Losartan Potassium Capsules

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.

Losartan potassium.

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 insufficient vascular volume (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 transient, and no case has occurred that required termination 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 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 postural 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, after using this product, whether or not it is related to the drug, the adverse reactions with an incidence of 1% or more include: Other adverse reactions reported after the product was marketed include: Allergic reactions: 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 rarely reported in a very small number of patients treated with losartan. Some of these patients had previously experienced angioedema due to taking other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported rarely. Gastrointestinal reactions: Hepatitis (rarely reported), abnormal liver function. Hematologic system: Anemia. Musculoskeletal system: Myalgia. Nervous/psychiatric system: Migraine. Respiratory system: Cough. Skin: Urticaria, pruritus. Laboratory test results In controlled clinical trials of essential hypertension, few patients treated with this product had clinically important changes in laboratory parameters. Hyperkalemia (serum potassium] 5.5 mEq/L) occurred in 1.5% of patients. Elevations in ALT are rare and return to normal after discontinuation of the drug.

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.

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.

Sealed and stored in a dry place.

50mg

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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