Fozikard tab 10mg 28 pc

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Fozikard tab 10mg 28 pc

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Description

Composition
Active substance:
fosinopril sodium 10 mg.
Excipients:
lactose monohydrate 118 mg, 4 mg of croscarmellose sodium, corn starch pregelatinized (starch 1500) 24 mg Microcrystalline cellulose 40 mg Glyceryl dibehenate 4 mg.
Description:
Round tablet ploskotsilindricheskoy form white or almost white, labeled «FL 10″ for the dosage of 10 mg,
Product form:
Tablets, 10 mg.
28 tablets per pack of cardboard, on which the protective sticker can be applied in addition.
Contraindications
– Hypersensitivity to fosinopril or any other components of the preparation.
– hereditary and / or idiopathic angioedema, including history, after receiving other ACE inhibitors.
– Pregnancy.
– The period of breastfeeding.
– Age 18 years (effectiveness and safety have been established).
– lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
– simultaneous use of aliskiren and preparations containing aliskiren in patients with diabetes and / or moderate to severe renal function (glomerular filtration rate (GFR) of less than 60 ml / min / 1.73 m2 body surface area).
– simultaneous use of antagonists of angiotensin II (ARA II) patients with diabetic nephropathy.
Carefully
Hypotension, bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; renal failure; condition after kidney transplantation; aortic or mitral stenosis; hypertrophic obstructive cardiomyopathy; III-IV CHF functional class (NYHA classification on); Coronary heart disease (CHD); cerebrovascular diseases (including cerebrovascular insufficiency..); systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma..), suppression of medullary hemopoiesis; immunosuppressive therapy, the simultaneous application of allopurinol or procainamide, or a combination of these complicating factors (elevated risk of neutropenia and agranulocytosis); diabetes; hyperkalemia; simultaneous use of potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes food; simultaneous application of drugs lithium; allergic history or a history of angioneurotic edema; simultaneous desensitization; simultaneous low-density lipoprotein apheresis using a dextran sulfate; simultaneous hemodialysis using vysokoprotochnyh membranes; state, accompanied by decrease in the bcc (including diarrhea, vomiting, previous treatment with diuretics, diet restriction salt..), hyponatremia (risk of dehydration, hypotension, chronic renal failure); use during major surgery or general anesthesia; Use in patients blacks; the use in elderly patients.
Dosage
10 mg
Indications
Arterial hypertension (alone or in combination with other antihypertensive agents (in particular, a thiazide diuretic)).
Chronic heart failure (CHF) (in combination therapy).
Interaction with other drugs
antacids
The simultaneous use of antacid (e.g. aluminum or magnesium hydroxide, simethicone) Fozikard can reduce the absorption of the drug. Therefore said means is necessary to apply at intervals of not less than 2 hours.
Lithium
With simultaneous use of ACE inhibitors with lithium salts, lithium concentration in the blood serum and the risk of lithium intoxication can be increased, so Fozikard simultaneously used drugs and lithium with caution.
Nonsteroidal anti-inflammatory drugs (NSAIDs)
It is known that indomethacin, and other NSAIDs, including Selective inhibitors of cyclooxygenase-2 (COX-2) and aspirin at a dose exceeding 3 grams per day may reduce the antihypertensive effect of the ACE inhibitors, especially in patients with low-renin hypertension. In patients older than 65 years, from hypovolemia (including the treatment of diuretics), with impaired renal function, co-administration of NSAIDs, including selective COX-2 inhibitors and ACE inhibitors (including fosinopril) can lead to a deterioration of the function kidney, up to acute renal failure. Usually this condition is reversible. It is necessary to carefully monitor renal function in patients
taking fosinopril and NSAIDs.
diuretics
While the use of diuretics in combination with a strict diet, limiting salt intake, dialysis or may develop pronounced decrease in blood pressure, particularly in the first hour after taking the initial dose Fozikard preparation.
potassium Formulations potassium-sparing diuretics (amiloride, spironolactone, triamterene) and formulations containing cotrimoxazole [trimeoprim sulfamethoxazole +] increase risk of hyperkalemia. In patients with heart failure, diabetes, simultaneously receiving potassium-sparing diuretics, potassium, kalisodergaszczye solezameniteli or other means for causing hyperkalemia (e.g., heparin), ACE inhibitors increase the risk of increasing the content of potassium in serum.
