Active substanceLosartanLosartan
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active ingredient: Losartan potassium 50 mg;

    auxiliary ingredients: lactose 58 mg, microcrystalline cellulose 19.25 mg, pregelatinized starch 20.5 mg, magnesium stearate 2.25 mg;

    shell: opadray green [giprolose 35%, hypromellose 34%, titanium dioxide 26.64%, indigo dye 2.56%, dye yellow quinoline 1.79%, dye sunset yellow 0.01%] 4.55 mg.

    Description:

    Oblong biconvex tablets, covered with a shell of green color.

    The core of the tablet is broken in a white or almost white color.

    Pharmacotherapeutic group:Angiotensin II receptor blocker
    ATX: & nbsp

    C.09.C.A.01   Losartan

    C.09.C.A   Angiotensin II antagonists

    Pharmacodynamics:

    A hypotensive drug, is a specific antagonist of angiotensin II receptors (subtype AT1). Does not inhibit kinase II - an enzyme that destroys bradykinin. Reduces the overall peripheral vascular resistance (OPSS), the concentration in the blood of adrenaline and aldosterone, blood pressure (BP), pressure in the small circle of the circulation; reduces afterload, has a diuretic effect. It interferes with the development of myocardial hypertrophy, increases tolerance to exercise in patients with heart failure.

    After a single dose, the hypotensive effect (decreases systolic and diastolic blood pressure) reaches a maximum after 6 hours, then gradually decreases within 24 hours.

    The maximum hypotensive effect is achieved in 3-6 weeks after the start of the drug.

    Pharmacological data indicate that the concentration of losartan in the blood plasma in patients with cirrhosis of the liver is significantly increased, so patients with liver disease in the history should be used in a lower dose.

    Pharmacokinetics:

    Losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%.Has the effect of a "first pass" through the liver, is metabolized by carboxylation with the participation of the 2S9 cytochrome P450 isoenzyme with the formation of an active metabolite. Connection with blood plasma proteins - 99%.

    The time to reach the maximum concentration of losartan is 1 hour, the active metabolite is 3-4 hours after ingestion. The half-life is 1.5-2 hours, and its main metabolite is 6-9 hours, respectively. About 35% of the dose is excreted in the urine, about 60% - through the intestine.

    Indications:Arterial hypertension.
    Contraindications:
    • Hypersensitivity to the components of the drug;
    • Arterial hypotension;
    • Hyperkalemia;
    • Dehydration;
    • Pregnancy and lactation;
    • Age to 18 years (effectiveness and safety not established).
    Carefully:Hepatic and / or renal insufficiency.
    Pregnancy and lactation:

    There are no data on the use of losartan in pregnancy. However, it is known that drugs acting directly on the renin-angiotensin system, when applied in the II and III trimesters of pregnancy, can cause a developmental defect or even the death of a developing fetus. Therefore, if pregnancy occurs, Cardominov-sanovel should be stopped immediately.

    When appointing during lactation, a decision should be made to stop breastfeeding or to stop treatment with Cardomin-sanove.

    Dosing and Administration:

    Cardominogen-sanovel is taken orally, regardless of food intake, once a day. With arterial hypertension, the average daily dose is 50 mg. In some cases, to achieve a greater effect, the dose is increased to 100 mg in two divided doses or once a day.

    When appointing the drug to patients receiving diuretics in high doses, the initial dose of losartan should be reduced to 25 mg once a day.

    It is not necessary to adjust the dose to elderly patients or patients with impaired renal function, including patients on hemodialysis. Patients with impaired liver function should be prescribed lower doses of losartan.

    Pediatric Use

    Safety and efficacy of the drug in children under 18 years of age have not been established.

    Side effects:

    * There are side effects, the incidence of which is comparable to placebo.

    The association of side effects occurring with a frequency of less than 1% of cases with the use of losartan is not proven.

    From the nervous system and sensory organs: 1% and more - dizziness, asthenia, headache, fatigue, insomnia; less than 1% - anxiety, sleep disturbance, drowsiness, memory disorders, peripheral neuropathy, paresthesia, hyposthenia, migraine, tremor, ataxia, depression, syncope, ringing in the ears, taste disturbance, vision change, conjunctivitis.

    From the respiratory system: 1% and more - nasal congestion, cough *, upper respiratory tract infections (elevated body temperature, sore throat, sinusopathy *, sinusitis, pharyngitis), less than 1% - dyspnoea, bronchitis, rhinitis.

    On the part of the organs of the gastrointestinal tract: 1% or more - nausea, diarrhea *, dyspeptic phenomena *, abdominal pain; less than 1% - anorexia, dry mouth, toothache, vomiting, flatulence, gastritis, constipation.

    From the musculoskeletal system: 1% and more - convulsions, myalgia *, pain in the back, chest, legs; less than 1% -artralgia, shoulder pain, knee, arthritis, fibromyalgia.

    From the cardiovascular system: Orthostatic hypotension (dose-dependent), palpitations, tachy- or bradycardia, myocardial infarction, marked decrease in arterial pressure, atrioventricular blockade of degree II, arrhythmias, angina.

    From the genitourinary system: less than 1% - mandatory urination, urinary tract infections, impaired renal function, weakened libido, impotence.

    From the skin: less than 1% - dry skin, erythema, rush of blood, photosensitization, increased sweating, alopecia.
    Allergic reactions: less than 1% - urticaria, skin rash, itching, angioedema, incl. face, lips, throat and / or tongue.

    Other: hyperkalemia (potassium serum more than 5.5 mmol / l), anemia, less than 1% - fever, gout, increased activity of "liver" transaminases, hyperbilirubinemia.

    Overdose:

    Symptoms: a marked decrease in blood pressure, tachycardia, because of parasympathetic (vagal) stimulation, bradycardia may appear.

    Treatment: forced diuresis, symptomatic therapy; Hemodialysis is ineffective.

    Interaction:

    Can be prescribed with other antihypertensive drugs.

    There was no clinically significant interaction with hydrochlorothiazide, digoxin, indirect anticoagulants, cimetidine, phenobarbital.

    In patients with dehydration (previous treatment with large doses of diuretics), there may be a marked decrease in blood pressure.

    Strengthens (mutually) the effect of other antihypertensive drugs (diuretics, beta-adrenoblockers, sympatholytics).

    Increases the risk of hyperkalemia when combined with potassium-sparing diuretics and potassium preparations.

    Special instructions:

    It is necessary to correct the dehydration before the appointment of Cardomin-Sanovel or start treatment with the use of the drug in a lower dose.

    Drugs that affect the renin-angiotensin system can increase the concentration of urea in the blood and serum creatinine in patients with bilateral renal stenosis or stenosis of the artery of a single kidney.

    During the treatment period, the concentration of potassium in the blood should be monitored regularly, especially in elderly patients, with renal dysfunction.

    Form release / dosage:Tablets, film-coated 50 mg.
    Packaging:14 tablets in a blister of PVC / aluminum foil. 2, 4 blisters in a cardboard pack together with instructions for use.
    Storage conditions:In a dry place at a temperature of no higher than 30 ° C. Keep out of the reach of children.
    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003085/08
    Date of registration:24.04.2008 / 05.11.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Sanovel Pharmaco-industrial trading companySanovel Pharmaco-industrial trading company Turkey
    Manufacturer: & nbsp
    Representation: & nbspSANOVEL branch of the company pharmaco-industrial trading companySANOVEL branch of the company pharmaco-industrial trading companyRussia
    Information update date: & nbsp12.12.2017
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