Skin and Appendages: alopecia, pruritus, urticaria. Drug class: Angiotensin II inhibitors with thiazides. Last updated on Dec 1, 2022. The active ingredients of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets target three separate mechanisms involved in blood pressure regulation. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. An AT2 receptor is found also in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Pregnancy: Advise female patients of childbearing age about the consequences of exposure to Olmesartan Medoxomil and Hydrochlorothiazide tablets during pregnancy. Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The antihypertensive efficacy of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets was studied in a double-blind, active-controlled study in hypertensive patients. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics. There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18). Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose [see Clinical Pharmacology (12.3)]. Lesser effects, 4% and 15% reduction in C max and AUC respectively, were observed when olmesartan medoxomil was administered 4 hours prior to colesevelam hydrochloride [see Drug Interactions ( 7.5)]. Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. They are available in bottles of 30 (NDC 0093-5006-56). Hydrochlorothiazide Common side effects of Benicar HCT include nausea, hyperuricemia, dizziness, upper respiratory tract infection, chest pain, back pain, swelling in extremities, spinning sensation ( vertigo ), abdominal pain, indigestion, upset stomach, diarrhea, SGOT increased, GGT increased, SGPT increased, hyperlipemia, creatine phosphokinase increased, high b. Intestinal biopsies of patients often demonstrated villous atrophy. Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of olmesartan or thiazide diuretics. Hypersensitivity Reactions [see Warnings and Precautions ( 5.4)] Initiate treatment with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets under close medical supervision. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. No teratogenic effects were observed when 1.6:1 combinations of Olmesartan Medoxomil and Hydrochlorothiazide were administered to pregnant mice at oral doses up to 1625 mg/kg/day (122 times the maximum recommended human dose [MRHD] on a mg/m 2 basis) or pregnant rats at oral doses up to 1625 mg/kg/day (280 times the MRHD on a mg/m2 basis). Benicar HCT may cause serious side effects including: muscle pain, tenderness or weakness, fever, unusual tiredness, dark colored urine, eye pain, vision problems, lightheadedness, yellowing of the skin or eyes (jaundice), easy bruising, unusual bleeding, little or no urination, painful or difficult urination, In a controlled clinical trial, 123 hypertensive patients treated with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets were 65 years of age and 18 patients were 75 years of age. Special Senses: transient blurred vision, xanthopsia. The pharmacokinetics of hydrochlorothiazide is dose proportional in the range of 12.5 to 75 mg. Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours. Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Pregnancy Category D Olmesartan medoxomil Brands listed are the trademarks of their respective owners. Introduction Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. Many patients will require more than one drug to achieve blood pressure goals. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Maalox (antacid): Coadministration of the antacid Maalox with a single dose of amlodipine had no significant effect on the pharmacokinetics of amlodipine. The pharmacokinetics of olmesartan in patients undergoing hemodialysis has not been studied. Its empirical formula is C 7H 8ClN 3O 4S 2 and its structural formula is: Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see Clinical Pharmacology (12.3)]. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Hydrochlorothiazide. Olmesartan Medoxomil and Hydrochlorothiazide were tested individually and in combination ratios of 40:12.5, 20:12.5 and 10:12.5, for clastogenic activity in the in vitro Chinese hamster lung (CHL) chromosomal aberration assay. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Olmesartan medoxomil, USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. Smoothie. These effects are usually reversible. The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. As a result, olmesartan relaxes the blood vessels. Acute myopia and secondary angle-closure glaucoma: Advise patients to discontinue Olmesartan Medoxomil and Hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.6)]. Bile acid sequestering agent colesevelam The order of the blood pressure lowering effects among the different dose strengths of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is expected to be 20 mg/5 mg/12.5 mg < 40 mg/5 mg/12.5 mg < (40 mg/10 mg/12.5 mg 40 mg/5 mg/25 mg) < 40 mg/10 mg/25 mg. This content does not have an Arabic version. Disease-Associated Maternal and/or Embryo/Fetal Risk. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Discuss treatment options with women planning to become pregnant. Use with Colesevelam Hydrochloride: Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Food does not affect the bioavailability of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Available for Android and iOS devices. Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with severely impaired hepatic function, titrate slowly when administering to patients with severe hepatic impairment. (Calculations based on a 60 kg patient.). Amlodipine. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment. OlmetecPlus (all strengths) should not be used in patients with severe hepatic impairment (see sections 4.3 and 5.2), cholestasis and biliary obstruction (see section 4.3). Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Normotensive patients experienced no clinically significant change in blood pressures (+1/-2 mmHg). Olmesartan medoxomil. Olmesartan and hydrochlorothiazide are substantially excreted by the kidney, and the risk of toxic reactions to Olmesartan Medoxomil and Hydrochlorothiazide tablets may be greater in patients with impaired renal function. Monitor lithium levels in patients receiving olmesartan medoxomil, amlodipine, and hydrochlorothiazide and lithium. Hydrochlorothiazide Hydrochlorothiazide Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening. Metabolic: glycosuria, hyperuricemia After oral administration of hydrochlorothiazide, diuresis begins within 2 hours, peaks in about 4 hours, and lasts about 6 to 12 hours. The recommended initial dose of amlodipine in patients with severe hepatic impairment is 2.5 mg, a dose not available with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets [see Warnings and Precautions (5.5)]. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amlodipine. cyclophosphamide, methotrexate): Concomitant use of thiazide diuretics may reduce renal excretion of cytotoxic agents and enhance their myelosuppressive effects. The safety and effectiveness of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets in pediatric patients have not been established. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Following the rapid and complete conversion of olmesartan medoxomil to olmesartan during absorption, there is virtually no further metabolism of olmesartan. Olmesartan Medoxomil and Hydrochlorothiazide tablets is a combination of an angiotensin II receptor antagonist (AT 1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Hydrochlorothiazide is a thiazide diuretic. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Olmesartan and hydrochlorothiazide combination is used alone or together with other medicines to treat high blood pressure (hypertension). Absolute bioavailability is estimated between 64% and 90%. Olmesartan: Olmesartan does not undergo further metabolism. Hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk. The antihypertensive effect of olmesartan medoxomil was similar in men and women and in patients older and younger than 65 years. Limited data are available related to overdosage of olmesartan medoxomil in humans. Olmesartan/hydrochlorothiazide, sold under the brand name Benicar HCT among others, is a fixed-dose combination medication used to treat high blood pressure. Banning abortions disproportionately impacts poor women and women of color. Non-melanoma Skin Cancer. Its empirical formula is C 29H 30N 6O 6 and its structural formula is: Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. Olmesartan medoxomil doses greater than 40 mg had little additional effect. For the rat, the highest dose was, on a mg/m2 basis, about two times the MRHD (calculations based on a 60 kg patient). Positive test results were obtained in the in vitro CHO Sister Chromatid Exchange (clastogenicity) assay, the Mouse Lymphoma Cell (mutagenicity) assay and the Aspergillus nidulans non-disjunction assay. Tell patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. OM is a prodrug that is hydrolyzed in the gastrointestinal tract to form its active metabolite, olmesartan.17 Once absorbed, the metabolite does not undergo further changes, and 35%-50% of the absorbed dose is excreted in the urine.17 Peak plasma concentrations are achieved in 1-2 hours, followed by an elimination half-life of 13 hours.17 . Pregnancy Category D However, litter size was significantly decreased (by about 50%), and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. After oral administration of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets in normal healthy adults, peak plasma concentrations of olmesartan, amlodipine, and hydrochlorothiazide are reached in about 1.5 to 3 hours, 6 to 8 hours, and 1.5 to 2 hours, respectively. The volume of distribution of olmesartan is approximately 17 L. Olmesartan is highly bound to plasma proteins (99%) and does not penetrate red blood cells. Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. Fetal testing may be appropriate, based on the week of pregnancy. Thiazides may precipitate azotemia in patients with renal disease. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. However, these studies have been conducted for Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide alone, and olmesartan medoxomil and hydrochlorothiazide together. Olmesartan medoxomil. Hydrochlorothiazide. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. CYP3A Inducers: No information is available on the quantitative effects of CYP3A inducers on amlodipine. The following adverse reactions have been reported in postmarketing experience: Body as a Whole: asthenia, angioedema, anaphylactic reactions, peripheral edema The rate and extent of absorption of olmesartan medoxomil, amlodipine, and hydrochlorothiazide from olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are the same as when administered as individual dosage forms. After repeated dosing, the AUC was approximately tripled in patients with severe renal impairment (creatinine clearance <20 mL/min). There are no studies of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets in patients with renal impairment. This content does not have an English version. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers. Amlodipine and hydrochlorothiazide are present in human milk. These trials included one placebo- controlled factorial trial in mild-moderate hypertensive patients (n=502) with combinations of olmesartan medoxomil (10 mg, 20 mg, 40 mg, or placebo) and hydrochlorothiazide (12.5 mg, 25 mg, or placebo). Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Respiratory System: coughing Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of Olmesartan Medoxomil and Hydrochlorothiazide tablets. Amlodipine. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Hydrochlorothiazide, USP is slightly soluble in water, freely soluble in hydroxide solution, in n-butylamine and in dimethylformamide (DMF), sparingly soluble in methanol and insoluble in ether, in chloroform and in dilute mineral acids. It is taken by mouth . Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Olmesartan Medoxomil and Hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. You may opt-out of email communications at any time by clicking on Olmesartan medoxomil tested negative in vivo for mutations in the MutaMouse intestine and kidney and for clastogenicity in mouse bone marrow (micronucleus test) at oral doses of up to 2000 mg/kg (olmesartan not tested). Central and Peripheral Nervous System: vertigo Product Information Customer Reviews Product Summary This product requires a valid prescription for shipment, please note that HealthWarehouse.com may not accept prescriptions faxed or emailed by patients. When pregnancy is detected, discontinue Olmesartan Medoxomil and Hydrochlorothiazide tablets as soon as possible. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics. CYP3A Inhibitors: Coadministration of amlodipine with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. other information we have about you. Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. Read our disclaimer for details. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If syncope occurs advise patients, to contact their healthcare provider. Dose can be titrated up to 40 /25 mg if necessary. (, Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see Clinical Considerations]. No dose adjustment is required in patients with mild (CrCl 60-90 mL/min) or moderate (CrCl 30-60) renal impairment. This copyrighted material has. The dialyzability of olmesartan is unknown. There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18). cyclophosphamide, methotrexate): Olmesartan Medoxomil and Hydrochlorothiazide, Table 2: Placebo-Adjusted Reductions in Sitting Systolic/Diastolic Blood Pressure (mmHg), Olmesartan Medoxomil and Hydrochlorothiazide tablet. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets also contain olmesartan, a drug that affects the RAS. Concomitant administration of 40 mg olmesartan medoxomil and 3750 mg colesevelam hydrochloride in healthy subjects resulted in 28% reduction in C max and 39% reduction in AUC of olmesartan. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. Female patients had approximately 20% smaller clearances of hydrochlorothiazide than male patients. The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Approximately 35% to 50% of the absorbed dose is recovered in urine while the remainder is eliminated in feces via the bile. Hydrochlorothiazide: The estimated absolute bioavailability of hydrochlorothiazide after oral administration is about 70%. No significant drug interactions were reported in studies in which olmesartan medoxomil was coadministered with warfarin in healthy volunteers. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations (8.1)]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Olmesartan Medoxomil and Hydrochlorothiazide tablets are supplied as film-coated, non-scored tablets: Olmesartan Medoxomil and Hydrochlorothiazide tablets are contraindicated: 40 mg/5 mg/12.5 mg - yellow to dark yellow, film-coated, round biconvex tablet, debossed with "TEVA" on one side and "5006" on the other side of the tablet and contains 40 mg of olmesartan medoxomil, 6.93 mg amlodipine besylate equivalent to 5 mg of amlodipine base, and 12.5 mg hydrochlorothiazide. Olmesartan Medoxomil-Hctz is a Angiotensin II Receptor Antag & Thiazide/Thiazide-Like class drug which is manufactured by Aurobindo Pharma. amlodipine, lisinopril, metoprolol, losartan, furosemide, hydrochlorothiazide. Cumulative effects of the drug may develop in patients with impaired renal function. 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