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Adults. Hypertension. Monotherapy: The recommended initial dosage is 10 mg once daily in uncomplicated hypertension. Depending upon clinical response, patient's dosage may be titrated 4 doubling the dose allowing adequate time for dosage adjustment) to a maintenance dosage of 20 to 40 mg/day given as a single 4 or divided into 2 4.

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Quinapril 20 mg Tablets - Summary of Product Characteristics (SmPC) - (emc)

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The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses Hypertension For the treatment of all grades of essential hypertension.
Quinapril Tablet is effective as monotherapy or concomitantly with diuretics in patients with hypertension.
Treatment of congestive heart failure with Quinapril Tablets should always be initiated under close medical supervision.
Posology For oral use.
Adults Hypertension Monotherapy: The recommended initial dosage is 10 mg once daily in uncomplicated hypertension.
Long-term control is maintained in most patients with a single daily dosage regimen.
Concomitant Diuretics: In order to determine if excess hypotension will occur, an initial dosage of 2.
After this the dosage of Quinapril Tablets should be titrated as described above to the optimal response.
Congestive Heart Failure In order to closely monitor patients for symptomatic hypotension, a single 2.
Take either перейти на страницу or without food.
The dose should always be taken at about the same time of day to help increase compliance.
Severe Heart Failure In the treatment of severe or unstable congestive heart failure, Quinapril Tablets should always be initiated in hospital under close medical supervision.
Other patients who may also be considered to be at higher risk and should have treatment initiated in hospital include: patients who are on high dose loop diuretics e.
Take either with or without food.
The dose should always be taken at about the same time of day to help increase compliance.
Paediatric population Currently available data are described in sections 5.
Dual blockade of the renin-angiotensin-aldosterone system RAAS There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia https://prognozadvisor.ru/seriy/bistrosemniy-povorotniy-kronshteyn-eaw-na-merkel-sr1-300-05186.html 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.
Quinapril Tablets should be used with caution in selected patients with aortic stenosis or outflow obstruction.
Sensitivity reactions: Sensitivity reactions may occur in patients with or without Оптический привод ASUS DRW-22B1L history of allergy or bronchial asthma, e.
Symptomatic hypotension: Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients but it is a possible consequence of ACE inhibition.
If symptomatic hypotension occurs, the patient should be placed in the supine position and, if necessary, receive an intravenous infusion 4 normal saline.
A transient hypotensive response is not a contraindication to further doses; however, lower doses of quinapril or any concomitant diuretic therapy should be considered if this event occurs.
In patients with congestive heart failure, who are at risk of excessive hypotension, quinapril therapy should be started at the recommended dose under close medical supervision; these patients should be followed closely for the first two weeks of treatment and whenever the dosage of quinapril is increased.
Similar considerations apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
Impaired Renal Function In patients with renal insufficiency, monitoring of renal function during therapy should be performed as deemed appropriate; although in the majority renal function will not alter or may improve.
The half-life of quinaprilat is prolonged as creatinine clearance falls.
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
In clinical studies in hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine have 4 observed in some patients following ACE inhibitor therapy.
In such patients, renal function should be monitored during the first продолжение здесь weeks of therapy.
These increases are more likely to occur in patients with pre-existing renal impairment.
Treatment is therefore not recommended in these patients.
Angioedema: Angioedema has been reported in patients treated with angiotensin-converting enzyme inhibitors.
If laryngeal stridor or angioedema of 4 face, tongue, or glottis occur, treatment should be discontinued immediately, the patient treated appropriately in accordance with accepted medical care, and carefully observed until the swelling disappears.
In instances where swelling 4 confined to the face and lips, the condition generally resolves without treatment; antihistamines may be useful in relieving symptoms.
Angioedema associated with laryngeal involvement may be fatal.
Where there is involvement of the tongue, glottis, or larynx likely to cause airway obstruction, appropriate therapy e.
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor see Section 4.
Intestinal angioedema: Intestinal angioedema has been reported in patients treated with ACE inhibitors.
These patients presented with abdominal pain with or without nausea or vomiting ; in some cases there was no prior history of facial angioedema 4 C-1 esterase levels were normal.
The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor.
Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Ethnic Differences Black patients receiving ACE inhibitor therapy generally have a higher incidence of angioedema than non-black patients.
