QUINAPRIL PILLS 10 MG

Trade name of the drug:

Hinapril-SZ

International non-proprietary name:

hinapril

Dosage Form:

film coated tablets

Composition:

1 tablet, film coated, contains:

dosage 5 mg:

active ingredient: Quinapril hydrochloride-5.416 mg in terms of quinapril -5 mg;

excipients (core):

lactose monohydrate (milk sugar) -28,784 mg; Magnesium hydroxycarbonate pentahydrate (magnesium carbonate basic aqueous) -75.0 mg; Croscarmellose sodium (primelloza) -3.0 mg; Povidone (medium molecular weight polyvinylpyrrolidone) -6.0 mg; colloidal silicon dioxide (Aerosil) -0.6 mg; magnesium stearate -1.2 mg;

excipients (shell):

Opadry II (polyvinyl alcohol, partially hydrolyzed -1.6 mg; talc-0.592 mg; titanium dioxide E171-0.8748 mg; macrogol (polyethylene glycol 3350) -0.808 mg; aluminum varnish based on dye quinoline yellow -0.1204 mg; aluminum varnish based on dye sunsets yellow-0.0028 mg; iron dye oxide (II) yellow -0.0012 mg; aluminum varnish based on indigo carmine dye -0.0008 mg);

dosage 10 mg:

active ingredient: quinapril hydrochloride -10.832 mg in terms of quinapril -10 mg;

excipients (core): lactose monohydrate (milk sugar) -46,168 mg; magnesium hydroxycarbonate pentahydrate (magnesium carbonate basic water)-125.0 mg; croscarmellose sodium (primelloza) -5.0 mg; Povidone (medium molecular weight polyvinylpyrrolidone) -10.0 mg; colloidal silicon dioxide (Aerosil) -1.0 mg; magnesium stearate - 2.0 mg;

excipients (shell):

Opadry II (polyvinyl alcohol, partially hydrolyzed -2.4 mg; talc -0.888 mg; titanium dioxide E 171-1.3122 mg; macrogol (polyethylene glycol 3350) -1.212 mg; aluminum varnish based on dye quinoline yellow -80806 mg; aluminum lacquer based on dye sunsets yellow -0.0042 mg; iron dye oxide (II) yellow -0.0018 mg; aluminum lacquer based on indigo carmine dye -0.0012 mg);

dosage 20 mg:

active ingredient: quinapril hydrochloride -21.664 mg in terms of quinapril -20 mg;

excipients (core): lactose monohydrate (milk sugar) -48,736 mg;

magnesium hydroxycarbonate pentahydrate (magnesium carbonate basic aqueous) -157.0 mg;

croscarmellose sodium (primelloza) -6.3 mg; Povidone (medium molecular weight polyvinylpyrrolidone) -12.5 mg; colloidal silicon dioxide (Aerosil) -1.3 mg; magnesium

Stearate -2.5 mg; excipients (shell):

Opadry II (polyvinyl alcohol, partially hydrolyzed -3.2 mg; talc -1.184 mg; titanium dioxide E 171 -1.7496 mg; macrogol (polyethylene glycol 3350) -1.616 mg; aluminum varnish based on dye quinoline yellow -0.2408 mg; aluminum lacquer based on dye sunsets yellow -0.0056 mg; iron dye oxide (II) yellow -0.0024 mg; aluminum lacquer based on indigo carmine dye -0.0016 mg);

dosage 40 mg:

active ingredient: quinapril hydrochloride -43,328 mg based on quinapril -40mg;

excipients (core): lactose monohydrate (milk sugar) -70,672 mg;

magnesium hydroxycarbonate pentahydrate (magnesium carbonate basic water) -250.0 mg; Croscarmellose sodium (primelloza) -10.0 mg; povidone (polyvinylpyrrolidone

weight) -20.0 mg; colloidal silicon dioxide (Aerosil) -2.0 mg; magnesium

stearate, 4.0 mg;

excipients (shell):

Opadry II (polyvinyl alcohol, partially hydrolyzed -4.8 mg; talc -1.776 mg; titanium dioxide E 171-2.6244 mg; macrogol (polyethylene glycol 3350) -2.424 mg; aluminum varnish based on dye quinoline yellow -0.3612 mg; aluminum lacquer based on dye sunsets yellow -0.0084 mg; iron dye oxide (II) yellow -0.0036 mg; aluminum lacquer based on indigo carmine dye -0.0024 mg).

