Fozicard H (Fosicard H)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydrochlorothiazide + FosinoprilHydrochlorothiazide + Fosinopril
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  • Fozicard H
    pills inwards 
    Aktavis, AO     Iceland
  • Fosinotek H
    pills inwards 
    Ranbaxy Laboratories Limited     India
    • Dosage form: & nbspPills.
    Composition:

    Each tablet contains:

    active substances: fosypipril sodium 20 mg and hydrochlorothiazide 12.5 mg;

    Excipients: lactose monohydrate 101.5 mg. pigment mixture PB- 23601 (includes: titanium dioxide 4.92 mg, lactose monohydrate 0.6 mg iron dye yellow oxide 0.36 mg, ferric oxide red 0.12 mg) 6 mg pregelatinized starch (starch 1500) 25 mg, croscarmellose sodium 9 mg, lactose monohydrate (Tabletose 80) 120 mg, glntseril dibehenate 6 mg, magnesium stearate (traces).

    Description:Round, flat pills of light orange color with engraving "FH" on the one hand, it is supposed the presence of marble.
    Pharmacotherapeutic group:hypotensive combined agent (angiotensin-converting enzyme inhibitor + diuretic).
    ATX: & nbsp

    C.09.B.A   ACE inhibitors in combination with diuretics

    C.09.B.A.09   Fosinopril in combination with diuretics

    Pharmacodynamics:Fosinopril refers to prodrugs. In the body of fosinopril formed an active metabolite - fosinoprilat, which prevents the conversion of angiotensin I into angiotensin II. The drug has antihypertensive, vasodilating, diuretic and potassium-sparing effect.Reduces overall peripheral resistance and systemic blood pressure (BP). The drug inhibits the synthesis of aldosterone, inhibits tissue ACE.

    Hydrochlorothiazide affects the mechanism of reabsorption of electrolytes in the renal tubules, increasing the release of sodium and chlorine ions to about the same extent, as well as ions of potassium and bicarbonate. Increases the activity of renin plasma, the secretion of aldosterone 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 oral administration, the decrease in blood pressure begins after 1 hour, reaches its maximum values ​​after 2-6 hours. Decrease in blood pressure after 24 hours is 60-90% of the maximum decrease in blood pressure, which allows taking the drug once a day.
    Pharmacokinetics:
    The pharmacokinetics of fosinopril and hydrochlorothiazide with simultaneous administration does not differ from that in their separate administration. After oral intake of fosinopril 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. With impaired liver function, the rate of hydrolysis can be slowed down, but the degree of hydrolysis does not change noticeably.
    The maximum concentration of fosinoprilat in blood plasma is reached after approximately 3 hours and does not depend on the dose of fosinopril taken. Fosinopril has linear pharmacokinetics. Fosinoprilat binds to a high degree of blood plasma proteins (90-95%) and binds to the cellular components of the blood to a small extent. Has a relatively small amount of distribution. In patients with hypertension with normal kidney and liver function, the half-life of fosinoprilat is approximately 11.5 hours.
    After oral intake of hydrochlorothiazide is 60-80%. The maximum concentration of hydrochlorothiazide in the blood is reached 1-5 hours after ingestion.
    Binding to plasma proteins is 64%. Hydrochlorothiazide is not metabolized and is rapidly excreted through the kidneys. The half-life is 5-15 hours.
    Renal insufficiency: with renal insufficiency, absorption, bioavailability and binding of the drug to 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 through the liver with bile partially compensates for the decrease in excretion through the kidneys, the clearance of fosinoprilat does not differ significantly in patients with an average degree of renal insufficiency from that in patients with severe renal failure. In patients with renal insufficiency of various degrees, including renal failure in the terminal stage (creatinine clearance less than 10 ml / min / 1.73 m2), the area under the concentration-time curve (AUC) was observed to increase by 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.
    Liver failure: The degree of hydrolysis of fosinoprilat in patients with alcoholic or biliary cirrhosis is reduced to an insignificant degree, despite the fact that the rate of hydrolysis can be reduced.The maximum concentration and AUC of fosinoprilat is higher in patients with hepatic insufficiency after the first dose, however, when introducing repeated doses, this difference is not clinically significant.
    Indications:Arterial hypertension (patients who are shown combined therapy).
    Contraindications:Hypersensitivity to the drug components or other ACE inhibitors, to sulfonamide derivatives, including thiazides. Genetically determined or idiopathic angioedema (including the use of other ACE inhibitors in the history), severe renal failure (creatinine clearance less than 30 ml / min / 1.73 m2), anuria, gout, severe electrolyte imbalance, pregnancy, lactation, age under 18 (efficacy and safety not established).
    Carefully:arterial hypotension, connective tissue diseases (including systemic lupus erythematosus, scleroderma), impaired liver function or progressive liver disease (small changes in water-electrolyte balance can cause hepatic coma), metabolic acidosis,renal arterial stenosis or stenosis of the single kidney (an increase in the concentration of urea nitrogen and serum creatinine), hematopoiesis (agranulocytosis, neutropenia), conditions accompanied by a decrease in the volume of circulating blood (diarrhea, vomiting), aortic stenosis, cerebrovascular diseases (including cerebral circulatory insufficiency), coronary heart disease, chronic heart failure, a diet with salt restriction, a condition after transplantation , Diabetes, advanced age.
    Dosing and Administration:
    Inside, regardless of the time of eating, squeezed with enough liquid. The dose is selected individually. Usual dose -1 tablet once a day. When creatinine clearance is less than 30 ml / min the drug is not recommended. Patients with severe impairment of renal function are prescribed loop diuretics. For mild to moderate renal impairment (creatinine clearance greater than 30 mL / min, serum creatinine approximately 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 effects:

    Side effects with Fosicard H are similar to the side effects observed with each drug alone.

