Losartan Canon , 50 mg, 60 pcs.

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Product Description

Composition

1 film-coated tablet, 50 mg contains:

active substance: losartan potassium 50 mg;

Excipients:

 corn starch 25.4 mg,

croscarmellose sodium 5.5 mg,

mannitol 30 mg,

magnesium stearate 1 mg,

povidone 3.1 mg,

microcrystalline cellulose 25 mg;

film casing :

Opadrai white 4 mg, including: hypromellose (hydroxypropyl methylcellulose) 1.35 mg, hyprolose (hydroxypropyl cellulose) 1.35 mg, talc 0.8 mg, titanium dioxide 0.5 mg.

pharmachologic effect

Pharmacotherapeutic group:

Angiotensin II receptor antagonist. 

ATC code: C09CA01

Indications

  • Arterial hypertension.
  • Reducing the risk of cardiovascular disease and mortality in patients with arterial hypertension and left ventricular hypertrophy.
  • Chronic heart failure (as part of combination therapy, with intolerance or ineffectiveness of therapy with ACE inhibitors).
  • In patients with type 2 diabetes mellitus with proteinuria, to slow the progression of renal failure, manifested by a decrease in the incidence of hypercreatininemia, the incidence of end-stage chronic renal failure requiring dialysis or kidney transplantation, mortality rates, and a decrease in proteinuria.

Contraindications

  • Hypersensitivity to the active substance or to other components of the drug. 
  • Arterial hypotension. 
  • Severe liver failure (more than 9 points on the Child-Pugh scale). 
  • Primary hyperaldosteronism.
  • Simultaneous use with aliskiren in patients with diabetes mellitus and patients with renal failure (creatinine clearance less than 60 ml / min).
  • Pregnancy, breastfeeding period. 
  • Age up to 18 years (efficacy and safety have not been established). 

 Carefully

  • Violation of the water-electrolyte balance of the blood (hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia, hyperkalemia).
  • Decreased circulating blood volume (BCC).
  • Bilateral stenosis of the renal arteries or stenosis of an artery of a solitary kidney, renal failure.
  • Condition after kidney transplantation (no experience with use).
  • Aortic and mitral stenosis, hypertrophic obstructive cardiomyopathy, heart failure with concomitant severe renal failure, severe chronic heart failure (NYHA functional class IV), heart failure with life-threatening arrhythmias, ischemic heart disease.
  • Cerebrovascular diseases.
  • Liver failure (less than 9 points on the Child-Pugh scale).
  • A history of angioneurotic edema.

Side effects

WHO classification of incidence of side effects:
very often ≥1 / 10 appointments (> 10%)
 often from ≥1 / 100 to <1/10 appointments (> 1% and <10%)
infrequently from ≥1 / 1000 to <1 / 100 prescriptions (> 0.1% and <1%)
rarely ≥1 / 10000 to <1/1000 prescriptions (> 0.01% and <0.1%)
very rarely <1/10000 prescriptions (<0.01%)
frequency unknown from available data Establish frequency of occurrence is not possible.

Disturbances from the blood and lymphatic system:
Rarely: anemia, thrombocytopenia.

Immune system disorders:
Rarely: skin rash, urticaria, itching, angioedema (including edema of the larynx and tongue), Quincke's edema, allergic vasculitis, Schenlein-Genoch purpura.

Nervous system disorders:
Often: dizziness, headache, sleep disturbances, insomnia.
Uncommon: anxiety, drowsiness, memory disorder, peripheral neuropathy, paresthesia, hypesthesia, migraine, tremor, ataxia, depression, syncope, acute cerebrovascular accident.

Violations of the organ of vision:
Uncommon: impaired visual acuity, conjunctivitis.

Hearing and labyrinth disorders:
Uncommon: ringing in the ears.

Taste
disorders : Uncommon: taste disturbances.

Heart disorders:
Often: palpitations, tachycardia, bradycardia, arrhythmia.
Uncommon: angina pectoris.

Vascular disorders:
Uncommon: orthostatic hypotension (dose-dependent).

Disturbances from the respiratory system, chest and mediastinal organs:
Often: cough, upper respiratory tract infections (pharyngitis, rhinitis, sinusitis, bronchitis), swelling of the nasal mucosa.
Uncommon: dyspnea.

Disorders from the gastrointestinal tract:
Often: nausea, diarrhea, abdominal pain, dyspeptic disorders.
Uncommon: anorexia, dry mouth, vomiting, flatulence, constipation, gastritis.

Liver and biliary tract
disorders : Uncommon: liver dysfunction.
Rarely: hepatitis.

Disorders of the skin and subcutaneous tissues:
Uncommon: dry skin, erythema, skin flushing, photosensitivity, increased sweating, alopecia.

Musculoskeletal and connective tissue disorders:
Often: cramps in the muscles of the lower extremities, myalgia, back pain, chest pain, legs.
Uncommon: arthritis, arthralgia, fibromyalgia, rhabdomyolysis.

Disorders of the kidneys and urinary tract:
Uncommon: urinary tract infections, impaired renal function, urge to urinate, acute renal failure.

Violations of the genitals and mammary gland:
Uncommon: decreased libido, impotence.

General disorders:
Often: asthenia, increased fatigue.

Laboratory and instrumental data:
Often: hyperkalemia.
Uncommon: moderate increase in serum urea and creatinine levels, hypoglycemia, hyponatremia, hyperuricemia.
Very rare: increased activity of "liver" enzymes, hyperbilirubinemia.