Patients taking enzyme inhibitors, mTOR (such as temsirolimus, sirolimus, everolimus), inhibitors of dipeptidylpeptidase IV type (DPP-IV) (gliptiny, e.g., sitagliptin, saxagliptin, vildagliptin, linagliptin) racecadotril or estramustine simultaneously with ACE inhibitors may be more the degree of risk of developing angioedema.
Fosinopril enhances hypoglycemic effect sulfonylureas, insulin, the risk of leukopenia while the application of allopurinol, cytostatic agents, immunosuppressants, procainamide.
Estrogens can weaken the antihypertensive effect of fosinopril because of the ability to retain water.
Hypotensive, narcotic analgesics, drugs for general anesthesia increase the antihypertensive effect of the drug Fozikard.
The simultaneous use of ACE inhibitors with preparations containing aliskiren, contraindicated in patients with diabetes and / or with moderate or severe renal failure (GFR of less than 60 ml / min / 1.73 m2 body surface area) and are not recommended for other patients.
The simultaneous use of ARA II contraindicated in patients with diabetic nephropathy.
The bioavailability of the preparation when the simultaneous use of chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propantheline bromide, digoxin, aspirin and warfarin does not change.
Overdose
Symptoms: marked reduction of blood pressure, bradycardia, shock, impaired vodnoelektrolitnogo balance, acute renal failure, stupor.
Treatment: the drug should be stopped, shown gastric lavage, adsorbents (e.g., activated carbon), vasodepressor means, infusion of 0.9% sodium chloride solution and more symptomatic and supportive treatment.
The use of hemodialysis ineffective.
pharmachologic effect
Pharmacological group:
angiotensin converting enzyme (ACE) inhibitor
Pharmacodynamics:
ACE inhibitor prodrugs of the subgroups. The body of active metabolite formed fosinopril – fozinoprilat which prevents the conversion of angiotensin I into the vasoconstrictive peptide angiotensin II, which leads to vasodilation and reduced aldosterone secretion. It has antihypertensive, vasodilating, diuretic and potassium-sparing effect. , Decreases total peripheral vascular resistance and systemic arterial pressure (BP). The drug inhibits the synthesis of aldosterone with ACE inhibits tissue. The antihypertensive effect is also caused by the suppression of metabolism of bradykinin, which possesses a strong vasodilating effect. Decrease in blood pressure are not accompanied by a change in blood volume (CBV), cerebral and renal blood flow, blood supply to internal organs, skeletal muscle, skin, the reflex activity of the myocardium. The antihypertensive effect is maintained during long-term treatment, tolerance to the drug does not develop. After oral antihypertensive effect develops over 1 hour reaches the maximum after 2-6 hours and is maintained for 24 hours.
Pharmacokinetics:
After ingestion fosinopril absorbed from the gastrointestinal tract.
Absorption averages 30 – 40%. The extent of absorption is independent of food intake, but its speed can be slowed down. The time to reach maximum plasma concentration of 3 hours and not dependent on the dose.
Communication with blood plasma proteins fozinoprilata – 95%. Fozinoprilat has a relatively small volume of distribution, and to a small extent connected with the cellular components of blood. It does not cross the blood-brain barrier.
Fosinopril excreted equally through the liver and kidneys.
In patients with hypertension with normal renal function and liver half-life (T1 / 2) fozinoprilata is approximately 11.5 hours. In patients with heart failure the value of T1 / 2 of 14 hours. Fozinoprilata Clearance in hemodialysis and peritoneal dialysis averages 2 % and 7%, respectively, relative to the values ​​of urea clearance.
Patients with impaired renal function (creatinine clearance (CC) of less than 80 ml / min / 1.73 m2) fozinoprilata total clearance from the body is approximately twice lower than in patients with normal renal function. In this case, the absorption, bioavailability and protein binding is not appreciably changed. Reduced excretion by the kidney is offset by increased excretion through the liver. A moderate increase in the values ​​of area under the curve “concentration-time» (AUC) in plasma (less than half, compared with the norm), is observed in patients with renal insufficiency varying degrees, including kidney failure in the terminal stage (CC less than 10 ml / min / 1.73 m2).
In patients with impaired liver function (in alcoholic or biliary cirrhosis) fosinopril hydrolysis rate can be reduced, but the degree of hydrolysis does not change appreciably. Fozinoprilata total clearance in such patients is about half as compared with patients with normal liver function.
