Benicar is used for treating high blood pressure, alone or with other medicines. It may also be used for other conditions.
Other names for this medication:
Also known as: Olmesartan.
Benicar is an angiotensin II receptor antagonist. It works by inhibiting the action of a chemical transmitter (angiotensin II) and allowing the blood vessels to dilate (widen) and the kidneys to eliminate extra sodium and fluids. These actions combine to help lower blood pressure.
Generic name of Benicar is Olmesartan.
Benicar is also known as Olmesartan, Olmetec, Olmezest, Olmecip.
Brand name of Benicar is Benicar.
Take Benicar orally with or without food.
If you want to achieve most effective results do not stop taking Benicar suddenly.
If you overdose Benicar and you don't feel good you should visit your doctor or health care provider immediately.
Store your medicine at room temperature between 15 and 30 degrees C (59 and 86 degrees F) away from moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children and in a container that small children cannot open.
The most common side effects associated with Benicar are:
Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.
Do not take Benicar if you are allergic to Benicar components.
Do not take Benicar if you're pregnant or you plan to have a baby, or you are a nursing mother.
Avoid machine driving.
Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment.
Be careful if you use salt substitute or a product that has potassium in it.
Do not stop taking Benicar suddenly.
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Patient demographics were similar but mean baseline SeBP was higher in the OM study (163.8/101.6 mmHg) than in the VAL studies (152.8/99.3 and 156.7/99.1 mmHg), possibly suggesting that the OM study included a more difficult-to-treat patient population. AML/ARB combinations consistently produced greater mean SeBP reductions than monotherapy. Least squares (LS) mean SeDBP reductions were 19.4 mmHg (AML/OM 10/40 mg; placebo-corrected: 15.9 mmHg) and 18.6 mmHg (AML/VAL 10/320 mg; placebo-corrected: 9.8 mmHg). LS mean SeSBP reductions were 28.5 mmHg (AML/OM 10/40 mg; placebo-corrected: 25.7 mmHg) and 28.4 mmHg (AML/VAL 10/320 mg; placebo-corrected: 15.5 mmHg).
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The results indicated that the initial crystalline state is preserved following particle size reduction and that the saturation solubility, dissolution velocity and diffusion rate of the drug from the nanosuspension is significantly higher than that of the plain drug suspension as well as from the marketed tablet formulation.
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In these adult patients with moderate to severe hypertension, triple combination treatment with OM 40 mg + AML 10 mg + HCTZ 25 mg was associated with significant BP reductions compared with dual combinations of the individual components. All treatments were generally well tolerated. ClinicalTrials. gov identifier: NCT00649389.
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Treatment with CS866 and amlodipine induced a significant reduction of blood pressure in 2K1C-RVH rats. In rats treated with pH 3.5 dialysis solution, necropsy findings revealed features identical to those of encapsulating peritoneal sclerosis (EPS). The typical appearance was multiple surfaces covered with granulation tissue or fibrosic tissue or both. Multiple adhesions were present. Microscopic findings revealed that acidic dialysis solution induced peritoneal fibrosis and loss of mesothelium. Treatment with CS866 prevented the progression of peritoneal fibrosis and adhesions. However amlodipine did not improve the progression of peritoneal fibrosis and peritoneal adhesions. In CS866-treated rats, no signs of EPS were present.
The authors studied the combination of hydrochlorothiazide (HCTZ) 50 mg/d plus olmesartan medoxomil (OM) 40 mg/d in stage 2 systolic hypertension during an extension phase of an open-label 12-week dose titration study. Subjects whose blood pressure remained above 120/80 mm Hg (n=105) on OM 40/HCTZ 25 mg/d subsequently received OM 40/HCTZ 50 mg/d for 4 weeks. Increasing HCTZ from 25 mg/d to 50 mg/d decreased systolic blood pressure by 3.6 mm Hg, increased BP control rates (<140/90 mm Hg) from 70.4% to 77.5%, and increased BP normalization rates (<120/80 mm Hg) from 15.4% to 27.8%. The combination was well tolerated. Compared with OM 40 mg/d monotherapy, neither dose of HCTZ affected serum potassium, but both increased serum glucose by about 5%. There was a dose-dependent increase in uric acid but no acute gout attacks. OM 40/HCTZ 50 mg/d is an effective strategy for managing stage 2 systolic hypertension.
