| Ottan Omesartan Ester Tablets 20mg*7 Tablets Instruction |
| Please read the instructions carefully and use it under the guidance of the doctor |
| Omesa Tablet tablets |
| AoMeiShaTanZhiPian |
| Olmesartan Medoxomil Tablets |
| Aotan Omeshadatt tablet |
| Omesa Tablet tablets |
| White film-coated tablets, coat them with white coating. |
| This product is suitable for the treatment of hypertension. |
| 20mg |
| Dosage should be individualized.In patients with normal blood volume, the starting dose is usually recommended as a single treatment drug.For patients who still need to further lower blood pressure after 2 weeks of treatment, the dose can be increased to 40 mg.Dosages greater than 40 mg did not show greater antihypertensive effect.When the daily dose is the same, twice daily dosage showed no superiority.Whether you eat or not, Aotan can be taken.Aotan can be used in combination with other diuretics or in combination with other antihypertensive drugs.Children: Olmesartan pharmacokinetics studies have not been conducted in people under 18 years of age.Elderly: Maximum plasma concentrations of olmesartan in young adults and older people (≥Similar in 65 years old).Mild accumulation of olmesartan was observed in older adults who took multiple medications; the area under the curve (AUCss) at the average steady-state medication was 33% higher in older adults, and the corresponding renal clearance rate (CLR) was reduced by 30%.Hepatic insufficiency: AUC0 in patients with moderate liver impairment→∞and maximum blood drug concentration (Cmax) both increased, with AUC increased by about 60%.Renal insufficiency: Patients with severe renal impairment (creatinine clearance less than 20 ml/min) have a surface area under the curve (AUC) after multiple doses of patients with normal renal function.No studies were conducted on patients undergoing hemodialysis. |
| The safety of olmesartan was evaluated in controlled clinical trials in up to 3275 patients, of which about 900 patients received treatment for at least 6 months and more than 525 patients received treatment for 1 year.The results showed that olmesartan was well tolerated and the incidence of adverse events was similar to that of the placebo group.Adverse events are usually mild and transient and independent of dose, age, and racial differences.In placebo-controlled clinical trials, the only adverse event in patients treated with olmesartan was greater than 1% and higher than that in the placebo-treated group was dizziness (3% vs 1%); the incidence was similar to placebo, with adverse events greater than 1% being: back pain, bronchitis, elevated creatine phosphokinase, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, pharyngitis, rhinitis, and sinusitis.The incidence of cough was similar in the placebo group (0.7%) and the olmesartanate group (0.9%) patients.The incidence rate was similar to that of the placebo group. The adverse events with less than 1% and greater than 0.5% were: chest pain, fatigue, pain, peripheral edema, vertigo, abdominal pain, indigestion, gastroenteritis, nausea, tachycardia, hypercholesterolemia, hyperlipidemia, hyperuricemia, joint pain, arthritis, muscle pain, bone pain, rash, and facial edema.It is unclear whether the above adverse events are related to Aotan.Laboratory examination results: In clinically controlled trials, changes in laboratory parameters with clinical significance are less correlated with olmesartan ester. |
| It is prohibited for those who are allergic to the ingredients contained in olmesartan. |
| 1. Renal artery stenosis: It has been reported that ACE inhibitors may increase serum creatinine or blood urea nitrogen (BUN) in patients with unilateral or bilateral renal artery stenosis, but there is no long-term experience in using Aotan in such patients, but similar results may occur.2. Renal impairment: In patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system (such as patients with severe adequacy heart failure), Oliguria and/or progressive azo immunity, renal failure and/or death (rare), treatment with olmesartan methyl 3. Fetal/neonatal morbidity and death: In the case of Class D pregnancy (Stage II and III), drugs that act directly on RAS are associated with fetal and neonatal injury.Once pregnancy is found, Aotan should be stopped as soon as possible.If medication is required, these pregnant women should be informed about the potential harm of the medication to their fetus and conduct a series of ultrasound examinations to evaluate the condition in the amniotic membrane.Infants who have been in contact with angiotensin II receptor antagonists in the uterus should closely monitor their hypotension, oligouria and hyperkalemia, and should be treated appropriately if necessary.4. Insufficient blood volume or low sodium: Patients with hypotension in patients with insufficient blood volume or low sodium (such as those treated with high-dose diuretics), symptomatic hypotension may occur after the first use of Aotan, and the drug must be treated under careful medical supervision.If hypotension occurs, the patient should lie on his back |