It should also be noted that in controlled clinical trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
Agranulocytosis has been rarely reported during treatment with quinapril.
Desensitization: Patients receiving ACE inhibitors during desensitising treatment with hymenoptera venom have sustainedlife threatening anaphylactoid reactions.
In the same patients, these reactions have beenavoided whenACE inhibitors were temporarily withheld, but they have reappeared upon inadvertent re-challenge.
Haemodialysis and LDL Apheresis: Patients haemodialysed using high-flux polyacrylonitrile 'AN69' membranes are highly likely to experience anaphylactoid reactions if they are treated with ACE inhibitors.
This combination should therefore be avoided, either by use of alternative antihypertensive drugs or alternative membranes for читать статью />Similar reactions have been observed during low-density lipoprotein apheresis with dextran-sulphate.
This method should therefore not be used in patients treated with ACE inhibitors.
Impaired Hepatic Function: Quinapril when combined with a diuretic should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
The metabolism of quinapril to quinaprilat is 4 dependent upon hepatic esterase.
Quinaprilat concentrations are reduced in patients with alcoholic cirrhosis due to impaired de-esterification of quinapril.
Rarely, ACE inhibitors have been associated with a syndrome beginning as a 4 jaundice and progressing to a fulminant hepatic necrosis in some cases fatal.
Patients who during ACE 4 therapy experience jaundice or clearly elevated hepatic enzymes should discontinue quinapril and receive appropriate medical follow-up.
Cough: Cough has been reported with the use of ACE inhibitors.
Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy.
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion see Section 4.
Hyperkalemia and Potassium-sparing Diuretics: Patients on quinapril alone may have increased serum potassium levels.
When administered concomitantly, quinapril may reduce the hypokalemia induced by thiazide diuretics.
Because of the risk of further potentiating increases in serum potassium it is advised that combination therapy with potassium-sparing diuretics be initiated with caution and the patient's serum potassium levels be closely monitored see Hypotension above and Section 4.
Diabetic patients: In diabetic patients ACE inhibitors may enhance insulin sensitivity ссылка на подробности have been associated with hypoglycaemia in patients treated with oral antidiabetic agents привожу ссылку insulin.
Glycaemic control should be closely monitored particularly during the first month of treatment with an ACE inhibitor see Section 4.
Pregnancy ACE inhibitors should not be initiated during pregnancy.
Unless continued ACE inhibitor 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 ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started see sections 4.
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system Жмите сюда through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such увидеть больше hypotension, hyperkalaemia and decreased renal function including acute renal failure compared to the use of a single RAAS-acting agent see sections 4.
Tetracycline and other drugs that interact with magnesium: Because of the presence 4 magnesium carbonate in the formulation, Quinapril Tablets has been shown in healthy volunteers to reduce the absorption of tetracycline in concomitant administration by 28-37%.
It is recommended that concomitant administration with tetracycline be avoided.
Concomitant diuretic therapy: Patients on diuretics, especially those on recently instituted diuretic therapy, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with quinapril.
Hypotensive effects after the first dose of quinapril may be minimised by discontinuing the diuretic a few days посетить страницу источник to initiation of therapy.
If it is not possible to discontinue the diuretic, the starting dose of quinapril should be reduced.
In patients in whom a diuretic is continued, medical supervision should be provided for up Раковина 57 см GSI Vulcano MVULCN two hours after the initial dose of quinapril See Sections 4.
Agents increasing serum potassium: Quinapril is an angiotensin-converting enzyme inhibitor capable of lowering aldosterone levels, which in turn can result in elevation in serum potassium.
Concomitant treatments with potassium sparing diuretics, potassium supplements or potassium salts should be used with caution and with appropriate monitoring of serum potassium.
As with other ACE inhibitors, patients on quinapril alone may have increased serum potassium levels.
When administered concomitantly, quinapril may reduce the hypokalaemia induced by thiazide diuretics.
This may lead to hypotension, which can be corrected by volume expansion.
Lithium: Increased serum lithium levels and symptoms of lithium toxicity have been reported 4 patients receiving concomitant lithium and ACE inhibitor therapy due to the sodium-losing effect of these agents.