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Carotid IMT and BP decreased similarly with olmesartan and atenolol, but only olmesartan reduced the volume of larger atherosclerotic plaques.
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The optimized formulation comprised glyceryl monostearate, soya phosphatidylcholine and Tween 80 as lipid, co-emulsifier and surfactant, respectively, with an average particle size of 100 nm, PDI 0.291, zeta potential of -23.4 mV and 78% entrapment efficiency. Pharmacokinetic evaluation in male Sprague Dawley rats revealed 2.32-fold enhancement in relative bioavailability of drug from SLN when compared to that of OLM plain drug on oral administration.
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Vascular injury was induced by polyethylene cuff-placement around the mouse femoral artery. Some mice were treated with AT1 receptor blocker, olmesartan, at the dose of 3 mg.kg(-1).day(-1) with an osmotic minipump. Neointima formation and the proliferation of vascular smooth muscle cells (VSMCs) were measured by morphometric analysis and bromodeoxyuridine (BrdU) incorporation. MCP-1 and TNF-alpha expression was detected by Western blot and immunohistochemical staining.
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We have evaluated the effects of different doses of an angiotensin-converting enzyme (ACE) inhibitor, enalapril (ENA) and of an angiotensin II type 1 receptor blocker olmesartan (OLM), on extracellular matrix of the heart, kidney, aorta and mesenteric artery of spontaneously hypertensive rats (SHR). Forty SHR and eight Wistar-Kyoto controls (WKY) were included in the study. Eight SHR were treated with high-dose OLM 15 mg/kg per day, eight with high-dose ENA 25 mg/kg per day, eight with low-dose OLM 1 mg/kg per day and eight with low-dose ENA (2 mg/kg per day). Eight SHR and eight WKY were kept untreated as controls. Treatment was from age 4 to 12 weeks. Systolic blood pressure (SBP) was measured non-invasively every week. The left ventricular weight to body weight (RLVM) was measured, and the cardiac, aortic and glomerular interstitial collagen content was evaluated using Sirius red staining and image analysis. Mesenteric small arteries were dissected and mounted on a micromyograph, and the media:lumen ratio (M/L) was calculated. Collagen subtypes were evaluated by polarized light microscopy. The SHR treated with high-dose OLM or ENA showed a normalization of SBP. The RLVM was significantly increased in untreated SHR compared with untreated WKY, whereas significantly lower values were observed in the groups of SHR treated with high-dose OLM or ENA. A significant increase in cardiac and glomerular collagen content was observed in untreated SHR. Both high- or low-dose OLM and ENA normalized collagen content in the heart and the kidney. Both high-dose OLM and high-dose ENA normalized M/L ratio; however, OLM proved to be more effective than ENA in normalizing collagen pattern. In fact, aortic collagen content was normalized by both high-dose and low-dose OLM, but only by high-dose ENA. In conclusion, both OLM and ENA were significantly and equally effective in the prevention of cardiac and renal damage in SHR, whereas OLM was more effective than ENA in terms of effects on vascular extracellular matrix.
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To evaluate the efficacy of angiotensin II receptor blockers (ARBs) for use in the treatment of diabetic nephropathy, we examined the effects of olmesartan medoxomil (olmesartan), an angiotensin II type 1 (AT1) specific ARB, on the progression of nephropathy in Zucker diabetic fatty (ZDF) rats, an animal model of type 2 diabetes. We used 2 doses of olmesartan, a sub-antihypertensive dose and an antihypertensive dose, to specifically examine whether the drug exerts beneficial effects on the kidney without lowering blood pressure. Olmesartan mixed in the diet at a concentration of 0.001% (approximately 0.6 mg/kg/day) or 0.01% (approximately 6 mg/kg/day) was administered for 19 weeks starting from 12 weeks of age, when the animals developed microalbuminuria. Lean non-diabetic rats served as controls. ZDF rats had hyperglycemia, hyperinsulinemia, and moderate hypertension as compared to lean control rats. Plasma glucose and insulin concentrations were not affected by olmesartan, and blood pressure was lowered only by the high dose of olmesartan. Progressive proteinuria in ZDF rats was greatly (about 70%) suppressed by the high dose of olmesartan and moderately (about 30%) suppressed by the low dose that did not significantly lower blood pressure. ZDF rats exhibited hyperlipidemia and hypoalbuminemia, both of which were substantially corrected by treatment with olmesartan. The histological evidence of glomerular and tubular damage in the ZDF rats was also reduced by the drug. These results indicate that AT1 receptor blockade with olmesartan retards the progression of nephropathy associated with type 2 diabetes without affecting glucose metabolism, and that this renal protective effect is at least partly independent of the antihypertensive effect of the drug.
