Fozicard N pills 12.5mg+20mg, 28pcs

Composition

1 tablet contains:

active ingredients:

fosinopril sodium 20 mg,

hydrochlorothiazide 12.5 mg,

excipients:

lactose monohydrate;

croscarmellose sodium;

pregelatinized starch (starch 1500);

glycerol dibegenate;

PB-23601 pigment mixture:

titanium dioxide,

lactose monohydrate,

iron oxide yellow,

iron oxide red

Pharmacological action

Fozicard H has a hypotensive, vasodilating, diuretic, potassium-sparing effect.

Pharmacodynamics

In the body, fosinopril forms an active metabolite, fosinoprilate, which prevents the conversion of angiotensin I to angiotensin II. Reduces OPSS and systemic blood pressure. The drug suppresses the synthesis of aldosterone, inhibits tissue ACE. After oral use, a decrease in blood pressure begins in 1 hour, reaches maximum values in 2-6 hours. The hypotensive effect lasts for 24 hours after taking one dose per day. Hydrochlorothiazide acts on the mechanism of reabsorption of electrolytes, potassium ions and bicarbonate. Increases the activity of aldosterone and reduces the concentration of potassium ions in the serum. Fosinopril and hydrochlorothiazide have an additive effect. Fosinopril reduces the loss of potassium ions caused by taking hydrochlorothiazide.

Pharmacokinetics

The pharmacokinetics of fosinopril sodium and hydrochlorothiazide when taken simultaneously does not differ from that when they are administered separately. After oral use, the absorption of fosinopril sodium is approximately 30-40%, of which 50-100% is hydrolyzed in the liver to fosinoprilate, which has pharmacological activity. The degree of absorption of fosinopril does not depend on food intake, but the rate of absorption may be slow. With impaired liver function, the rate of hydrolysis can be slowed down, while the degree of hydrolysis does not change significantly. _{Cmax of}fosinoprilate in blood plasma is reached in approximately 3 hours and does not depend on the dose of fosinopril taken. Fosinopril has linear pharmacokinetics. Fosinoprilate is highly bound to plasma proteins (90-95%) and slightly bound to blood cell components. It has a relatively small distribution volume. In patients with arterial hypertension with normal renal and hepatic function, the T_1/2 of fosinoprilate is approximately 11.5 hours. After oral use, the absorption of hydrochlorothiazide is 60-80%. _{Cmax of}hydrochlorothiazide in the blood is reached in 1-5 hours after oral use. Binding to plasma proteins is 64%. Hydrochlorothiazide is not metabolized and is rapidly excreted through the kidneys. T_1/2 is 5-15 hours.

Renal insufficiency: in renal insufficiency, the absorption, bioavailability and binding of the drug to plasma proteins do not change significantly. The total clearance of fosinoprilate in patients with renal insufficiency is almost 50% lower than in patients with normal renal function. Since liver and bile excretion partially compensates for decreased renal excretion, the clearance of fosinoprilate does not significantly differ in patients with moderate renal insufficiency from that in patients with severe renal insufficiency. In patients with renal insufficiency, there is a moderate increase in AUC (less than 2 times compared to that in patients with normal renal function). The clearance of fosinoprilate during hemo – and peritoneal dialysis is on average 2 and 7% compared to urea clearance.

Hepatic insufficiency: the degree of hydrolysis of fosinoprilate in patients with moderate hepatic insufficiency decreases slightly, although the rate of hydrolysis may be reduced. The maximum concentration and AUC of fosinoprilate are higher in patients with hepatic insufficiency after the first dose, but this difference is not clinically significant when repeated doses are administered.

Indications

Arterial hypertension.

Contraindications

• hypersensitivity to Fozikard H or to other ACE inhibitors, to a derivative of sulfonamide, including thiazides;
• genetically mediated or idiopathic angioedema (including from using other ACE inhibitors in history);
• severe renal insufficiency (Cl creatinine less than 30 ml/min/1.73 m 2);
• anuria;
• gout;
• severe electrolyte imbalance;
• pregnancy;
• breastfeeding;
• age to 18 years (efficacy and safety not established).

