Fosinopril
Fozinopril: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Fosinopril
ATX code: C09AA09
Active ingredient: fosinopril (fosinoprilum)
Manufacturer: Biocom (Russia), Izvarino (Russia), FP Obolenskoe (Russia), Ozone LLC (Russia)
Description and photo update: 2018-25-10
Prices in pharmacies: from 109 rubles.
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Fosinopril is an angiotensin-converting enzyme (ACE) inhibitor.
Release form and composition
Fosinopril dosage form - tablets: flat-cylindrical, white or almost white, with bevels on both sides and a risk on one side - for dosages of 5 and 10 mg; with a cross-shaped line on one side - for a dosage of 20 mg (10, 14, 25 or 50 pieces in blisters, in a cardboard box 1, 2, 3 or 10 packs; 10, 20, 30, 40, 50 or 100 tablets in a can, in a cardboard box 1 can).
Composition of 1 tablet:
- active substance: fosinopril sodium - 5/10/20 mg;
- auxiliary components: lactose, microcrystalline cellulose, croscarmellose sodium, povidone-K25, colloidal silicon dioxide, sodium stearyl fumarate.
Pharmacological properties
Pharmacodynamics
Fosinopril is an ACE inhibitor with hypotensive, diuretic, vasodilating, potassium-sparing properties. It prevents the transformation of angiotensin I into angiotensin II, and, as a consequence, reduces systemic arterial pressure (BP) and total peripheral vascular resistance, inhibits aldosterone replication, and inhibits tissue ACE.
In addition, the drug inhibits the metabolism of bradykinin, which has a powerful vasodilator effect.
When taking Fosinopril, a decrease in blood pressure occurs without a decrease in the volume of circulating blood (BCC), renal, cerebral circulation, blood supply to skeletal muscles, internal organs, skin, as well as reflex contraction of the myocardium.
Therapy of hypertension in dystrophy of the left ventricle leads to a decrease in its mass, as well as narrowing of the septal wall. Long-term treatment does not lead to metabolic disorders.
After taking Fosinopril, the hypotensive effect occurs after 1 hour, the maximum effectiveness of the drug is achieved after 3-6 hours. The duration of exposure to a single dose is 24 hours.
Pharmacokinetics
The absorption of fosinopril is 36% and does not depend on food intake. In the liver and mucous membrane of the gastrointestinal tract (GIT), the drug is hydrolyzed with the release of fosinoprilat. The time to reach the maximum concentration of the substance is 3 hours. Its half-life (T 1/2) is 11 hours.
The connection with plasma proteins is 95%. Fosinopril crosses the blood-brain barrier. It is excreted from the body in urine and bile.
Indications for use
- arterial hypertension (both monotherapy and as part of a combination treatment);
- heart failure (as part of a combination treatment).
Contraindications
Absolute:
- angioneurotic edema - idiopathic, or hereditary (as well as in the past and associated with the use of ACE inhibitors);
- galactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- co-administration with aliskiren and aliskiren-containing drugs in patients with impaired renal function (glomerular filtration rate less than 60 ml / min / 1.73 m 2) and diabetes mellitus;
- age up to 18 years;
- pregnancy and lactation;
- increased sensitivity to the components of Fosinopril, as well as other ACE inhibitors.
Relative contraindications:
- aortic stenosis;
- cerebro- and cardiovascular pathologies (coronary heart disease, insufficient cerebral blood supply, coronary insufficiency);
- systemic autoimmune diseases of connective tissue in a severe stage (including scleroderma, systemic lupus);
- inhibition of hematopoiesis;
- hyperkalemia;
- hyponatremia (due to the risk of arterial hypotension, dehydration, chronic renal failure);
- diabetes;
- bilateral stenosis of the renal arteries or stenosis of an artery of a solitary kidney;
- condition after kidney transplantation;
- gout, low sodium diet;
- renal / hepatic impairment;
- chronic heart failure (NYHA functional class III-IV);
- conditions leading to a decrease in the volume of circulating blood (including vomiting, diarrhea);
- desensitization programs;
- hemodialysis using high-flow membranes;
- low density lipoprotein apheresis;
- elderly age.