Description

Dosage 5 mg

Tablets, film coated yellow, round, biconvex with

risk. In cross section, the core of the pill is white or almost white.

Dosage 10 mg, 20 mg and 40 mg

Tablets, film coated yellow, round, biconvex. On

cross-section the core of the pill is white or almost white.

Pharmacotherapeutic group:

Angiotensin-converting enzyme (ACE) inhibitor

Pharmacological properties

Pharmacodynamics

ACE is an enzyme that catalyzes the conversion of angiotensin I in

Angiotensin II, which has a vasoconstrictor effect and increases vascular tone,

including by stimulating the secretion of aldosterone by the adrenal cortex. Quinapril

competitively inhibits ACE and causes a decrease in vasopressor activity and aldosterone secretion.The elimination of the negative effect of angiotensin II on renin secretion by the feedback mechanism leads to an increase in plasma renin activity. At the same time, a decrease in arterial pressure (BP) is accompanied by a decrease in total peripheral vascular resistance (OPS) and resistance of renal vessels, while changes in heart rate (HR), cardiac output, renal blood flow, glomerular filtration rate and filtration fraction are minor or absent.

Quinapril increases exercise tolerance. With prolonged use contributes to the reverse development of myocardial hypertrophy in patients with arterial hypertension; improves blood supply to ischemic myocardium. Enhances

coronary and renal blood flow. Reduces platelet aggregation. The onset of action after taking a single dose - after 1 hour, a maximum of 2-4 hours, the duration of action depends on the size of the dose (up to 24 hours). A clinically pronounced effect develops several weeks after the start of therapy.

The concentration of quinapril in the blood plasma after oral administration reaches a maximum in

for 1 h, quinaprilat -2 h. Eating does not affect the degree of absorption, but may

increase the time to reach maximum concentration (TCmax) (fatty foods can reduce the rate and extent of absorption of quinapril). Taking into account the excretion of quinapril and its metabolites by the kidneys, the degree of absorption is about 60%.Under the influence

“Hepatic” enzymes quinapril are rapidly metabolized to quinapril by cleaving the ester group (the main metabolite is quinapril two-basic acid),

which is an ACE inhibitor.

About 38% of the ingested dose of quinapril circulates in the blood plasma in the form of

hinaprilat. The half-life (T1 / 2) of quinapril from blood plasma is about 1-2 hours, quinaprilat -3 hours. Rendered by the kidneys -61% (56% as quinapril and quinaprilat) and through the intestines -37%. Approximately 97% of quinapril and quinaprilat circulate in the blood plasma in protein-bound form. Quinapril and its metabolites do not penetrate the blood-brain barrier.

In patients with renal insufficiency, T1 / 2 hinaprilat increases as

reduce creatinine clearance (CK). Elimination of hinaprilat is also reduced in elderly patients (over 65 years) and is closely correlated with impaired renal function, however, in general, differences in the efficacy and safety of treatment of patients in the elderly and younger age have not been identified.

In patients with alcoholic cirrhosis of the liver, the concentration of hinaprilat is reduced due to a violation of de-esterification of Quinapril.

Arterial hypertension

(in monotherapy or in combination with thiazide diuretics and beta-blockers).

Chronic heart failure

(as part of combination therapy).

• Hypersensitivity to any component of the drug.
• Angioedema in history as a result of prior therapy with ACE inhibitors, hereditary and / or idiopathic angioedema.
• Age up to 18 years.
• Pregnancy and breastfeeding period.
• Lactase deficiency, lactose intolerance and glucose-galactose malabsorption syndrome.
• Concurrent use with aliskiren and aliskiren containing agents or with

angiotensin II receptor antagonists (APA II) or with other drugs inhibiting the renin-angiotensin-aldosterone system (RAAS) (double blockade of the RAAS):

• in patients with diabetes mellitus or in patients with diabetes with organ damage

targets (diabetic nephropathy);

• in patients with impaired renal function (glomerular filtration rate (GFR) less

60 ml / min / 1.73 m2);

• in patients with hyperkalemia (more than 5 mmol / l);
• in patients with chronic heart failure and arterial hypotension.

