Universal reference book for medicines
Product name: FOSICARD (FOSICARD)

Active substance: fosinopril

Type: ACE inhibitor

Manufacturer: ACTAVIS GROUP PTC ehf.
(Iceland) manufactured by ACTAVIS hf. (Iceland)
Composition, form of production and packaging

Tablets are white or almost white, round, flat-cylindrical, labeled "FL 5".

1 tab.

fosinopril sodium 5 mg

Excipients: lactose monohydrate - 59 mg, croscarmellose sodium - 2 mg, corn starch pregelatinized starch (starch 1500) - 12 mg, microcrystalline cellulose - 20 mg, glyceryl dibehenate - 2 mg.

7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
Tablets are white or almost white, round, flat-cylindrical, labeled "FL 10".

1 tab.

fosinopril sodium 10 mg

Excipients: lactose monohydrate - 118 mg, croscarmellose sodium - 4 mg, corn starch pregelatinized starch (starch 1500) - 24 mg, microcrystalline cellulose - 40 mg, glyceryl dibehenate - 4 mg.

7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
Tablets are white or almost white, round, flat-cylindrical, labeled "FL 20".

1 tab.

fosinopril sodium 20 mg

Excipients: lactose monohydrate - 108 mg, croscarmellose sodium - 4 mg, corn starch pregelatinized starch (starch 1500) - 24 mg, microcrystalline cellulose - 40 mg, glyceryl dibehenate - 4 mg.

7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

ACE inhibitor.
Fosinopril is a prodrug, from which the active metabolite fosinoprilat is formed in the body. The drug has antihypertensive, vasodilating, diuretic and potassium-sparing effect.
Fosinoprilat inhibits the conversion of angiotensin I into the vasoconstrictor substance angiotensin II, which leads to vasodilation and a decrease in the secretion of aldosterone.
Reduces OPSS and systemic blood pressure. Suppresses the synthesis of aldosterone, inhibits tissue ACE. Antihypertensive effect is also caused by suppression of bradykinin metabolism, which has a pronounced vasodilating effect.
Reduction of blood pressure is not accompanied by a change in BCC, cerebral and renal blood flow, blood supply to internal organs, skeletal muscles, skin, reflex activity of the myocardium.

The antihypertensive effect of the drug persists with long-term treatment, tolerance to the drug does not develop.
After ingestion, the antihypertensive effect develops within 1 hour, reaches a maximum after 2-6 hours and persists for 24 hours.
PHARMACOKINETICS

Suction

After oral absorption from the gastrointestinal tract is about 30-40%.
The degree of absorption does not depend on the intake of food, but the rate of absorption can be slowed down. The time to reach C max in blood plasma is 3 hours and does not depend on the dose taken.
Distribution

The binding with plasma proteins of fosinoprilata is 95%.
Fosinoprilat has a relatively small V d and binds to a small extent with the cellular components of the blood.Does not penetrate the BBB.
Excretion

Fosinopril is excreted from the body equally through the liver and kidneys.
In patients with arterial hypertension with normal renal function and liver T 1/2Fosinoprilata is approximately 11.5 hours. In patients with heart failure, T 1/2 is 14 hours.
Pharmacokinetics in specific patient groups

In patients with impaired renal function (CC less than 80 ml / min / 1.73 m 2 ), the total clearance of fosinoprilat from the body is approximately twice lower than in patients with normal renal function, while absorption, bioavailability and binding to plasma proteins do not change noticeably .
Reduced excretion through the kidney is compensated by increased excretion through the liver. A moderate increase in plasma AUC values ​​(less than twice the norm) is observed in patients with renal insufficiency of various degrees, including renal failure in the terminal stage (CC less than 10 ml / min / 1.73 m2). The clearance of fosinoprilat for hemodialysis and peritoneal dialysis is on average 2% and 7%, respectively, relative to the values ​​of urea clearance.
In patients with impaired liver function (with alcoholic or biliary cirrhosis), the rate of hydrolysis of fosinopril may be reduced, but the degree of hydrolysis does not change noticeably.
The total clearance of fosinoprylate from the body of such patients is approximately half that in patients with normal liver function.
INDICATIONS

- arterial hypertension (in monotherapy or in combination with other antihypertensive agents / in particular, with thiazide diuretics);

- chronic heart failure (as part of combination therapy).

DOSING MODE

The drug is taken orally.
The dose should be selected individually.
With arterial hypertension, the recommended initial dose of the drug is 10 mg 1 time / day.
The dose of the drug should be selected depending on the dynamics of blood pressure. The maintenance dose is 10-40 mg 1 time / day. In the absence of a sufficient therapeutic effect, additional prescription of diuretics is possible.
If the treatment with Fosicard is started against the background of diuretic therapy, its initial dose should not exceed 10 mg with careful medical monitoring of the patient's condition.

In chronic heart failure, the recommended initial dose is 5 mg 1 or 2 times / day.
Depending on the therapeutic effectiveness, the dose can be increased with a weekly interval up to a maximum daily dose of 40 mg 1 time / day.
If the kidney and / or liver function is impaired, correction of the dose of the drug is not required.