Instructions for the use of Fosinopril: method and dosage
Fozinopril tablets are intended for oral administration.
Recommended dosage according to indications:
- arterial hypertension: the initial dose is 10 mg / day for 1 dose. Further, the dose is adjusted depending on the dynamics of lowering blood pressure, and is usually 10–40 mg / day per dose. In case of insufficient antihypertensive effect, it is possible to use diuretics together, when Fosinopril is started against the background of diuretic therapy, its initial dose should not exceed 10 mg / day with regular medical monitoring of the patient's condition. The maximum recommended dose of the drug is 40 mg;
- chronic heart failure (CHF): the initial dose is 5 mg 1 or 2 times a day; when the patient tolerates the drug well, the dose is gradually increased to 40 mg / day per dose (the interval between dose increases should be at least a week). Treatment should be started under medical supervision.
Side effects
- lymphatic and hematopoietic system: transient decrease in hemoglobin and hematocrit, leukopenia, eosinophilia, neutropenia, thrombocytopenia, lymphadenopathy, transient anemia, agranulocytosis;
- metabolism: exacerbation of gout, decreased appetite, hyperkalemia;
- central nervous system (CNS): headache, dizziness, mood lability, sleep disturbance, paresthesia, depression, drowsiness, tremors, taste disturbances, sleep disturbances, confusion, memory and speech disturbances, disorientation, anxiety, inappropriate behavior, imbalance, ischemia brain, hemorrhagic stroke;
- organ of vision: visual impairment;
- cardiovascular system: tachycardia, orthostatic hypotension, marked decrease in blood pressure, angina pectoris, arrhythmia, increased blood pressure, shock, peripheral edema, transient ischemia, hemorrhage, flushing of the face, peripheral circulatory disorders, hypertensive crisis;
- respiratory system: dry cough, rhinitis, pharyngitis, shortness of breath, tracheobronchitis, sinusitis, pneumonia, bronchospasm, pulmonary infiltrates, nosebleeds, laryngitis, dysphonia, chest pain;
- digestive system: diarrhea, abdominal pain, nausea, vomiting, dryness of the oral mucosa, constipation, taste disturbance, loss of appetite, pancreatitis, stomatitis, dysphagia, intestinal obstruction, angioedema of the intestine;
- liver and biliary tract: hepatitis, liver failure;
- skin and subcutaneous tissues: dermatitis, skin rash, angioedema, increased sweating, pruritus, urticaria, exfoliative dermatitis, ecchymosis;
- musculoskeletal system: myalgia, arthralgia, convulsions, arthritis, muscle weakness;
- urinary system: urinary disorders, proteinuria, development or worsening of symptoms of chronic renal failure, acute interstitial nephritis, acute renal failure;
- reproductive system: sexual dysfunction, disorders of the prostate gland;
- infectious and parasitic diseases: upper respiratory tract infections, viral infection;
- other: weakness, pain of unclear localization, fever, weight gain, sudden death;
- laboratory parameters: increased activity of hepatic transaminases, lactate dehydrogenase and alkaline phosphatase; hyperbilirubinemia, increased urea concentration, hypercreatininemia, hyperkalemia, a slight increase in hemoglobin, hyponatremia, decreased hematocrit, hyponatremia.
Overdose
Symptoms of an overdose of Fosinopril: a pronounced decrease in blood pressure, cough, dizziness, anxiety, bradycardia, renal failure, imbalance in water and electrolyte balance, tachycardia, temporary hyperventilation of the lungs, stupor.
Treatment is carried out in a hospital, in the intensive care unit. Control of electrolyte and creatinine levels is required. Within 30 minutes after taking the drug, you should wash the stomach, start taking adsorbents, sodium sulfate. With a pronounced decrease in blood pressure, lay the patient horizontally, raise his legs, intravenously inject 0.9% sodium chloride solution, catecholamines. With bradycardia, atropine is required, in some cases, an artificial pacemaker may be required. Dialysis and peritoneal dialysis are ineffective.
special instructions
Previous antihypertensive therapy should be discontinued a few days before the start of Fosinopril. In a hospital setting, patients with malignant arterial hypertension or concomitant decompensation of chronic heart failure should start taking it. It is recommended to stop taking diuretics 2-3 days before starting therapy with Fozinopril. Before the start, as well as during therapy, it is necessary to monitor renal function, creatinine, urea, control blood pressure and electrolyte content, and the activity of liver enzymes.
While taking Fosinopril, care should be taken with increased physical activity, as well as in hot weather due to the increased risk of dehydration and arterial hypotension.
Conditions that occur when taking ACE inhibitors:
- angioedema of the extremities, face, lips, tongue, mucous membranes, pharynx, larynx: this condition is usually reversible when the drug is discontinued, but in some cases it can lead to airway obstruction and possibly death. Immediate withdrawal of the drug and symptomatic measures are recommended, for example, subcutaneous administration of a solution of epinephrine (adrenaline) (1: 1000);
- swelling of the intestinal mucosa: symptoms disappear after drug withdrawal. Sometimes the swelling of the intestinal mucosa proceeds without nausea, vomiting and facial edema, while the activity of C1-esterase is normal, its only symptom may be abdominal pain;
- anaphylactic reactions during dialysis using high-permeability membranes, and during apheresis of low-density lipoproteins with adsorption on dextran sulfate: it is advisable to consider the use of dialysis membranes of a different type and the use of antihypertensive drugs of a different class;
- anaphylactic reactions during desensitization: desensitization should be carried out with extreme caution in patients taking ACE inhibitors, if signs of anaphylactoid reaction appear, they should be stopped immediately;
- neutropenia / agranulocytosis: it is recommended to control the leukocyte count and leukocyte count once a month at the beginning of treatment, especially in patients with impaired renal function, in the presence of systemic connective tissue diseases (systemic lupus erythematosus or scleroderma);
- arterial hypotension: most often occurs when diuretics are used along with ACE inhibitors, a diet that restricts the use of table salt, as well as during dialysis. After taking measures to restore the volume of circulating blood, you can continue taking the drug, you may need to reduce the dose of the diuretic. In patients with CHF, the intake of ACE inhibitors can cause an excessive antihypertensive effect, which can lead to the development of oliguria and azotemia, as well as in some cases, acute renal failure with a fatal outcome, and therefore this group of patients needs careful observation in the first 2 weeks. taking Fosinopril, as well as with any dose increase. However, a slight decrease in blood pressure at the beginning of taking ACE inhibitors is normal for patients with CHF. Typically, blood pressure returns to normal within 1-2 weeks without reducing the therapeutic efficacy of the drug;
- hyperkalemia: when taking ACE inhibitors, there have been cases of increased potassium in the blood, especially in patients with renal failure, type 1 diabetes mellitus, in patients taking potassium-sparing diuretics or drugs that increase serum potassium (heparin, etc.);
- cough: taking ACE inhibitors can cause a persistent, unproductive cough that goes away on its own after discontinuation of the drug;
- general anesthesia, surgical operations: it is possible to increase the antihypertensive effect of drugs used for general anesthesia, in connection with which the surgeon and anesthesiologist should be warned about taking ACE inhibitors.
Influence on the ability to drive vehicles and complex mechanisms
Care should be taken when driving vehicles and engaging in other potentially hazardous activities that require the speed of psychomotor reactions due to the risk of side effects, such as dizziness.
Application during pregnancy and lactation
The use of Fosinopril during pregnancy is contraindicated due to its teratogenic and fetotoxic effects. In the event that pregnancy occurs while taking the drug, it should be stopped immediately and switched to an alternative treatment that is safe during pregnancy. The patient should be informed of the risk to the fetus, and a thorough ultrasound scan should be performed to identify fetal abnormalities.
In newborns, whose mothers took ACE inhibitors during pregnancy, oliguria, arterial hypotension, and hyperkalemia were noted.
If it is necessary to take Fosinopril during lactation, breastfeeding should be discontinued.
Pediatric use
The efficacy and safety of the use of Fosinopril in pediatric practice has not been established, and therefore it is contraindicated to use the drug in children and adolescents under 18 years of age.
With impaired renal function
Fozinopril should be used with caution in patients with renal impairment.
With stenosis of the renal arteries or the artery of the only kidney during the period of taking ACE inhibitors, an increase in blood urea nitrogen and serum creatinine is possible. After the end of treatment, these effects disappear. At the beginning of treatment, this group of patients needs to be monitored.
For violations of liver function
According to the instructions, Fosinopril should be administered with caution to patients with impaired liver function.
There are described episodes when, while taking ACE inhibitors, cholestatic jaundice appeared, and then fulminant necrosis of the liver developed, in some cases leading to death. If jaundice appears and the activity of liver enzymes increases, the drug should be discontinued and symptomatic therapy should be started.
Use in the elderly
Usually, dose adjustment of Fosinopril is not required in elderly patients, however, the possible delayed elimination of the drug in the elderly should be considered, which can lead to an overdose.
Drug interactions
- antacids: reduce the absorption of fosinopril. It is recommended to observe the interval between taking these drugs at least 2 hours;
- lithium salts: the risk of developing lithium intoxication increases, and therefore, when they are taken together, careful monitoring of the lithium content in the blood serum is necessary;
- nonsteroidal anti-inflammatory drugs (NSAIDs) (indomethacin, acetylsalicylic acid at a dose of 3 g / day or more, selective inhibitors of cyclooxygenase-2): can reduce the antihypertensive effect of fosinopril, especially in patients with arterial hypertension and low plasma renin activity. In patients over 65 years of age, with hypovolemia and impaired renal function, these drugs can lead to deterioration of renal function, up to acute renal failure, and therefore patients taking NSAIDs and fosinopril need careful monitoring of renal function;
- diuretics, low salt diet, dialysis: the risk of a pronounced decrease in blood pressure, especially in the first hour after taking the initial dose of the drug;
- potassium-sparing diuretics containing trimethoprim drugs: the risk of hyperkalemia increases;
- inhibitors of mTOR enzymes (temsirolimus, sirolimus, everolimus): the risk of angioedema increases;
- sulfonylurea derivatives, insulin: their hypoglycemic effect increases;
- allopurinol, cytostatic drugs, immunosuppressants, procainamide: risk of developing leukopenia;
- estrogens: reduce the antihypertensive effect of fosinopril;
- drugs for general anesthesia, antihypertensive drugs, narcotic analgesics: enhance the antihypertensive effect of fosinopril;
- chlorthalidone, nifedipine, propranalol, hydrochlorothiazide, cimetidine, metoclopramide, propantheline bromide, digoxin, warfarin: do not affect the bioavailability of fosinopril;
- aliskiren: concomitant use is contraindicated in patients with diabetes mellitus and moderate to severe renal impairment. The appointment of these drugs in the complex is allowed only in individual cases, and with regular monitoring of renal function.
Analogs
Fosinopril's analogs are Lisinopril, Enalapril, Captopril, Berlipril, Accupro, Moex, Prenessa, Prestarium, Renitek, Hartil, Tritace, Enap, Ramipril, etc.
Terms and conditions of storage
Store away from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Fozinopril
Reviews of Fozinopril are mostly positive. Patients report significant relief and stabilization of blood pressure. There are some mentions of mild side effects in the form of cough, hot flashes and changes in taste.
The price of Fozinopril in pharmacies
The approximate price for Fozinopril in pharmacies is 270 rubles. per package containing 30 tablets of 10 mg.
Fozinopril: prices in online pharmacies
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Drug name Price Pharmacy |
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Fozinopril tablets 20mg 30 pcs. 377 r Buy |
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Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
