Fosinotek H (Fozinotec N)

Archive
"Trade product
in Russia is not registered "
Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceHydrochlorothiazide + FosinoprilHydrochlorothiazide + Fosinopril
Similar drugsTo uncover
  • Fozicard H
    pills inwards 
    Aktavis, AO     Iceland
  • Fosinotek H
    pills inwards 
    Ranbaxy Laboratories Limited     India
    • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    Active substances: fosinopril sodium 20 mg, hydrochlorothiazide 12.5 mg.

    Excipients: lactose - 46.70 mg, crospovidone - 6.00 mg, povidone - 6.00 mg, isopropanol * - q.s., microcrystalline cellulose - 21.00 mg, silicon dioxide colloid - 3.00 mg, talc - 4.80 mg.

    * expended in the production process.

    Description:
    Round, flat tablets with beveled edges from white to almost white, engraved with "FH1" and with a risk for division on one side and smooth on the other.
    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:Antihypertensive combination drug. Fosinopril - inhibitor of angiotensin-converting enzyme (ACE). In the body of fosinopril formed an active metabolite - fosinoprilat,which prevents the conversion of angiotensin I into angiotensin II. Has antihypertensive, vasodilating, diuretic and potassium-sparing effect. Reduces the overall peripheral vascular resistance (OPSS) and blood pressure (BP). Suppresses the synthesis of aldosterone, inhibits tissue ACE.
    Hydrochlorothiazide is a thiazide diuretic. 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 content of potassium ions in the blood serum.
    Fosinopril and hydrochlorothiazide have additive effect. Fosinopril reduces the loss of potassium ions caused by the intake of hydrochlorothiazide. Antihypertensive effect begins to appear 1 hour after taking the drug inside, the maximum effect develops in 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

    differs from that in case of their separate appointment.

    Fosinopril

    The pharmacokinetics of fosinopril is linear.

    - suction: after ingestion, absorption from the gastrointestinal tract (GIT) is approximately 30-40%. The degree of absorption does not depend on the intake of food, but the rate of absorption can be slowed down. The maximum concentration of fosinoprilat in blood plasma is reached after approximately 3 hours and does not depend on the dose of fosinopril taken.

    - distribution: communication with blood plasma proteins - 95%. Fosinopril has a relatively small volume of distribution. Does not penetrate the blood-brain barrier.

    - metabolism: 50-100% of absorbed fosinopril is hydrolyzed in the liver to fosinoprilat. If the liver function is impaired, the rate of hydrolysis can be slowed down, and the degree of hydrolysis does not change noticeably.

    - excretion: Fosinoprilat is excreted through the intestines and kidneys. In patients with hypertension with normal kidney and liver function, the half-life of fosinoprilat is approximately 11.5 hours. In patients with chronic heart failure, the half-life (T 1/2) is 14 hours. The clearance of fosinoprilat for hemodialysis and peritoneal dialysis is on average 2% and 7%, respectively, relative to the values ​​of urea clearance.

    In patients with impaired renal function, creatinine clearance (CK) is less than 80 ml / min, the total clearance of fosinoprilat is approximately half that in patients with normal renal function. At the same time, both absorption, bioavailability and association with plasma proteins are not significantly altered.

    In patients with impaired liver function (with alcoholic or biliary cirrhosis), the rate of hydrolysis of fosinopril may be reduced, but the degree does not change significantly.

    The total clearance of fosinoprilat in these patients is about half

    compared with patients with normal liver function.

    Hydrochlorothiazide

    - suction: after oral absorption of the gastrointestinal tract is 60-80%. The maximum concentration in the blood plasma is reached after 1-5 hours after ingestion.

    - distribution: the binding to plasma proteins is 64%. Does not penetrate the blood-brain barrier.

    - metabolism and excretion: Hydrochlorothiazide is not metabolized and is rapidly excreted by the kidneys. T 1/2 is 5-15 hours.

