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, and no toxicity was found to prevent administration at therapeutic dose levels.

The main ingredient of this product is losartan potassium.

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 can 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.

This product is well tolerated; adverse reactions are mild and short-lived, and there have been no cases of treatment termination 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 essential 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 are individual reports. In these clinical double-blind controlled studies of essential hypertension, adverse reactions with an incidence of 1% or more after the use of this product, regardless of whether they are drug-related, are as follows: Losartan Potassium Tablets (n=2085) Blank Tablets (n=535) Abdominal pain 1.7 1.7 Fatigue/tiredness 3.8 3.9 Chest pain 1.1 2.6 Edema/swelling 1.7 1.9 Cardiovascular system Palpitations 1.0 0.4 Tachycardia 1.0 1.7 Digestive system Diarrhea 1.9 1.9 Indigestion 1.1 1.5 Nausea 1.8 2.8 Musculoskeletal system Back pain 1 .61.1 Muscle spasm 1.01.1 Nervous/psychiatric system Dizziness 4.12.4 Headache 14.117.2 Insomnia 1.10.7 Respiratory system Cough 3.12.6 Nasal congestion 1.31.1 Pharyngitis 1.52.6 Sinus disorder 1.01.3 Upper respiratory tract infection 6.55.6 Other adverse reactions reported after the product was marketed include: Allergic reaction: Angioedema (including swelling of the larynx and glottis leading to airway obstruction, and/or swelling of the face, lips, pharynx and/or tongue) has been reported in a very small number of patients treated with losartan. Some of these patients had previously developed angioedema due to taking other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been rarely reported. Gastrointestinal reactions: Hepatitis (rarely reported), abnormal liver function. Blood system: anemia. Musculoskeletal system: myalgia. Nervous/psychiatric system: migraine. Respiratory system: cough. Skin: urticaria, itching. Laboratory test results In the controlled clinical trials of essential hypertension, few patients using this product showed clinically significant changes in laboratory parameters. 1.5% of patients developed hyperkalemia (serum potassium 5.5mEq/L). ALT elevation is rare and returns to normal after discontinuation of the drug.

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

Zhe JIANG HUA HAI Pharmaceutical Co., Ltd.

• Founded in:

  2001-02-28

• Address:

  Xunqiao, Linhai City, Zhejiang Province

• Tax NO.:

  91330000147968817N

• Registered Funds:

  1.491754938 yuan

• Website:

  Log in to view

• Email:

  Log in to view