Universal reference book for medicines
Product name: FOSINAP ® (FOSINAP)

Active substance: fosinopril

Type: ACE inhibitor

Manufacturer: КАНОНФАРМА ПРОДАКШН (Russia)
Composition, form of production and packaging
Tablets are
white or almost white, flat-cylindrical, with a bevel.

1 tab.

fosinopril sodium 10 mg

Auxiliary substances: silicon dioxide colloid - 0.7 mg, croscarmellose sodium - 5 mg, lactose monohydrate - 66.8 mg, macrogol (polyethylene glycol 4000) - 0.5 mg, sodium stearyl fumarate - 1 mg, povidone - 7 mg, cellulose microcrystalline - 47.88 mg, calcium stearate - 1.12 mg.

7 pcs.
- Packings contour mesh (1) - packs cardboard.
7 pcs.
- packings contour mesh (2) - packs cardboard.
7 pcs.
- packings contour mesh (4) - packs cardboard.
7 pcs.
- packings contour mesh (8) - packs cardboard.
10 pieces.
- Packings contour mesh (1) - packs cardboard.
10 pieces.
- Packings contour mesh (3) - packs cardboard.
15 pcs.
- Packings contour mesh (1) - packs cardboard.
15 pcs.
- packings contour mesh (2) - packs cardboard.
30 pcs.
- Packings contour mesh (1) - packs cardboard.
Tablets are white or almost white, flat-cylindrical, with a bevel.

1 tab.

fosinopril sodium 20 mg

Auxiliary substances: silicon colloidal dioxide - 1 mg, croscarmellose sodium - 5.7 mg, lactose monohydrate - 97.3 mg, macrogol (polyethylene glycol 4000) - 1 mg, sodium stearyl fumarate - 1.5 mg, povidone - 10.5 mg, microcrystalline cellulose - 71.32 mg, calcium saccharate - 1.68 mg.

7 pcs.
- Packings contour mesh (1) - packs cardboard.
7 pcs.
- packings contour mesh (2) - packs cardboard.
7 pcs.
- packings contour mesh (4) - packs cardboard.
7 pcs.
- packings contour mesh (8) - packs cardboard.
10 pieces.
- Packings contour mesh (1) - packs cardboard.
10 pieces.
- Packings contour mesh (3) - packs cardboard.
15 pcs.
- Packings contour mesh (1) - packs cardboard.
15 pcs.
- packings contour mesh (2) - packs cardboard.
30 pcs.
- Packings contour mesh (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

ACE inhibitor.
Has hypotensive, vasodilating, diuretic and potassium-sparing effect. Fosinopril inhibits the conversion of angiotensin I into a vasoconstrictor substance, angiotensin II, as a result of which vasopressor activity and aldosterone secretion decrease, which can lead to a slight increase in the potassium ion concentration in the blood serum with simultaneous loss of sodium and liquid ions. As a result, OPSS and systemic blood pressure decrease. Suppresses the synthesis of aldosterone, inhibits tissue ACE.
Fosinopril inhibits the metabolic degradation of bradykinin, which has a powerful vasopressor effect;
due to this, the antihypertensive effect of the drug can be enhanced.
Reduction of blood pressure is not accompanied by a change in BCC, cerebral and renal blood flow, blood supply to internal organs, skeletal muscles, skin, reflex activity of the myocardium.
With arterial hypertension and left ventricular hypertrophy, treatment results in a decrease in left ventricular mass and a decrease in the thickness of the interventricular septum. Long-term therapy does not lead to metabolic disorders. After oral administration, the hypotensive effect develops within 1 hour, reaches a maximum after 3-6 hours, and persists for 24 hours.
In chronic heart failure, the positive effects of fosinopril are achieved mainly by suppressing the activity of the renin-aldosterone system.
Inhibition of ACE leads to a reduction in both preload and postload on the myocardium.
Fosinopril promotes increased tolerance to physical activity, reducing the severity of chronic heart failure.

PHARMACOKINETICS

Suction

After oral absorption from the gastrointestinal tract is about 30-40%.
The degree of absorption does not depend on the intake of food, but the rate of absorption can be slowed down. The time to achieve C max fosinoprilata in blood plasma is 3 hours and is independent of the dose taken.
Distribution

Binding to plasma proteins is more than 95%.
Fosinoprilat has a relatively small V d and is slightly associated with the cellular components of the blood. Does not penetrate the BBB.
Metabolism

The metabolism of fosinopril under the action of enzymes with the formation of fosinoprilata occurs mainly in the liver and in the mucosa of the gastrointestinal tract.

Excretion

Fosinopril is excreted from the body in equal parts by the kidneys and through the liver.
With arterial hypertension in patients with normal renal and hepatic function T1/2 fosinoprilata is about 11.5 hours. In chronic heart failure, T 1/2 is 14 hours.
INDICATIONS

- arterial hypertension (as a monotherapy or as part of a combination therapy);

- chronic heart failure (as part of combination therapy).

DOSING MODE

The drug is taken orally, regardless of food intake.
Tablets should be swallowed, not liquid, squeezed with a small amount of liquid.
The dose is set individually.

