Fosinap tabs 20mg #28

Fosinap instruction for use

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Composition

In one tablet, Fosinap can contain 10 or 20 mg of active substance - fosinopril sodium and inactive compounds: 0.7 / 1 mg of colloidal silica (aerosil), 5 / 5.7 mg of croscarmellose sodium (impellose), 66.8 / 97, 3 mg lactose (sugar milk), 0.5 / 1 mg macrogol (polyethylene glycol 4000), 1 / 1.5 mg sodium stearyl fumarate, 7 / 10.5 mg povidone (kollidona 30) and 49/73 mg MCC.

Form of issue

Fosinap is produced in white tablets of flat cylindrical shape with chamfers. In one package 1 or 3 blisters for 10 tables, 1 or 2 blisters for 15 tables, 1/2/4/8 blisters for 7 tables. or 1 contour plate per 30 tab.

pharmachologic effect

The drug has potassium-sparing, vasodilating, hypotensive and diuretic effect.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

As an ACE inhibitor, fosinopril is able to prevent the conversion of angiotensin I into angiotensin II, which reduces vasopressor activity and aldosterone secretion and leads to an insignificant increase in the serum concentration of potassium ions and, simultaneously, loss of body fluids and sodium ions. This leads to a decrease in OPSS and systemic blood pressure. Due to the action of fosinopril, there is an inhibition of metabolic degradation of bradykinin, which has a powerful vasopressor effect, which can potentiate the antihypertensive effect of the agent.
When diagnosed - chronic heart failure of a positive effect is achieved, mainly due to the suppression of the level of activity of the RAAS (renin-aldosterone system) by Fosinap. Inhibition of ACE leads to a decrease in preload and afterload on the heart muscle, the drug increases tolerance to physical exertion, reduces the severity of chronic heart failure.
After taking Fosinap inside, the development of the hypotensive effect in the first hour is observed, reaching its maximum after 3-6 hours, and remaining for a day.

Pharmacokinetics

Absorption from the gastrointestinal tract occurs on 30-40% regardless of the diet, but the rate of absorption can be reduced. Fosinopril is metabolized by enzymes to fosinoprilata mainly in the liver, as well as the mucosa of the gastrointestinal tract. The maximum plasma concentration is achieved after 3 hours regardless of the dose, connecting to plasma proteins by more than 95%. Fosinoprilat does not penetrate the BBB.
Excretion occurs equally through the kidneys and liver, the elimination half-life is usually - 11.5 h, in the presence of chronic heart failure - up to 14 hours.

Indications for use of Fosinap

    The drug is prescribed for arterial hypertension as a monotherapy or combined treatment.
    With chronic heart failure, Fosinap is usually included in the combined treatment.

Contraindications

    hypersensitivity to fosinopril or other components;
    angioedema;
    patients with glucose-galactose malabsorption or lactose intolerance, lactase deficiency;
    special groups: children under 18 years, nursing and pregnant women.

With caution, it is recommended to apply

    with renal insufficiency;
    hyponatremia, as the risk of dehydration, arterial hypotension and development of chronic kidney failure increases), as well as hyperkalemia;
    with bilateral stenosis of the arteries of the kidneys or a single kidney;
    with aortic stenosis;
    with ischemic heart disease (CHD);
    with chronic heart failure of the 3rd-4th grade by NYHA;
    Post-transplantation period in kidney transplantation;
    presence of desensitization;
    the presence of systemic connective tissue diseases, for example, lupus erythematosus or scleroderma), which may lead to an increased risk of agranulocytosis or neutropenia;
    state of oppression of bone marrow hematopoiesis;
    use of a salt-restricted diet;
    conducting hemodialysis;
    such cerebrovascular diseases as insufficiency of cerebral circulation;
    patients with diabetes mellitus;
    gout;
    age group: elderly patients;
    a condition with a reduced bcc, for example, with diarrhea, vomiting, previous to treatment with diuretics.

Side effects

Such undesirable reactions from systems and organs were recorded:
    CCC: lowering blood pressure, the appearance of orthostatic hypotension, collapse, tachycardia, palpitation, arrhythmia, angina pectoris, myocardial infarction, blood flushing to the face, cases of fainting and heart failure.
    The urinary system: the detection and aggravation of symptoms of chronic failure of kidney function and proteinuria.
    Central and peripheral nervous system: strokes, cerebral vascular ischaemia, dizziness and headaches, sensation of weakness, various memory disorders; reception of high doses can be accompanied by insomnia, anxiety, depression, confusion, drowsiness, paresthesia.
    Organs of the senses: visual, hearing, tinnitus are possible.
    Digestive system: the appearance of nausea, diarrhea, intestinal obstruction, development against the background of therapy - pancreatitis, hepatitis, cholestatic jaundice, the presence of abdominal pain, vomiting, constipation, anorexia, stomatitis, glossitis, dysphagia, flatulence, appetite disorders, changes in body weight, dryness in mouth; In rare cases, there was an intestinal edema.
    Respiratory system: presence of dry cough, pulmonary infiltrate, bronchospasm, dyspnea, rhinorrhea, pharyngitis, dysphonia, nosebleeds.
    Metabolism: gout.
    Musculoskeletal: arthritis.
    Hematopoiesis: lymphadenitis.
    Immune system: skin rash and itching, right up to the angioedema.
    Laboratory indicators: hypercreatininaemia, hyperbilirubinemia, hyponatremia, hyperkalemia, leukopenia, eosinophilia, neutropenia, increased urea concentration, hepatic transaminase activity, erythrocyte sedimentation rate increased; the concentration of hemoglobin and hematocrit decreased.

Fosinap, instructions for use (Method and dosage)

Take Fosinap tablets inside regardless of the diet. Do not chew and drink with a small amount of water. Dosage should be set individually on the basis of the patient's condition, laboratory tests and a diagnostic picture:
Arterial hypertension
A standard initial dose of 10 mg per day, which can vary with respect to the dynamics of blood pressure lowering within 10-40 mg per day. The maximum permissible single dose is 40 mg per day.
Chronic heart failure
The recommended initial daily dose is 5 mg (0.5 tablets) for 1 or 2 doses. The maximum permissible is also not more than 40 mg per day.

Overdose

Symptomatic picture
Admission in excess of doses of Fosinap is accompanied by a marked decrease in blood pressure, bradycardia, shock, a violation of water-electrolyte balance, acute renal failure, stupor.
Treatment Events
Immediate withdrawal of the drug, gastric lavage, the use of sorbents such as activated charcoal, as well as vasopressor drugs (infusion 0.9% solution of sodium chloride), symptomatic and supportive therapy. Hemodialysis is ineffective.

Interaction

    With antacids, as well as aluminum and magnesium hydroxide, a decrease in the absorption of fosinopril is observed, therefore an interval of at least 2 hours is necessary.
    With Lithium preparations, the plasma concentration of lithium rises, which leads to intoxication last.
    With Indomethacin and other NSAIDs (including with acetylsalicylic acid more than 3 g and inhibitors of COX-2), it is possible to reduce the antihypertensive effect of ACE inhibitors.
    With diuretics, or against a background of a strict diet that limits sodium salts, as well as hemodialysis, severe arterial hypotension may develop (occurs predominantly within an hour after taking the first dose of fosinopril).
    With drugs, potassium supplements and potassium-sparing diuretics (such as: Amyloride, Triamteren, Spironolactone) - increased risk of hyperkalemia.
    With the derivatives of sulfonylurea and insulin, it is possible to enhance their hypoglycemic effect.
    With Allopurinol, Procainamide, immunosuppressants, cytostatic agents - increased risk of developing leukopenia.
    With estrogens, weakening of the hypotensive effect of fosinopril.
    With antihypertensive drugs, opioid analgesics, preparations of general anesthesia enhance the potency of the hypotensive effect of fosinopril.

Terms of sale

To buy Fosinap you don't need a prescription.

Storage conditions

    Absence of moisture, protection from penetration of light rays.
    Temperature regime up to 25 ° Celsius.
    Lack of access to children.
Shelf life - 24 months.

In pregnancy and lactation

The drug is contraindicated in pregnant and lactating patients. Use in the second and third trimester of pregnancy can cause damage and death of the fetus. Mothers who took ACE inhibitors during pregnancy require careful monitoring in order to timely detect arterial hypotension, oliguria, and hyperkalemia.

Effects on the fetus and newborns

     a violation of kidney development and in the future - kidney function;
     a decrease in blood pressure;
     hyperkalemia;
     oligohydramnion (low water);
     hypoplasia of the bones of the skull, and also of the lungs;
     limb contractures.

Reviews about Fosinap

Reviews about the drug are different. Among the positive qualities are noted its affordable price, efficacy and convenient mode of admission, among the negative - individual intolerance and a fairly large list of side effects.