Active substanceLosartan + HydrochlorothiazideLosartan + Hydrochlorothiazide
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  • Vasotens H
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  • Losartan-N Richter
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    GEDEON RICHTER, OJSC     Hungary
  • Losartan-N Richter
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Dosage form: & nbspfilm-coated tablets
    Composition:

    Tablets, film-coated, 12.5 mg + 50 mg:

    Active substances: hydrochlorothiazide -12,50 mg, potassium losartan - 50,00 mg.

    Excipients: magnesium stearate - 3.25 mg, lactose monohydrate - 63.00 mg, pregelatinized starch - 25.00 mg, microcrystalline cellulose - 96.25 mg.

    Composition of the film coat: Opapray orange code: 85F23426 (polyvinyl alcohol - 4,000 mg, titanium dioxide - 2,2783 mg, macrogol 2,020 mg, talc -1,480 mg, iron oxide yellow oxide 0.166 mg, dye sunset yellow (E110) - 0.050 mg, ferric oxide black oxide -0.0057 mg).

    Film-coated tablets, 25 mg + 100 mg:

    Active substances: hydrochlorothiazide - 25 mg, losartan potassium - 100 mg.

    Excipients: magnesium stearate - 6.50 mg, lactose monohydrate - 126.00 mg, pregelatinized starch - 50.00 mg, microcrystalline cellulose - 192,50 mg.

    The composition of the film shell: Fail orange code: 85F23426 (polyvinyl alcohol - 8,000 mg, titanium dioxide - 4,5566 mg, macrogol - 4.040 mg, talc - 2.960 mg, iron oxide oxide yellow - 0.332 mg, dye sunset yellow (E110) - 0.100 mg, iron-oxide-black oxide-0.0101 mg).

    Description:

    Tablets 12.5 mg + 50 mg:

    Round, biconvex tablets, covered with a film coating of brownish-yellow color with engraving "C23" on one side.

    Tablets 25 mg + 100 mg:

    Oval, biconcave tablets covered with a film coating of brownish-yellow color with engraving "C24" on one side.

    Pharmacotherapeutic group:A combined hypotensive drug (angiotensin II receptor antagonist + diuretic)
    ATX: & nbsp

    C.09.D.A   Angiotensin II antagonists in combination with diuretics

    C.09.D.A.01   Losartan in combination with diuretics

    Pharmacodynamics:

    The combined drug has an antihypertensive effect. Contains losartan potassium - an antagonist of angiotensin II receptors (subtype AT1) and hydrochlorothiazide - Diuretic.

    Losartan 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), concentration in the blood of epinephrine and aldosterone, blood pressure (BP), pressure in the small circle of the circulation; reduces afterload, has a diuretic effect. Preventing the development of myocardial hypertrophy, increases exercise tolerance in patients with chronic heart failure.

    Hydrochlorothiazide is a thiazide diuretic. Reduces the reabsorption of sodium ions, increases the release of kidney ions of potassium, bicarbonate and phosphate. Reduces blood pressure by reducing the volume of circulating blood (BCC), changes in the reactivity of the vascular wall, reducing the pressor effect of vasoconstrictor substances.

    Pharmacokinetics:

    Losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. Has the effect of "first passage" through the liver, is metabolized by carboxylation to form an active metabolite. Relationship with blood plasma proteins -99%. The time to reach the maximum concentration in the blood plasma 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 3-4 hours, respectively. About 35% of the dose is excreted by the kidneys, about 60% by the intestine.

    Hydrochlorothiazide is rapidly absorbed from the gastrointestinal tract. The half-life is 5.8-14.8 hours. It is not metabolized in the liver. About 61% is excreted by the kidneys unchanged.

    Indications:

    - Treatment of arterial hypertension in patients who are shown combined therapy.

    - Reducing the risk of cardiovascular disease and mortality in patients with hypertension and left ventricular hypertrophy.

    Contraindications:

    - Hypersensitivity to the components of the drug, increased sensitivity to other derivatives of sulfinamides;

    - anuria;

    - severe arterial hypotension; severe liver dysfunction;

    - severe renal dysfunction (creatinine clearance (CK) less than 30 ml / min.);

    - hypovolemia (including against a background of high doses of diuretics);

    - pregnancy and lactation;

    - age under 18 years (efficiency and safety not established).

    The drug contains lactose, so patients with rare hereditary lactose intolerance, lactase deficiency or impaired glucose / galactose absorption should not take this drug.

    Carefully:Two-sided stenosis of the renal arteries or stenosis of the single kidney artery, hypovolemic conditions (including diarrhea, vomiting), hyponatremia (increased risk of hypotension in patients on a low-salt or salt-free diet), hypochloraemic alkalosis, hypomagnesemia, hypokalemia,connective tissue diseases (including systemic lupus erythematosus), diabetes mellitus, gout, bronchial asthma, allergic history, hyperuricemia, hypercalcemia, concomitant administration with non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 inhibitors (COX-2 inhibitors).
    Pregnancy and lactation:

    Pregnancy

    The use in pregnancy is contraindicated, and if pregnancy is detected during the course of Losartan-N Richter therapy, the drug should be discontinued immediately.

    Breastfeeding period

    There is no data on whether the losartan in mother's milk. If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

    Dosing and Administration:

    Inside, regardless of food intake. Typically, the initial and maintenance dose of the drug is 12.5 mg hydrochlorothiazide + 50 mg losartan (1 tablet Lozartan-N Richter) per day. For those patients who do not manage to achieve adequate blood pressure control at this dosage, the dose can be increased to a maximum of 2 tablets (12.5 mg + 50 mg) or up to 1 tablet (25 mg + 100 mg) once a day preparation Lozartan-R Richter.

