Universal reference book for medicines
Name of the preparation: FOSICARD H (FOSICARD H)

Active substance: fosinopril, hydrochlorothiazide

Type: Antihypertensive drug

Manufacturer: ACTAVIS hf.
(Iceland) manufactured by FHI ZDRAVLJE (Serbia)
Composition, form of production and packaging
Tablets of
light orange color, round, flat, with engraving "FH" on the one hand, the presence of marble is supposed.

1 tab.

fosinopril sodium 20 mg

hydrochlorothiazide 12.5 mg

Auxiliary substances: lactose monohydrate - 101.5 mg, a mixture of pigments PB-23601 (titanium dioxide - 4.92 mg, lactose monohydrate - 0.6 mg, iron oxide oxide yellow - 0.36 mg, iron oxide red oxide - 0.12 mg) - 6 mg, pregelatinized starch starch 1500) - 25 mg, croscarmellose sodium - 9 mg, lactose monohydrate (tabletose 80) - 120 mg, glyceryl dibehenate - 6 mg.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

A combined antihypertensive drug containing an ACE inhibitor and a diuretic.

Fosinopril - an ACE inhibitor, is a prodrug.
In the body of fosinopril formed active metabolite fosinoprilat, which prevents the conversion of angiotensin I into angiotensin II. Has antihypertensive, vasodilating, diuretic and potassium-sparing effect. Reduces OPSS and systemic blood pressure. Suppresses the synthesis of aldosterone, inhibits tissue ACE.
Hydrochlorothiazide acts on the mechanism of reabsorption of electrolytes in the renal tubules, increasing the release of sodium and chloride ions approximately in the same degree, as well as ions of potassium and bicarbonate.
Increases the activity of plasma renin, aldosterone secretion and reduces the concentration of potassium ions in the blood serum.
Fosinopril and hydrochlorothiazide have an additive effect.
Fosinopril reduces the loss of potassium ions caused by the intake of hydrochlorothiazide.
After taking the medication, the decrease in blood pressure begins within 1 hour, reaches the maximum values ​​after 2-6 hours. The decrease in blood pressure after 24 hours is 60-90% of the maximum decrease in blood pressure, which allows taking the drug 1 time / day.

PHARMACOKINETICS

The pharmacokinetics of fosinopril and hydrochlorothiazide with simultaneous administration does not differ from that in their separate administration.

Suction

After oral intake of fosinopril a is approximately 30-40%, of which only 50-100% is hydrolyzed in the liver to fosinoprilata.
The degree of absorption of fosinopril does not depend on the intake of food, but the rate of absorption can be slowed down. If the liver function is impaired, the rate of hydrolysis can be slowed down, and the degree of hydrolysis does not change noticeably. C max fosinoprilata in blood plasma is achieved in about 3 hours and does not depend on the dose of fosinopril taken. Fosinopril has linear pharmacokinetics.
After oral intake of hydrochlorothiazide is 60-80%.
C max hydrochlorothiazide in the blood is achieved 1-5 hours after ingestion.
Distribution

Fosinoprilat binds to a high degree of blood plasma proteins (90-95%) and binds to the cellular components of blood to a small extent.
Has a relatively small V d .
The binding of hydrochlorothiazide to plasma proteins is 64%.

Metabolism and excretion

In patients with arterial hypertension, with normal renal and hepatic function, T 1/2 fosinoprilat is approximately 11.5 h.

