It is taken by mouth. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue Olmesartan Medoxomil and Hydrochlorothiazide, taking into account the importance of the drug to the mother.Neonates with a history of in utero exposure to Olmesartan Medoxomil and Hydrochlorothiazide:Safety and effectiveness of Olmesartan Medoxomil and Hydrochlorothiazide in pediatric patients have not been established.Clinical studies of Olmesartan Medoxomil and Hydrochlorothiazide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist.. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1 hydroxy-1- methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 … There is no experience of the administration of olmesartan medoxomil in patients with a recent kidney transplant or in patients with end-stage renal impairment (i.e. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. It is rapidly converted to the pharmacologically active metabolite, olmesartan, by esterases in the gut mucosa and in portal blood during absorption from the gastrointestinal tract.No intact olmesartan medoxomil or intact side chain medoxomil moiety have been detected in plasma or excreta. Distribution. The most likely effect of overdosage is hypotension. In patients whose renal function may depend upon the activity of the renin-angiotensin- aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death. Olmesartan medoxomil is a potent, orally active, selective angiotensin II receptor (type AT 1) antagonist. In general, avoid combined use of RAS inhibitors. (See also 5.3 “Preclinical Safety Data”. Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.Olmesartan medoxomil should not be used in children below 1 years of age because of safety concerns and lack of data in this age group.In order to assist compliance, it is recommended that Olmetec tablets be taken at about the same time each day, with or without food, for example at breakfast time. Many patients will require more than one drug to achieve blood pressure goals. There are no controlled trials demonstrating risk reduction with Olmesartan Medoxomil and Hydrochlorothiazide.Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Absorption . 8.4 Absorption, Distribution and Excretion. The study was terminated early because of an increased risk of adverse outcomes. Drugs that inhibit the RAS can cause hyperkalemia. This should be borne in mind when considering changing the dose regimen for any patient.No adjustment of dosage is generally required in elderly people (see below for dose recommendations in patients with renal impairment). Consider discontinuation of Olmesartan Medoxomil and Hydrochlorothiazide in cases where no other etiology is identified.The following adverse reactions with Olmesartan Medoxomil and Hydrochlorothiazide are described elsewhere: • Hypotension in Volume- or Salt-Depleted Patients Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.The rate of withdrawals for adverse events in all trials of hypertensive patients was 2.0% (25/1243) on olmesartan medoxomil plus hydrochlorothiazide and 2.0% (7/342) on placebo.In a placebo-controlled, factorial clinical trial of olmesartan medoxomil (2.5 mg to 40 mg) and hydrochlorothiazide (12.5 mg to 25 mg), the following adverse reactions reported in Table 1 occurred in >2% of patients, and more often on the Olmesartan Medoxomil and Hydrochlorothiazide combination than on placebo.Other adverse reactions that have been reported with an incidence of greater than 1.0%, whether or not attributed to treatment, in the more than 1200 hypertensive patients treated with Olmesartan Medoxomil and Hydrochlorothiazide in controlled or open-label trials are listed below.Facial edema was reported in 2/1243 patients receiving Olmesartan Medoxomil and Hydrochlorothiazide.
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