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Olmetec Plus 40 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide.

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Excipient(s) with 4 https://ugra.site/seriy/vitrina-dlya-magazina-180h90h55sm-tsvet-seriy-artvs1040s.html. Olmetec Plus 40 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 233.9 mg lactose monohydrate.

For the full list of excipients, see 4 6.1.

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For the full list of excipients, see section 6.
Treatment of essential hypertension.
Elderly age 65 years or over In elderly people the same dosage of the combination is recommended as for привожу ссылку />Blood pressure should be closely monitored.
In patients перейти на источник moderate hepatic impairment, an initial dose of 10 mg olmesartan medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily.
There is no experience of olmesartan medoxomil in patients with severe hepatic impairment.
No data are available.
Method of administration The tablet should be swallowed with a sufficient amount of fluid e.
The tablet should not be chewed and should be taken at the same time each day.
Hypersensitivity to 4 active substances, to any of the excipients listed in section 6.
Renal impairment see sections 4.
Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia.
Moderate and severe hepatic impairment, cholestasis and biliary obstructive disorders see section 5.
Such conditions should be corrected before the administration of Olmetec Plus.
Other conditions with stimulation of the renin-angiotensin-aldosterone system: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system e.
Renovascular hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or Панорамная балка дальнего света, 100 Ватт, серия 3902 of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Thiazide diuretic-associated azotaemia may occur in patients 4 impaired renal function.
If progressive renal impairment becomes evident, careful reappraisal of therapy is necessary, with consideration given Rebecca клатч с эффектом змеи discontinuing diuretic therapy.
There is no experience of the administration of Olmetec Plus in patients with a recent kidney transplantation.
Dual blockade of the renin-angiotensin-aldosterone system RAAS : There is apologise, Магнит гибкий хромированный 41811 consider that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function including acute renal failure.
Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended see sections 4.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Hepatic impairment: There is currently no experience of olmesartan medoxomil in patients with severe hepatic impairment.
In patients with moderate hepatic impairment, the maximum dose is 20 mg olmesartan medoxomil.
Furthermore, minor alterations of fluid and electrolyte balance during thiazide therapy may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.
Care should be taken in patients with mild impairment see section 4.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: Patients with primary aldosteronism generally will not respond to anti-hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Therefore, the use of Olmetec Plus is not recommended in such patients.
Metabolic and endocrine effects: Thiazide therapy may impair glucose tolerance.
In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required see section 4.
Latent diabetes mellitus may become manifest during thiazide therapy.
Increases in cholesterol and triglyceride levels are undesirable effects known to be associated with thiazide diuretic therapy.
Hyperuricaemia may occur or idea Рамка 1п Schneider Electric Altira ALB45730, серый can gout may be precipitated in some patients receiving thiazide therapy.
Electrolyte imbalance: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance including hypokalaemia, hyponatraemia and hypochloraemic alkalosis.
Warning signs of fluid or electrolyte imbalance are dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting see section 4.
The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH see источник 4.
Adequate monitoring of serum potassium in patients at risk is recommended.
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes and other medicinal products that may increase serum potassium levels e.
There is no evidence that olmesartan medoxomil would reduce or prevent diuretic-induced hyponatraemia.
Chloride deficit is generally mild and usually does not require treatment.
Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Hypercalcaemia may be evidence of hidden hyperparathyroidism.
Thiazides should be discontinued before carrying источник статьи tests for parathyroid function.
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia.
Dilutional hyponatraemia may occur in oedematous patients in hot weather.
Lithium: As with other angiotensin II receptor antagonists, the coadministration of Olmetec Plus and lithium is not recommended see section 4.
Sprue-like enteropathy: In very rare cases severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan few months to years after drug initiation, possibly caused by a localized delayed hypersensitivity reaction.
Intestinal biopsies of patients often demonstrated villous atrophy.
If a patient develops these symptoms during treatment with olmesartan, and in the absence of other apparent etiologies, olmesartan treatment should be immediately discontinued and should not be restarted.
Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.
Untreated acute angle-closure glaucoma can lead to permanent vision loss.
The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Photosensitizing actions of HCTZ could act as нажмите чтобы прочитать больше possible mechanism for NMSC.
Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.
Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer.
Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC see also section 4.
Ethnic differences: As with all other angiotensin II receptor antagonist containing products, the blood pressure lowering effect of Olmetec Plus is somewhat less in black patients than in non-black patients, possibly because of a higher prevalence of low-renin status in the black hypertensive population.
Anti-doping test: Hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Pregnancy: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Unless continued angiotensin II receptor antagonists therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started see sections 4.
Other: As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic heart disease or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
This medicinal product contains lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Potential interactions related to the Olmetec 4 combination: Concomitant use not recommended Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors and, rarely, with angiotensin II receptor antagonists.
In addition, renal clearance of lithium is reduced by thiazides and consequently the risk of lithium toxicity may be increased.
Therefore use of Olmetec Plus and lithium in combination is not recommended see section 4.
If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Concomitant use requiring caution Baclofen: Potentiation of узнать больше здесь effect may occur.
Non-steroidal anti-inflammatory medicinal products: NSAIDs i.
In some patients with compromised renal function e.
Therefore, the combination should be administered with caution, especially in elderly people.
Patients should be adequately 4 and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Concomitant use to be taken into account Amifostine: Potentiation of antihypertensive effect may occur.
Other antihypertensive agents: The blood pressure lowering effect of Olmetec Plus can be increased by concomitant use of other antihypertensive medicinal products.
Alcohol, barbiturates, narcotics or antidepressants: Potentiation of orthostatic hypotension may occur.
Potential interactions related to olmesartan medoxomil: Concomitant use not recommended ACE-inhibitors, angiotensin II receptor blockers or aliskiren: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function including acute renal failure compared to the use of a single RAAS-acting agent see sections 4.
Medicinal products affecting potassium levels: Based on Холодильник NORDFROST NRG 119-542 with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels e.
If medicinal products which affect potassium levels are to be prescribed in combination with Olmetec Plus, monitoring of potassium plasma levels is advised.
Administration of olmesartan medoxomil at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.
Administering olmesartan medoxomil at least 4 hours before the colesevelam hydrochloride dose should be considered see section 5.
Additional information After treatment with antacid aluminium magnesium hydroxidea modest reduction in bioavailability of olmesartan was observed.
Olmesartan medoxomil had no significant effect on the pharmacokinetics or pharmacodynamics of warfarin or the pharmacokinetics of digoxin.
Coadministration of olmesartan medoxomil with pravastatin had no clinically relevant effects on the pharmacokinetics of either component in healthy subjects.
No clinically relevant interactions between olmesartan and medicinal products metabolised by the above cytochrome P450 enzymes are expected.
Potential interactions related to hydrochlorothiazide: Concomitant use not recommended Medicinal products affecting potassium levels: The potassium-depleting effect of hydrochlorothiazide see section 4.
Such concomitant use is share Переходная рамка Ford C-Max, Focus 2, Fusion, Fiesta, Transit 2DIN (Incar RFO-N02S) new not recommended.
Concomitant use requiring caution Calcium salts: Thiazide diuretics may increase serum calcium levels due to decreased excretion.
If calcium supplements must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.
Cholestyramine and colestipol resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Digitalis glycosides: Thiazide-induced hypokalaemia or hypomagnesaemia may favour the onset of digitalis-induced cardiac arrhythmias.
Medicinal products affected by serum potassium disturbances: Periodic monitoring of serum potassium and ECG is recommended when Olmetec Plus is administered with medicinal products affected by serum potassium disturbances e.
Non-depolarizing skeletal muscle relaxants e.
Antidiabetic medicinal products oral agents and insulin : The treatment with a thiazide may influence the glucose tolerance.
Dosage adjustment of the antidiabetic medicinal product may be required see section 4.
Metformin: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Beta-blockers and diazoxide: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Pressor amines eg noradrenaline : The effect of pressor amines may be decreased.
Medicinal products used in the treatment of gout e.
Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Coadministration of a Стойка администратора Alsav - Серый #17938 may increase the incidence of hypersensitivity reactions to allopurinol.
Amantadine: Thiazides may increase the risk of adverse effects caused by amantadine.
Salicylates: In case of high dosages of salicylates hydrochlorothiazide may enhance the toxic effect of the salicylates on the central nervous system.
Methyldopa: There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Cyclosporine: Concomitant treatment with cyclosporine may increase the risk of hyperuricaemia and gout-type complications.
Tetracyclines: Concomitant administration of tetracyclines and thiazides increases the risk of tetracycline-induced increase in urea.
This interaction is probably not applicable to doxycycline.
Pregnancy Given the effects of the individual components in this combination product on pregnancy, the use of Olmetec Plus is not recommended during the first вот ссылка of pregnancy see section 4.
The use of Olmetec Plus is contra-indicated during the 2nd and 3rd trimester of pregnancy see sections 4.
Olmesartan Roller Int.

электр. серии Panini R The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy see section 4.
The use of angiotensin II receptor antagonists is contra-indicated during the 2nd and 3rd trimester of pregnancy see sections 4.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Unless continued angiotensin receptor blocker therapy is considered essential, patients planning pregnancy https://ugra.site/seriy/fox-racing-motoshlem-podrostkoviy-fox-v1-przm-youth-helmet-blackwhite.html be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to angiotensin II receptor antagonists therapy during the 2nd and 3rd trimesters is known to induce human fetotoxicity decreased renal function, oligohydramnios, skull ossification retardation and neonatal toxicity renal failure, https://ugra.site/seriy/zo-skin-health-antitsellyulitniy-krem-serii-oraser-oraser-cellulite-control-body.html, hyperkalaemia.
Should exposure to angiotensin II https://ugra.site/seriy/kofevarka-qilive-cm2097-seriy.html antagonists have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension see also sections 4.
Hydrochlorothiazide: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Animal studies are insufficient.
Hydrochlorothiazide crosses the placenta.
Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the 2nd and 3rd trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or pre-eclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Breast-feeding Olmesartan medoxomil: Because no information is available regarding the use of Olmetec Plus during breast-feeding, Olmetec Plus is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Hydrochlorothiazide: Hydrochlorothiazide is excreted in human milk in small amounts.
Thiazides in high doses causing intense diuresis can inhibit the milk production.
продолжить use of Olmetec Plus during breast-feeding is not recommended.
If Как сообщается здесь Plus is used during breast-feeding, doses should be kept as low как сообщается здесь possible.
Dizziness or fatigue may occasionally occur in patients taking antihypertensive therapy, which may impair the ability to react.
Hydrochlorothiazide may cause or exacerbate volume depletion which may lead to electrolyte imbalance see section 4.
Adverse reactions from Olmetec Plus in clinical trials, post-authorisation safety studies and spontaneous reporting are summarised in the below table as well as adverse reactions from the individual components olmesartan medoxomil and hydrochlorothiazide based on the known safety profile of these substances.
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed see also sections 4.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Management depends upon the time since ingestion and the severity of the symptoms.
Activated charcoal may be useful in the treatment of overdose.
Serum electrolytes and creatinine should be monitored frequently.
If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
The most likely manifestations of olmesartan medoxomil overdose are перейти to be hypotension and tachycardia; bradycardia might also occur.
Overdose with hydrochlorothiazide is associated with electrolyte depletion hypokalaemia, Рюкзак фотокамеры KATA PL and dehydration resulting from excessive diuresis.
The most common signs and symptoms of overdose are nausea and somnolence.
No information is available regarding the dialysability of olmesartan or hydrochlorothiazide.
Pharmacotherapeutic group: Angiotensin II antagonists and diuretics, ATC code: C09D A 08.
The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Once daily dosing with Olmetec Plus provides an effective and smooth reduction in blood pressure over the 24 hour dose interval.
Olmesartan medoxomil is an orally active, selective angiotensin II receptor type AT 1 antagonist.
Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a significant role in the pathophysiology of hypertension.
The effects of angiotensin II include vasoconstriction, stimulation of the synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium.
Olmesartan blocks https://ugra.site/seriy/gel-lak-bluesky-seriya-z-10-ml.html vasoconstrictor and aldosterone-secreting effects of angiotensin II by blocking its binding to the AT 1 receptor in tissues including vascular smooth muscle and the adrenal gland.
The action of olmesartan is independent of the source or route of synthesis of angiotensin II.
The selective antagonism of the angiotensin II AT 1 receptors by olmesartan results in increases in plasma renin levels and angiotensin I and II concentrations, and some decrease in plasma aldosterone concentrations.
In hypertension, olmesartan medoxomil causes a dose-dependent, long-lasting reduction in arterial blood pressure.
There has been no evidence of first-dose hypotension, of tachyphylaxis during long-term treatment, or of rebound hypertension after abrupt cessation of therapy.
Once daily dosing with olmesartan medoxomil provides an effective and smooth reduction in blood pressure over the 24 hour dose interval.
Once daily dosing produced similar decreases in blood pressure as twice daily dosing at the same total daily dose.
With continuous treatment, maximum reductions in blood pressure https://ugra.site/seriy/datacard-503876-101-lenta-golograficheskaya-laminatsionnaya-topcoat-600-otpechatkov.html achieved by 8 weeks after the initiation of therapy, although a substantial proportion of the blood pressure lowering effect is already observed after 2 weeks of treatment.
The effect of olmesartan medoxomil on mortality and morbidity is not yet known.
The Randomised Olmesartan and Diabetes Microalbuminuria Prevention ROADMAP study in 4447 patients with type 2 diabetes, normo-albuminuria and at least one additional cardiovascular risk factor, investigated whether treatment with olmesartan could delay the onset of microalbuminuria.
During the median follow-up duration of 3.
For the primary endpoint, the study demonstrated a significant risk reduction in the time to onset of microalbuminuria, in favour of olmesartan.
After adjustment for BP differences this risk reduction was no longer statistically significant.
For the secondary endpoints, https://ugra.site/seriy/katushka-rubicon-combat-cm615f-41bb.html events occurred in 96 patients 4.
The incidence of cardiovascular mortality was higher with olmesartan compared to placebo treatment 15 patients 0.
Overall mortality with olmesartan was numerically increased 26 patients 1.
The Olmesartan Reducing Incidence of End-stage Renal Disease in Diabetic Nephropathy Trial ORIENT investigated the effects of olmesartan on renal and cardiovascular outcomes in 577 randomized Japanese and Chinese type 2 diabetic patients with overt nephropathy.
During a median follow-up of 3.
The primary composite endpoint time to 4 event of the doubling of serum creatinine, end-stage renal disease, all-cause death occurred in 116 patients in the olmesartan group 41.
The composite secondary cardiovascular endpoint occurred in 40 olmesartan-treated patients 14.
This composite cardiovascular endpoint included cardiovascular death in 10 3.
Hydrochlorothiazide is a thiazide diuretic.
The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
The renin-aldosterone link is mediated by angiotensin II and therefore coadministration of an angiotensin Rexant 20-3505 receptor antagonist tends to reverse the potassium loss associated with thiazide diuretics.
With hydrochlorothiazide, onset of diuresis occurs at about 2 hours and peak effect occurs at about 4 hours post-dose, whilst the action persists for approximately 6-12 hours.
Epidemiological studies have shown that long-term treatment with hydrochlorothiazide monotherapy reduces the risk of cardiovascular mortality and morbidity.
Clinical efficacy and safety The combination of olmesartan medoxomil and hydrochlorothiazide produces additive reductions in blood pressure which generally increase with the dose of each component.
Withdrawal of olmesartan medoxomil therapy, with or without concomitant 4 therapy, did not result in rebound hypertension.
A second double-blind, randomised, placebo-controlled study evaluated the effectiveness of adding hydrochlorothiazide to the treatment of patients not adequately controlled after 8 weeks of treatment with Olmetec 40 mg.
Patients either continued on Olmetec 40 mg or received additional hydrochlorothiazide 4 />Ambulatory blood pressure monitoring ABPM based on the mean changes on 24-hour, daytime and night-time diastolic and systolic blood pressure data confirmed the results of conventional blood pressure measures.
The difference between both treatment groups was not statistically significant when using conventional blood pressure measurement, which might be explained by the known flat dose response effect of angiotensin II receptor antagonists such as Olmesartan medoxomil.
The antihypertensive effect of Olmetec Plus was similar irrespective of age, gender or diabetes status.
Other information: Two large randomised, controlled trials ONTARGET ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial and VA NEPHRON-D The Veterans Affairs Nephropathy in Diabetes have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage.
VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
Given адрес страницы similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.
ALTITUDE Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
The study was terminated early because of an increased risk of adverse outcomes.
Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest hyperkalaemia, hypotension and renal dysfunction were more frequently reported in the aliskiren group than in the placebo group.
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed.
One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
A clear cumulative dose response relationship was observed for both BCC and SCC.
Another study showed a possible association between lip cancer SCC and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy.
A cumulative dose-response relationship was demonstrated with an adjusted OR 2.
Absorption and distribution Olmesartan medoxomil: Olmesartan medoxomil is a prodrug.
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 на этой странице intact side chain medoxomil moiety смотрите подробнее been detected in plasma or excreta.
The mean absolute bioavailability of olmesartan from a tablet formulation was 25.
The mean peak plasma concentration C max of olmesartan is reached within about 2 hours after oral dosing with olmesartan medoxomil, and olmesartan plasma concentrations increase approximately linearly with increasing single oral doses up to about 80 mg.
Food had minimal effect on the bioavailability of olmesartan and therefore olmesartan medoxomil may be administered with or without food.
No clinically relevant gender-related differences in the pharmacokinetics of olmesartan have been observed.
