Irbesartan Tablets

1. Irbesartan is an effective, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist. Regardless of the source or synthesis pathway of angiotensin-II, it should be able to block all angiotensin-II effects mediated by the AT1 receptor. Its selective antagonism of angiotensin-II receptor (AT1) leads to an increase in plasma renin and angiotensin-II levels and a decrease in plasma aldosterone levels. When the recommended dose of irbesartan is given alone to patients without electrolyte disorders, serum potassium will not be significantly affected. 2. Irbesartan does not inhibit angiotensin-converting enzyme (ACE kininase II), under the action of which angiotensin-II can be generated, and bradykinin can also be degraded into inactive metabolites. 3. The activity of irbesartan does not require metabolic activation. There is no evidence of abnormal body or target organ toxicity when using clinically relevant doses. 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. In addition, irbesartan induced proliferation and hypertrophy of the juxtaglomerular apparatus (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 juxtaglomerular apparatus cells was not associated with it.

Irbesartan.

This product is a film-coated tablet, which appears white or off-white after removing the coating.

Treatment of essential hypertension. Treatment of type 2 diabetic nephropathy with hypertension.

Oral. 1. The recommended starting dose is 0.15g, once a day. It can be increased to 0.3g, once a day, depending on the condition. 2. It can be used alone or in combination with other antihypertensive drugs. For severe hypertension and when the blood pressure is still not reduced satisfactorily after the increase in drug dosage, a small dose of diuretics (such as thiazides) or other antihypertensive drugs can be added.

1. The incidence of the adverse reactions listed below adopts the following definition conventions: very common (ge; 1/10); common (ge; 1/100); occasional (ge; 1/1000, 1/100); rare (ge; 1/10000, 1/1000); very rare <1/10000). 2. For hypertension: In placebo-controlled trials in patients with hypertension, the total incidence of adverse events was no different between the irbesartan group (56.2%) and the placebo group (56.5%). The incidence of discontinuation of treatment due to clinical or laboratory adverse events was lower in the irbesartan treatment group (3.3%) than in the placebo group (4.5%). The occurrence of adverse events was not related to dose (within the recommended dose range), gender, age, race or treatment period. In the placebo-controlled trials, 1965 patients received irbesartan, and the following adverse drug reactions were reported: 2.1 Nervous system abnormalities - common: dizziness; infrequent: postural dizziness 2.2 Cardiac abnormalities - infrequent: tachycardia, edema 2.3 Vascular abnormalities - infrequent: flushing 2.4 Respiratory, chest, diaphragmatic abnormalities - infrequent: cough 2.5 Gastrointestinal abnormalities - common: nausea and vomiting; infrequent: diarrhea, dyspepsia/heartburn 2.6 Reproductive system and breast abnormalities - infrequent: sexual dysfunction 2.7 General abnormalities and administration site conditions - common: fatigue; infrequent: chest pain 2.8 Examination: Common: Significant increases in plasma creatine kinase levels were generally observed in the irbesartan treatment group (1.7%). However, none of the increases were related to clinically recognizable skeletal muscle events. 3. For hypertension and type 2 diabetes with renal disease: In addition to the adverse drug reactions mentioned under hypertension, in diabetic hypertensive patients with microalbuminuria and normal renal function, postural dizziness and postural hypotension were reported in 0.5% of patients (i.e., occasionally), which was higher than the placebo group. In diabetic hypertensive patients with chronic renal insufficiency and significant proteinuria, the following adverse reactions were reported in 2% of patients, which was higher than the placebo group. 3.1 Nervous system abnormalities - very common: dizziness: common: postural dizziness 3.2 Vascular abnormalities - common: postural hypotension 3.3 Skeletal muscle, connective tissue and bone abnormalities - common: skeletal muscle pain 3.4 Examination: The incidence of hyperkalemia in diabetic patients treated with irbesartan was higher than that in the placebo group. In diabetic hypertensive patients with microalbuminuria and normal renal function, 29.4% (very common) of patients in the 300 mg group of irbesartan developed hyperkalemia (ge; 5.5mEq/L). The incidence of hyperkalemia in the placebo group was 22%. In diabetic hypertensive patients with chronic renal insufficiency and significant proteinuria, 46.3% (very common) of patients in the 300 mg group of irbesartan developed hyperkalemia (ge; 5.5mEq/L), while the incidence of hyperkalemia in the placebo group was 26.3%. In hypertensive patients with progressive diabetic nephropathy treated with irbesartan, 1.7% of patients (common) developed hemoglobin reduction, but it was not clinically significant. 4. In addition, the following adverse reactions have been reported since irbesartan was launched: 4.1 Immune system abnormalities - rare: Like other angiotensin II receptor antagonists, a small number of cases have high sensitivity reactions such as rash, urticaria, and angioedema. 4.2 Metabolic and Nutritional Disorders - Very rare: Hyperkalemia 4.3 Nervous System Disorders - Very rare: Headache, vertigo 4.4 Ear and Labyrinth Disorders - Very rare: Tinnitus 4.5 Gastrointestinal Disorders - Very rare: Anorexia 4.6 Hepatobiliary Disorders - Very rare: Liver function abnormalities, hepatitis, jaundice 4.7 Skeletal Muscle, Connective Tissue and Bone Disorders - Very rare: Myalgia, arthralgia 4.8 Renal and Urinary Tract Disorders - Very rare: Renal impairment, including isolated cases of renal failure in at-risk patients. (See Precautions) 4.9 Systemic Disorders - Very rare: Asthenia

