Fozicard tablets 10mg, No. 28

Arterial hypertension.
Chronic heart failure (as part of combination therapy).

Inside. The dosage should be adjusted individually.

When treating arterial hypertension, it is necessary, if possible, to stop taking antihypertensive drugs a few days before starting taking Fozicard.

The initial dose is 10 mg once a day. The further dose of the drug is selected in accordance with the blood pressure indicators. The maintenance dose is 10-40 mg once a day. In the absence of a positive effect from monotherapy with Fozicard, an additional prescription of diuretics is possible.

If treatment with Fozicard is started against the background of ongoing diuretic therapy, then its initial dose should be no more than 10 mg with close medical supervision.

In the treatment of chronic heart failure, the initial dose of Fozicard is 10 mg once a day. Further, the dose of the drug is selected in accordance with the dynamics of therapeutic efficacy, increasing by 10 mg at weekly intervals. The maximum dose is 40 mg per day. An additional appointment of a diuretic is possible.

1 tablet contains:
Active ingredient : Fosinopril sodium 10 mg
Excipients : lactose monohydrate, sodium croscarmellose, pregelatinized corn starch (starch 1500), microcrystalline cellulose, glycerol dibehenate.

Hypersensitivity to fosinopril or other components of the drug, hereditary or idiopathic angioedema, including in history, after taking other ACE inhibitors, pregnancy, lactation, age up to 18 years (efficacy and safety have not been established).

Carefully:renal failure, hyponatremia (risk of dehydration, arterial hypotension, chronic kidney 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 diseases of connective tissue (including systemic lupus erythematosus, scleroderma ) -increased risk of developing neutropenia or agranulocytosis, with hemodialysis, cerebrovascular diseases (including cerebral circulation insufficiency), coronary heart disease, chronic heart failure III and IV stages. (NYHA classification), diabetes mellitus, inhibition of bone marrow hematopoiesis, hyperkalemia, old age, with a diet with limited salt, conditions accompanied by a decrease in circulating blood volume (including diarrhea, vomiting).

Trade name of the drug: FOSICARD

International Non- Proprietary Name (INN): Fosinopril

Dosage form:

pills

Composition:

1 tablet contains:
Active ingredient : Fosinopril sodium 5, 10 or 20 mg.
Excipients : lactose monohydrate, sodium croscarmellose, pregelatinized corn starch (starch 1500), microcrystalline cellulose, glycerol dibehenate.

Description
Round tablets of flat-cylindrical shape, white or almost white, marked on one side of the letters 'FL' and the numbers '5' (for tablets with a dosage of 5 mg), '10' (for tablets with a dosage of 10 mg), '20' (for tablets with a dosage of 20 mg).

Pharmacotherapeutic group:

angiotensin converting enzyme (ACE) inhibitor

Pharmacological action
Pharmacodynamics
ACE inhibitor. Refers to prodrugs. In the body, an active metabolite, fosinoprilat, is formed from fosinopril, which prevents the conversion of angiotensin I into the vasoconstrictor substance angiotensin II, this leads to vasodilation and a decrease in aldosterone secretion. It has hypotensive, vasodilating, diuretic and potassium-sparing effects. Reduces total peripheral resistance and systemic blood pressure. The drug inhibits the synthesis of aldosterone, inhibits tissue ACE. The antihypertensive effect is also due to the suppression of the metabolism of bradykinin, which has a pronounced vasodilator effect. A decrease in blood pressure (BP) is not accompanied by a change in the volume of circulating blood, 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 oral administration, the hypotensive effect develops within 1 hour, reaches a maximum after 2-6 hours and lasts for 24 hours.

Pharmacokinetics
Absorption. After oral administration, fosinopril is absorbed from the gastrointestinal tract. Absorption averages 30 - 40%. The absorption rate is independent of food intake, but the rate of absorption may slow down. The time to reach the maximum concentration in blood plasma is 3 hours.
Distribution. Communication with blood plasma proteins - 95%. Fosinopril has a relatively small volume of distribution. Does not penetrate the blood-brain barrier.
Metabolism. In the mucous membrane of the gastrointestinal tract and, partially, in the liver, fosinopril is hydrolyzed to fosinoprilat.
Excretion. Fozinoprilat is excreted in bile and urine. The half-life of the final phase is 11.5 hours.

Indications for use
Arterial hypertension.
Chronic heart failure (as part of combination therapy).

Contraindications
Hypersensitivity to fosinopril or other components of the drug, hereditary or idiopathic angioedema, including a history, after taking other ACE inhibitors, pregnancy, lactation, age up to 18 years (efficacy and safety have not been established).

Carefully:renal failure, hyponatremia (risk of dehydration, arterial hypotension, chronic kidney 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 diseases of connective tissue (including systemic lupus erythematosus, scleroderma ) -increased risk of developing neutropenia or agranulocytosis, with hemodialysis, cerebrovascular diseases (including cerebral circulation insufficiency), coronary heart disease, chronic heart failure III and IV stages. (NYHA classification), diabetes mellitus, inhibition of bone marrow hematopoiesis, hyperkalemia, old age, with a diet with limited salt, conditions accompanied by a decrease in circulating blood volume (including diarrhea, vomiting).

Dosing and Administration
Inside. The dosage should be adjusted individually.

When treating arterial hypertension, it is necessary, if possible, to stop taking antihypertensive drugs a few days before starting taking Fozicard.

The initial dose is 10 mg once a day. The further dose of the drug is selected in accordance with the blood pressure indicators. The maintenance dose is 10-40 mg once a day. In the absence of a positive effect from monotherapy with Fozicard, an additional prescription of diuretics is possible.

If treatment with Fozicard is started against the background of ongoing diuretic therapy, then its initial dose should be no more than 10 mg with close medical supervision.

In the treatment of chronic heart failure, the initial dose of Fozicard is 10 mg once a day. Further, the dose of the drug is selected in accordance with the dynamics of therapeutic efficacy, increasing by 10 mg at weekly intervals. The maximum dose is 40 mg per day. An additional appointment of a diuretic is possible.

Side effect
From the side of the cardiovascular system: lowering blood pressure, orthostatic hypotension, tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction, chest pain.

From the digestive tract: nausea, vomiting, constipation, intestinal obstruction, pancreatitis, hepatitis, stomatitis, glossitis, dyspepsia, abdominal pain, anorexia, cholestatic jaundice.

From the respiratory system: dry cough, shortness of breath, pharyngitis, laryngitis, sinusitis, pulmonary infiltrates, bronchospasm, dysphonia.

From the urinary system: 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.

From the senses: hearing and visual impairments, tinnitus, disorders of the vestibular apparatus.

Allergic reactions: skin rash, itching, angioedema.

On the part of laboratory indicators: hypercreatininemia, increased urea concentration, increased activity of hepatic transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia; a decrease in the concentration of hemoglobin and hematocrit, neutropenia, leukopenia, eosinophilia, an increase in the erythrocyte sedimentation rate (ESR).

Overdose
Symptoms: marked decrease in blood pressure reduction, bradycardia, shock, imbalance in water and electrolyte balance, acute renal failure, stupor.
Treatment: stop taking the drug, place the patient in the 'lying' position with raised legs. In mild cases of overdose - gastric lavage, administration of sorbents and sodium sulfate within 30 minutes after ingestion. With a decrease in blood pressure, intravenous administration of catecholamines, angiotensin II; with bradycardia - the use of a pacemaker. Hemodialysis is ineffective.

Interaction with other drugs
Antihypertensive drugs, diuretics, narcotic analgesics, agents for general anesthesia enhance the hypotensive effect of Fosinopril.

Potassium supplements, potassium-sparing diuretics increase the risk of hyperkalemia. When taken simultaneously with lithium salts, an increase in the concentration of lithium in the blood is possible.

The drug enhances the hypoglycemic effect of sulfonylurea derivatives, insulin, the risk of leukopenia when used simultaneously with allopurinol, cytostatic drugs, immunosuppressants, procainamide.

Non-steroidal anti-inflammatory drugs and estrogens reduce the severity of the hypotensive effect.

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

Before and during treatment with the drug, it is necessary to control blood pressure, kidney function, potassium concentration, hemoglobin, creatinine, urea, electrolyte concentration and the activity of 'liver' enzymes in the blood.

While taking Fozicard, the number of leukocytes in the peripheral blood should be periodically monitored, especially in patients with an increased risk of neutropenia: with impaired renal function and systemic connective tissue diseases.

Due to the increased risk of arterial hypotension, care must be taken when prescribing the drug to patients on a low-salt or salt-free diet.

The safety and efficacy of using Fozicard in children has not been established.

Care must be taken when driving vehicles or when performing any work requiring increased attention due to the possible appearance of dizziness, especially after the initial dose of the drug in patients taking diuretic drugs.

Release form
Tablets 5 mg, 10 mg and 20 mg.
7, 10 or 14 tablets in a PVC / aluminum foil blister. 4 blisters of 7 tablets, 3 blisters of 10 tablets or 2 blisters of 14 tablets each with instructions for use in a cardboard box.

Storage conditions
At a temperature not exceeding 25 ? —.
Keep out of the reach of children!

Shelf life is
2 years.
The drug should not be used after the expiry date indicated on the package.

Terms of dispensing from pharmacies
Prescription.