FOZIKARD

Active material: Fosinopril
When ATH: C09AA09
CCF: ACE inhibitor
ICD-10 codes (testimony): I10, I50.0
When CSF: 01.04.01.03
Manufacturer: Actavis hf. (Iceland)

Pharmaceutical form, composition and packaging

Pills round, Valium, white or nearly white, с обозначением на одной стороне букв “FL” и цифры “5”.

Excipients: lactose monohydrate, sodium croscarmellose, pregelatinized corn starch (starch 1500), microcrystalline cellulose, glycerol dibehenat.

14 PC. – блистеры (2) – пачки картонные.

Pills round, Valium, white or nearly white, с обозначением на одной стороне букв “FL” и цифры “10”.

Excipients: lactose monohydrate, sodium croscarmellose, pregelatinized corn starch (starch 1500), microcrystalline cellulose, glycerol dibehenate.

14 PC. – блистеры (2) – пачки картонные.

Pills round, Valium, white or nearly white, с обозначением на одной стороне букв “FL” и цифры “20”.

Excipients: lactose monohydrate, sodium croscarmellose, pregelatinized corn starch (starch 1500), microcrystalline cellulose, glycerol dibehenate.

14 PC. – блистеры (2) – пачки картонные.

Pharmacological action

ACE inhibitor. Фозиноприл – сложный эфир, из которого в организме образуется активный метаболит – фозиноприлат.

Fozinoprilat prevents the conversion of angiotensin I to the vasoconstrictor compound angiotensin II, leading to vasodilation.

The drug has anti-hypertensive, vazodilatirtee, diureticheskoe and kaliysberegayushtee action.

The antihypertensive effect is due to inhibition of metabolism of bradykinin also, which has a strong vasodilator effect.

The decrease in blood pressure are not accompanied by changes in the bcc, cerebral and renal blood flow, blood supply to internal organs, skeletal muscle, skin, reflex activity of the myocardium.

The antihypertensive effect of the drug is maintained during long-term treatment, Tolerance to the drug does not develop. After oral antihypertensive effect develops within 1 no, reaches through 2-6 h and stored 24 no.

Pharmacokinetics

Absorption

After oral administration, absorption from the gastrointestinal tract is approximately 30-40%. The extent of absorption is independent of food intake, but the rate of absorption may be delayed. C_max fozinoprilata plasma achieved through 3 no.

Distribution

Plasma protein binding - 95%. Fosinopril has a relatively small V_d. Do not cross the BBB.

Metabolism

The mucosa of the gastrointestinal tract, and, partially, liver fosinopril hydrolyzed to fozinoprilata.

Deduction

Fozinoprilat excreted in bile and urine. T_1/2 fozinoprilata is about 11.5 no.

Testimony

- Arterial hypertension;

- Congestive heart failure (in a combination therapy).

Dosage regimen

Before treatment hypertension, possibly, should cease to apply before antihypertensive treatment for a few days before you start taking Fozikarda^®.

The initial dose is 10 mg 1 time / day. In the future, the dose should be selected depending on the dynamics of blood pressure lowering. The average maintenance dose is 10-40 mg 1 time / day. In the absence of a positive effect from monotherapy Fozikardom^® possible additional diuretics.

If treatment Fozikardom^® begin on the background diuretic therapy, its initial dose should not exceed 10 mg with careful medical supervision.

When treating chronic heart failure initial dose Fozikarda^® is 10 mg 1 time / day. Further, the dose selected in accordance with the dynamics of the therapeutic efficacy, increasing on 10 mg at weekly intervals. The maximum dose is 40 mg / day. Perhaps additional diuretics.

Side effect

Cardio-vascular system: decrease in blood pressure, orthostatic hypotension, tachycardia, heartbeat, Arrhythmia, angina, myocardial infarction, chest pain.

From the digestive system: nausea, vomiting, constipation, ileus, stomatitis, glossitis, phenomenon dyspepsyy, abdominal pain, anorexia, cholestatic jaundice, pancreatitis, hepatitis.

