Description
Release form
Tablets.
Packing
28 pcs.
Pharmacological action of
Fosicard H is a combined drug with a pronounced vasodilating, hypotensive, diuretic and potassium-sparing effect. The composition of the drug includes two active components – hydrochlorothiazide and fosinopril. The therapeutic effects and mechanism of action of the drug are based on the pharmacological properties of the active components that make up its composition.
Fosinopril – is metabolized in the body with the formation of a pharmacologically active metabolite – fosinoprilat – an angiotensin-converting enzyme inhibiting. The drug has a pronounced hypotensive effect, dilates peripheral vessels, reduces total peripheral vascular resistance. Fosinoprilat reduces the synthesis of aldosterone and inhibits the conversion of angiotensin-I to angiotensin-II.
Hydrochlorothiazide is a thiazide diuretic that increases the release of potassium and bicarbonate ions. The drug enhances diuresis, increases the activity of blood plasma renin and the synthesis of aldosterone.
The active components of the drug have an additive effect.
After oral administration, the therapeutic effect of the drug develops within 1 hour, the maximum therapeutic effect develops within 2-6 hours. The antihypertensive effect of the drug persists for 24 hours after a single dose.
The active components of the drug are well absorbed in the gastrointestinal tract, the bioavailability of fosinopril is about 30-40%, hydrochlorothiazide is about 65%. The peak concentration of fosinopril in blood plasma is noted 3 hours after oral administration. Fosinopril is characterized by a high degree of binding to plasma proteins (about 95%).
Fosinopril is excreted equally by the kidneys and liver in the form of metabolites and to a small extent unchanged, hydrochlorothiazide is almost completely excreted by the kidneys unchanged. The half-life of fosinopril is 11.5 hours, hydrochlorothiazide – 5-15 hours.
In patients with severe renal failure, the overall clearance of fosinopril is almost 50% lower than in patients with normal renal function.
There were no significant changes in the pharmacokinetics of the drug in patients with impaired liver function, as well as in elderly patients with normal renal function.
Indications
The drug is used in patients with hypertension requiring combination therapy.
Contraindications
Hypersensitivity to the drug components and other drugs of the angiotensin-converting enzyme inhibitor group and sulfonamide derivative.
The use of the drug for the treatment of patients with lactase deficiency, glucose-galactose malabsorption syndrome and galactosemia is contraindicated.
The drug is not prescribed for patients with hereditary or idiopathic Quincke edema, severe renal failure, gout, anuria and severe disturbances in the water-salt balance.
The drug should not be used to treat patients undergoing kidney transplantation, since there are no data on the safety of fosinopril in this category of patients.
The drug is not used for the treatment of women during pregnancy and breastfeeding, as well as for the treatment of children and adolescents under the age of 18 years.
The drug should be prescribed with caution to patients suffering from coronary heart disease, impaired cerebral blood flow, impaired outflow of blood from the left ventricle (including with aortic or mitral valve stenosis, stenosis of the aortic orifice, etc.), renal failure and stenosis of a single kidney artery or bilateral renal artery stenosis.
In addition, care must be taken when prescribing the drug to patients undergoing hemodialysis using high permeability membranes, as well as to patients undergoing apheresis using dextran sulfate.
With caution, the drug is prescribed for patients suffering from impaired liver function, metabolic acidosis, systemic lupus erythematosus, scleroderma, diabetes mellitus, as well as elderly patients and patients whose work is associated with the management of potentially dangerous mechanisms and driving a car.
Special instructions
Before starting therapy with the drug Fosicard N, water-electrolyte balance should be corrected.
Fosinopril can cause symptomatic arterial hypotension, which is most likely in patients with reduced BCC as a result of prolonged previous treatment with diuretics, restriction of salt intake, dialysis, diarrhea, or vomiting.
Arterial hypotension is not an absolute contraindication for further use of the drug Fozicard N.
The maximum decrease in blood pressure is noted in the early stages of treatment and usually stabilizes at 2 weeks of therapy. With further use of the drug, there is no decrease in its therapeutic effectiveness.
When using ACE inhibitors, included fosipopril may develop angioedema. With swelling of the tongue, pharynx, and larynx, airway obstruction may develop. Patients should stop taking the drug and immediately inform the attending physician about the appearance of edema on the face, eyes, lips and tongue, spasms of the larynx muscles or shortness of breath. In such cases, prompt emergency measures are needed.
Caution should also be exercised when using ACE during desensitization procedures.
During hemodialysis through highly permeable membranes, as well as during apheresis of LDL with adsorption on dextran sulfate, anaphylactic reactions can occur. In these cases, dialysis membranes of a different type or other drug treatment should be used.
In patients with impaired renal function, especially in the presence of systemic diseases of the connective tissue, agranulocytosis and suppression of bone marrow function may develop. In this case, the white blood cell count should be monitored. Such patients should be warned about the need to report the appearance of any signs of infection, including fever, sore throat.
In patients with arterial hypertension with renal artery stenosis of one or both kidneys, as well as with the simultaneous use of diuretics during treatment with ACE inhibitors, an increase in the level of urea nitrogen and serum creatinine is possible. These effects are reversible and disappear after discontinuation of treatment. In such patients, it is necessary to monitor renal function during the first 2 weeks of treatment. A dose reduction may be required.
In patients with severe heart failure, oliguria and / or progressive azotemia in the presence or absence of renal failure, treatment with ACE inhibitors can cause an excessive hypotensive effect, which may lead to increased oliguria or azotemia, and in rare cases, death. Therefore, in such patients, treatment with the drug should begin with a minimum therapeutic dose and under strict control of blood pressure, especially during the first 2 weeks of treatment.
