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Fosinopril, 20 mg, tablets, 28 pcs.

2-3 days before starting treatment with fosinopril, it is recommended to discontinue previous diuretic therapy, with the exception of patients with malignant or difficult-to-treat hypertension. In such cases, fosinopril therapy should be started immediately, at a reduced dose, with close medical supervision and careful dose escalation.

Symptomatic hypotension with the use of ACE inhibitors most often develops in patients after intensive treatment with diuretics, a diet limiting salt intake, or during renal dialysis. Transient arterial hypotension is not a contraindication for continuing treatment after measures to restore blood volume.

In patients with chronic heart failure, treatment with ACE inhibitors may cause excessive antihypertensive effects, which can lead to oliguria or azotemia, which can be fatal. Therefore, when treating patients with chronic heart failure with fosinopril, careful clinical monitoring is necessary, especially during the first 2 weeks of treatment, as well as with any increase in the dose of fosinopril or diuretic.

ACE inhibitors rarely cause swelling of the intestinal mucosa. In this case, patients experience abdominal pain (sometimes without nausea and vomiting), facial swelling may also be absent, and the level of C1-esterases is normal. After stopping taking ACE inhibitors, symptoms disappear. Swelling of the intestinal mucosa should be taken into account in the differential diagnosis of patients with abdominal pain while taking ACE inhibitors.

During treatment with ACE inhibitors during hemodialysis using highly permeable membranes, as well as during LDL apheresis with adsorption on dextran sulfate, anaphylactic reactions may develop. In these cases, the use of a different type of dialysis membrane or other antihypertensive therapy should be considered.

It is possible to develop agranulocytosis and suppression of bone marrow function during treatment with ACE inhibitors. These cases occur more often in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (systemic lupus erythematosus or scleroderma). Before starting therapy with ACE inhibitors and during treatment, the total number of leukocytes and the leukocyte formula are determined (once a month in the first 3-6 months of treatment and in the first year of treatment in patients with an increased risk of neutropenia).

If noticeable jaundice and a marked increase in liver enzyme activity occur, fosinopril treatment should be discontinued and appropriate treatment should be prescribed.

In case of arterial hypertension in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, as well as with the simultaneous use of diuretics without signs of renal impairment during treatment with ACE inhibitors, the concentration of blood urea nitrogen and serum creatinine may increase. These effects are usually reversible and disappear after treatment is stopped. A dose reduction of diuretic and/or fosinopril may be required.

In patients with severe chronic heart failure with altered RAAS activity, treatment with ACE inhibitors can lead to oliguria, progressive azotemia and, in rare cases, acute renal failure and possible death.

During fosinopril therapy, the patient should be careful when performing physical exercise or in hot weather due to the risk of dehydration and hypotension due to a decrease in blood volume.

No special adjustment of the fosinopril dosage regimen is required in elderly patients. Safety of use in children has not been established.

Before and during treatment with the drug, it is necessary to monitor blood pressure, kidney function, potassium levels, hemoglobin levels, creatinine, urea, electrolyte concentrations and the activity of liver transaminases in the blood.

Influence on the ability to drive vehicles and operate machinery.

Caution is required when driving vehicles or performing other work that requires increased attention, because Dizziness may occur, especially after the initial dose of fosinopril.

Pharmacological properties of the drug Fozinopril

ACE inhibitor. Reduces the formation of angiotensin II from angiotensin I, which leads to a decrease in peripheral vascular resistance and systemic blood pressure. Suppresses the synthesis of aldosterone in the adrenal glands. The onset of therapeutic action is observed 1 hour after oral administration, the maximum reduction in blood pressure is achieved within 3–6 hours. The hypotensive effect persists for 24 hours, however, it may take 2–3 weeks to achieve a stable hypotensive effect in some patients. During long-term treatment, the effect persists. After oral administration, about 36% of fosinopril is absorbed in the digestive tract; the degree of absorption does not depend on food intake. Hydrolysis of fosinopril with the formation of pharmacologically active fosinoprilat occurs in the mucous membrane of the digestive tract and partially in the liver. The maximum concentration of fosinoprilat in blood plasma is achieved after 3 hours. Plasma protein binding is 95%. Does not penetrate the BBB. Fosinoprilat is excreted unchanged in urine and bile. The half-life is 11.5 hours. In patients with renal failure, there is no noticeable change in the pharmacokinetics of fosinopril due to a compensatory increase in its excretion by the liver. In patients with impaired liver function, a slight decrease in the hydrolysis of fosinopril is possible. There is evidence of a compensatory increase in the excretion of fosinopril by the kidneys with a simultaneous decrease in the hepatic clearance of fosinopril in this category of patients.