Differences in the efficacy and safety of drug treatment in patients aged 65 years and older and young patients are not observed.
However, it is impossible to exclude a greater susceptibility in some elderly patients to the drug, due to possible overdose phenomena due to delayed excretion of the drug.
SIDE EFFECT

From the cardiovascular system: excessive reduction in blood pressure, orthostatic hypotension, tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction, chest pain, blood flushes to the skin of the face, hypertensive crisis, cardiac arrest, fainting.

On the part of the digestive system: nausea, vomiting, constipation, intestinal obstruction, pancreatitis, hepatitis, stomatitis, glossitis, dyspepsia, abdominal pain, anorexia, intestinal edema, cholestatic jaundice, dysphagia, flatulence, appetite, weight change, dry mucous shell of the oral cavity.

On the part of the respiratory system: dry cough, shortness of breath, pharyngitis, laryngitis, sinusitis, pulmonary infiltrates, bronchospasm, dysphonia, dyspnea, nosebleeds, rhinorrhea.

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

From the side of the central nervous system: stroke, cerebral ischemia, dizziness, headache, weakness;
when used in high doses - insomnia, anxiety, depression, confusion, paresthesia, drowsiness.
From the senses: hearing and vision impairment, tinnitus.

Allergic reactions: skin rash, itching, angioedema.

On the part of the organs of hematopoiesis: inflammation of the lymph nodes.

From the musculoskeletal system: arthritis.

From the side of metabolism: exacerbation of gout.

On the part of laboratory indicators: hypercreatininaemia, increased urea concentration, increased activity of hepatic transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia;
reduction of hemoglobin and hematocrit, neutropenia, leukopenia, eosinophilia, increased ESR.
Influence on the fetus: impaired fetal kidney development, decreased fetal and newborn infants, impaired renal function, hyperkalemia, hypoplasia of the skull bones, oligohydramnion, limb contracture, lung hypoplasia.

CONTRAINDICATIONS

- hypersensitivity to fosinopril and other components of the drug;

- hereditary and / or idiopathic angioedema (including in anamnesis) after taking other ACE inhibitors;

- Pregnancy;

- the period of lactation (breastfeeding);

- age under 18 years (effectiveness and safety not established);

- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

With caution should be used in cases of renal failure, hyponatremia (risk of dehydration, arterial hypotension, chronic renal failure), bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, aortic stenosis, condition after kidney transplantation, with desensitization, systemic connective tissue diseases, in tons .h.
SLE, scleroderma (increased risk of developing neutropenia or agranulocytosis), hemodialysis, cerebrovascular diseases (including cerebral circulatory insufficiency), IHD, chronic cardiac insufficiency III and IV of the functional class according to NYHA classification, diabetes mellitus, oppression of bone marrow hematopoiesis, hyperkalemia , while observing a diet with restriction of table salt, in conditions accompanied by a decrease in BCC (including diarrhea, vomiting), in elderly patients.
PREGNANCY AND LACTATION

Fosicard is contraindicated for use during pregnancy.
The use of ACE inhibitors in the II and III trimesters of pregnancy causes damage or even death of the developing fetus. For newborns whose mothers took ACE inhibitors during pregnancy, careful monitoring is recommended for the timely detection of arterial hypotension, oliguria and hyperkalemia.
Fosinopril is excreted in breast milk, therefore it is not recommended to take the drug during lactation.
If the use of the drug during this period is necessary, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER

If the kidney function is not corrected, dose adjustment is not required.

Caution should be used in cases of kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If the liver function is not corrected, dose adjustment is not required.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

With caution should be used in elderly patients.

SPECIAL INSTRUCTIONS

Before the beginning of treatment it is required to conduct an analysis of previous antihypertensive therapy, the degree of increase in blood pressure, restriction of ration for salt and / or fluid and other clinical circumstances.

Patients with severe arterial hypertension or concomitant decompensated chronic heart failure should begin treatment with Fosicard in a hospital setting.

Before and during treatment the drug requires control of blood pressure, kidney function, potassium content, hemoglobin, creatinine, urea concentration, electrolyte concentration and hepatic transaminase activity in the blood.

Angioedema

It was reported on the development of angioedema in patients with Fosicard.
When swelling of the tongue, throat or larynx, airway obstruction may develop with possible fatal outcome. In case of development of such reactions, it is necessary to stop taking the drug, injecting epinephrine (adrenaline) solution (1: 1000) and carrying out other emergency therapy.
Swelling of the intestinal mucosa

During the administration of ACE inhibitors, edema of the intestinal mucosa was rarely observed.
These patients complained of abdominal pain (with nausea and vomiting may not be), in some cases, edema of the intestinal mucosa appeared without edema of the face, the level of C1-esterases was normal. Symptoms disappeared after the cessation of the use of ACE inhibitors. Swelling of the intestinal mucosa should be included in the differential diagnosis of patients taking ACE inhibitors who complain of abdominal pain.
Anaphylactic reactions during dialysis using high-permeability membranes can develop in patients who used ACE inhibitors during hemodialysis through high-permeability membranes, as well as during LDL-apheresis with dextran sulfate adsorption.
In these cases, the use of dialysis membranes of another type or other antihypertensive therapy should be considered.
Neutropenia / agranulocytosis

Perhaps the development of agranulocytosis and suppression of bone marrow function during treatment with ACE inhibitors.
These cases are noted more often in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (systemic lupus erythematosus or scleroderma). Before the beginning of therapy with ACE inhibitors and during the treatment, the total number of leukocytes and the leukocyte formula are determined (once a month for the first 3-6 months of treatment and in the first year of use in patients with an increased risk of neutropenia).
Arterial hypotension

Patients with uncomplicated form of hypertension may develop arterial hypotension due to the use of the drug Fozicard.