Pregnancy and breast-feeding
Fozikard is contraindicated for use during pregnancy. The use of ACE inhibitors in the second and third trimester of pregnancy causes damage or even death of the developing fetus. Of newborns whose mothers took ACE inhibitors during pregnancy, it is recommended to carry out careful monitoring for early detection of arterial hypotension, oliguria and hyperkalemia.
Fosinopril is released in breast milk, so taking the drug during lactation is not recommended.
If use of the drug during this period it is necessary, breast-feeding should be discontinued.
Conditions of supply of pharmacies
Prescription.
side effects
Adverse reactions are systematized in accordance with the Classification
World Health Organization (WHO): very common (> 1/10); common (> 1/100,
special instructions
Before treatment requires an analysis of earlier antihypertensive therapy, a degree of increase in blood pressure, limit salt diet and / or liquid, and other clinical circumstances.
Patients with severe hypertension or concomitant decompensated CHF should begin treatment with Fozikard in the hospital.
Before and during the treatment with necessary control of blood pressure, renal function, potassium content, hemoglobin content, creatinine, urea, electrolytes and concentrations “liver” transaminases in blood.
angioedema
It reported on the development of angioedema in patients with the use of the drug Fozikard. Edema tongue, pharynx or larynx may develop airway obstruction which can be fatal. In the case of such reactions patients must cessation drug administration and subcutaneous administration of epinephrine solution (epinephrine) (1: 1000), as well as other measures of emergency treatment.
There is a risk of anaphylactic reactions during desensitization Hymenoptera venom in patients receiving an ACE inhibitor.
Swelling of the intestinal mucosa
While receiving ACE inhibitors rarely observed swelling of the intestinal mucosa. These patients complained of abdominal pain (with nausea and vomiting could be), in some cases, swelling of the intestinal mucosa arose without facial edema, C1-esterase levels were normal. Symptoms disappeared after discontinuation of ACE inhibitors. Swelling of the intestinal mucous membrane must be included in the differential diagnosis of patients taking ACE inhibitors, complaining of abdominal pain.
Anaphylactic reactions during dialysis using membranes of high permeability may develop anaphylactic reactions in patients treated with ACE inhibitors during hemodialysis through highly permeable membrane, as well as during low-density lipoprotein apheresis adsorption on dextran sulfate. In these cases, you should consider using a different type of dialysis membrane or other antihypertensive therapy.
Neutropenia / agranulocytosis
Possible development of agranulocytosis and bone marrow suppression during treatment with ACE inhibitors. These cases are more common in patients with impaired renal function, especially in the presence of systemic diseases of connective tissue (systemic lupus erythematosus or scleroderma). Before starting therapy inhibitors
ACE inhibitors and in the treatment process is carried out determination of the total number of leukocytes and leukocyte formula (1 once a month during the first 3-6 months of treatment and in the first year of the drug in patients with an increased risk of neutropenia).
hypotension
In patients with uncomplicated hypertension may develop hypotension in connection with the use of the drug Fozikard.
Symptomatic hypotension when used ACE inhibitors most often develops in patients after intensive treatment with diuretics, diet, limiting salt intake, or during kidney dialysis. Transient hypotension is not a contraindication for the use of the drug after the restoration BCC measures.
In patients with CHF treatment with ACE inhibitors may cause excess antihypertensive effect, which can lead to oliguria or azotemia fatal. Therefore, in the treatment of chronic heart failure drug Fozikard need to closely monitor patients, especially during the first 2 weeks of treatment,
as well as any increase in the dose or Fozikard diuretic.
May need to reduce the dose of diuretics in patients with hyponatremia and patients previously heavily treated with diuretics. Hypotension is not a contraindication for further use Fozikard preparation.
Some decrease in systemic blood pressure is a common and desired effect at the start of the drug in heart failure. The degree of this reduction is maximal in the early stages of treatment and stabilized within one or two weeks of treatment. BP is normally returned to the values ​​before the treatment period without compromising therapeutic efficacy.
Abnormal liver function
When expressed appreciable yellowness and increase in liver enzymes reception Fozikard preparation should be discontinued and appropriate treatment.
In rare cases the use of ACE inhibitors is noted syndrome, the first manifestation of which is cholestatic jaundice. Followed by fulminant hepatic necrosis, sometimes with fatal consequences. The mechanism of this syndrome is not understood.