Side effects of the drug Fozinopril

from the digestive system: rarely - nausea, vomiting, dyspepsia, increased activity of liver transaminases; cases of pancreatitis and hepatitis have been described; from the respiratory system: cough, rarely - pharyngitis, laryngitis, sinusitis, bronchospasm; from the cardiovascular system: palpitations, chest pain, rarely - orthostatic hypotension, collapse, hot flashes, arrhythmia; allergic and immunological reactions - skin rash, itching, photosensitivity, angioedema, myalgia, arthralgia; from the urinary system - proteinuria, oliguria, disorders of excretory function, accompanied by an increase in the concentration of creatinine and urea in the blood plasma; other reactions - dizziness, fatigue, impaired taste and other types of sensitivity.

Special instructions for the use of the drug Fozinopril

Prescribe with caution to patients with renovascular hypertension, heart failure, patients on hemodialysis, as well as patients with hypovolemia and/or reduced plasma osmolarity of any etiology due to the increased risk of developing side effects from the kidneys. In order to reduce the risk of arterial hypotension, diuretics should be discontinued 2-3 days before fosinopril is prescribed and the water and electrolyte balance should be corrected. In patients with left ventricular hypertrophy, long-term use of fosinopril leads to a decrease in left ventricular mass and a decrease in the thickness of the interventricular septum. After discontinuation of fosinopril, no withdrawal syndrome (sharp increase in blood pressure) is observed. The safety and effectiveness of fosinopril in pediatric practice has not been established. No special adjustment of the fosinopril dosage regimen is required in elderly patients. Women of reproductive age receiving fosinopril should use reliable contraception.

Fozinap® (10mg, 20mg)

Arterial hypotension

In patients with uncomplicated arterial hypertension, arterial hypotension may develop due to the use of fosinopril. Symptomatic arterial hypotension when using ACE inhibitors more often develops in patients during intensive treatment with diuretics, a diet associated with limiting sodium chloride, or during dialysis. Transient arterial hypotension is not a contraindication for the use of fosinopril after measures to restore blood volume.

In patients with chronic heart failure, treatment with ACE inhibitors may cause excessive antihypertensive effects, which can lead to oliguria or azotemia and, in rare cases, to fatal acute renal failure. Therefore, when treating chronic heart failure with fosinopril, patients should be closely monitored, especially during the first 2 weeks of treatment, as well as with any increase in the dose of fosinopril or diuretic.

It may be necessary to reduce the diuretic dose in patients with normal or low blood pressure, who have previously received diuretic therapy, or who have hyponatremia. Arterial hypotension as such is not a contraindication for further use of fosinopril in chronic heart failure. Some reduction in systemic blood pressure is a common and desirable effect when initiated in chronic heart failure. The extent of this reduction is greatest early in treatment and stabilizes within one or two weeks of starting treatment. Blood pressure usually returns to baseline levels without a decrease in therapeutic efficacy.

Before starting treatment, it is necessary to analyze previous antihypertensive therapy, the degree of increase in blood pressure, dietary restrictions on salt and/or liquid, and other clinical circumstances. If possible, previous antihypertensive therapy should be discontinued several days before starting treatment. To reduce the likelihood of arterial hypotension, diuretics should be discontinued 2-3 days before starting treatment. Before and during treatment, it is necessary to monitor blood pressure, renal function, the content of potassium ions, creatinine, urea, electrolyte concentrations and the activity of liver enzymes in the blood.

Aortic or mitral stenosis/hypertrophic obstructive cardiomyopathy

Like all drugs that have a vasodilating effect, ACE inhibitors should be used with extreme caution in patients with left ventricular outflow tract obstruction.

Renal dysfunction

In patients with arterial hypertension with unilateral or bilateral renal artery stenosis or stenosis of the artery of a solitary kidney, the concentration of blood urea nitrogen and serum creatinine may increase during treatment with ACE inhibitors. These effects are usually reversible and disappear after treatment is stopped. It is necessary to monitor renal function in such patients in the first weeks of treatment. In some patients, increases in blood urea nitrogen and serum creatinine concentrations (usually small and transient) may be observed even without obvious renal impairment during concomitant use of fosinopril and diuretics. A dose reduction of fosinopril may be required.

In patients with severe chronic heart failure, renal function may be dependent on the activity of the renin-angiotensin-aldosterone system, so treatment with ACE inhibitors may be accompanied by oliguria and/or progressive azotemia, and in rare cases, acute renal failure and death.

Kidney transplant

There is no experience with the use of fosinopril in patients who have recently undergone kidney transplantation.

Liver dysfunction

In rare cases, when using ACE inhibitors, a syndrome is observed, the first manifestation of which is cholestatic jaundice. This is followed by fulminant liver necrosis, sometimes fatal.

The mechanism of development of this syndrome has not been studied. If noticeable icterus and a marked increase in liver enzyme activity occur, fosinopril treatment should be discontinued and appropriate treatment should be prescribed.

In patients with impaired liver function, increased plasma concentrations of fosinopril may be observed. In liver cirrhosis (including alcoholic cirrhosis), the apparent total clearance of fosinoprilat is reduced, and the AUC is approximately 2 times higher than in patients without liver dysfunction.