Symptomatic arterial hypotension with ACE inhibitors most often develops in patients after intensive treatment with diuretics, a diet limiting intake of table salt, or in the conduct of renal dialysis.
Transient arterial hypotension is not a contraindication for the use of the drug after taking measures to restore BCC.
In patients with chronic heart failure, treatment with ACE inhibitors can cause an excessive antihypertensive effect, which can lead to oliguria or azotemia with a fatal outcome.
Therefore, in the treatment of chronic heart failure with Fosicard, patients should be closely monitored, especially during the first 2 weeks of treatment, as well as with any increase in the dose of the drug Fosicard or diuretic.
It may be necessary to reduce the dose of diuretic in patients with hyponatremia and patients previously intensively treated with diuretics.
Arterial hypotension is not a contraindication for further use of the drug Fosicard. Some reduction in systemic BP is a common and desirable effect at the beginning of the drug in heart failure. The degree of this decrease is maximal at early stages of treatment and stabilizes within one or two weeks from the start of treatment. BP usually returns to the values ​​of the period before the start of treatment without decreasing the therapeutic effectiveness.
Impaired liver function

When there is a noticeable icterus and a marked increase in the activity of liver enzymes, treatment with Fosicard should be stopped and appropriate treatment prescribed.

Impaired renal function

In patients with arterial hypertension with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, and also with the simultaneous use of diuretics without signs of impaired renal function during treatment with ACE inhibitors, the concentration of blood urea nitrogen and serum creatinine can increase.These effects are usually reversible and pass after discontinuation of treatment.
It may be necessary to reduce the dose of a diuretic and / or Fosicard preparation.
In patients with severe chronic heart failure, with altered activity of RAAS, treatment with ACE inhibitors can lead to oliguria, progressive azotemia, and, in rare cases, to acute renal failure and a possible fatal outcome.

Surgical interventions / general anesthesia

ACE inhibitors can enhance the antihypertensive effect of agents used for general anesthesia.
Before surgery (including dentistry), it is necessary to alert the surgeon / anesthesiologist about the use of ACE inhibitors.
Care must be taken when driving a vehicle or doing other work that requires increased attention, because
there may be dizziness, especially after the initial dose of an ACE inhibitor in patients taking diuretics.
Caution should be exercised when performing physical exercises or in hot weather due to the risk of dehydration and arterial hypotension due to a decrease in BCC.

Use in Pediatrics

Safety and effectiveness of the use of the drug Fozicard in children is not established.

Impact on the ability to drive vehicles and manage mechanisms

Care must be taken when driving vehicles and working with mechanisms that require a high concentration of attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: excessive decrease in blood pressure, bradycardia, shock, disturbance of water-electrolyte balance, acute renal failure, stupor.

Treatment: the drug should be discontinued;
gastric lavage, intake of sorbents (for example, activated charcoal), vasodepressor agents, infusion of 0.9% sodium chloride solution and further symptomatic and supportive treatment. The use of hemodialysis is ineffective.
DRUG INTERACTION

Simultaneous use of antacids (for example, aluminum or magnesium hydroxide, simethicone) can reduce the absorption of the drug Fosicard.
Therefore, it is necessary to apply these means with an interval of at least 2 hours.
With the simultaneous use of ACE inhibitors with lithium salts , the concentration of lithium in the blood serum and the risk of lithium intoxication may increase, so at the same time use Fosicard and lithium preparations with caution.

NSAIDs can reduce the antihypertensive effect of other ACE inhibitors, especially in patients with hypertension and low renin plasma concentrations.

With simultaneous use with diuretics , in combination with a strict diet limiting intake of table salt, or with dialysis, excessive BP decrease may develop, especially in the first hour after taking the initial dose of the drug Fosicard.

Potassium preparations, potassium-sparing diuretics (amiloride, spironolactone, triamterene) increase the 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.
Fosinopril enhances hypoglycemic effect sulfonylureas, insulin.
Fosinopril increases the risk of leucopenia while the use of allopurinol, cytostatic agents, immunosuppressants, procainamide.
Estrogens attenuate the antihypertensive effect of fosinopril because of the ability to retain water.
Antihypertensive drugs, narcotic analgesics, drugs for general anesthesiaFozikard enhance the hypotensive effect of the drug.
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.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

FOSI-RU-00004-Doc-PHARM
TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 2 years.
Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y
Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!