The respiratory system: dry cough, breathlessness, pharyngitis, laringit, sinusitis, pulmonary infiltrates, bronchospasm, disfonija.

From the urinary system: development or exacerbation of the symptoms of chronic renal failure, proteinuria, oligurija.

From the central and peripheral nervous system: stroke, golovnogo ischemia mozga, dizziness, headache, weakness, hearing and visual impairment, noise in ears, disorders of the vestibular system; при использовании в высоких дозах – бессонница, anxiety, depression, confusion, paresthesia.

Allergic reactions: skin rash, itch, angioedema.

From the laboratory parameters: giperkreatininemiя, increasing concentrations of urea, increase in liver transaminases, giperʙiliruʙinemija, hyperkalemia, giponatriemiya, reduction of the concentration of hemoglobin and hematocrit, neutropenia, leukopenia, eozinofilija, increased erythrocyte sedimentation rate.

Contraindications

- Hereditary or idiopathic angioedema (incl. history) after administration of other ACE inhibitors;

- Pregnancy;

- Lactation (breast-feeding);

- Childhood and adolescence up 18 years;

- Hypersensitivity to fosinopril and other ingredients.

FROM caution use in patients with renal insufficiency, giponatriemii (the risk of dehydration, hypotension, chronic renal failure), bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, aortic stenosis, condition after kidney transplantation, when desensitization, systemic connective tissue diseases, incl. SLE, Scleroderma (increased risk of neutropenia or agranulocytosis), hemodialysis, cerebrovascular diseases (incl. cerebrovascular insufficiency), at IBS, chronic heart failure III and IV functional class NYHA classification, diabetes, suppression of bone marrow hematopoiesis, hyperkalemia, in elderly patients, with a diet with restriction of salt, under conditions, accompanied by a decrease in the bcc (incl. diarrhea, rvote).

Pregnancy and lactation

Application Fozikarda^® contraindicated during pregnancy and lactation.

Cautions

Patients with severe hypertension or concomitant decompensated chronic heart failure should begin treatment Fozikardom^® in hospital.

Before and during drug treatment requires monitoring of blood pressure, renal function, the concentration of potassium, hemoglobin content, creatinine, urea, the concentration of electrolytes and liver enzymes in the blood.

While taking Fozikarda^® should periodically monitor the number of leukocytes in peripheral blood, especially in patients with an increased risk of neutropenia (If the kidney function and systemic connective tissue diseases). Because of the increased risk of arterial hypotension must be careful when administering the drug to patients, We are on a salt-free diet or malosolevoy.

Use in Pediatrics

The safety and efficacy of the drug Fozikard^® in children have not been established.

Effects on ability to drive vehicles and management mechanisms

Be careful when driving or doing any other work, requiring greater attention, because of the possible occurrence of dizziness, especially after receiving the initial dose Fozikarda^® patients, while taking diuretics.

Overdose

Symptoms: marked reduction in blood pressure, bradycardia, shock, violation vodno-elektrolitnogo balance, acute renal failure, stupor.

Treatment: stop taking the drug, place the patient in the supine position with raised legs. В легких случаях передозировки – промывание желудка, introduction of adsorbents and sodium sulphate within 30 minutes after administration. При снижении АД – в/в введение катехоламинов, angiotensin II; при брадикардии – применение пейсмекера. Hemodialysis nyeeffyektivyen.

Drug Interactions

Antihypertensive agents, Diuretic, opioid analgesics, funds for general anesthesia while the use of Fozikardom^® enhance its hypotensive effect.

NSAIDs and estrogenic drugs while reducing the use of antihypertensive effect Fozikarda^®.

In an application Fozikarda^® with potassium preparations, potassium-sparing diuretics increase the risk of hyperkalemia.

Fozikard^® enhances hypoglycemic effect of sulfonylurea derivatives, insulin.

In an application Fozikarda^® with allopurinol, cytostatic drugs, immunosuppressants, procainamide increases the risk of leucopenia.

At simultaneous reception Fozikarda^® salts of lithium may increase the concentration of lithium in the blood.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life - 2 year.