Neutropenia/agranulocytosis/thrombocytopenia/anemia

It is possible to develop agranulocytosis and suppression of bone marrow function during treatment with ACE inhibitors. These cases occur more often in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (SLE or scleroderma). Before starting therapy with ACE inhibitors and during treatment, leukocytes and leukocyte formula are determined (once a month in the first 3-6 months of treatment and in the first year of fosinopril use in patients with an increased risk of neutropenia).

Hypersensitivity reactions/angioedema

The development of angioedema of the extremities, face, lips, mucous membranes, tongue, pharynx or larynx has been reported in patients receiving fosinopril. Swelling of the tongue, pharynx, or larynx can cause airway obstruction, which can be fatal. In such cases, it is necessary to stop taking fosinopril and take emergency measures, including subcutaneous injection of epinephrine (adrenaline) solution (1:1000), as well as other emergency treatment measures. In most cases of swelling of the face, oral mucosa, lips and extremities, stopping fosinopril resulted in normalization of the condition; however, appropriate therapy was sometimes required.

Swelling of the intestinal mucosa

Swelling of the intestinal mucosa has rarely been observed while taking ACE inhibitors. Patients complained of abdominal pain (there may have been no nausea and vomiting); in some cases, swelling of the intestinal mucosa occurred without swelling of the face; C1-esterase activity was normal. Symptoms disappeared after stopping the use of ACE inhibitors. Edema of the intestinal mucosa should be included in the differential diagnosis of patients taking ACE inhibitors who complain of abdominal pain.

Patients with a history of angioedema not associated with ACE inhibitors may be at greater risk of developing angioedema during ACE inhibitor therapy.

In representatives of the Negroid race, cases of the development of angioedema when using ACE inhibitors were observed with a higher frequency compared to representatives of other races.

Anaphylactic reactions during desensitization

In two patients, during desensitization with hymenoptera venom while taking the ACE inhibitor enalapril, life-threatening anaphylactoid reactions were noted. In the same patients, these reactions were avoided by timely interruption of the ACE inhibitor; however, they reappeared after inadvertent resumption of an ACE inhibitor. Particular care should be taken when desensitizing patients taking ACE inhibitors.

Anaphylactoid reactions during low-density lipoprotein apheresis (LDL apheresis)

Life-threatening anaphylactoid reactions have rarely been observed in patients taking AFP inhibitors during LDL apheresis using dextran sulfate. The development of these reactions can be prevented by temporarily discontinuing the ACE inhibitor before each LDL apheresis procedure.

Hemodialysis using high-flow membranes

When performing hemodialysis in patients receiving ACE inhibitors, the use of high-flow polyacrylonitrile dialysis membranes (for example, AN69) should be avoided, since in such cases the risk of developing anaphylactoid reactions increases. In such cases, it is necessary to use a different type of dialysis membrane or use antihypertensive drugs of other classes.

Cough

When using ACE inhibitors, including fosinopril, a non-productive, persistent cough was observed, which disappeared after discontinuation of therapy. When cough occurs in patients taking ACE inhibitors, this therapy should be considered as a possible cause in the differential diagnosis.

Surgery/general anesthesia

ACE inhibitors may enhance the antihypertensive effect of drugs used for general anesthesia. Before surgery (including dentistry), you must warn your doctor/anesthesiologist about the use of ACE inhibitors. Caution should be exercised when performing physical exercise or in hot weather due to the risk of dehydration and hypotension due to a decrease in blood volume.

Hyperkalemia

There have been cases of increased levels of potassium ions in the blood serum of patients taking ACE inhibitors, including fosinopril. The risk group in this regard includes patients with renal failure, type 1 diabetes mellitus, as well as those taking potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene or amiloride), with drugs containing co-trimoxazole ([trimethoprim + sulfamethoc-

sazol]), potassium preparations, potassium-containing nutritional supplements or other drugs that increase the content of potassium ions in the blood serum. If necessary, simultaneous use of fosinopril and the above potassium-containing or increasing potassium levels in the blood plasma drugs should be used with caution and regularly monitor the potassium level in the blood serum.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS)

The simultaneous use of drugs from different groups that act on the RAAS is not recommended (dual blockade of the RAAS), since it has been associated with an increased incidence of side effects such as arterial hypotension, hyperkalemia, and decreased renal function (including acute renal failure).

The simultaneous use of ACE inhibitors with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate or severe renal impairment (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients.

Concomitant use of ACE inhibitors with angiotensin II receptor antagonists is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Ethnic differences

ACE inhibitors are less effective in blacks than in Caucasians, which may be due to the higher prevalence of low renin activity in blacks.

Impact on the ability to drive vehicles and machinery

Care must be taken when driving vehicles or performing other work that requires increased attention, because Dizziness may develop, especially after taking the initial dose of Fosinap.