Description
Release form
Tablets
Packing
28 pcs.
Pharmacological action
Fosinap – an ACE inhibitor. It has hypotensive, vasodilating, diuretic and potassium-sparing effects. Fosinopril prevents the conversion of angiotensin I into a vasoconstrictor substance, angiotensin II, as a result of which the vasopressor activity and aldosterone secretion are reduced, which can lead to a slight increase in the content of potassium ions in blood serum with the simultaneous loss of sodium and liquid ions by the body. As a result, total peripheral vascular resistance and systemic blood pressure (BP) are reduced. Suppresses aldosterone synthesis, inhibits tissue ACE.
Fosinopril inhibits the metabolic degradation of bradykinin, which has a powerful vasopressor effect, due to which the antihypertensive effect of the drug can be enhanced.
A decrease in blood pressure is not accompanied by a change in the volume of circulating blood, cerebral and renal blood flow, blood supply to the internal organs, skeletal muscles, skin, and reflex activity of the myocardium. With arterial hypertension and left ventricular hypertrophy, treatment leads to a decrease in the mass of the left ventricle 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 to 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. ACE inhibition leads to a decrease in both preload and afterload on the myocardium.
Fosinopril helps increase exercise tolerance, reduce the severity of chronic heart failure.
Contraindications
hypersensitivity to fosinopril and other components of the
preparation hereditary or idiopathic angioedema
angioedema with other ACE inhibitors (history)
lactose deficiency or lactose deficiency (18 years old) -galactase malabsorption.
Use with caution in case of renal insufficiency, hyponatremia (risk of dehydration, arterial hypotension, chronic renal failure), bilateral renal artery stenosis or artery stenosis of a single kidney, aortic stenosis, condition after kidney transplantation during desensitization of systemic diseases of the connective tissue (including systemic lupus erythematosus, scleroderma) due to an increased risk of neutropenia or agranulocytosis during hemodialysis in cerebrovascular diseases (including cerebrovascular insufficiency) ischemic heart disease of chronic heart failure III-IV functional class according to NYHA diabetes mellitus inhibition of bone marrow hematopoiesis of hyperkalemia in elderly patients with gout diets with salt restriction in conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting, previous e treatment with diuretics).
Pregnancy and lactation
Fosinopril is contraindicated in pregnancy. The use of the drug in the II and III trimesters of pregnancy causes damage or death to the developing fetus.
For newborns whose mothers took ACE inhibitors during pregnancy, careful monitoring is recommended for the timely detection of arterial hypotension, oliguria and hyperkalemia.
Since fosinoprilat is excreted in breast milk, if it is necessary to use the drug during lactation, breastfeeding should be discontinued.
Special instructions
Before starting treatment, an analysis of previous antihypertensive therapy, the degree of increase in blood pressure, dietary restrictions on salt and / or liquid, and other clinical situations is required.
If possible, previous antihypertensive treatment should be discontinued several days before the start of Fozinap treatment.
To reduce the likelihood of arterial hypotension, diuretics should be canceled 2-3 days before the start of treatment with Fosinap.
Before and during treatment with Fosinap, it is necessary to control blood pressure, kidney function, the content of potassium, creatinine, urea ions, the concentration of electrolytes and the activity of ² Ñliver ² Ñ transaminases in the blood.
The development of angioedema in patients with fosinopril has been reported. With spreading edema of the tongue, pharynx or larynx, airway obstruction can develop with a possible fatal outcome. In the case of the development of such reactions, it is necessary to stop taking the drug and take emergency treatment measures, including inject a solution of epinephrine (adrenaline) subcutaneously (1: 1000).
While taking ACE inhibitors, in rare cases, swelling of the intestinal mucosa was noted. Swelling of the intestinal mucosa should be taken into account in the differential diagnosis in patients with complaints of abdominal pain during treatment with ACE inhibitors. Symptoms disappeared after stopping the use of ACE inhibitors.
During therapy with ACE inhibitors, anaphylactic reactions may develop during hemodialysis through high-flow membranes, as well as during plasmapheresis of low-density lipoproteins adsorbed on dextran sulfate. In such cases, the use of a different type of dialysis membrane or other drug treatment should be considered.
Agranulocytosis and suppression of bone marrow function during treatment with ACE inhibitors are possible. These cases are more often observed in patients with impaired renal function, especially in the presence of systemic diseases of the connective tissue (including systemic lupus erythematosus or scleroderma). Before starting therapy with ACE inhibitors and during treatment, the total number of leukocytes and leukocyte formula is monitored (once a month in the first 3-6 months of treatment and in the first year of use of the drug in patients with an increased risk of neutropenia).
Symptomatic arterial hypotension with the use of ACE inhibitors most often develops in patients after intensive treatment with diuretics, a diet that restricts salt intake, or during renal dialysis. Transient arterial hypotension is not a contraindication for further use of the drug.
In patients with arterial hypertension with bilateral renal artery stenosis or stenosis of a single kidney artery, as well as 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 disappear after discontinuation of treatment, it is necessary to reduce the dose of Fosinap and / or diuretic.
In some cases, in patients with severe chronic heart failure, treatment with ACE inhibitors can cause a more pronounced antihypertensive effect, which can lead to fatal oliguria or azotemia. Therefore, in the treatment of chronic heart failure with Fozinap, monitoring of patients is necessary, especially during the first 2 weeks of treatment, as well as with any increase in the dose of Fosinap or diuretic.
If noticeable jaundice and a marked increase in the activity of ² Ñhepatic ² Ñ transaminases appear, the therapy with Fosinap should be discontinued and appropriate treatment should be prescribed.