Hydrochlorothiazide is not metabolized and is rapidly excreted by the kidneys.
T 1/2 is 5-15 hours.
Pharmacokinetics in special clinical cases

With renal insufficiency, absorption, bioavailability and binding of fosinoprilat with plasma proteins does not change significantly.
The total clearance of fosinoprilat in patients with renal insufficiency is almost 50% lower than in patients with normal renal function. Since excretion with bile partially compensates for the decrease in kidney excretion, the clearance of fosinoprilat is not significantly different in patients with moderate renal insufficiency from that in patients with severe renal insufficiency. In patients with renal insufficiency of various degrees, including renal failure in the terminal stage (CC <10 ml / min / 1.73 m 2 ), there is a moderate increase in AUC (less than 2 times compared with that in patients with normal renal function). The clearance of fosinoprilat for hemodialysis and peritoneal dialysis is on average 2% and 7% compared to urea clearance.
The degree of hydrolysis of fosinoprilat in patients with alcoholic or biliary cirrhosis is reduced to a small extent, despite the fact that the rate of hydrolysis can be reduced.
Cmax and AUC of fosinoprilat are higher in patients with hepatic insufficiency after the first dose, however, when administered in repeated doses, the difference is not clinically significant.
INDICATIONS

- Arterial hypertension (patients who are shown combined therapy).

DOSING MODE

The drug is taken orally regardless of the time of eating, squeezed with enough liquid.

The dose is selected individually.
Usual dose is 1 tab. 1 time / day.
With a mild or moderate degree of renal dysfunction (CK> 30 mL / min, serum creatinine about 3 mg / dL or 265 μmol / L) , the usual dose of Fosicard N. is recommended.

If the liver function is not corrected, dose adjustment is not required.

Elderly patients may be more sensitive to the action of the drug due to delayed metabolism.

SIDE EFFECT

Side effects with the use of the drug Fosicard H are similar to the side effects noted with the use of each drug alone.

Most often (2%): dizziness, headache, cough, musculoskeletal pain, fatigue.

From the side of the cardiovascular system: orthostatic hypotension, flushes of blood to the face skin, fainting, edema, heart rhythm disturbances.

On the part of the endocrine system: a decrease in sexual function, a change in libido.

On the part of the digestive system: nausea, vomiting, diarrhea, heartburn, abdominal pain, gastritis, esophagitis.

From the musculoskeletal system: muscle pains, convulsions.

On the part of the respiratory system: nasal congestion, pharyngitis, rhinitis.

From the urinary system: increased frequency of urination, dysuria.

From the nervous system: drowsiness, depression, paresthesia.

From the senses: a decrease in hearing.

From the skin: rash, hives, itching.

From the immune system: angioedema.

On the part of laboratory: indicators: decrease in the content of ions of potassium, sodium, chlorine, magnesium, glucose, increasing the content of calcium ions, uric acid in the blood, increasing cholesterol and TG, neutropenia.

Other: chest pain, fatigue, chills.

Side effects described with fosinopril

From the side of the cardiovascular system: a decrease in blood pressure, orthostatic collapse, tachycardia, palpitation, arrhythmia, angina pectoris, myocardial infarction.

On the part of the digestive system: nausea, diarrhea, intestinal obstruction, pancreatitis, hepatitis, cholestatic jaundice, abdominal pain, vomiting, constipation, decreased appetite, stomatitis, glossitis.

On the part of the respiratory system: dry cough, pulmonary infiltrates, bronchospasm, dyspnea, rhinorrhea, pharyngitis, dysphonia.

From the nervous system: stroke, cerebral ischemia, dizziness, headache, weakness;
when used in high doses - insomnia, anxiety, depression, confusion, violations of the vestibular apparatus, paresthesia.
From the senses: hearing and vision impairment, tinnitus.

On the part of laboratory indicators: increased urea concentration, increased activity of hepatic enzymes, hypercreatininaemia, hyperbilirubinemia, hyperkalemia, hyponatremia;
reduction of hemoglobin and hematocrit, increase in ESR.
Other: allergic, toxic-allergic and immunopathological reactions.

Side effects described with the use of hydrochlorothiazide

On the part of the digestive system: dry mouth, nausea, vomiting, diarrhea, hemorrhagic pancreatitis, acute cholecystitis (against cholelithiasis).

From the nervous system: dizziness, headache.

From the urinary system: hypercreatininaemia, acute interstitial nephritis.

On the part of metabolism: hypokalemia, gastrocnemius muscle cramps, hypomagnesemia, hyponatremia, hyperuricemia, hypercalcemia, hyperglycemia, exacerbation of gout.

