or patients with renal impairment, including those undergoing hemodialysis. A lower dose should be considered for patients with a history of hepatic impairment (see Precautions). This product can be used with other antihypertensive drugs. It can be taken with or without food.
[Adverse Reactions]
Symptomatic hypotension may occur in patients with hypotension, electrolyte/fluid imbalance, or insufficient vascular volume (e.g., patients receiving high-dose diuretics). These conditions should be corrected before treatment with this product, or a lower initial dose should be used. (See Dosage and Administration). Hepatic Impairment: Pharmacokinetic data indicate that plasma concentrations of losartan are significantly increased in patients with cirrhosis. Therefore, a lower dose should be considered for patients with a history of hepatic impairment (see Dosage and Administration). Renal Impairment: Due to inhibition of the renin-angiotensin system, changes in renal function, including renal failure, have been reported in susceptible individuals; these changes resolve with discontinuation of treatment. Other drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or renal artery stenosis in only one kidney. Similar changes in renal function have been reported with this product. These changes resolve with discontinuation of treatment.
[Contraindications]
This product is contraindicated in patients with allergies to any of its components.
[Precautions]
Symptomatic hypotension may occur in patients with hypotension, electrolyte/fluid imbalance, or vascular volume depletion (e.g., those receiving high-dose diuretics). These conditions should be corrected before treatment with this product, or a lower initial dose should be used. (See Dosage and Administration). Hepatic Impairment: Pharmacokinetic data indicate that plasma concentrations of losartan are significantly increased in patients with cirrhosis. Therefore, a lower dose should be considered for patients with a history of hepatic impairment (see Dosage and Administration). Renal Impairment: Due to inhibition of the renin-angiotensin system, changes in renal function, including renal failure, have been reported in susceptible individuals; these changes resolve with discontinuation of treatment. Other drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine levels in patients with bilateral renal artery stenosis or unilateral renal artery stenosis. Similar changes have been reported with this product. These changes in renal function resolve with discontinuation of treatment.
[Use in Special Populations]
Precautions for Pediatric Use:The safety and efficacy of this drug in children have not been established.Precautions for Pregnancy and Lactation:Drugs that directly act on the renin-angiotensin system can cause harm or even death to the developing fetus when used by pregnant women during the second and third trimesters. This drug should be discontinued as soon as possible upon discovery of pregnancy. Although there is no experience with the use of this drug in pregnant women, animal studies with losartan potassium have demonstrated fetal and neonatal harm and death, the mechanism of which is believed to be drug-mediated effects on the renin-angiotensin system. Renal perfusion in the human fetus from the second trimester onward is dependent on the development of the renin-angiotensin system. Therefore, the risk to the fetus is increased if this drug is used during the second and third trimesters. It is not known whether losartan is excreted in human milk. Because many drugs are excreted in human milk and can cause adverse effects in nursing infants, the decision to discontinue nursing or discontinue the drug should be based on maternal considerations.
Precautions for Elderly Patients:In clinical studies, there were no age-related differences in the efficacy and safety of this drug.
[Drug Interactions]
In clinical pharmacokinetic studies, no clinically significant drug interactions have been confirmed with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, and erythromycin. Rifampicin and fluconazole have been reported to reduce the levels of the active metabolite. The clinical consequences of these interactions have not been evaluated. Like other drugs that inhibit angiotensin II and its effects, coadministration of this drug with potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes may result in elevated serum potassium. Like other antihypertensive drugs, the nonsteroidal anti-inflammatory drug indomethacin may reduce the antihypertensive effect of losartan.
[Pharmacological Actions]
This drug is an angiotensin II receptor (AT1) antagonist. It can block the various pharmacological effects of endogenous and exogenous angiotensin II (including vasoconstriction and aldosterone release); this product can selectively act on the AT1 receptor, does not affect the function of other hormone receptors or important ion channels in the cardiovascular system, does not inhibit the angiotensin-converting enzyme (kininase II) that degrades bradykinin, and does not affect the metabolic process of angiotensin II and bradykinin. The LD50 of losartan potassium in male mice after oral administration is 2248 mg/Kg (6744 mg/m2) (1124 times the recommended maximum daily dose for adults). The significant minimum lethal dose of this product in mice and rats after oral administration is 1000 mg/Kg (3000 mg/m2) and 2000 mg/Kg (11800 mg/m2), respectively, which are 500 times and 1000 times the recommended maximum daily dose for adults, respectively. The potential toxicity of losartan potassium was evaluated through a series of toxicity tests involving multiple oral administrations for three months in monkeys and one year in rats and dogs, and no obstacles were found to prevent medication at therapeutic dose levels.
[Storage]
Store below 30°C in a dry place.
[Specifications]
50mg*7 tablets
[Packaging]
Box
[Expiry Period]
24 months
[Approval Number]
National Medicine Standard H20080371
[Manufacturer]
Company Name: Yangtze River Pharmaceutical Group Sichuan Hairong Pharmaceutical Co., Ltd.