Those who are allergic to this product are prohibited from using. 4th to 9th month of pregnancy. (See [Precautions]) Lactation period.

Precautions for children: The safety and efficacy of Ambovi in children have not been established. Precautions for pregnancy and lactation: 1. As a safety measure, it is best not to use this product in the first three months of pregnancy; 2. This product is contraindicated for pregnant women from April to September; 3. This product is contraindicated during lactation. Precautions for the elderly: Although 75 mg can be considered as a starting dose for elderly patients over 75 years old, the dose does not usually need to be adjusted for elderly patients.

1. 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-receptor 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 it is not recommended to use them together. 2. 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. In addition, thiazide diuretics can reduce the renal clearance of lithium, and similar effects have rarely been reported with the use of this product. Therefore, combined use is not recommended (4.4). If this product needs to be used in combination with lithium, it is recommended to carefully monitor serum lithium concentrations. 3. Nonsteroidal anti-inflammatory drugs: Like other drugs with antihypertensive effects, the antihypertensive effect of irbesartan will be weakened by nonsteroidal anti-inflammatory drugs. 4. Other information on drug interactions: In healthy male subjects, the pharmacokinetics of digoxin did not change when co-administered with 150 mg of irbesartan. When co-administered with hydrochlorothiazide, the pharmacokinetics of irbesartan were not affected. Irbesartan is mainly metabolized by CYP2C9, and a smaller part is metabolized by glucuronidation. Inhibition of the glucuronyl transferase pathway does not lead to clinically significant interactions. In vitro experiments have observed interactions between irbesartan and warfarin, tolbutamide (CYP2C9 substrate) and nifedipine (CYP2C9 inhibitor). However, in healthy male subjects, no significant pharmacokinetic and pharmacodynamic interactions were observed when irbesartan and warfarin were co-administered. The pharmacokinetics of irbesartan are not affected when co-administered with nifedipine. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetics of irbesartan have not been studied. Based on in vitro data, no interaction occurs with drugs whose metabolism depends on cytochrome P450 isoenzymes CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2D6, CYP2E1 or CYP3A4.

Store in a dry place below 30℃.

75mg

36 months.

Anhui Globe Pharmaceutical Co., Ltd.

• Founded in:

  2000-11-13

• Address:

  No. 3809 Huangshan Avenue, Bengbu City

• Tax NO.:

  91340300723348633W

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  98.5 million yuan

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