    In general, the maximum hypotensive effect is achieved within 3 weeks of regular intake of the drug.

    There is no need for a special selection of an initial dose for elderly patients.

    Side effects:

    Side effects are limited to those previously observed when using losartan and / or hydrochlorothiazide.

    The most common side effects in the treatment of essential hypertension include dizziness.

    Allergic reactions: anaphylactic reactions, angioedema, including laryngeal and / or tongue edema, resulting in airway obstruction, and / or swelling of the face, lips, pharynx and / or tongue occasionally noted with losartan. Some of these patients had angioedema earlier with other drugs, including ACE inhibitors. Very rarely, when taking losartan, there were manifestations of vasculitis, including Shenlen-Henoch disease.

    From the cardiovascular system: marked decrease in blood pressure, less than 1% - bradycardia, arrhythmias, angina pectoris;

    From the digestive system: when receiving losartan, rare (less than 1%) cases of hepatitis, diarrhea, decreased appetite, dry mouth, toothache, vomiting, flatulence, gastritis were reported.

    From the respiratory system: dyspnea, bronchitis, rhinitis, with the use of losartan - cough.

    From the skin: urticaria, less than 1% - dryness, skin hyperemia, photosensitivity, increased sweating, alopecia.

    From the genitourinary system: less than 1% - mandatory urination, urinary tract infections, impaired renal function, weakening of libido, decreased potency.

    From the musculoskeletal system: 1% or more - pain in the legs, less than 1% - pain in the shoulder, knee, arthritis, fibromyalgia.

    From the nervous system and sensory organs: less than 1% - anxiety, sleep disorders, drowsiness, memory disorders, peripheral neuropathy, paresthesia, hypesthesia, tremor, ataxia, depression, loss of consciousness, ringing in the ears, taste disturbance, vision change, conjunctivitis.

    Laboratory indicators: rarely (less than 1%) hyperkalemia (potassium serum more than 5.5 mmol / l), increased activity of "hepatic" enzymes.

    Other: less than 1% - fever, gout.

    Overdose:

    Symptoms: losartan - marked decrease in blood pressure, tachycardia, bradycardia (as a result of vagal stimulation). Hydrochlorothiazide - loss of electrolytes (hypokalemia, hypochloraemia, hyponatremia), as well as dehydration resulting from excessive diuresis.

    Treatment: symptomatic and supportive therapy. If the drug is taken recently, the stomach should be washed; if necessary, correct the water-electrolyte disturbances.

    Lozartan and its active metabolites are not removed by hemodialysis.

    Interaction:

    Losartan strengthens the effect of other antihypertensive drugs. There was no clinically significant interaction with hydrochlorothiazide, digoxin, indirect anticoagulants, cimetidine, phenobarbital, ketoconazole, erythromycin. There are reports that rifampicin and fluconazole decrease the level of the active metabolite. The clinical significance of these interactions has not been studied.

    Like other drugs that block angiotensin II or its effect, the simultaneous administration of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium or salt substitutes containing potassium, can lead to hyperkalemia.

    Non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2) can reduce the effect of diuretics and other antihypertensive agents.

    In some patients with impaired renal function receiving NSAID therapy (including COX-2 inhibitors), treatment with angiotensin II receptor antagonists can cause further impairment of kidney function, including acute kidney failure, which is usually reversible.

    The hypotensive effect of losartan, as well as other antihypertensive agents, may be weakened by taking a non-steroidal anti-inflammatory drug of indomethacin.

    Hydrochlorothiazide

    The following medicines can interact with thiazide diuretics with the simultaneous appointment:

    Barbiturates, narcotic drugs, ethanol - potentiation of antihypertensive action.

    Hypoglycemic agents (for oral administration and insulin) - may be required dosage correction of hypoglycemic agents.

    Other antihypertensives - additive effect is possible.

    Kolestyramine and colestipol reduces the absorption of hydrochlorothiazide.

    Corticosteroids, adrenocorticotropic hormone - increased loss of electrolytes, in features of potassium.

    Pressor amines - a slight decrease in the effect of pressor amines, which does not prevent their use, is possible.

    Non-depolarizing muscle relaxants (eg, tubocurarine chloride) - it is possible to increase the effect of muscle relaxants.

    Lithium preparations - Diuretics reduce renal clearance of lithium and increase the risk of lithium intoxication, so simultaneous use is not recommended.

    Impact on laboratory results

    Due to the effect on calcium excretion, thiazides can distort the results of studies of the function of parathyroid glands.

    Special instructions:

    Can be prescribed together with other antihypertensive drugs.

    There is no need for a special selection of an initial dose for elderly patients. The drug can increase the concentration of urea and creatinine in the blood plasma in patients with bilateral stenosis of the renal arteries or stenosis of the renal artery of a single kidney.

    Hydrochlorothiazide can increase arterial hypotension and disturbances of water-electrolyte balance (decrease in the volume of circulating blood, hyponatremia, hypochloraemic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, reduce the excretion of calcium by the kidneys and cause transient,a slight increase in the concentration of calcium ions in the blood plasma, increase the concentration of cholesterol and triglycerides, provoke the occurrence of hyperuricemia and / or gout.

    Effect on the ability to drive transp. cf. and fur:There is no information on the effect on the ability to drive and other mechanisms.
    Form release / dosage:
    Tablets, film-coated, 12.5 mg + 50 mg and 25 mg + 100 mg.
    Packaging:

    For 10 tablets, film-coated, in a blister of PA / A1 / PVC-foil and aluminum foil.

    For 3 blisters in a cardboard box with instructions for use.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children!

    Shelf life:

    4 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007917/09
    Date of registration:06.10.2009 / 17.12.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp04.04.2018
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