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

    Active substance:

    Losartan potassium 25 mg and 50 mg

    Excipients:

    Microcrystalline cellulose, lactose, pregelatinized starch, magnesium stearate, talc purified tabkbat TC - 1001 (for a dosage of 25 mg - hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide), tabkoat TC-2023 (for a dosage of 50 mg - hydroxypropylmethylcellulose, polyethylene glycol, talc, titanium dioxide, iron oxide red).

    Description:

    25 mg Tablets: White Round biconvex tablets coated with a hexagon on one side and scored on the other.

    50 mg Tablets: light pink oblong, biconvex tablets coated scored on one side.

    Pharmacotherapeutic group:Angiotensin II receptor antagonist
    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 ATI). Does not suppress kinase II-ferment, which 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 antihypertensive effect is achieved 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;

    - Heart failure (as part of combination therapy, with intolerance or ineffective therapy with ACE inhibitors).

    Contraindications:

    Hypersensitivity to the components of the drug;

    Arterial hypotension;

    Hyperkalemia;

    Dehydration;

    Pregnancy and lactation;

    Age to 18 years (effectiveness and safety not established).

    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, when a pregnancy occurs, the use of Renicard should be stopped immediately.

    When appointing during lactation, a decision should be made whether to stop breastfeeding or stop treatment with Renicard.

    Dosing and Administration:

    Preparation Renicard is taken inside, regardless of food intake, the frequency of reception - 1 time per day.

    When 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.

    Initial dose for patients with heart failure is 12.5 mg once a day. Typically, the dose increases with a weekly interval (ie, 12.5 mg / day, 25 mg / day and 50 mg / day) to an average maintenance dose of 50 mg 1 time per day, depending on the patient's tolerability.

    When the drug is prescribed patients receiving diuretics in high doses, the initial dose of Renicard 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 hepatic function should be prescribed a lower dose of Renicard.

    In elderly patients, as well as in patients with impaired renal function, including patients on dialysis, there is no need to adjust the initial dose.

    Pediatric Use

    Safety and efficacy of the drug in children are not 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.

    In most cases, Renicard is well tolerated, side effects are transient and do not require withdrawal of the drug.

    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 disorder, 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, arrhythmias, angina pectoris, anemia .. 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, rash, itching, angioedema, incl. face, lips, throat and / or tongue.

    Other: Hyperkalemia (serum potassium more than 5.5 mmol / l).

    Overdose:

    Symptoms: marked decrease in blood pressure, tachycardia, because of parasympathetic (vagus) 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-blockers, 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 Renicard is appointed or to start treatment with the drug at a lower dose.

    Drugs that affect the renin-angiotensin system can increase the concentration of urea in the blood and serum creatine 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:

    The coated tablets are 25 and 50 mg.

    Packaging:

    For 10 tablets in a blister of PVC and aluminum foil. For 1 or 3 blisters with instructions for use are placed in a cardboard box.

    Storage conditions:

    In a dry place 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-001703
    Date of registration:21.10.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Unikem Laboratories Ltd.Unikem Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspUNICEM LABORATORIES LTD. UNICEM LABORATORIES LTD. India
    Information update date: & nbsp29.08.2016
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