    Indications:- arterial hypertension (in cases when combined therapy is indicated).
    Contraindications:
    - hereditary or idiopathic angioedema (including after taking other ACE inhibitors in the anamnesis);

    - severe renal failure (CC less than 30 ml / min / 1.73 m2);

    - anuria;

    - gout;

    - pronounced violations of water-electrolyte balance or acid-base state;

    - pregnancy and lactation;

    - children and adolescents under 18;

    - hypersensitivity to fosinopril and other drug components, other ACE inhibitors, to thiazide diuretics or sulfonamide derivatives;

    - deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.
    Carefully:With caution should prescribe the drug with arterial hypotension, with connective tissue diseases (including systemic lupus erythematosus, scleroderma), impaired liver function or progressive liver disease (severe water-electrolyte balance disorders can cause hepatic coma), metabolic acidosis, impaired function kidney, bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney (possibly increasing the concentration of urea nitrogen and serum creatinine), violation of ovetvoreniya (agranulocytosis, neutropenia), conditions involving decrease of blood volume (diarrhea,vomiting), aortic stenosis, cerebrovascular diseases (including cerebral circulatory insufficiency), coronary heart disease, chronic heart failure, with a diet with restriction of table salt, conditions after kidney transplantation, diabetes mellitus, and elderly patients.
    Pregnancy and lactation:The use of the drug Fosinotek N is contraindicated in pregnancy. The use of ACE inhibitors in the II and III trimester can cause damage or even death of the fetus (possibly development of violations of kidney fetus, lowering blood pressure, hypoplasia of the skull bones, oligohydramnia, limb contracture, lung hypoplasia). Fosinopril excreted in breast milk. If you need to use the drug Fosinotek H during lactation, breastfeeding should be discontinued.
    Dosing and Administration:
    Tablets are taken orally, regardless of the time of ingestion, with a sufficient amount of liquid.
    The dose is selected individually. The usual dose is 1 tablet once a day.
    With a mild or moderate degree of renal dysfunction (QC greater than 30 mL / min, serum creatinine approximately 3 mg / dL or 265 μmol / L), the usual dose of Fosinotek N. is recommended.With QC less than 30 ml / min the drug is not recommended. Patients with severe impairment of renal function are prescribed "loop" diuretics.
    If the liver function is not corrected, dose adjustment is not required.
    When prescribing a drug for elderly patients, it should be taken into account that they may be more sensitive to the action of the drug due to a delayed metabolism, so it is recommended that the dose of Fosinoteka H be individually selected.
    Side effects:

    Side effects observed with the use of the drug Fosinotek H are similar to the side effects observed with each drug individually. Are common:

    Allergic reactions: angioedema, urticaria.

    From the central nervous system (CNS): dizziness, headache, fatigue, drowsiness, depression.

    From the nervous system: paresthesia.

    From the skin: skin rash, itching.

    From the urinary system: frequency of urination, dysuria.

    From the side of the musculoskeletal system: muscle pain, joint pain, convulsions.

    From the digestive system: nausea, vomiting, diarrhea, heartburn, abdominal pain,

    gastritis, esophagitis.

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

    From the sense organs: hearing loss.

    From the cardiovascular system: orthostatic hypotension, "tides" of blood to the skin of the face, fainting, peripheral edema, heart rhythm disturbances, retrosternal pain.

    On the part of the reproductive system: decrease sexual function, change libido.

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

    Other: chills.

    Side effects described with fosinopril:

    From the side of the central nervous system: stroke, cerebral ischemia, dizziness, headache, weakness; when used in high doses - insomnia, anxiety, depression, confusion, violations of the vestibular apparatus.

    From the nervous system: paresthesia.

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

    From the respiratory system: dry cough, pulmonary infiltrates, bronchospasm, dyspnea, rhinorrhea, pharyngitis, dysphonia.

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

    From the cardiovascular system: marked decrease in blood pressure, orthostatic collapse, tachycardia, palpitations, arrhythmia, angina pectoris, myocardial infarction. From the laboratory indicators: increased urea concentration, increased activity of liver enzymes, hyperbilirubinemia, hypercreatininaemia, hyperkalemia, hyponatremia; reduction of hemoglobin and hematocrit, increase in the rate of erythrocyte sedimentation (ESR).

    Side effects described with the use of hydrochlorothiazide:

    Allergic reactions: dermatitis.

    From the side of the central nervous system: weakness, increased fatigue, dizziness, headache. From the urinary system: hypercreatininemia, acute interstitial nephritis.

    From the digestive system: dryness of the oral mucosa, nausea, vomiting, diarrhea; hemorrhagic pancreatitis, acute cholecystitis (against cholelithiasis).