Quinapril and lithium should be co-administered with caution and frequent monitoring of serum lithium levels is recommended.
If a diuretic is also used, it may increase the risk of lithium toxicity.
Non-steroidal anti-inflammatory drugs: In это Sinteros Паркетная доска SINTEROS Дуб серый oil, браш, масло, 2283х194х13,2 мм.

(2,658 кв.м.) очередь patients, the administration of a non-steroidal anti-inflammatory agent may reduce the antihypertensive effect of ACE inhibitors.
Furthermore, it has been described that NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium, whereas renal function may decrease.
These effects are in principle reversible and occur especially in patients with compromised renal function.
Gold: Nitritoid reactions symptoms include facial flushing, nausea, vomiting, and hypotension have been reported rarely in patients on therapy with injectable gold sodium aurothiomalate and concomitant ACE как сообщается здесь therapy.
Allopurinol, cytostatic and immunosuppressive agents, systemic corticosteroids or procainamide: Concomitant administration with ACE inhibitors may lead FL-2001 серый МГЛ симметричный RX7s-24 FOTON an increased risk for leucopenia See section 4.
Other hypertensive drugs: There may be an additive effect or potentiation.
Other agents: Co-administration детальнее на этой странице multiple 10 mg doses of atorvastatin with 80 mg quinapril resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.
Antacids: May decrease the bioavailability of Quinapril Tablets.
Antidiabetic drugs oral hypoglycaemic agents and insulin : In diabetic patients ACE inhibitors may enhance insulin sensitivity and have been associated with hypoglycaemia in patients treated with oral antidiabetic agents or insulin.
Glycaemic control should be closely monitored particularly during the first month of treatment with an ACE inhibitor see section 4.
Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy see section 4.
The use of ACE inhibitors is contra-indicated during the 2nd and 3rd trimester of pregnancy see sections 4.
Unless continued ACE inhibitor 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 ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity decreased renal function, oligohydramnios, нажмите чтобы увидеть больше ossification retardation 4 neonatal toxicity renal failure, hypotension, hyperkalaemia.
Should exposure to ACE inhibitors 4 occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension see sections 4.
Lactation Limited DeLonghi CTA 2103 Avvolta data demonstrate very low concentration in breast milk see section 5.
Although these concentrations seem to be clinically irrelevant the use of quinapril in breastfeeding is not recommended for preterm infants and for the first few weeks after delivery, because of the hypothetical risk of cardiovascular and renal effects and because there is not enough clinical experience.
In case of an older infant the use of quinapril in the breastfeeding mother may be considered if this treatment is necessary for the mother and the child is observed for any adverse effect.
There are no studies on the effect of this medicine on the ability to drive.
The ability to engage in activities such as operating machinery or operating a motor vehicle may be impaired, especially when initiating quinapril therapy.
System Organ To Crowdfunding (How To: Academy) Frequency Undesirable effects Blood and lymphatic system disorders Not Known Agranulocytosis, haemolytic anaemia, neutropenia, thrombocytopenia Immune system disorders Not Known Anaphylactoid reaction Metabolism and nutrition disorders Common Hyperkalaemia Psychiatric disorders Common Insomnia Uncommon Confusional state, depression, nervousness, sleep disorders Nervous system disorders Common Dizziness, headache, paraesthesia Uncommon Transient ischaemic attack, somnolence Rare Balance disorder, syncope, Neuropathy Not known Cerebrovascular accident Eye disorders Uncommon Amblyopia Very Rare Vision blurred Ear and labyrinth disorders Uncommon Vertigo, tinnitus Cardiac disorders Uncommon Myocardial infarction, angina pectoris, tachycardia, asystole, palpitations Rare Cerebral haemorrhage Vascular disorders Common Hypotension Uncommon Vasodilatation Not known Orthostatic hypotension Respiratory, thoracic and mediastinal disorders Common Dyspnoea, cough Uncommon Dry throat, Rare Eosinophilic pneumonia, worsening of asthma Very Rare Allergic посетить страницу, anaphylactoid reaction Not known Bronchospasm.
In patients with a congenital G-6-PDH deficiency, individual cases of haemolytic anaemia have been reported.
These observed increases will often reverse on continued therapy.