The present study was undertaken to elucidate the effect of the ACE inhibitor and the angiotensin II type 1 (AT1) receptor antagonist in combination on neointimal hyperplasia after balloon injury.
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The population pharmacokinetic analysis of olmesartan showed that: (i) severe renal impairment (serum creatinine >265 micromol/L [approximately 3 mg/dL]) could cause a clearance decrease of > or =30%; (ii) older age, lower bodyweight and being female were determinants of lower clearance but their effects on olmesartan clearance were within 20%; (iii) no statistically significant difference in clearance was found between Westerners and Japanese.
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Olmesartan medoxomil was prepared from ethyl 4-(1-hydroxy-1-methylethyl)-2-propylimidazole-5-carboxylate via hydrolysis and lactonization to afford 4,4- dimethyl-2-propyl-4,6-dihydrofuro [3,4-d]-1H-imidazole-6-one which was condensed with 2-(triphenylmethyl)-5-[4'-(bromomethylbiphenyl)-2-yl] tetrazole, followed by esterification with 4-chloromethyl-5-methyl-1,3-dioxol-2-one, and deprotection. The chemical structure of the major impurity in condensation reaction is the regio-isomer in the imidazole moiety, and confirmed by single crystal X-ray diffraction. The corresponding regio-isomer of olmesartan medoxomil was synthesized from the impurity by similar method. Optimization of the condensation conditions reduced the impurity to a negligible quantity.
After single and multiple doses of olmesartan medoxomil/amlodipine 20 mg/5 mg FDC tablets the pharmacokinetic profiles of olmesartan or amlodipine were comparable to those reported for monotherapy with olmesartan medoxomil or amlodipine, except that the elimination half-life of olmesartan was longer because of the longer time course over which pharmacokinetic blood sampling was carried out in this study. The response profiles of BP indicate a concentration-dependent antihypertensive effect of the olmesartan medoxomil/amlodipine 20 mg/5 mg FDC tablet after a single dose and stabilization of such effects after multiple doses.
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An AML/OM ± HCTZ treatment regimen provided effective and safe BP control in obese patients with hypertension uncontrolled on monotherapy.
In this study, OM/AML/HCTZ was an effective treatment option in Hispanic/ Latino patients with hypertension.
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This study investigated the relative bioavailability and fasting pharmacokinetic properties of olmesartan after single doses of a 20-mg test tablet, a 20-mg test capsule, and a commercially available 20-mg reference tablet in healthy Chinese male volunteers. The study was conducted to satisfy Chinese State Food and Drug Administration regulatory requirements for approval of a generic formulation of olmesartan medoxomil.
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12-week, multicenter, double-blind, randomized, parallel-group study.
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After a 2-week placebo washout, 351 elderly hypertensive patients aged 65-89 years (office sitting diastolic blood pressure, DBP, 90-109 mmHg and office sitting systolic blood pressure, SBP, 140-179 mmHg) were randomized double-blind to 12-week treatment with O 10 mg or R 2.5 mg once daily. After the first 2 and 6 weeks, doses could be doubled in non-normalized (blood pressure <140/90 mmHg for non-diabetic and <130/80 mmHg for diabetic) subjects, up to 40 mg for O and 10 mg for R. Office blood pressures were assessed at randomization, after 2, 6 and 12 weeks of treatment; 24-h ambulatory blood pressure (ABP) was recorded at randomization and after 12 weeks.
Results from two long-term studies (ROADMAP and ORIENT) indicated a numerical imbalance in the number of cardiovascular deaths between the olmesartan medoxomil (OM) and placebo groups.