With caution:

• hypotension;
• connective tissue diseases (including systemic lupus erythematosus, scleroderma);
• violation of liver function or progressive liver disease (small changes in water and electrolyte balance may cause liver coma);
• metabolic acidosis;
• violation of kidney function, renal artery stenosis or stenosis of the artery to a solitary kidney (may increase the concentration of urea nitrogen and creatinine serum);
• the violation of blood (agranulocytosis, neutropenia);
• state, accompanied by a decrease in BCC (diarrhea, vomiting);
• aortic stenosis;
• cerebrovascular disease (including cerebrovascular insufficiency);
• CHD, chronic heart failure;
• a diet with restriction of salt;
• condition after kidney transplantation;
• diabetes mellitus;
• elderly age.

Side effects

Side effects of Fozicard H are similar to the side effects observed with the use of each drug separately. The most common symptoms (2% of patients) are dizziness, headache, cough, musculoskeletal pain, and fatigue.

Common: chest pains, feeling tired, chills.

From the cardiovascular system: orthostatic hypotension, “flushes” of blood to the skin of the face, fainting, edema, cardiac arrhythmias.

From the endocrine system: decreased sexual function, altered libido.

Immune system disorders: angioedema.

From the digestive tract: nausea, vomiting, diarrhea, heartburn, abdominal pain, gastritis, esophagitis.

Musculoskeletal system: muscle aches, cramps.

From the respiratory system: nasal congestion, pharyngitis, rhinitis.

From the urinary system: increased urination, dysuria.

From the central nervous system: drowsiness, depression, paresthesia.

From the side of the sensory organ: hearing loss.

Skin disorders: rash, including urticaria, pruritus.

From the laboratory parameters: a decrease in the concentration of potassium, sodium, chlorine, magnesium, glucose, an increase in the concentration of calcium ions, uric acid in the blood, an increase in cholesterol and triglycerides, neutropenia.

Side effects described when using fosinopril:

From the cardiovascular system: reduced blood pressure, orthostatic collapse, tachycardia, palpitations, arrhythmia, angina, myocardial infarction.

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

Respiratory system disorders: dry cough, pulmonary infiltrates, bronchospasm, shortness of breath, rhinorrhea, pharyngitis, dysphonia. Allergic, toxic-allergic, and immunopathological reactions.

From the central nervous system: stroke, cerebral ischemia, dizziness, headache, weakness; when used in high doses — insomnia, anxiety, depression, confusion, vestibular disorders, paresthesia.

From the sensory organs: hearing and vision disorders, tinnitus.

From the laboratory parameters: increased urea concentration, increased activity of liver enzymes, hypercreatininemia, hyperbilirubinemia, hyperkalemia, hyponatremia; decreased hemoglobin and hematocrit concentrations, increased ESR.

Side effects described when using hydrochlorothiazide:

Dry mouth, nausea, vomiting, diarrhea; weakness, fatigue, dizziness, headache, palpitations, calf muscle spasms, hypokalemia, hypomagnesemia, hyponatremia, hyperuricemia, hypercalcemia, hyperglycemia; exacerbation of gout, thrombosis, thromboembolism, hypercreatininemia, acute interstitial nephritis, vasculitis, progressive myopia, neutropenia, thrombocytopenia, hemorrhagic pancreatitis, acute cholecystitis (with cholelithiasis), orthostatic hypotension, allergic dermatitis.

Interaction

Potassium supplements, potassium-sparing diuretics (spironolactone, amiloride, triamterene) increase the risk of hyperkalemia. It is necessary to monitor the level of potassium in the blood serum (1 time in 2-3 weeks).

Antihypertensive agents, diuretics, narcotic analgesics, and general anaesthetics enhance the antihypertensive effect of Fozicard H.

When taken concomitantly with lithium salts, it is possible to increase the concentration of lithium in the blood serum and the risk of lithium toxicity.

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

Medications for the treatment of gout: it may be necessary to increase the doses of probenecid or sulfinpyrazone used for the treatment of gout, since hydrochlorothiazide can increase the concentration of uric acid in the blood.

NSAIDs reduce the severity of the hypotensive effect.

Alcohol, barbiturates, and narcotic analgesics may reduce the antihypertensive effect of the drug.

Colestyramine resin and colestipol may reduce the absorption of hydrochlorothiazide. Fozicard H should be taken at least 1 hour before or 4-6 hours after taking these medications.

Calcium salts: hydrochlorothiazide can increase the concentration of calcium ions in the blood serum by reducing its excretion from the body. When used concomitantly with Fozicard H, a reduction in the dose of calcium supplements may be required.