Gynaecomastia and vasculitis have been reported with other ACE-inhibitors and it cannot be excluded that these unwanted effects are class specific.
Laboratory values: Transient increases in serum creatinine and urea values have been reported, especially in association with concomitant therapy with diuretics.
Slight decreases in haemoglobin and haematocrit values have been reported for other ACE-inhibitors.
It cannot be excluded that these observations are group specific.
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.
No specific information is available on the treatment of overdosage with quinapril.
The most likely clinical manifestation would be symptoms attributable to severe hypotension, which should normally be treated by intravenous volume expansion.
Haemodialysis and peritoneal dialysis have little effect on the elimination of quinapril and quinaprilat.
Treatment is symptomatic and supportive consistent with established medical care.
ATC code: C09AA06 Pharmacotherapeutic group: Angiotensin-converting enzyme ACE inhibitor.
Quinapril is rapidly de-esterified to quinaprilat quinapril diacid, the principal metabolitewhich is a potent angiotensin-converting enzyme ACE inhibitor.
ACE is a peptidyl dipeptidase that catalyses the conversion of angiotensin I to the vasoconstrictor angiotensin II which is involved in vascular control and function through many different mechanisms, including stimulation of aldosterone secretion by the adrenal cortex.
The mode of action of quinapril in humans and animals is to inhibit circulating and tissue ACE activity, thereby decreasing vasopressor activity and aldosterone secretion.
In animal studies, the antihypertensive effect of quinapril outlasts its inhibitory effect on circulating ACE, whereas, tissue ACE inhibition more closely correlates with the duration of antihypertensive effects.
Administration of 10-40 mg of quinapril to patients with mild to severe hypertension results in a reduction of both sitting and standing blood pressure with minimal effect on heart rate.
Antihypertensive activity commences within one hour with peak effects usually achieved by two to four hours after dosing.
Achievement of maximum blood pressure lowering effects may require two weeks of therapy in some patients.
At the recommended doses, antihypertensive effects are maintained in most patients throughout the 24hour dosing interval and continue during long term therapy.
In a randomised clinical trial using target doses of 2.
For systolic blood pressure secondary objective of efficacy at Week 2 only there was a statistically significant linear dose response across treatments with a significant difference between the quinapril 20 mg QD and placebo treatment groups.
Long term effects of quinapril on growth, puberty and general development have not been studied.
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 their 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.
Peak plasma quinapril tablets concentrations are observed within 1 hour of oral administration.
The extent of absorption is approximately 60%, and is not influenced by food.
Following absorption, quinapril is de-esterified to its major active metabolite, quinaprilat, and to minor здесь metabolites.
Quinapril tablets have an apparent half-life of approximately one hour.
Peak plasma quinaprilat concentrations are observed approximately 2 hours following an oral dose of quinapril.
Quinaprilat is eliminated primarily by renal excretion and has an effective accumulation half-life of 3 hours.
In patients with renal insufficiency and creatinine clearance of 65 years and correlates well with the impaired renal function which frequently occurs in the elderly.
Quinaprilat concentrations are reduced in patients with alcoholic cirrhosis due to impaired de-esterification of quinapril tablets.
Studies in rats indicate that quinapril tablets and its metabolites do not cross the blood-brain barrier.
The pharmacokinetics of quinapril has been studied in a single dose study 0.
As in adults, quinapril was rapidly converted to quinaprilat.
Quinaprilat concentrations generally peaked 1 to 2 hours post dose and declined with a mean half-life of 2.
In infants and young children the exposure термос 106-2200Р (2,2 л) a single 0.
Quinapril was not detected in milk after 4 hours after the dose.
It is estimated that a breastfed infant would receive about 1.
Core Magnesium carbonate, Heavy Calcium Sulfate dihydrate Silica, Colloidal Anhydrous Crospovidone Povidone Magnesium Stearate Coating Bez Бра 13650 Abaka Alfa Wenge alcohol Titanium dioxide E171 Talc Lecithin Iron Oxide Yellow E172 Xanthan gum Quinapril tablets are supplied in blister packs using aluminium as forming base material and aluminium foil as the lidding, which are further packed in cartons.
Packs of 1, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 250, 300 and 500 tablets.
Not all pack sizes may be marketed.
Any unused or waste material should be disposed of in accordance with local requirements.
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