Irbesartan Dispersible Tablets

Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist. It should block all AT1 receptor-mediated effects of angiotensin-II, regardless of the source or synthetic pathway of angiotensin-II. Its selective antagonism of the angiotensin-II receptor (AT1) results in increased plasma renin and angiotensin-II levels and decreased plasma aldosterone levels. Serum potassium is not significantly affected when irbesartan is administered alone at recommended doses to patients without electrolyte disturbances. Irbesartan does not inhibit angiotensin-converting enzyme (ACE or kinase II), which generates angiotensin-II, nor does it degrade bradykinin to inactive metabolites. Irbesartan does not require metabolic activation for its activity. There is no evidence of unusual somatic or target organ toxicity when clinically relevant doses are used. In preclinical safety studies, high doses of irbesartan (250 mg/kg/day in mice and 100 mg/kg/day in rhesus monkeys) resulted in a decrease in erythrocyte parameters (erythrocyte count, hemoglobin, hematocrit). At very high doses (500 mg/kg/day in mice), irbesartan induced renal degenerative effects (e.g., interstitial nephritis, tubular swelling, and increases in plasma urea nitrogen and creatinine concentrations) in mice and rhesus monkeys, which were thought to be secondary to the hypotensive effect of the drug, which may lead to renal hypoperfusion. Furthermore, irbesartan induced proliferation/hypertrophy of the juxtaglomerular apparatus (at 90 mg/kg/day in mice and 10 mg/kg/day in rhesus monkeys). All these changes are thought to be due to the pharmacological effects of irbesartan. At the therapeutic doses of irbesartan used in humans, proliferation/hypertrophy of the juxtaglomerular apparatus cells was not associated with this effect. There is no evidence that the drug causes mutagenesis, mitogenesis, or carcinogenesis. Animal studies of irbesartan have shown that it has transient toxic effects on mouse embryos (increased renal pelvic cavitation, ureteral or subcutaneous edema), which are eliminated after birth. In rabbit experiments, abortion or early absorption can be observed at doses that can clearly cause female toxicity. No teratogenic effects were observed in mouse and rabbit experiments.

The main ingredient of this product is irbesartan. Chemical name: 2-butyl-3-[[o-1H-5-tetrazolylphenyl]benzyl]-1,3-diazepine.

This product is white or off-white tablets.

Treat essential hypertension.

The usually recommended initial dose and maintenance dose are 0.15g (two tablets) per day, and diet has no effect on medication. In general, 0.15g of irbesartan once a day can better control 24-hour blood pressure than 75mg (one tablet). However, for some special patients, especially those undergoing hemodialysis and those over 75 years old, an initial dose of 75mg may be considered. For patients whose blood pressure cannot be effectively controlled using 0.15g of irbesartan once a day, the dose of this product can be increased to 0.30g (four tablets), or other antihypertensive drugs can be added. In particular, the addition of hydrochlorothiazide diuretics has been shown to have additive effects. In hypertensive patients with type 2 diabetes, the initial treatment dose should be 0.15g once a day, and can be increased to 0.30g once a day.

Adverse reactions in patients treated with this product are generally mild and temporary. Hypertensive patients: In clinical trials using this product for placebo-controlled treatment of patients with high direct pressure, the overall incidence of adverse reactions was no different between the treatment group and the placebo group. The number of events leading to treatment interruption due to any clinical and experimental abnormal events was less in the treatment group than in the placebo group. The incidence of adverse reactions is unrelated to dose (within the recommended dose range), gender, age, race or treatment time. See the instructions for details.

1. Those who are allergic to this product are prohibited from using it; 2. Pregnant and lactating women are prohibited from using it.

Precautions for children: There is no data on the safety and effectiveness of this product for children. Precautions for pregnancy and lactation: It is contraindicated for pregnant and lactating women. Precautions for the elderly: Although the initial treatment dose of 75 mg is recommended for patients over 75 years old, there is usually no need to adjust the dose for elderly patients.

Diuretics and other antihypertensive drugs: When this product is used in combination with other antihypertensive drugs, its antihypertensive effect may be enhanced. However, this product can be safely used in combination with other antihypertensive drugs such as long-acting calcium channel blockers, beta-blockers and thiazide diuretics. When high doses of diuretics have been used before the first use of this product, there may be a risk of volume depletion and hypotension. Potassium supplements and potassium-sparing diuretics: Based on clinical experience with other drugs that can affect the renin-angiotensin system, the combined use of potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that can increase serum potassium levels (such as heparin sodium) can lead to an increase in serum potassium, so co-use is not recommended. Lithium: When lithium and angiotensin-converting enzyme inhibitors are used in combination, there have been reports of reversible increases in serum lithium and toxic effects.

Sealed in a cool, dry place.

75mg

24 months

Yiling Pharmaceutical Ltd.

• Founded in:

  2014-07-28

• Address:

  No. 36, Zhujiang Avenue, Shijiazhuang High-tech Zone

• Tax NO.:

  911301013989550179

• Registered Funds:

  675 million yuan

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