Hydrochlorothiazide can cause hypokalemia, hyponatremia, and hypochloremic alkalosis. In the presence of fosinopril sodium, the risk of hypokalemia is reduced. Hydrochlorothiazide helps to reduce the excretion of calcium ions from the body to increase the excretion of magnesium ions in the urine, which can lead to hypomagnesemia. Periodic monitoring of the concentration of electrolytes in blood serum is necessary.
An increase in the concentration of uric acid in the blood is possible, and some patients taking thiazide diuretics may develop an acute attack of gout.
In patients with diabetes, a change in the need for insu is possibleIn other words, latent forms of diabetes mellitus can take on a manifest form with the use of thiazides.
Increased triglycerides and cholesterol concentrations are associated with thiazide diuretics.
The cough caused by ACE inhibitors, including fosinopril, is usually unproductive and persistent, and disappears after stopping the medication. Cough caused by ACE inhibitors should be considered as one of the options for the differential diagnosis of cough.
In rare cases, the use of ACE inhibitors can lead to cholestatic jaundice with the development of fulminant hepatocyte necrosis.
Composition
1 tablet contains: Fosinopril sodium – 20 mg Hydrochlorothiazide – 12.5 mg.
Dosage and administration
The drug is intended for oral use. It is recommended to swallow the tablet whole, without chewing or crushing, with a sufficient amount of liquid. The drug is taken regardless of the meal. The duration of the course of treatment and the dose of the drug is determined by the attending physician individually for each patient.
Adults are usually prescribed 1 tablet of the drug 1 time per day. If necessary, the dose can be increased to 2 tablets per day.
The maximum daily dose is 2 tablets.
Dose adjustment is not required for patients with moderate renal impairment and impaired liver function.
Patients with severe impaired renal function and creatinine clearance of less than 30 ml / min are not prescribed Fozicard N.
Side effects of
When using the drug in patients, the development of such side effects was noted: from the gastrointestinal tract and liver: nausea, vomiting, epigastric pain, stool, digestion, dry mouth, hepatitis, change in taste increased activity of liver enzymes. In isolated cases, the development of pancreatitis and liver failure was noted.
From the cardiovascular and hematopoietic systems: arterial hypotension, cardiac arrhythmias, Raynaud’s disease, decreased hemoglobin and hematocrit, anemia, thrombocytopenia, leukopenia, agranulocytosis, neutropenia. In isolated cases, the development of autoimmune diseases, lymphadenopathy, myocardial infarction and cerebral stroke was noted.
From the central and peripheral nervous system: headache, dizziness, sleep and wake disturbance, nightmares, emotional lability, fatigue, paresthesia, convulsions.
From the urinary system: uremia, anuria, oliguria, acute renal failure, interstitial nephritis.
Allergic reactions: skin rash, itching, urticaria, allergic rhinitis, bronchospasm, eosinophilic pneumonia, Stevens-Johnson syndrome. In isolated cases, the development of Quincke edema was noted (including swelling of the intestines, face, lips, tongue, larynx, limbs).
Others: cough, psoriasis, excessive sweating, erectile dysfunction, gynecomastia, myalgia. It is also possible to increase the level of potassium, calcium, glucose, creatinine and bilirubin in the blood, increase the level of blood urea, decrease the level of sodium, magnesium and potassium in the blood.
In case of side effects, you should stop taking the drug and consult your doctor as soon as possible, who will decide on the possibility of further use of the drug.
Drug interactions
With the combined use of the drug with potassium preparations, as well as potassium-sparing diuretics, the risk of developing hyperkalemia is increased. With the combined use of these drugs, potassium levels in the blood should be monitored.
The drug Fosicard N should not be prescribed in combination with diuretic drugs. Diuretics should be discontinued a few days before the start of therapy with the drug Fosicard N.
Antihypertensive drugs, vasodilators, nitrates, diuretics, anesthetics, tetracyclic antidepressants and antipsychotic drugs with combined use with the drug Fosicard N enhance its hypotensive effect.
The drug increases plasma concentrations of lithium.
Antacid preparations with simultaneous use, reduce the absorption of fosinopril. An interval of at least 2 hours between taking antacids and the drug Fozicard N.
should be observed. When combined with non-narcotic analgesics, the risk of nephrotoxicity increases and the hypotensive effect of fosinopril decreases.
Sympathomimetics with combined use reduce the hypotensive effect of the drug Fozicard N.
The drug with combined use increases the effectiveness of oral hypoglycemic agents and insulin. When prescribing the drug Fozicard N, patients with diabetes should monitor the level of glucose in the blood.
The drug should not be prescribed in combination with immunosuppressive drugs, allopurinol and procainamide.
Overdose of
When using excessive doses of the drug, patients develop headache, dizziness, arterial hypotension, stupor and bradycardia. With a further increase in dose, the development of circulatory shock, renal failure, and disturbances in the water-electrolyte balance are possible.
There is no specific antidote. In case of an overdose, gastric lavage is indicated (if after taking the drug no more than 30 minutes have passed) and taking enterosorbents. If necessary, carry out symptomatic therapy, in particular, with the development of bradycardia, atropine is prescribed, with severe arterial hypotension, the administration of angiotensin II is indicated.
In case of severe overdose, measures are also taken to maintain the function of the cardiovascular system.
Therapy of an overdose of the drug Fosicard N should be carried out in a hospital.
Storage Conditions
The product should be stored at a temperature not exceeding 25 ° C.
Deystvuyuschee substances
Hydrohlorotyazyd, fosinopril
prescription
pharmacy prescription pf14 df8 pf14 pf14 pf14 pf14 pf14 pf14 dff8
Prescription
Form of Treatment
tablets
Zdravle HFZ AD, Serbia
