Olmesartan Medoxomil Tablets

Under the catalysis of angiotensin converting enzyme (ACE, kinase II), angiotensin I (ATⅠ) is converted into angiotensin II (ATⅡ). Angiotensin II is the main pressor 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 renal reabsorption of sodium. Olmesartan medoxomil 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 vasoconstriction effect of angiotensin II by selectively blocking the binding of angiotensin II to the vascular smooth muscle AT1 receptor. Therefore, its action is independent of the ATⅡ synthesis pathway. Olmesartan has an affinity for AT1 that is more than 12,500 times greater than its affinity for AT2. Blocking the renin-angiotensin system (RAS) with ACE inhibitors is a mechanism of action for many drugs used to treat hypertension, but ACE inhibitors also inhibit the degradation of bradykinin, whereas olmesartan medoxomil does not inhibit ACE and therefore does not affect bradykinin. Whether this difference is clinically relevant is unclear. Blockade of angiotensin II receptors inhibits the negative feedback regulation of angiotensin II on renin secretion. However, the resulting increase in plasma renin activity and circulating angiotensin II concentrations does not affect the antihypertensive effect of olmesartan.

Olmesartan Medoxomil. Chemical name: 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazolyl-5-phenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonic acid Molecular weight: C29H30N6O6

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

No data yet

Dosage should be individualized. As monotherapy in normovolemic patients, a starting dose of 20 mg once daily is generally recommended. For patients who require further lowering of blood pressure after 2 weeks of treatment, the dose may be increased to 40 mg. Doses greater than 40 mg have not shown a greater antihypertensive effect. When the daily dose is the same, twice-daily dosing has not shown superiority compared to once-daily dosing. Olmesartan can be taken with or without food. Olmesartan can be used in combination with other diuretics and with other antihypertensive drugs. Children: Olmesartan pharmacokinetics have not been studied in people under 18 years of age. Elderly: Maximum plasma concentrations of olmesartan are similar in young adults and the elderly (≥65 years). Olmesartan has been observed in the elderly with multiple doses.

The safety of Olmesartan Medoxomil was evaluated in controlled clinical trials of up to 3275 patients, of which approximately 900 patients received at least 6 months of treatment and more than 525 patients received 1 year of treatment. The results showed that Olmesartan Medoxomil was well tolerated, with an adverse event rate similar to that of the placebo group. Adverse events were generally mild and transient, and were not related to dose, age, or racial differences. In placebo-controlled clinical trials, the only adverse event with an incidence greater than 1% and higher than that of the placebo-treated group in patients treated with Olmesartan Medoxomil was dizziness (3% vs 1%); the incidence was similar to that of placebo, and the adverse events greater than 1% were: back pain, bronchitis, increased creatine phosphokinase, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, pharyngitis, rhinitis, and sinusitis. The incidence of cough was similar in patients in the placebo group (0.7%) and the Olmesartan Medoxomil group (0.9%). The incidence was similar to that of the placebo group, less than 1% and greater than 0.5% of adverse events included: chest pain, fatigue, pain, peripheral edema, dizziness, abdominal pain, dyspepsia, gastroenteritis, nausea, tachycardia, hypercholesterolemia, hyperlipidemia, hyperuricemia, joint pain, arthritis, muscle pain, bone pain, rash and facial edema. It is not clear whether the above adverse events are related to Olmesartan. Laboratory test results: In clinical controlled trials, changes in clinically significant laboratory parameters were less associated with Olmesartan Medoxomil. Hemoglobin and hematocrit:

Olmesartan is contraindicated for use by those who are allergic to the ingredients contained in it.

Precautions for children: Safety and efficacy data for children have not been established. Precautions for pregnancy and lactation: Pregnant and lactating women are prohibited. Precautions for the elderly: In clinical trials, no overall difference in the efficacy or safety of Optan was observed between elderly and young patients. Elderly patients do not need to adjust the dose of Optan. However, the possibility that some older individual patients are more sensitive cannot be ruled out.

Olmesartan medoxomil is not metabolized by the hepatic cytochrome P450 system and has no effect on P450 enzymes. Therefore, drug interactions related to inhibition, induction or metabolism of these enzymes will not occur. There were no significant drug interactions with the concomitant use of digoxin or warfarin in healthy subjects, and the concomitant use of antacids [Al(OH)3/Mg(OH)2] did not significantly change the bioavailability of Olmesartan medoxomil.

seal.

20mg

24 months

Fujian Tianquan Pharmaceutical Co., Ltd.

• Founded in:

  1996-09-03

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  No. 28, Lianzhuang North Road, Xinluo District, Longyan City, Fujian Province

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  91350800157879471K

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