ACE inhibitors can enhance the hypotensive effect of drugs used for general anesthesia. Before surgery (including dentistry), it is necessary to warn the anesthetist about the use of ACE inhibitors.
Caution should be exercised when exercising or in hot weather because of the risk of dehydration and arterial hypotension due to a decrease in circulating blood volume.
Influence on the ability to drive vehicles and operate mechanisms
Care must be taken when driving vehicles or performing other work that requires increased attention, since dizziness is possible, especially after taking the initial dose of Fozinap.
Composition
1 tablet contains:
active substance:
fosinopril sodium 20.00 mg
excipients:
silicon dioxide colloidal (aerosil) 1.0 mg
croscarmellose sodium (primrose) 5.7 mg lactose (srdlk) 97.3 mg
macrogol (polyethylene glycol 4000) 1.0 mg
sodium stearyl fumarate 1.5 mg,
povidone (collidone 30) 10.5 mg
microcrystalline cellulose 73.0 mg.
Dosage and administration
The drug Fozinap is prescribed orally, regardless of food intake. Take without chewing, with a small amount of liquid. The dose is set individually.
For arterial hypertension, the recommended starting dose is 10 mg 1 time / day.
The dose should be selected depending on the dynamics of lowering blood pressure. Doses vary from 10 to 40 mg 1 time / day. The maximum daily dose is 40 mg.
In chronic heart failure, the recommended starting dose is 5 mg (1/2 tablet 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 elderly patients, do not need to adjust the dosage regimen of Fosinap.
Side effects of
From the cardiovascular system: marked decrease in blood pressure, orthostatic hypotension, collapse, tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction, flushing of the face, fainting, cardiac arrest.
From the urinary system: the development or worsening of the symptoms of chronic renal failure, proteinuria.
From the central and peripheral nervous system: stroke, cerebral ischemia, dizziness, headache, weakness, memory impairment when used in high doses – insomnia, anxiety, depression, confusion, drowsiness, paresthesia.
On the part of the sensory organs: hearing and vision impairment, tinnitus.
From the digestive system: nausea, diarrhea, intestinal obstruction, pancreatitis, hepatitis, cholestatic jaundice, abdominal pain, vomiting, constipation, anorexia, stomatitis, glossitis, dysphagia, flatulence, impaired appetite, changes in body weight, dry mouth, intestinal edema (very rare).
From the respiratory system: dry cough, pulmonary infiltrates, bronchospasm, shortness of breath, rhinorrhea, pharyngitis, dysphonia, nosebleeds.
From the hemopoietic organs: lymphadenitis.
From the musculoskeletal system: arthritis.
Metabolism: gout.
Allergic reactions: skin rash, itching, angioedema.
On the part of laboratory indicators: hypercreatininemia, increased urea concentration, increased activity of liver transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia, decreased hemoglobin and hematocrit concentrations, increased erythrocyte sedimentation rate, leukopenia, neutropenia, eosinophilia.
Effect on the fetus: impaired development of the kidneys of the fetus, decrease in blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, hypoplasia of the bones of the skull, oligohydramnios, limb contractures, hypoplasia of the lungs.
Drug Interactions
The simultaneous use of antacids (including aluminum hydroxide, magnesium hydroxide) can reduce the absorption of fosinopril (fosinopril and these funds should be taken with an interval of at least 2 hours).
In patients receiving fosinopril concurrently with lithium preparations, an increase in the concentration of lithium in the blood plasma and a risk of lithium intoxication are possible (it is necessary to control the concentration of lithium in the blood plasma).
When prescribing fosinopril, it should be borne in mind that indomethacin and other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid in a dose exceeding 3 g, and cyclooxygenase-2 inhibitors) can reduce the antihypertensive effect of ACE inhibitors, especially in patients with low hypertensive artery.
With the combined use of fosinopril with diuretics or in combination with a strict diet that limits sodium intake, or with hemodialysis, severe arterial hypotension may develop, especially in the first hour after taking the initial dose of fosinopril.
With the combined use of fosinopril with potassium preparations, potassium-sparing diuretics (including with amiloride, spironolactone, triamteren), with food supplements containing potassium, the risk of developing hyperkalemia increases. In patients with chronic heart failure, diabetes mellitus, while taking potassium-sparing diuretics, potassium, potassium salt substitutes or other agents that cause hyperkalemia (for example, heparin), ACE inhibitors increase the risk of hyperkalemia.
Fosinopril enhances the hypoglycemic effect of sulfonylurea derivatives, insulin.
With simultaneous use with allopurinol, cytostatic agents, immunosuppressants, procainamide, the risk of developing leukopenia increases.
Estrogens weaken the hypotensive effect of fosinopril due to its ability to retain fluid.
Antihypertensive drugs, opioid analgesics, drugs for general anesthesia enhance the hypotensive effect of fosinopril.
The bioavailability of fosinopril when used concurrently with chlortalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propantheline bromide, digoxin, acetylsalicylic acid and warfarin does not change.
Overdose
Symptoms: severe BP, bradycardia, shock, water-electrolyte disturbance, acute renal failure, stupor.
Treatment: The drug should be discontinued, gastric lavage, sorbents (eg, activated carbon), vasopressors, infusion of 0.9% sodium chloride solution and further symptomatic and supportive treatment. Hemodialysis is ineffective.
Storage Conditions
In a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Shelf life
2 years.
Deystvuyushtee substance
Fosinopril
Terms and conditions
prescription
dosage form
tablets
Possible product names
Fosinap tablets 20 mg 28 pcs.
Kanonfarma, Russia