Symptomatic arterial hypotension in patients previously taking diuretics and following a diet with restriction of salt intake;

severe heart failure in patients at high risk of arterial hypotension; severe chronic heart failure; conditions accompanied by a decrease in circulating blood volume (BCC) (including vomiting and diarrhea); hyperkalemia; oppression of bone marrow hematopoiesis; aortic stenosis,hypertrophic obstructive cardiomyopathy, mitral stenosis; cerebral circulatory failure, coronary heart disease, coronary insufficiency - a sharp decrease in blood pressure during therapy with ACE inhibitors, can worsen the course of these diseases; bilateral renal artery stenosis or arterial stenosis of a single kidney, the state after kidney transplantation; renal dysfunction; in patients on hemodialysis (CC less than 10 ml / min) (data on the use of quinapril in these patients is not enough); autoimmune systemic diseases of the connective tissue (including systemic lupus erythematosus, scleroderma); abnormal liver function (especially when used simultaneously with diuretics); with simultaneous use with potassium-sparing diuretics; diabetes; extensive surgical interventions and general anesthesia; simultaneous reception of other antihypertensive drugs, as well as inhibitors of the enzymes mTOR and DPP-4.

Use during pregnancy and during breastfeeding

The use of the drug Hinapril-SZ is contraindicated during pregnancy, in women planning a pregnancy, as well as in women of reproductive age who do not use reliable methods of contraception.

Women of reproductive age taking the drug Hinapril-SZ should

use reliable contraceptive methods.

When diagnosing pregnancy, the drug Hinapril-SZ should be canceled as soon as possible.

The use of ACE inhibitors during pregnancy is accompanied by an increase in the risk of developing abnormalities in the cardiovascular and nervous systems of the fetus. In addition, while taking ACE inhibitors during pregnancy, cases of low water, premature birth, birth of children with arterial hypotension, kidney pathology (including acute renal failure), hypoplasia of the skull bones, contractures of the limbs, craniofacial deformities, hypoplasia of the lungs, delayed intrauterine development, open arterial duct, as well as cases of fetal death of the fetus and death of the newborn. Often malnutrition is diagnosed after the fetus has been irreversibly damaged.

Newborns who were exposed to ACE inhibitors in utero,

should be observed in order to identify arterial hypotension, oliguria and

hyperkalemia. When oliguria appears, blood pressure and renal perfusion should be maintained.

The drug Hinapril-SZ should not be prescribed during breastfeeding due to the fact that ACE inhibitors, including Quinapril, to a limited extent, penetrate into breast milk. Given the possibility of serious adverse events in the newborn, Hinapril-SZ should be canceled during lactation or breastfeeding should be stopped.

Accept inside, without chewing, regardless of mealtime, washing down with water.

Arterial hypertension

Monotherapy: the recommended initial dose of the drug Hinapril-SZ in patients, not

receiving diuretics, is 10 mg 1 time per day. Depending on the clinical

effect of the dose can be increased (doubled) to a maintenance dose of 20 or 40

mg / day, which is usually prescribed in 1 or 2 doses. As a rule, the dose should be changed with

4 week intervals. In most patients, the use of the drug Hinapril-SZ 1 time per day allows you to achieve a stable therapeutic response. The maximum daily dose is -80 mg / day.

With simultaneous use with diuretics: the recommended initial dose of the drug Hinapril-SZ in patients who continue to receive diuretics is 5 mg 1 time per day; subsequently, it is increased (as indicated above) until the optimum therapeutic effect is achieved (see the section “Interaction with Other Medicines”).

Chronic heart failure

The recommended initial dose of the drug Hinapril-SZ is 5 mg 1 or 2 times a day.

After taking the drug, the patient should be under medical supervision in order to identify symptomatic arterial hypotension. In the case of good tolerability of the initial dose of the drug Hinapril-SZ, it can be increased to 10-40 mg / day by dividing into 2 doses.

Use in patients with impaired renal function

Taking into account the clinical and pharmacokinetic data in patients with impaired renal function, the initial dose should be selected as follows:

QC Recommended Initial Dose (ml / min) (mg)

more than 60 10

30-60 5

10-30 2.5 (1/2 pill 5 mg)

If the tolerance of the initial dose is good, then the drug Hinapril-SZ can be used 2 times a day. The dose of Hinapril-SZ can be gradually, not more than once a week, increased, taking into account the clinical, hemodynamic effects, as well as renal function.

Use in elderly patients

The recommended initial dose of the drug Hinapril-SZ in elderly patients is 10 mg 1 time per day; it is subsequently increased until the optimum therapeutic effect is achieved.

In a dry, dark place, at a temperature not higher than 25 ° C.

Keep out of the reach of children.

Do not use beyond the expiration date printed on the package.

Vacation conditions

Prescription.