Fosinap pills 10mg, 28pcs

Composition

of 1 tab. : – fosinopril sodium 10 mg

Pharmacological action

Fosinap is an ACE inhibitor. It has antihypertensive, vasodilating, diuretic and potassium-sparing effects. Fosinopril interferes with the conversion of angiotensin I into the vasoconstrictor substance angiotensin II, as a result of which vasopressor activity and aldosterone secretion are reduced, which can lead to a slight increase in the content of potassium ions in the blood serum with simultaneous loss of sodium ions and fluid by the body. As a result, total peripheral vascular resistance and systemic arterial pressure (BP) are reduced. 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.

A decrease in blood pressure is not accompanied by changes in the volume of circulating blood, cerebral and renal blood flow, blood supply to internal organs, skeletal muscles, skin, and reflex activity of the myocardium. In patients 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 use, the hypotensive effect develops within 1 hour, reaches a maximum in 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 increases exercise tolerance and reduces the severity of chronic heart failure.

Indications

-arterial hypertension (in monotherapy or in combination therapy);- chronic heart failure (as part of combination therapy).

Contraindications

-hypersensitivity to fosinopril and other components of the drug Fosinap;- hereditary or idiopathic angioedema; – angioedema with the use of other ACE inhibitors (in the anamnesis);- pregnancy; – lactation period (breastfeeding);- age up to 18 years (efficacy and safety have not been established);- lactose intolerance, lactase deficiency, or glucose-galactase malabsorption.

With caution, Fosinap is used for renal failure; hyponatremia (risk of dehydration, hypotension, chronic renal failure); bilateral renal artery stenosis or stenosis of the artery of a single kidney; aortic stenosis; condition after kidney transplantation; desensitization; systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma) due to an increased risk of neutropenia or agranulocytosis; hemodialysis; cerebrovascular diseases (including cerebral circulatory insufficiency); ischemic heart disease; chronic heart failure of NYHA functional class III-IV; diabetes mellitus; suppression of bone marrow hematopoiesis; hyperkalemia; in elderly patients; gout; against the background of a diet with salt restriction; in conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting, previous treatment with diuretics).

Side effects

From the cardiovascular system: marked decrease in blood pressure, orthostatic hypotension, collapse, tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction, “flushes” of blood to the skin of the face, fainting, cardiac arrest.

From the urinary system: development or aggravation of symptoms of chronic renal failure, proteinuria.

From the central and peripheral nervous system: stroke, cerebral vascular ischemia, dizziness, headache, weakness, memory impairment; when used in high doses – insomnia, anxiety, depression, confusion, drowsiness, paresthesia.

From the sensory organs: hearing and vision disorders, 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, weight loss, dry mouth; intestinal edema (very rare).

From the respiratory system: “dry” cough, pulmonary infiltrates, bronchospasm, shortness of breath, rhinorrhea, pharyngitis, dysphonia, nosebleeds.

Hematopoietic disorders: lymphadenitis.

Musculoskeletal disorders: arthritis.

From the side of metabolism: gout.

Allergic reactions: skin rash, pruritus, angioedema.

From the laboratory parameters: hypercreatininemia, increased urea concentration, increased activity of “hepatic” transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia; decreased hemoglobin and hematocrit concentrations, increased erythrocyte sedimentation rate, leukopenia, neutropenia, eosinophilia.

Effects on the fetus: impaired renal development of the fetus, decreased blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, hypoplasia of the skull bones, oligohydramnios, contractures of the extremities, hypoplasia of the lungs.

Interaction

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

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

When prescribing fosinopril, it should be taken into account that Indometacin and other nonsteroidal 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-renin arterial hypertension.

When fosinopril is co-administered with diuretics or in combination with a strict diet that restricts sodium intake, or with hemodialysis, severe hypotension may develop, especially in the first hour after taking the initial dose of fosinopril.

When fosinopril is co-administered with potassium preparations, potassium-sparing diuretics (including amiloride, spironolactone, triamterene), and food supplements containing potassium, the risk of hyperkalemia increases. In patients with chronic heart failure, diabetes mellitus, and concomitant use of potassium-sparing diuretics, potassium-containing salt substitutes, or other agents that cause hyperkalemia (for example, heparin), ACE inhibitors increase the risk of hyperkalemia.