With arterial hypertension, the recommended initial dose is 10 mg 1 time / day.
The dose should be selected depending on the dynamics of blood pressure lowering.Doses vary from 10 to 40 mg once a day. The maximum daily dose is 40 mg.
In chronic heart failure, the recommended initial dose is 5 mg (1/2 tablespoons of 10 mg) 1 or 2 times / day.
The maximum daily dose is 40 mg / day.
Patients with impaired renal and / or liver function , as well as patients of advanced age, do not need to adjust the dosage regimen.

SIDE EFFECT

From the central and peripheral nervous system: stroke, cerebral vascular ischaemia, dizziness, headache, weakness, memory impairment;
when used in high doses - insomnia, anxiety, depression, confusion, drowsiness, paresthesia.
From the senses: hearing and vision impairment, tinnitus.

From the cardiovascular system: excessive reduction in blood pressure, orthostatic hypotension, collapse, tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction, "hot flashes" of blood to the skin of the face, fainting, cardiac arrest.

On the part of the respiratory system: dry cough, pulmonary infiltrates, bronchospasm, dyspnea, rhinorrhea, pharyngitis, dysphonia, nosebleeds.

On the part of the digestive system: nausea, diarrhea, intestinal obstruction, pancreatitis, hepatitis, cholestatic jaundice, abdominal pain, vomiting, constipation, anorexia, stomatitis, glossitis, dysphagia, flatulence, appetite, weight change, dry mouth;
swelling of the intestinal mucosa (very rarely).
From the side of the urinary system: the development or aggravation of the symptoms of chronic renal failure, proteinuria.

On the part of the organs of hematopoiesis: lymphadenitis.

From the musculoskeletal system: arthritis.

From the side of metabolism: gout.

Allergic reactions: skin rash, itching, angioedema.

On the part of laboratory indicators: hypercreatininaemia, increased urea concentration, increased activity of hepatic transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia;
a decrease in the concentration of hemoglobin and hematocrit, an increase in ESR, leukopenia, neutropenia, eosinophilia.
Influence on the fetus: impaired fetal kidney development, decreased fetal and newborn infants, impaired renal function, hyperkalemia, hypoplasia of the skull bones, oligohydramnion, limb contractures, lung hypoplasia.

CONTRAINDICATIONS

- hereditary or idiopathic angioedema;

- angioedema with use of other ACE inhibitors (in the anamnesis);

- Pregnancy;

- lactation period (breastfeeding);

- age under 18 years (effectiveness and safety not established);

- lactose intolerance, lactase deficiency or glucose malabsorption / galactose syndrome;

- hypersensitivity to fosinopril and other components of the drug.

Caution should be given to the drug for kidney failure;
hyponatremia (risk of dehydration, arterial hypotension, chronic renal failure); bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney; aortic stenosis; condition after kidney transplantation; with desensitization; systemic diseases of connective tissue (including systemic lupus erythematosus, scleroderma) due to increased risk of developing neutropenia or agranulocytosis; with hemodialysis; with cerebrovascular diseases (including cerebral circulatory insufficiency); IHD; chronic heart failure of III-IV functional class according to NYHA classification; diabetes mellitus;oppression of bone marrow hematopoiesis; hyperkalemia; gout; observance of a diet with salt restriction; Conditions accompanied by a decrease in BCC (including diarrhea, vomiting, previous treatment with diuretics); in elderly patients.
PREGNANCY AND LACTATION

Fosinap ® is contraindicated in pregnancy.
The use of the drug in the II and III trimesters of pregnancy causes damage or death of the developing fetus. For newborns whose mothers took ACE inhibitors in pregnancy, careful monitoring is recommended for the timely detection of arterial hypotension, oliguria and hyperkalemia.
Because fosinoprilat is excreted in breast milk, if you need to use the drug during lactation, breastfeeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function
correction of the dosing regimen is not required.
With co-administration, the drug should be given to patients with renal insufficiency, with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney;
after kidney transplantation.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with violations of liver function correction of the dosing regimen is not required.

APPLICATION FOR CHILDREN

The use of the drug in children and adolescents under the age of 18 is contraindicated (efficacy and safety not established).

APPLICATION IN ELDERLY PATIENTS

Elderly patients are not required to adjust the dosage regimen, however, caution should be used to prescribe the drug.

SPECIAL INSTRUCTIONS

Before the start of treatment, it is necessary to conduct an analysis of previous antihypertensive therapy, the degree of blood pressure increase, the restriction in the diet of salt and / or fluid, and other clinical situations.

If possible, the previous antihypertensive treatment should be discontinued a few days before the start of treatment with Fosinap ® .

To reduce the likelihood of arterial hypotension, diuretics should be discontinued 2-3 days before the start of treatment with Fozinap ® .

Before and during treatment with Fosinap ®, it is necessary to monitor blood pressure, kidney function, potassium ion, creatinine, urea concentration, electrolyte concentration and hepatic transaminase activity in the blood.