    The most common (in 2% of patients) are: dizziness, headache, cough, osteo-muscular pain, fatigue.

    Are common: chest pain, feeling tired, chills.

    From the cardiovascular system: Orthostatic hypotension, "hot flashes" of blood to the skin of the face, fainting, swelling, heart rhythm disturbances.

    From the endocrine system: decrease sexual function, change libido.

    From the immune system: angioedema.

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

    Musculoskeletal system: muscle pain, cramps.

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

    From the urinary system: frequency of urination, dysuria.

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

    From the sense organ: hearing loss.

    From the skin: rash, including urticaria, itching.

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

    Side effects described with fosinopril:

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

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

    From the respiratory system: dry cough, pulmonary infiltrates, bronchospasm, dyspnea, 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 of insomnia, anxiety, depression, confusion, violations of the vestibular apparatus, paresthesia.

    From the sense organs: hearing and vision impairment, tinnitus.

    From the laboratory indicators: increased urea concentration, increased activity of "hepatic" enzymes, hypercreatininaemia, hyperbilirubinemia, hyperkalemia, hyponatremia; decrease in the concentration of hemoglobin and hematocrit, increase in the rate of erythrocyte sedimentation (ESR).

    Side effects described with the use of hydrochlorothiazide:

    Dry mouth, nausea, vomiting, diarrhea; weakness, increased fatigue, dizziness, headache, palpitations, calf muscle cramps, hypokalemia, hypomagnesemia, hyponatremia, hyperuricemia, hypercalcemia, hyperglycaemia; exacerbation of gout, thrombosis, thromboembolism, hypercreatininaemia, acute interstitial nephritis, vasculitis, progression of myopia, neutropenia, thrombocytopenia, hemorrhagic pancreatitis; acute cholecystitis (against cholelithiasis), orthostatic hypotension, allergic dermatitis.

    Overdose:Symptoms: marked decrease in blood pressure, bradycardia, shock, disturbance of water-electrolyte balance, acute renal failure, stupor.
    Treatment: put the patient in the "lying" position, with raised legs.In mild cases of overdose - induce vomiting and / or gastric lavage, administration of adsorbents and sodium sulfate for 30 minutes, after administration. With a decrease in blood pressure - intravenous injection of catecholamines, angiotensin II; with bradycardia - the use of pacemaker.
    The drug is not excreted during hemodialysis and peritoneal dialysis.
    Interaction:

    Potassium preparations, potassium-sparing diuretics (spironolactone, amiloride, triamterene) increase the risk of hyperkalemia. It is necessary to control the potassium level in the blood serum (once every 2-3 weeks).

    Hypotensive drugs, diuretics, narcotic analgesics, means for general anesthesia increase the hypotensive effect of Fosicard N.

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

    The drug increases the hypoglycemic effect derivatives of sulfonylureas, insulin, the risk of developing leukopenia with concomitant use with allopurinol, cytostatic LC, immunodepressants, procainamide.

    Preparations for the treatment of gout. It may be necessary to increase the dose of probenecid or sulfinpyrazone used to treat gout, since hydrochlorothiazide can increase the concentration of uric acid in the blood.

    Nonsteroidal anti-inflammatory drugs reduce the severity of the hypotensive effect.

    Alcohol, barbiturates and narcotic drugs can reduce the hypotensive effect of the drug.

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

    Salts of calcium. Hydrochlorothiazide can 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 the motility of the gastrointestinal tract.

    Antacids (aluminum or magnesium hydroxide, simethicone and others) can reduce the absorption of Fosicard H. It is necessary to take these drugs with an interval of at least 2 hours.

    Precautions for use

    Start therapy Fozikardom H follows from the adjustment of the water-electrolyte balance. Fosinopril can cause symptomatic arterial hypotension, which is most likely in patients with reduced circulating blood volume 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 the subsequent use of Fosicard N. The maximum decrease in blood pressure is noted in the 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 swelling of the tongue, throat, larynx, airway obstruction may develop. 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 when treating patients with ACE during desensitization procedures. In the course of hemodialysis through high-permeability membranes, as well as during apheresis of low-density lipoproteins, anaphylactic reactions may occur with adsorption to dextran sulfate. 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 diseases of connective tissue, agranulocytosis and suppression of bone marrow function may develop. In this case, it is necessary to monitor the content of white blood cells in such patients. Such patients should be warned about the need to report any signs of infection - fever, sore throat, etc. 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 the simultaneous use of diuretics during treatment with ACE inhibitors, blood urea nitrogen and serum creatinine levels may increase.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, which can enhance 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 control of blood pressure, especially during the first 2 weeks of treatment. Hydrochlorothiazide can 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, 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. The concentration of uric acid in the blood can increase, and in some patients taking thiazide diuretics, an acute attack of gout can develop.

    In patients with diabetes mellitus, the need for insulin may change, the latent forms of diabetes mellitus may 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 nature, and passes after discontinuation of 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. The effectiveness and safety of the drug in children is not established.

    Form release / dosage:
    Tablets 20 mg + 12.5 mg.

    Packaging:
    For 7, 10 or 14 tablets in a blister from Al / PVC / Al. For 2, 4 blisters for 7 tablets, 1, 3 blisters for 10 tablets or 1.2 blisters for 14 tablets together with instructions for use in cardboard
    pack.
    Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children!
    Shelf life:
    2 years.
    The drug should not be used after the expiry date indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001573
    Date of registration:17.06.2011
    The owner of the registration certificate:Aktavis, AOAktavis, AO Iceland
    Representation: & nbspAktavis, Open Company Aktavis, Open Company
    Information update date: & nbsp29.12.2015
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