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.

The main component of this product is 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. Chemical structure: Molecular formula: C22H22ClKN6O Molecular weight: 461.01

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

This product is suitable for the treatment of 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 hypovolemia (such as patients treated with large doses of diuretics), a starting dose of 25 mg once a day should 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. For patients with a history of liver damage, a lower dose should be considered (see Precautions). This product can be used together with other antihypertensive drugs. This product can be taken with or without food.

Clinical trials have found that this product is well tolerated, with mild and transient adverse reactions, and generally no need to terminate treatment. The overall incidence of adverse reactions with this product is similar to that with placebo. In controlled clinical studies of essential hypertension, the only adverse reaction with an incidence ≥1%, drug-related, and higher than placebo was dizziness. In addition, less than 1% of patients experienced dose-related orthostatic hypotension. Although the incidence of rash in controlled clinical trials is lower than that of placebo, there have been individual reports. In these double-blind controlled clinical studies of essential hypertension, after the use of this product, adverse reactions with an incidence of 1% or more, regardless of whether they were drug-related, included: Losartan Potassium Tablets (n=2085) Blank Tablets (n=535) General abdominal pain 1.7 1.7 Fatigue/tiredness

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: The safety and effectiveness of the drug in children have not been established. Precautions for pregnancy and lactation: Use with caution in pregnant women. Precautions for the elderly: In clinical studies, there is no age difference in the effectiveness and safety of this product.

1. Clinical pharmacokinetic studies have shown that losartan potassium has no clinically significant drug interactions with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, and erythromycin. It has been reported that rifampicin and fluconazole can reduce the levels of active metabolites of losartan. The clinical consequences of these interactions have not been evaluated. 2. Like other drugs that block angiotensin II and its effects, this product can cause increased blood potassium when used in combination with potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), 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 below 30℃ in a dry place.

50mg

18 months

Beijing Foyou Pharma Co., Ltd.

• Founded in:

  1999-02-03

• Address:

  No. 8 Guangyuan East Street, Tongzhou Industrial Development Zone, Tongzhou District, Beijing

• Tax NO.:

  91110112700216160K

• Registered Funds:

  480 million yuan

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