From the cardiovascular system: palpitation, orthostatic hypotension, thrombosis, thromboembolism.

From the hemopoietic system: thrombocytopenia, neutropenia.

Allergic reactions: allergic dermatitis, vasculitis.

Other: weakness, fatigue, progression of myopia.

CONTRAINDICATIONS

- genetically caused or idiopathic angioedema (including and from the use of other ACE inhibitors in
anamnesis);
- renal failure of severe degree (CC <30 ml / min / 1.73 m 2 );

anuria;

- gout;

- severe electrolyte imbalance;

- Pregnancy;

- the period of lactation (breastfeeding);

- age under 18 years (effectiveness and safety not established);

- hypersensitivity to the components of the drug;

- Hypersensitivity to other ACE inhibitors;

- hypersensitivity to other sulfonamide derivatives, including thiazides.

With caution , the drug should be used in cases of arterial hypotension, connective tissue diseases (including systemic lupus erythematosus, scleroderma), impaired liver function or progressive liver disease (small changes in water-electrolyte balance may cause hepatic coma), metabolic acidosis, renal dysfunction, stenosis of the renal arteries or stenosis of the artery of a single kidney (possibly increasing the concentration of urea nitrogen and serum creatinine), in violation of hematopoiesis (agra
ulcytosis, neutropenia), conditions accompanied by a decrease in bcc (diarrhea, vomiting), aortic stenosis, cerebrovascular diseases (including cerebral circulatory insufficiency), ischemic heart disease, chronic heart failure, diabetes, post-renal transplantation, limiting salt, in elderly patients.
PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in patients with severe renal failure (CC <30 ml / min / 1.73 m 2 ), anuria.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If the liver function is not corrected, dose adjustment is not required.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

Elderly patients may be more sensitive to the action of the drug due to delayed metabolism.

SPECIAL INSTRUCTIONS

Before starting therapy with Fosicard H, the water-electrolyte balance should be corrected.

Fosinopril can cause symptomatic arterial hypotension, which is most likely in patients with reduced BCC as a result of prolonged previous treatment with diuretics, restriction of salt intake, dialysis, diarrhea, or vomiting.

Arterial hypotension is not an absolute contraindication for further use of the drug Fosicard N. The maximum decrease in blood pressure is noted at early stages of treatment and stabilizes usually at week 2 of therapy.
With further use of the drug, a decrease in its therapeutic efficacy is not observed.
With the use of ACE inhibitors, including fosinopril, angioedema may develop.
With edema of the tongue, throat, larynx, the development of airway obstruction is possible. Patients should stop taking the medication and immediately inform the attending physician about the appearance of edema on the face, eyes, lips and tongue, spasm of the muscles of the larynx or shortness of breath. In such cases, rapid emergency measures must be taken.
Care should also be taken with the use of an ACE during desensitization procedures.

In the course of hemodialysis through high-permeability membranes, as well as during apheresis of LDL with adsorption to dextran sulfate, anaphylactic reactions may occur.
In these cases, dialysis membranes of a different type or other medication should be used.
In patients with impaired renal function, especially in the presence of systemic connective tissue diseases, agranulocytosis and suppression of bone marrow function may develop.
In this case, the white blood cell count should be monitored. Such patients should be warned about the need to report the appearance of any signs of infection, including. fever, sore throat.
Care should be taken when prescribing the drug to patients with severe renal dysfunction.
In patients with arterial hypertension with renal artery stenosis of one or both kidneys, and also with simultaneous use of diuretics during treatment with ACE inhibitors, an increase in the level of urea nitrogen and serum creatinine is possible. These effects are reversible and pass after discontinuation of treatment. In such patients, it is necessary to monitor the kidney function during the first 2 weeks of treatment. You may need to reduce the dose of the drug.
In patients with severe heart failure, oliguria, and / or progressive azotemia, with or without renal failure, treatment with ACE inhibitors can cause an excessive hypotensive effect, possibly strengthening oliguria or azotemia, and in rare cases, death.
Therefore, in such patients treatment with the drug should begin with a minimum therapeutic dose and under strict control of blood pressure, especially during the first 2 weeks of treatment.
Hydrochlorothiazide is able to cause hypokalemia, hyponatremia and hypochloraemic alkalosis.
In the presence of fosinopril sodium, the risk of hypokalemia decreases. Hydrochlorothiazide helps to reduce the excretion of calcium ions from the body to increase the excretion of magnesium ions in the urine, which can lead to hypomagnesemia. Periodic monitoring of the concentration of electrolytes in serum is required.
It is possible to increase the concentration of uric acid in the blood, and in some patients taking thiazide diuretics, an acute attack of gout can develop.

