Losartan Potassium Tablets

This product is an angiotensin II receptor (AT1 type) antagonist. It can block various pharmacological effects of endogenous and exogenous angiotensin II (including vasoconstriction, aldosterone release, etc.); this product can selectively act on AT1 receptors, does not affect the functions of other hormone receptors or important ion channels in the cardiovascular system, does not inhibit angiotensin converting enzyme (kininase II) that degrades bradykinin, and does not affect the metabolic process of angiotensin II and bradykinin. The LD50 of oral losartan potassium in male mice is 2248mg/Kg (6744mg/m2) (1124 times the recommended maximum daily dose for adults). The significant minimum lethal dose of this product in mice and rats is 1000mg/Kg (3000mg/m2) and 2000mg/Kg (11800mg/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 in a series of toxicity studies using multiple oral administrations for three months in monkeys and one year in rats and dogs, and no toxicity was found to prevent administration at therapeutic dose levels.

Losartan potassium.

It is a white oval film-coated tablet. After removing the film, the core of the tablet appears white or off-white.

This product is suitable for the treatment of primary essential hypertension.

For most patients, the usual starting and maintenance dose is 50 mg once a day. The maximum antihypertensive effect can be achieved after 3 to 6 weeks of treatment. In some patients, increasing the dose to 100 mg once a day can produce further antihypertensive effects. For patients with insufficient vascular volume (such as patients treated with large doses of diuretics), a starting dose of 25 mg once a day may be considered (see Precautions). For elderly patients or patients with renal impairment, including those undergoing hemodialysis, there is no need to adjust the starting dose. A lower dose should be considered for patients with a history of liver damage (see Precautions). This product can be used together with other antihypertensive drugs. This product can be taken with or without food.

Hypotension and electrolyte/fluid imbalance Patients with insufficient vascular volume (e.g., patients treated with high-dose diuretics) may develop symptomatic hypotension. 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 show that the plasma concentration of losartan in patients with cirrhosis is significantly increased, so 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 sensitive individuals; these changes in renal function can be restored after cessation of treatment. For patients with bilateral renal artery stenosis or renal artery stenosis in only one kidney, other drugs that affect the renin-angiotensin system can increase their blood urea and serum creatinine levels. Similar reports have also been reported with this product. These changes in renal function can be restored after cessation of treatment.

It is contraindicated for those who are allergic to any ingredient of this product.

Precautions for children: The safety and effectiveness of the drug in children have not been established. Precautions for pregnancy and lactation: When pregnant women use the drug in the second and third trimesters, drugs that directly act on the renin-angiotensin system can cause damage to the developing fetus or even death. When pregnancy is discovered, this product should be discontinued as soon as possible. Although there is no experience of pregnant women using this product, animal studies using losartan potassium have demonstrated fetal and neonatal damage and death, and the mechanism is believed to be due to drug-mediated effects on the renin-angiotensin system. Renal perfusion of the human fetus from the second trimester of pregnancy depends on the development of the renin-angiotensin system. Therefore, if this product is used in the second and third trimesters of pregnancy, the risk to the fetus will increase. It is not known whether losartan is secreted in human milk. Since many drugs can be secreted in human milk and have adverse effects on breastfeeding infants, it should be decided whether to stop breastfeeding or stop taking the drug based on the importance of the mother. Precautions for the elderly: In clinical studies, there is no age difference in the effectiveness and safety of this product.

In clinical pharmacokinetic studies, no clinically significant drug interactions with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, and erythromycin have been confirmed. Rifampicin and fluconazole have been reported to reduce the levels of active metabolites. The clinical consequences of these interactions have not been evaluated. As with other drugs that inhibit angiotensin II and its effects, this product can cause an increase in serum potassium when used in combination with potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes. As with other antihypertensive drugs, the nonsteroidal anti-inflammatory drug indomethacin can reduce the antihypertensive effect of losartan.

Store in a dry place below 30℃.

50mg

36 months

Yangtze River Pharmaceutical Group Sichuan Hairong Pharmaceutical Co., Ltd.

• Founded in:

  2001-08-17

• Address:

  No. 802, South Section of Rainbow Avenue, Dujiangyan City, Chengdu City, Sichuan Province

• Tax NO.:

  91510181730231740X

• Registered Funds:

  50 million yuan

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