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In 578 patients who received olmesartan/amlodipine 40 mg/5 mg or 40 mg/10 mg and completed the study, the mean SeSBP reduction from baseline was 31.18 mmHg, and the proportions of patients with SeSBP reductions =15 mmHg, >15 to =30 mmHg, >30 to =45 mmHg and >45 mmHg were 12.8%, 36.0%, 35.3% and 15.9%, respectively. In patients who received olmesartan/amlodipine 40 mg/10 mg, the proportion of patients in the =15 mmHg group was smaller (12.2%) and in the >45 mmHg group was larger (21.6%). Moreover, patients in the >45 mmHg category showed the greatest reduction in SeSBP from baseline (53.5 mmHg for olmesartan/amlodipine 40 mg/10 mg recipients). Categorical analysis of patients treated with olmesartan/amlodipine 40 mg/10 mg in a separate, factorial study showed similar results: SeSBP reductions of =15 mmHg; >15 to =30 mmHg; >30 to =45 mmHg and >45 mmHg were seen in 17%, 34%, 36% and 14% of patients, respectively.
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Plasma concentrations of olmesartan medoxomil and hydrochlorothiazide were measured in 41 healthy volunteers enrolled in our bioequivalence study by LC-MS/MS following oral administration of an olmesartan medoxomil/hydrochlorothiazide (20/12.5 mg) fixed-dose combination tablet. This data and covariates were subjected to nonlinear mixed-effect modeling analysis using the NONMEM software. Evaluation featured a visual predicted check and bootstrapping.
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Treatment with a combination based upon olmesartan 40 mg plus amlodipine 5 or 10 mg effectively reduces elevated SeSBP, particularly in patients with high levels of SeSBP.
The objectives of this study were to identify the factors influencing antihypertensive response to the angiotensin receptor blocker, olmesartan medoxomil, or the calcium channel blocker, azelnidipine, and to discuss the possibility of utilizing them as predictors for drug selection prior to therapy. A two-way crossover study of olmesartan medoxomil and azelnidipine was conducted in 29 patients with mild to moderate essential hypertension. The 24-hour ambulatory blood pressure measurements (ABPM) and plasma drug concentrations were obtained on the first and at the end of each treatment period, and were analyzed using population pharmacokinetic/pharmacodynamic (PK/PD) modeling approach. The population PK/PD models considering circadian variations in baseline blood pressure well described the observed plasma drug concentrations and 24-hour ABPM profiles. Pre-treatment plasma renin activity (PRA) was identified as a significant covariate on the maximum drug effect (E(max)) of olmesartan, whereas azelnidpine E(max) was independent of patient background characteristics investigated. No patient was found to have a high E(max) to one agent who also had a high E(max) to the other. In conclusion, the effects of olmesartan medoxomil and azelnidipine were modestly correlated with pharmacokinetic profiles, and the pre-treatment PRA level could be a useful determinant of responsiveness in selecting olmesartan medoxomil and azelnidipine.
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After a placebo run-in period, 192 patients received OM 20 mg/day for 3 weeks. If blood pressure (BP) remained > or =120/70 mm Hg, patients were up-titrated to OM 40 mg/day for 3 weeks and subsequently (in 3-week intervals) to OM/HCTZ 40/12.5 mg/day, then OM/HCTZ 40/25 mg/day as necessary. Blood pressure was evaluated by mean 24-hour ambulatory BP monitoring (ABPM). The primary efficacy endpoint was the change in mean 24-hour ambulatory systolic BP (SBP) from baseline to Week 12. Secondary endpoints included: change in ambulatory diastolic BP (DBP) from baseline to Week 12; changes in ambulatory SBP and DBP during daytime, nighttime, and the last 2, 4, and 6 hours of the dosing interval; and achievement of prespecified ambulatory BP targets. CLINICAL TRIALS REGISTRY NUMBER: NCT00403481.
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This prespecified subgroup analysis of the TRINITY study evaluated the efficacy and safety of olmesartan medoxomil (OM) 40 mg, amlodipine besylate (AML) 10 mg, and hydrochlorothiazide (HCTZ) 25 mg triple-combination treatment compared with the component dual-combination treatments in Black and non-Black study participants.
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