| Olmesartan is not metabolized through the liver cytochrome P450 system and has no effect on P450 enzymes.Therefore, no drug interactions associated with inhibition, induction, or metabolism of these enzymes will occur.There was no obvious drug interaction in healthy subjects with digoxin or warfarin, and the combined antacid [Al(OH)3/Mg(OH)2] did not significantly change the bioavailability of olmesartan. |
| Under the catalysis of angiotensin converting enzyme (ACE, kinase II), angiotensin I (ATⅠ) is converted to angiotensin II (ATⅡ).Angiotensin II is the main booster factor of the renin-angiotensin system. Its functions include constricting blood vessels, promoting the synthesis and release of aldosterone, stimulating the heart, and promoting the reabsorption of sodium by the kidneys.Olmesartan is a prodrug that is absorbed and hydrolyzed into olmesartan through the gastrointestinal tract.Olmesartan is a selective angiotensin II type 1 receptor (AT1) antagonist. It blocks the contraction of angiotensin II by selectively blocking the binding of angiotensin II with the vaso smooth muscle AT1 receptor, so its effect is independent of the ATⅡ synthesis pathway.Olmesartan has more than 12,500 times greater affinity with AT1 than AT2.Blocking the renin-angiotensin system (RAS) with ACE inhibitors is a mechanism for many drugs for treating hypertension, but ACE inhibitors also inhibit the degradation of bradykinin, while olmesartan does not inhibit ACE, so it does not affect bradykinin. Whether this difference has clinical relevance is unclear.Blockade of angiotensin II receptor inhibits the negative feedback regulation mechanism of angiotensin II on renin secretion.However, the resulting increased plasma renin activity and increased circulating angiotensin II concentration did not affect the antihypertensive effect of olmesartan. |
| Olmesartan has linear pharmacokinetic properties regardless of single oral administration (maximum dose to 320 mg) or multiple oral administrations (maximum dose to 80 mg/time).Steady state blood drug concentration can be achieved within 3 to 5 days, and there is no accumulation in the plasma once a day.In 7 placebo-controlled clinical trials with doses ranging from 2.5 to 80 mg and a course of 6 to 12 weeks, a total of 2,693 patients with primary hypertension (2,145 patients took olmesartan and 548 patients took placebo), confirming that once-daily olmesartan could reduce diastolic blood pressure, and both blood pressure peak and blood pressure valley values were statistically significant.The antihypertensive effect of olmesartan is correlated with dose.20 mg of olmesartan ester daily can cause the blood pressure gutter value to drop by 10/6mmHg more than placebo; 40 mg of olmesartan ester daily can cause the blood pressure gutter value to drop by 12/7mmHg more than placebo.The antihypertensive effect takes effect within one week and achieves obvious results after two weeks.It can maintain the same antihypertensive effect during treatment for up to 1 year, and there will be no resistance to drugs, and there will be no blood pressure rebound after stopping the drug.Age and gender do not affect the antihypertensive effect of olmesartan.The combination of olmesartan ester and hydrochlorothiazide can enhance the effect of lowering blood pressure.Oral osartan ester tablets can be taken once a day, and the antihypertensive effect can be maintained for 24 hours, and the trough peak ratio of systolic blood pressure and diastolic blood pressure drop is between 60 and 80%. |
| Pregnant and lactating women are disabled. |
| No data on safety and effectiveness of children's medications have been established. |
| In clinical trials, no overall difference in drug efficacy or safety between elderly patients and young patients was observed, and the dosage adjustment is required for elderly patients.However, it cannot be ruled out that some older patients have higher sensitivity. |
| Seal, seal preservation. |
| Aluminum plastic packaging, 7 pieces/box. |
| 36 months |
| State medicine quasi -word H20060371 |
| Three Communist Pharmaceutical (Shanghai) Co., Ltd. |
| No. 500, Kuili Road, Zhangjiang High-tech Park, Pudong New District, Shanghai |
| Some products are replaced frequently. If the goods are not exactly the same as the pictures, please refer to the physical goods received. |