In patients with diabetes, there may be a change in the need for insulin, latent forms of diabetes mellitus can acquire a manifest form against the background of the use of thiazides.

Increase in the concentration of triglycerides and cholesterol is associated with treatment with thiazide diuretics.

Cough caused by ACE inhibitors, including fosinopril, is usually unproductive and persistent, and occurs after discontinuing medication.
Cough caused by ACE inhibitors should be considered as one of the options for differential diagnosis of cough.
In rare cases, the use of ACE inhibitors can lead to the appearance of cholestatic jaundice with the development of fulminant necrosis of hepatocytes.

Use in Pediatrics

The effectiveness and safety of the drug in children is not established.

OVERDOSE

Symptoms: marked decrease in blood pressure, bradycardia, shock, disturbance of water-electrolyte balance, acute renal failure, stupor.

Treatment: Patient should be placed in a prone position with raised legs.
In mild cases of overdose - artificial vomiting and / or gastric lavage, the introduction of adsorbents and sodium sulfate for 30 minutes after ingestion. With a decrease in blood pressure - IV injection of catecholamines, angiotensin II; with bradycardia - the use of pacemaker. Fosinopril is not excreted during hemodialysis and peritoneal dialysis.
DRUG INTERACTION

With the simultaneous use of Fosicard H with potassium preparations , potassium-sparing diuretics (spironolactone, amiloride, triamterene), the risk of hyperkalemia increases.
It is necessary to control the potassium level in the blood serum (once every 2-3 weeks).
Hypotensive drugs, diuretics, opioid analgesics, means for general anesthesia increase the hypotensive effect of the drug Fozikard N.

With simultaneous administration with lithium salts, it is possible to increase the concentration of lithium in the blood serum and the risk of developing lithium toxicity.

The drug enhances the hypoglycemic effect of derivatives of sulfonylurea, insulin.

The drug increases the risk of developing leukopenia with simultaneous use with allopurinol, cytostatic agents, immunosuppressants, procainamide.

If used simultaneously, an increase in the dose of probenecid or sulfinpyrazone used to treat gout may be required, as hydrochlorothiazide is able to increase the uric acid content in the blood.

NSAIDs reduce the severity of the hypotensive effect of the drug Fozikard N.

Ethanol, barbiturates and opioid analgesics can reduce the hypotensive effect of the drug.

Colestramine and colestipol can reduce the absorption of hydrochlorothiazide.
Fosicard H should be taken at least 1 hour before or 4-6 hours after the administration of these agents.
Hydrochlorothiazide is able to increase the concentration of calcium ions in the blood serum by reducing its excretion from the body.
When used concomitantly with Fosicard H, a dose reduction of calcium preparations may be required .
Bioavailability of the drug with simultaneous use with chlorthalidone, nifedipine, propranolol, cimetidine, metoclopramide, propanthelin bromide, digoxin, acetylsalicylic acid and warfarin does not change.

The absorption of hydrochlorothiazide increases with simultaneous administration of funds that reduce gastrointestinal motility.

Antacids (including aluminum or magnesium hydroxide, simethicone) can reduce the absorption of the drug Fosicard H Take these drugs should be at intervals of at least 2 hours.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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