In patients with impaired liver function may experience increased concentration of fosinopril in plasma. Liver cirrhosis (including alcohol), an apparent total body clearance decreased fosinopril and AUC of about 2 times higher than in patients without liver dysfunction.
Renal function
In patients with hypertension with bilateral renal artery stenosis or artery stenosis single kidney, and while the use of diuretics with no signs of renal dysfunction during treatment with ACE inhibitors may increase the concentration of blood urea nitrogen and serum creatinine. These effects are usually reversible and disappear after cessation of treatment. May need to reduce the dose of the diuretic and / or Fozikard drug.
In patients with severe heart failure, with altered activity of the renin-angiotenzinaldosteronovoy system, treatment with ACE inhibitors may lead to oliguria, progressive azotemia, and in rare cases acute renal failure and eventual death.
hyperkalemia
Cases of increase in serum potassium blood of patients receiving ACE inhibitors, including fosinopril. The risk group includes patients with renal failure, type 1 diabetes, as well as receiving potassium-sparing diuretics, kalisodergaszczye nutritional supplements or other drugs that increase in serum potassium content (e.g., heparin, a combination of trimethoprim + sulphamethoxazole).
Cough
When the use of ACE inhibitors, including fosinopril, some patients may experience non-productive, persistent cough, passing after discontinuation. At occurrence of cough in patients treated with ACE inhibitors should be considered the therapy as a possible cause as part of the differential diagnosis.
Surgery / general anesthesia
ACE inhibitors may enhance the antihypertensive effect of agents used for general anesthesia. Prior to surgery (including dental), you must notify the surgeon / anesthetist on the use of ACE inhibitors.
Special patient groups
Фозиноприл (как и другие ингибиторы АПФ) оказывает менее выраженное антигипертензивное действие и обладает более высоким риском развития ангионевротического отека у пациентов негроидной расы, по сравнению с представителями других рас.
Отсутствует опыт применения фозиноприла у пациентов, недавно перенесших трансплантацию почки.
Необходимо с осторожностью применять препарат у пациентов с обструкцией путей оттока крови из левого желудочка (аортальный или митральный стеноз/гипертрофическая обструктивная кардиомиопатия).
Необходимо соблюдать осторожность при выполнении работы, требующей повышенного внимания, так как возможно возникновение головокружения, особенно после начальной дозы ингибитора АПФ у пациентов, принимающих диуретики. Следует соблюдать осторожность при выполнении физических упражнений или при жаркой погоде из-за риска дегидратации и артериальной гипотензии вследствие уменьшения ОЦК.
Безопасность и эффективность применения препарата Фозикард у детей не установлена.
The effect on the ability to operate vehicles, machinery
Необходимо соблюдать осторожность при управлении транспортными средствами и работе с механизмами, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
Хранить при температуре не выше 30 градусов.
Keep out of the reach of children!
Dosing and Administration
Inside. Дозировка должна подбираться индивидуально.
Arterial hypertension
Рекомендуемая начальная доза препарата составляет 10 мг 1 раз в сутки. Дозу препарата необходимо подбирать в зависимости от динамики артериального давления.
Поддерживающая доза составляет 10-40 мг 1 раз в сутки. При отсутствии достаточного терапевтического эффекта возможно дополнительное назначение диуретиков.
Если лечение препаратом Фозикард начинают на фоне проводимой терапии диуретиком, то его начальная доза должна составлять не более 10 мг при тщательном врачебном контроле за состоянием пациента.
Chronic heart failure
Рекомендованная начальная доза составляет 5 мг 1 или 2 раза в сутки. Лечение начинают под обязательным медицинским контролем. Если фозиноприл при приеме в начальной дозе хорошо переносится, то дозу можно постепенно увеличивать с недельными интервалами, до максимальной суточной дозы 40 мг 1 раз в сутки.
Применение при нарушении функции почек и/или печени
Коррекции дозы препарата не требуется.
elderly patients
Различий в эффективности и безопасности лечения препаратом у пациентов в возрасте 65 лет и старше и молодых пациентов не наблюдается. Однако нельзя исключить большую восприимчивость у некоторых пациентов пожилого возраста к препарату, в связи с возможными явлениями передозировки из-за замедленного выведения препарата.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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