Olmesartan is highly bound to plasma protein 99.
The binding of olmesartan to blood cells is negligible.
The mean volume of distribution after intravenous dosing is low 16 – 29 L.
Hydrochlorothiazide: Following oral administration of olmesartan medoxomil and hydrochlorothiazide in combination, the median time to peak concentrations of hydrochlorothiazide was 1.
Hydrochlorothiazide is 68 % protein bound in the plasma and its apparent volume of distribution is 0.
Biotransformation and elimination Olmesartan medoxomil: Total plasma clearance of olmesartan was typically 1.
Following a single oral dose of 14C-labelled olmesartan medoxomil, 10 - 16% of the administered radioactivity was excreted in the urine the vast majority within 24 hours of dose administration and the remainder https://ugra.site/seriy/roliki-razdvizhnie-ridex-joker-green-razmer-35-38.html the recovered radioactivity was excreted in the faeces.
Based on the systemic availability of 25.
All recovered radioactivity was identified as olmesartan.
No other significant metabolite was detected.
Enterohepatic recycling of olmesartan is minimal.
Since a large proportion of olmesartan is excreted via the biliary route, use in patients with biliary obstruction is contraindicated see section 4.
The terminal elimination half life of olmesartan varied between 10 and 15 hours after multiple oral dosing.
Steady state was reached after the first few doses and no further accumulation was evident after 14 days of repeated dosing.
Renal clearance was approximately 0.
Hydrochlorothiazide: Hydrochlorothiazide is not metabolised in man and is excreted almost entirely as unchanged active Демосистема настольная на 10 панелей BRAUBERG, металлическая, с 10 серыми панелями А4, 231238 (арт. in urine.
About 60 % of the oral dose is eliminated as unchanged active substance within 48 hours.
The terminal elimination half-life of hydrochlorothiazide is 10 – 15 hours.
Olmetec Plus The systemic availability of hydrochlorothiazide is reduced by about 20% when co-administered with olmesartan medoxomil, but this modest decrease is not of any clinical relevance.
The kinetics of olmesartan are unaffected by the co-administration of hydrochlorothiazide.
Limited data suggest that the systemic clearance of hydrochlorothiazide is reduced in both healthy and hypertensive elderly people compared to young healthy volunteers.
Renal impairment: In renally impaired patients, the olmesartan AUC at steady state increased by 62%, 82% and 179% in patients with mild, moderate and severe renal impairment, respectively, compared to healthy controls see sections 4.
The half-life of hydrochlorothiazide is prolonged in patients with impaired renal function.
Hepatic impairment: After single oral administration, olmesartan AUC values were 6% and 65% higher in mildly and moderately hepatically impaired patients, respectively, than in their corresponding matched healthy controls.
The unbound fraction of olmesartan at 2 hours post-dose in healthy subjects, in patients with mild hepatic impairment and in patients with moderate hepatic impairment was 0.
Following repeated dosing in patients with moderate hepatic impairment, olmesartan mean AUC was again about 65% higher than in matched healthy controls.
Olmesartan mean C max values were similar in hepatically-impaired and healthy subjects.
In patients with moderate hepatic impairment, an initial dose of 10 mg olmesartan medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily.
Olmesartan medoxomil has not been evaluated in patients with severe hepatic impairment see sections 4.
Hepatic impairment does not significantly influence the pharmacokinetics of hydrochlorothiazide.
Drug interactions Bile acid sequestering agent colesevelam: 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.
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.
Elimination half life of olmesartan was reduced by 50 – 52% irrespectively of whether administered concomitantly or 4 hours prior to colesevelam hydrochloride see section 4.
As for each of the individual substances and other medicinal products in this class, the main toxicological target organ of the combination was the kidney.
High dosages caused tubular degeneration and regeneration in the kidneys of rats and dogs, probably via a change in renal haemodynamics reduced renal perfusion resulting from hypotension with tubular hypoxia and tubular cell degeneration.
These effects have also been observed for other AT 1 receptor antagonists and for ACE inhibitors and they seem to have been induced by the pharmacological action of high dosages of olmesartan medoxomil and seem to be not relevant to humans at the recommended therapeutic doses.
Genotoxicity studies using combined olmesartan medoxomil and hydrochlorothiazide as well as the individual components have not shown any signs of a clinically relevant genotoxic activity.
The carcinogenic potential of a combination of olmesartan medoxomil and hydrochlorothiazide was not investigated as there was no evidence of relevant carcinogenic effects for the two individual components under conditions of clinical use.
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