The bioavailability of the drug with simultaneous use with chlortalidone, nifedipine, propranolol, cimetidine, metoclopramide, propantelin bromide, digoxin, acetylsalicylic acid and warfarin does not change.

Absorption of hydrochlorothiazide increases with simultaneous use of drugs that reduce gastrointestinal motility.

Antacids (aluminum or magnesium hydroxide, simethicone, etc. ) can reduce the absorption of Fosicardia N. These drugs should be taken at intervals of at least 2 hours.

How to take, course of use and dosage

Fozicard H is taken orally, regardless of food intake, with a sufficient amount of liquid. The dose is selected individually. The usual dose for adults is 1 tablet per day.

When Cl creatinine is 30 ml/min, serum creatinine is approximately 3 mg/dl or 265 mmol/L), the usual dose of Fosicard H is recommended.

If liver function is impaired, no dose adjustment is required. Older people may be more sensitive to the drug’s effects.

Overdose

Symptoms: decreased blood pressure, bradycardia, shock, impaired water-electrolyte balance, acute renal failure, stupor.

Treatment: the patient is given a supine position with raised legs. In mild cases of overdose-gastric lavage, use of adsorbents and sodium sulfate within 30 minutes after ingestion.

With a decrease in blood pressure-intravenous use of catecholamines, angiotensin II; with bradycardia – the use of a pacemaker.

The drug is not excreted during hemo-and peritoneal dialysis.

Special instructions

Angioedema may develop when ACE inhibitors, including fosinopril, are used. With edema of the tongue, pharynx, larynx, airway obstruction may develop. Patients should stop taking the drug and immediately inform the attending physician about the appearance of swelling on the face, eyes, lips and tongue, about a spasm of the laryngeal muscles or difficulty breathing. In such cases, rapid emergency response is necessary.

Caution should also be exercised when treating patients with ACE during desensitization procedures. During hemodialysis through highly permeable membranes, as well as during LDL apheresis with adsorption on dextran sulfate, anaphylactic reactions may occur. In these cases, dialysis membranes of a different type or other medical treatment should be used. Patients with impaired renal function, especially in the presence of systemic connective tissue diseases, may develop agranulocytosis and suppression of bone marrow function. In this case, such patients should be monitored for white blood cells and warned to report any signs of infection (fever, sore throat, etc. ).

Caution should be exercised when prescribing the drug to patients with severe renal impairment. In patients with arterial hypertension with renal artery stenosis of one or both kidneys, as well as with the simultaneous use of diuretics during treatment with ACE inhibitors, the level of blood urea nitrogen and serum creatinine may increase. These effects are reversible and disappear after discontinuation of treatment. In such patients, renal function should be monitored during the first 2 weeks of treatment. It may be necessary to reduce the dose of the drug.

In patients with severe heart failure, oliguria, and/or progressive azotemia, in the presence or absence of renal insufficiency, treatment with ACE inhibitors may cause an excessive hypotensive effect, which may increase oliguria or azotemia, and in rare cases lead to death. Therefore, in such patients, treatment with the drug should begin with minimal therapeutic doses and under strict blood pressure control, especially during the first 2 weeks of treatment. Hydrochlorothiazide may cause hypokalemia, hyponatremia, and hypochloremic alkalosis. In the presence of fosinopril sodium, the risk of hypokalemia is reduced.

Hydrochlorothiazide reduces the excretion of calcium ions from the body, increases the excretion of magnesium ions in the urine, which can lead to hypomagnesemia. It is necessary to periodically check the concentration of electrolytes in the blood serum. Uric acid concentrations in the blood may increase, and some patients taking thiazide diuretics may develop an acute attack of gout. In patients with diabetes mellitus, the need for insulin may change, latent forms of diabetes mellitus may become manifest against the background of the use of thiazides.

Increased triglyceride and cholesterol concentrations were associated with treatment with thiazide diuretics. Cough caused by ACE inhibitors, including fosinopril sodium, is usually unproductive and persistent and resolves after discontinuation of medication. Cough caused by ACE inhibitors should be considered as one of the options in the differential diagnosis of cough. In rare cases, the use of ACE inhibitors can lead to the appearance of cholestatic jaundice with the development of lightning-fast necrosis of hepatocytes. The efficacy and safety of the drug in children has not been established.

Form of production

Tablets

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Hydrochlorothiazide, Fosinopril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension