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

Active substance: fosinopril

Type: ACE inhibitor

Manufacturer: BIOKOM (Russia)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
ACE inhibitor.
Is a prodrug, from which the active metabolite fosinoprilat is formed in the body. It is believed that the mechanism of antihypertensive action is associated with competitive inhibition of ACE activity, which leads to a decrease in the rate of conversion of angiotensin I into angiotensin II, which is a potent vasoconstrictor. As a result of a decrease in angiotensin II concentration, a secondary increase in plasma renin activity occurs due to elimination of negative feedback during the release of renin and a direct decrease in aldosterone secretion. In addition, fosinoprilat, apparently, has an effect on the kinin-kallikrein system, preventing the breakdown of bradykinin.
Due to vasodilator effect, reduces OPSS (afterload), wedging pressure in the pulmonary capillaries (preload) and resistance in the pulmonary vessels;
increases the minute volume of the heart and tolerance to the load.
PHARMACOKINETICS
When ingested slowly absorbed from the gastrointestinal tract.
Admission with food can slow down, but not the degree of absorption. Metabolized in the liver and in the mucous membrane of the gastrointestinal tract by hydrolysis with the formation of fosinoprilata, due to the pharmacological activity of which hypotensive action is realized. The binding of fosinoprilata to plasma proteins is 97-98%. T 1/2 of fosinoprilat is 11.5 hours. It is excreted by the kidneys - 44-50% and through the intestine - 46-50%.
INDICATIONS
Arterial hypertension (in the form of monotherapy or as part of combination therapy).

Chronic heart failure (as part of combination therapy).

DOSING MODE
Is taken internally.

With arterial hypertension, the initial dose is 10 mg 1 time / day.
The maintenance dose is 10-40 mg 1 time / day. In the absence of a sufficient therapeutic effect, additional use of diuretics is possible.
In chronic heart failure, the initial dose is 5 mg 1-2 times / day.
Depending on the therapeutic effectiveness, the dose can be increased with a weekly interval up to amaximum daily dose of 40 mg 1 time / day.
SIDE EFFECT
From the cardiovascular system: a marked decrease in blood pressure, orthostatic hypotension, tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction, chest pain, tidal flashes to the skin of the face, cardiac arrest, fainting.

From the side 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 shells of the oral cavity, increased activity of hepatic transaminases, hyperbilirubinemia.

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, hypercreatininaemia, increased urea concentration.

From the 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.

From the hemopoietic system: neutropenia, leukopenia, eosinophilia, lymphadenitis, a decrease in hemoglobin and hematocrit.

From the musculoskeletal system: arthritis.

On the part of metabolism: exacerbation of gout, hyperkalemia, hyponatremia, increased ESR.

CONTRAINDICATIONS
Pregnancy, lactation (breastfeeding), hypersensitivity to ACE inhibitors.

PREGNANCY AND LACTATION
Use during pregnancy is contraindicated.

In the period of treatment for women of childbearing age, reliable means of contraception should be used.

Fosinopril is excreted in breast milk.
If fosinopril is needed during lactation, the question of stopping breastfeeding should be resolved.
APPLICATION FOR CHILDREN
Safety of use in children is not established.

APPLICATION IN ELDERLY PATIENTS
Do not require a special correction of the dosage regimen of fosinopril in elderly patients.

SPECIAL INSTRUCTIONS
They are used with caution for renal vascular hypertension, cardiac insufficiency, hyperkalemia, quincke edema, hypovolemia and / or decreased osmolarity of plasma of various etiologies, as well as in hemodialysis patients.

2-3 days before the start of treatment with fosinopril, prior therapy with diuretics is recommended to be canceled, except for patients with malignant or difficult to treat hypertension.
In such cases, fosinopril therapy should be started immediately, in a reduced dose, with careful medical supervision and careful dose increase.
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 continuing treatment 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 fosinopril in patients with chronic heart failure, 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.
Inhibitors of ACE in rare cases cause edema of the intestinal mucosa.
In this case, patients have abdominal pain (sometimes without nausea and vomiting), face swelling may also be absent, the level of C1-esterases is normal. After discontinuation of ACE inhibitors, symptoms disappear. Swelling of the intestinal mucosa should be taken into account in differential diagnosis in patients with abdominal pain while taking ACE inhibitors.
Against the background of treatment with ACE inhibitors during hemodialysis using high-permeability membranes, as well as during the apheresis of LDL with the adsorption of dextran sulfate, anaphylactic reactions may develop.
In these cases, the use of dialysis membranes of a different type or other antihypertensive therapy should be considered.
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 treatment in patients with an increased risk of neutropenia).
When there is a noticeable icterus and a marked increase in the activity of liver enzymes, treatment with fosinopril should be discontinued and appropriate treatment should be prescribed.

In arterial hypertension in patients with bilateral renal artery stenosis 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 may increase.
These effects are usually reversible and pass after discontinuation of treatment. You may need to reduce the dose of a diuretic and / or fosinopril.
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, to acute renal failure and a possible fatal outcome.

During therapy with fosinopril, the patient must exercise caution when performing physical exercises or in hot weather due to the risk of dehydration and arterial hypotension due to a decrease in BCC.

Do not require a special correction of the dosage regimen of fosinopril in elderly patients.
Safety of use in children is not established.
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.

Impact on the ability to drive vehicles and manage mechanisms

Care must be taken when driving vehicles or doing other work that requires increased attention, because
possibly dizziness, especially after the initial dose of fosinopril.
DRUG INTERACTION
With simultaneous use with antacids, it is possible to increase the absorption of fosinopril.

With simultaneous use with antihypertensive drugs may increase the antihypertensive effect.

With simultaneous use with diuretics, the development of severe arterial hypotension is possible.

With simultaneous use with potassium-sparing diuretics, potassium preparations, an increase in the potassium concentration in the blood plasma is possible.

With the simultaneous use of lithium carbonate, it is possible to increase the concentration of lithium in blood plasma and increase the risk of intoxication.

When used simultaneously with drugs used in anesthesia, analgesics may increase the antihypertensive effect.

With simultaneous use with acenocoumarol, the case of bleeding is described.

With simultaneous use with indomethacin, other NSAIDs (acetylsalicylic acid), a decrease in the effectiveness of ACE inhibitors is possible.

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