Losartan Potassium Capsules

This product is an angiotensin II receptor (AT1 type) antagonist. In vitro and in vivo studies have shown that losartan and its pharmacologically active carboxylic acid metabolite (E-3174) can block the corresponding physiological effects of angiotensin II synthesized from any source and any route. Losartan can selectively act on AT1 receptors, does not affect the functions of other hormone receptors or important ion channels in the cardiovascular system, and does not inhibit angiotensin converting enzyme (kininase II) that degrades bradykinin. Therefore, effects that are not directly related to blocking AT1 receptors are not related to losartan. The LD50 of oral losartan potassium in male mice is 2248 mg/kg (6744 mg/m2) (1124 times the recommended maximum daily dose for adults). The minimum lethal dose of this product for mice and rats 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. To evaluate the toxic effects of losartan potassium, repeated oral toxicity studies were conducted in monkeys, rats and dogs for 3 months and 1 year, respectively. The results showed that the therapeutic dose of the drug had no obvious toxic effects. When rats and mice were given the maximum tolerated dose of this product, the observation time reached 105 weeks and 92 weeks, respectively, and no carcinogenic effect of losartan potassium was found. In vitro alkaline elution test and chromosome aberration test showed that the use of losartan potassium equivalent to 1700 times the maximum plasma concentration that can be achieved with the recommended therapeutic dose for humans had no direct mutagenic effect. Male and female rats were given losartan potassium 150 and 300 mg/kg orally every day, respectively, and no effect on reproductive capacity was found. Losartan potassium can cause adverse reactions to rat embryos and newborns, including weight loss, death and/or nephrotoxicity. In addition, the concentrations of losartan potassium and its active metabolites in the milk of rats taking the drug were high.

Main component: Losartan potassium. Chemical name: 2-butyl-4-chloro-1-[[2-(1H-tetrazolyl-5-yl)[1,1-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol monopotassium salt. Molecular weight: C22H22ClKN6O

The content of this product is white or off-white granular powder.

This product is suitable for the treatment of hypertension.

The usual starting and maintenance dose is 50 mg once a day, and the maximum antihypertensive effect can be achieved after 3 to 6 weeks of treatment. For patients with hypovolemia, a starting dose of 25 mg once a day should be considered. This product can be used together with other antihypertensive drugs.

This product is well tolerated, and the incidence of adverse reactions is similar to that of placebo. Adverse reactions are usually mild and transient, and generally do not require discontinuation of treatment.

1. Those who are allergic to any ingredient of this product are prohibited from using. 2. Pregnant women should use with caution.

Precautions for children: There is no safety and efficacy data for children. Precautions for pregnancy and lactation: Use with caution for pregnant women. Precautions for the elderly: There is no significant difference in the efficacy and safety of this product between the elderly and adults.

Like other drugs that block angiotensin II and its effects, this product can cause increased serum potassium when used with potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes. Like other antihypertensive drugs, the nonsteroidal anti-inflammatory drug indomethacin can reduce the antihypertensive effect of losartan.

Store in a cool, dry place.

100mg

24 months

Zhuozhou Dongle Pharmaceutical Co., Ltd.

• Founded in:

  1993-10-27

• Address:

  Huoju Road, Economic Development Zone, Zhuozhou City, Hebei Province

• Tax NO.:

  91130681X01523751H

• Registered Funds:

  12 million yuan

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