It was reported on the development of angioedema in patients with fosinopril.
With the spreading edema of the tongue, throat or larynx, airway obstruction can develop with a possible fatal outcome. In case of development of such reactions, it is necessary to stop taking the drug and take emergency measures, including. n / to enter a solution of epinephrine (adrenaline) (1: 1000).
Rarely, edema of the intestinal mucosa was observed during the application of ACE inhibitors.
Edema of the intestinal mucosa should be taken into account when conducting differential diagnosis in patients with complaints of abdominal pain while treating with ACE inhibitors. Symptoms disappeared after the cessation of the use of ACE inhibitors.
Against the background of therapy with ACE inhibitors, it is possible to develop anaphylactic reactions during hemodialysis using high-permeability membranes, as well as during LDLP plasmapheresis with adsorption on dextran sulfate.
In such cases, the use of dialysis membranes of a different type or other medication should be considered.
Perhaps the development of agranulocytosis and suppression of bone marrow function during treatment with ACE inhibitors.
These cases are more often observed in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (including systemic lupus erythematosus or scleroderma).Before the beginning of therapy with ACE inhibitors and during the treatment, the total number of leukocytes and the leukocyte formula (1 time / month in the first 3-6 months of treatment and in the first year of use in patients with an increased risk of neutropenia) are monitored.
Symptomatic arterial hypotension with ACE inhibitors most often develops in patients after intensive treatment with diuretics, adherence to a diet with limited salt intake or with renal dialysis.
Transient arterial hypotension is not a contraindication for the further use of the drug.
In patients with arterial hypertension with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, and also with the simultaneous use of diuretics in patients with unchanged renal function during treatment with ACE inhibitors, the concentration of urea nitrogen and serum creatinine may increase.
If these effects do not pass after discontinuation of treatment, it is necessary to reduce the dose of the drug Fosinap ® and / or diuretic.
In some cases, in patients with severe chronic heart failure, treatment with ACE inhibitors may cause a more pronounced antihypertensive effect, which can lead to oliguria or azotemia with a fatal outcome.
Therefore, in the treatment of chronic heart failure with the drug Fozinap ® , monitoring of the patients' condition is necessary, especially during the first 2 weeks of treatment, as well as with any increase in the dose of the drug Fosinap ® or diuretic.
If there is noticeable icterus and a marked increase in the activity of hepatic transaminases, therapy with Fosinap ® should be discontinued and appropriate treatment should be prescribed.

ACE inhibitors can increase the antihypertensive effect of the drugs used for general anesthesia.
Before surgical intervention (including in dentistry), it is necessary to warn an anesthesia doctor about the use of ACE inhibitors.
Care should be taken when doing physical exercises or in hot weather because of the risk of dehydration and arterial hypotension due to a decrease in BCC.

Impact on the ability to drive vehicles and manage mechanisms

Care must be taken when driving vehicles or performing other work requiring increased concentration of attention.
possibly development of dizziness, especially after taking the initial dose of the drug Fozinap ® .
OVERDOSE

Symptoms: excessive decrease in blood pressure, bradycardia, shock, disturbance of water-electrolyte balance, acute renal failure, stupor.

Treatment: the drug should be discontinued, gastric lavage, intake of sorbents (for example, activated carbon), vasopressor drugs, infusion of 0.9% sodium chloride solution and further symptomatic and supportive treatment.
The use of hemodialysis is ineffective.
DRUG INTERACTION

Simultaneous use of antacids (including aluminum hydroxide, magnesium hydroxide) can reduce the absorption of fosinopril (fosinopril and these drugs should be taken at intervals of at least 2 hours).

In patients receiving fosinopril simultaneously with lithium preparations, an increase in the concentration of lithium in the blood plasma and the risk of lithium intoxication are possible (it is necessary to monitor the concentration of lithium in the blood plasma).

When prescribing fosinopril, it should be taken into account that indomethacin and other NSAIDs (including acetylsalicylic acid in a dose exceeding 3 g and COX-2 inhibitors) can reduce the antihypertensive effect of ACE inhibitors, especially in patients with low-grade arterial hypertension.

When combined with fosinopril with diuretics or in combination with a strict diet that limits sodium intake or hemodialysis, it is possible to develop severe arterial hypotension, especially in the first hour after taking the initial dose of fosinopril.

When combined fosinopril with potassium preparations, potassium-sparing diuretics (including amiloride, spironolactone, triamterene), with additives to food containing potassium, increases the risk of hyperkalemia.
In patients with chronic heart failure, diabetes mellitus, concomitantly taking potassium-sparing diuretics, potassium preparations, potassium-containing salt substitutes, or other agents that cause hyperkalemia (eg, heparin), ACE inhibitors increase the risk of developing hyperkalemia.
Fosinopril enhances the hypoglycemic effect of derivatives of sulfonylurea, insulin.

With simultaneous use with allopurinol, cytostatic agents, immunosuppressants, procainamide, the risk of developing leukopenia increases.

Estrogens weaken the hypotensive effect of fosinopril because of its ability to retain fluid.

Antihypertensive drugs, opioid analgesics, medicines for general anesthesia increase the hypotensive effect of fosinopril.

Bioavailability of fosinopril with simultaneous application with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propanthelin bromide, digoxin, acetylsalicylic acid and warfarin does not change.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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