Description
Release form
Granules for preparation drdfro46 inside d1froaf46 d80 for administration
tablets.
Packing
28 tablets.
Pharmacological action of
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.
Indications
– arterial hypertension (as monotherapy or as part of combination therapy)
– chronic heart failure (as part of combination therapy).
Contraindications
– hypersensitivity to fosinopril and other components of the drug Fosinap
– hereditary or idiopathic angioneurotic edema
– angioedema with other ACE inhibitors (a history of) sperlc years (efficacy and safety not established)
– lactose intolerance, lactase deficiency or glucose-galactase malabsorption.
With caution, Fosinap is used for renal failure of hyponatremia (risk of dehydration, arterial hypotension, chronic renal failure) bilateral renal artery stenosis or artery stenosis of a single kidney aortic stenosis is a condition after kidney transplantation during desensitization of systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma) due to an increased risk of neutropenia or agranulocytosis during hemodialysis in cerebrovascular disease including cerebrovascular insufficiency) coronary heart disease chronic heart failure III-IV function NYHA classification of diabetes mellitus inhibition of bone marrow hematopoiesis of hyperkalemia in elderly patients with gout on a diet with a salt restriction in conditions accompanied by a decrease in circulating blood volume (including diarrhea, vomiting, previous treatment with diuretics).
Pregnancy and lactation
Fosinopril is contraindicated in pregnancy. The use of the drug Fozinap 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, it is recommended that careful monitoring is carried out to timely detect arterial hypotension, oliguria and hyperkalemia.
Since fosinoprilat is excreted in breast milk, if it is necessary to use the drug Fozinap during lactation, breastfeeding should be discontinued.
Special instructions
Before starting treatment, it is necessary to analyze the previous antihypertensive therapy, the degree of increase in blood pressure, dietary restrictions on salt and / or liquid and other clinical situations.
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, blood pressure, kidney function, potassium, creatinine, urea, electrolyte concentrations and hepatic transaminases in the blood should be monitored.
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, serum urea and creatinine concentrations may increase during treatment with ACE inhibitors. 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 the drug Fozinap, patient monitoring is necessary, especially during the first 2 weeks of treatment, as well as with any increase in the dose of Fozinap or diuretic.
If noticeable jaundice and a marked increase in the activity of “hepatic” 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 control mechanisms:
Care must be taken when driving vehicles or performing other work requiring increased attention, because dizziness may develop, especially after taking the initial dose of Fosinap.
Composition
1 tablet: – fosinopril sodium 10 mg.
Dosage and administration
Fosinap is prescribed orally, regardless of food intake. thyroid dose.
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, loss of appetite, change in body weight, dry mouth very rarely).
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, decreased 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 interaction
The simultaneous use of antacids (including aluminum hydroxide, magnesium hydroxide) can reduce the absorption of fosinopril (fosinopril and these funds should be taken at least 2 hours apart).
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-rhenin arterial hypertension.
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-containing salt substitutes or other means, causing hyperkalemia (e.g. heparin), ACE inhibitors increase the risk of hyperkalemia.
Fosinopril enhances the hypoglycemic effect of sulfonylurea derivatives, insulin.
With the simultaneous use of Fozinap with allopurinol, cytotoxic drugs, 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, impaired electro-electrolyte status, acute renal failure, stupor.
Treatment: The drug should be discontinued, gastric lavage, sorbents (eg, activated carbon), vasopressor agents, infusion of 0.9% sodium chloride solution followed and symptomatic and supportive treatment indicated. Hemodialysis is ineffective.
Active ingredient
Fosinopril
Form of Treatment
tablets
Kanonfarma, Russia
