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 administration of losartan potassium to male mice is 2248mg/Kg (6744mg/m2) (1124 times the recommended maximum daily dose for adults). The significant minimum lethal dose of this product for 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*. 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. No toxicity was found to prevent administration at therapeutic dose levels.

The main ingredient of this product is Losartan Potassium. Its chemical name is 2-butyl-4-chloro-1-[[2'-(1H-tetrazolyl-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol monopotassium salt. Molecular formula: C22H22ClKN6O Molecular weight: 461.01

This product 50 mg is a white oval film-coated tablet. After removing the film, the tablet core appears white or off-white.

This product is suitable for the treatment of 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 capacity (such as patients treated with large doses of diuretics), a starting dose of 25 mg once a day may be considered (see Precautions). There is no need to adjust the starting dose for elderly patients or patients with renal impairment, including those undergoing hemodialysis. 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.

This product is well tolerated; adverse reactions are mild and transient, and there have been no cases requiring discontinuation of treatment due to adverse drug reactions. The overall incidence of adverse reactions when using this product is similar to that of placebo. In clinical controlled studies of primary hypertension, the only adverse reaction related to the drug and with a higher incidence than placebo in 1% or more of patients treated with this product 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 clinical double-blind controlled studies of primary hypertension, after the use of this product, adverse reactions with an incidence of 1% or more, regardless of whether they are related to the drug, include: Losartan Potassium Tablets (n=2085) Blank Tablets (n=535)

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

Precautions for children: The antihypertensive effect of this product has been established in hypertensive children aged 1 month to 16 years. Evidence from adequate controlled studies in children and adults and literature reports on its use in children supports the use of this product in these age groups. A pharmacokinetic study of losartan was conducted on 50 hypertensive children aged 1 month to 16 years, with a dose of approximately 0.54-0.77 mg/Kg (average dose) of losartan taken orally once a day. Losartan forms active metabolites in all age groups. In general, the pharmacokinetics of losartan and its active metabolites are similar between the age groups studied, which is consistent with the existing adult pharmacokinetic data. A clinical study involving 177 hypertensive children aged 6-16 years Precautions for pregnancy and lactation: 1. Medication for pregnant women When pregnant women use drugs in the middle and late stages of pregnancy, 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 starting in mid-pregnancy depends on the development of the renin-angiotensin system. Therefore, if this product is used in mid- and late-pregnancy, the risk to the fetus will increase. 2. It is not known whether losartan is secreted in human milk for use in lactating women. Since many drugs can be secreted in human milk and have adverse effects on lactating infants, elderly precautions: There is no age difference in the effectiveness and safety of this product in clinical studies.

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.

Keep in a sealed container

50mg*7s (Cozaar)

36 months