Fosinopril enhances the hypoglycemic effect of sulfonylureas and insulin derivatives.

Concomitant use of Fosinap with allopurinol, cytostatic agents, immunosuppressants, procainamide increases the risk of leukopenia.

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

Antihypertensive agents, opioid analgesics, and drugs for general anesthesia enhance the hypotensive effect of fosinopril.

The bioavailability of fosinopril when co-administered with chlortalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propantelin bromide, digoxin, acetylsalicylic acid and warfarin does not change.

How to take, course of use and dosage

The drug Fosinap is prescribed orally, regardless of food intake. Take without chewing, with a small amount of liquid. The dose is set individually.

In patients 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 reduction. Doses vary from 10 to 40 mg 1 time/day. The maximum daily dose is 40 mg.

In patients with 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 hepatic function, as well as elderly patients, do not need to adjust the dosage regimen of Fosinap.

Overdose

Symptoms: marked decrease in blood pressure, bradycardia, shock, violation of the water-electrolyte state, acute renal failure, stupor.

Treatment: the drug should be discontinued, gastric lavage is indicated, taking sorbents (for example, activated carbon), vasopressors, infusions of 0.9% sodium chloride solution, and then symptomatic and supportive treatment. The use of hemodialysis is ineffective.

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 starting treatment with Fosinap.

To reduce the likelihood of hypotension, diuretics should be discontinued 2-3 days before starting treatment with Fosinap.

Before and during treatment with Fosinap, it is necessary to monitor blood pressure, kidney function, potassium, creatinine, urea, electrolyte concentrations, and the activity of “hepatic” transaminases in the blood.

Angioedema has been reported in patients receiving fosinopril. With spreading edema of the tongue, pharynx or larynx, airway obstruction can develop with a possible fatal outcome.In case of such reactions, it is necessary to stop taking the drug and take emergency therapy measures, including subcutaneous injection of epinephrine (epinephrine) solution (1: 1000).

While taking ACE inhibitors, edema of the intestinal mucosa was observed in rare cases. Edema of the intestinal mucosa should be considered in the differential diagnosis of patients with complaints of abdominal pain during treatment with ACE inhibitors. Symptoms disappeared after discontinuation of ACE inhibitors.

Against the background of ACE inhibitor therapy, anaphylactic reactions may develop during hemodialysis through high-flow membranes, as well as during plasmapheresis of low-density lipoproteins with adsorption on dextran sulfate. In such cases, a different type of dialysis membrane or other medical treatment should be considered.

Agranulocytosis and suppression of bone marrow function may occur during treatment with ACE inhibitors. These cases are more common in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (including systemic lupus erythematosus or scleroderma). Before starting therapy with ACE inhibitors and during treatment, the total number of leukocytes and the leukocyte formula are monitored (1 time per month in the first 3-6 months of treatment and in the first year of using the drug in patients with an increased risk of neutropenia).

Symptomatic hypotension associated with the use of ACE inhibitors is most common 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 hypertensive patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, as well as with the simultaneous use of diuretics in patients with unchanged renal function, the concentration of urea nitrogen and serum creatinine may increase during treatment with ACE inhibitors. If these effects persist after discontinuation of treatment, then 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 may cause a more pronounced antihypertensive effect, which may lead to oliguria or azotemia with a fatal outcome. Therefore, when treating chronic heart failure with Fosinap, it is necessary to monitor patients, especially during the first 2 weeks of treatment, as well as with any increase in the dose of Fosinap or a diuretic.

If there is noticeable jaundice and a marked increase in the activity of “hepatic” transaminases, therapy with Fosinap should be discontinued and appropriate treatment should be prescribed.

ACE inhibitors may increase the antihypertensive effect of drugs used for general anesthesia. Before surgery (including dentistry), it is necessary to warn the anesthesiologist about the use of ACE inhibitors.

Caution should be exercised when exercising or in hot weather because of the risk of dehydration and hypotension due to a decrease in the volume of circulating blood.

Influence on the ability to drive motor vehicles and manage mechanisms:

Caution should be exercised when driving vehicles or performing other work that requires increased attention, as dizziness may develop, especially after taking the initial dose of Fosinap.

Active ingredient

Fosinopril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Heart Failure