    From the cardiovascular system: heartbeat, orthostatic hypotension, thrombosis, thromboembolism, vasculitis.

    From the laboratory indicators: hypokalemia, hypomagnesemia, hyponatremia, hyperuricemia, hypercalcemia, hyperglycemia, neutropenia, thrombocytopenia.

    Other: spasms of calf muscles, exacerbation of gout, progression of myopia.

    Overdose:

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

    Treatment: patient to lay with raised legs. In mild cases, gastric lavage, provocation of vomiting, administration of adsorbents and sodium sulfate are shown within 30 minutes after taking the drug. With a pronounced decrease in blood pressure - intravenous injection of vasopressor drugs, catecholamines, angiotensin II; at a bradycardia - application of the artificial driver of a rhythm. The drug is not excreted in hemodialysis and peritoneal dialysis.

    Interaction:
    At simultaneous application with Fosinotek H preparations of potassium, potassium-sparing diuretics (spironolactone, amiloride, triamterene) increases the risk of hyperkalemia. It is necessary to control the potassium content in the blood serum (once every 2-3 weeks).
    Used simultaneously other antihypertensives, diuretics,narcotic analgesics, means for general anesthesia increase the antihypertensive effect of Fosinoteka N.
    Fosinotek H with simultaneous application enhances the hypoglycemic effect of derivatives of sulfonylurea, insulin.
    With the simultaneous use of Fosinoteka H with allopurinol, cytostatic agents, immunosuppressants, procainamide, the risk of developing leukopenia increases.
    Nonsteroidal anti-inflammatory drugs reduce the severity of the antihypertensive effect Fosinoteka N.
    With the simultaneous administration of Fosinotek H with lithium salts, an increase in the lithium content of serum and the risk of lithium toxicity may occur. When used simultaneously with Fosinotek H, an increase in the dose of probenecid or sulfinpyrazone used to treat gout may be required, since hydrochlorothiazide can increase the concentration of uric acid in the blood. Antacids (aluminum or magnesium hydroxide), simethicone can reduce the absorption of Fosinoteka N. Take these drugs should be at intervals of at least 2 hours.
    Kolestyramovoy resin and colestipol can reduce the absorption of hydrochlorothiazide.Fosinotek H should be taken at least 1 hour before or 4-6 hours after taking these drugs.
    Hydrochlorothiazide can increase the content of calcium ions in the blood serum by reducing its excretion from the body. When used simultaneously with Fosinotek 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 admission with drugs that reduce gastrointestinal motility.
    Special instructions:
    Before starting therapy with Fosinotek H, it is necessary to correct the water-electrolyte balance. Fosinopril can cause symptomatic arterial hypotension, which is most likely in patients with a reduced volume of blood circulation 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 Fosinoteka N.The maximum decrease in blood pressure is noted in the early stages of treatment and stabilizes usually in the second week 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 prescribing Fosinoteka H during desensitization procedures.
    In the course of hemodialysis through high-permeability membranes, as well as during apheresis of low-density lipoproteins 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, it is necessary to monitor the content of leukocyte cells in the peripheral blood. Such patients should be warned about the need to report any signs of infection - fever, sore throat.
    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. These patients need to monitor the kidney function during the first two 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 that can enhance oliguria or azotemia, and in rare cases, lead to death. Therefore, in such patients, the use of Fosinoteka H should begin with minimal therapeutic doses and under the strict control of blood pressure, especially during the first two weeks of treatment.
    Hydrochlorothiazide can cause hypokalemia, hyponatraemia and hypochloremic alkalosis. In the presence of fosinopril, 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 electrolyte content in the 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 can change, the latent forms of diabetes mellitus can acquire a manifest form against the background of the use of thiazide diuretics. Increase in the concentration of triglycerides and cholesterol is associated with treatment with thiazide diuretics.
    Cough caused by ACE inhibitors, including fosinopril, usually has an 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.
    Form release / dosage:
    Tablets 12.5 mg + 20 mg.


    Packaging:10 tablets in a blister of aluminum foil, PVC film and polyamide. 2, 3 or 10 blisters with instructions for use in a cardboard bundle.
    Storage conditions:Store in a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:
    2 years.
    Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:PL-000929
    Date of registration:18.10.2011
    Date of cancellation:2017-02-15
    The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp15.02.2017
    Illustrated instructions
      Instructions
      Up