Interaction

It can be used simultaneously with other antihypertensive drugs.

There were no clinically significant drug interactions of losartan with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin. Rifampicin and fluconazole have been reported to reduce the plasma concentration of the  active metabolite. The clinical significance of these interactions is still unknown.
As with the use of other drugs that block the formation of angiotensin II and its effects, the concomitant administration of potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium supplements and salts containing potassium can lead to an increase in the content of potassium ions in the blood serum.

Antihypertensive drugs can increase the antihypertensive effect of losartan. Also, tricyclic antidepressants, antipsychotics, baclofen, amifostine can increase the antihypertensive effect of losartan, which lower blood pressure as a main or side effect and may increase the risk of arterial hypotension.

With the simultaneous use of angiotensin II receptor antagonists and non-steroidal anti-inflammatory drugs (NSAIDs) (including selective inhibitors of cyclooxygenase-2, acetylsalicylic acid as an anti-inflammatory agent), the antihypertensive effect of losartan may decrease. In patients with impaired renal function, the simultaneous use of angiotensin II antagonists or diuretics and NSAIDs may cause further deterioration of renal function, including acute renal failure and an increase in serum potassium. This combination should be used with caution, especially in elderly patients.

With the simultaneous use of lithium with ACE inhibitors, a reversible increase in the concentration of lithium in the blood serum and the development of toxicity were recorded; in very rare cases, this has been observed with the use of angiotensin II receptor antagonists. Caution should be exercised with the simultaneous use of lithium with losartan. If this combination is necessary, it is recommended to monitor the serum lithium concentration.

Mutually enhances the effect of beta-blockers and sympatholytics; the combined use of losartan with diuretics causes an additive effect.

Double blockade of RAAS (for example, by combining an angiotensin II receptor antagonist with ACE inhibitors or aliskiren) in patients with an established diagnosis of atherosclerosis, heart failure, or diabetes mellitus with target organ damage is associated with a higher incidence of arterial hypotension, syncope, hyperkalemia and impaired function kidneys (including the development of acute renal failure) compared with the use of a single-component RAAS blockade. The question of the use of a double blockade of the RAAS should be decided in each case individually and with careful monitoring of blood pressure, water and electrolyte balance of blood and renal function.

How to take, course of administration and dosage

Inside, regardless of food intake. The tablets are swallowed without chewing with water. The frequency of admission is 1 time / day, preferably at the same time, in the morning.

Arterial hypertension

The initial and maintenance dose is 50 mg / day. If necessary, the daily dose can be increased to a maximum of 100 mg. If a single dose of the drug does not provide the target value of blood pressure, the daily dose should be divided into 2 doses: 25 mg each (it is possible to use losartan in 25 mg tablets or in 50 mg tablets with a scored) 2 times a day or 50 mg 2 times a day ...

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

The initial dose of the drug is 50 mg 1 time / day. In the future, hydrochlorothiazide can be added in low doses or the dose of Losartan Canon can be increased to a maximum of 100 mg in one or two doses, taking into account the decrease in blood pressure.
Chronic heart failure

The initial dose for patients with chronic heart failure is 12.5 mg (losartan may be used in scored 25 mg tablets) 1 time / day. The dose is titrated 2 times, depending on the patient's tolerance to the drug, with a weekly interval, i.e. 12.5 mg / day, 25 mg / day, 50 mg / day up to an average maintenance dose of 50 mg / day. In elderly patients with renal insufficiency, dose adjustment is not required.

In patients with type 2 diabetes mellitus with proteinuria, to slow the progression of renal failure, the
initial dose is 50 mg 1 time / day with a further increase in the dose to a maximum of 100 mg / day (taking into account the degree of decrease in blood pressure) in one or two doses.

Special patient groups

In patients with reduced circulating blood volume (BCC) (for example, when taking diuretics in high doses), the recommended initial dose of Losartan Canon is 25 mg (it is possible to use losartan in 25 mg tablets or in 50 mg tablets with a score).

Patients with hepatic impairment (less than 9 points on the Child-Pugh scale), during the hemodialysis procedure, as well as patients over 75 years old, are recommended a lower initial dose of the drug 25 mg (losartan may be used in 25 mg tablets or in 50 mg tablets with a score) Once a day.

There is not enough experience in using the drug in patients with severe hepatic impairment, therefore the drug is not recommended in this category of patients (see section "Contraindications").

In patients with moderate renal impairment (CC 20-30 ml / min), dose adjustment is not required.

Overdose

Symptoms: marked decrease in blood pressure (BP), tachycardia. Bradycardia can result from parasympathetic (vagal) stimulation.

Treatment: forced diuresis, symptomatic therapy. Hemodialysis is not effective.

Special instructions

In patients with reduced BCC (for example, receiving high doses of diuretics), symptomatic arterial hypotension may occur, therefore, before starting treatment, it is necessary to replenish the BCC or start treatment with Losartan Canon at a lower dose.

In patients with cirrhosis of the liver, the concentration of losartan in the blood plasma increases significantly, and therefore, in the presence of liver disease in the anamnesis, it should be prescribed in lower doses.

During the treatment period, the content of potassium in the blood plasma and creatinine clearance should be regularly monitored, especially in elderly patients, patients with impaired renal function, patients with type 2 diabetes mellitus complicated by nephropathy; and especially carefully, these indicators should be monitored in patients with heart failure with concomitant renal dysfunction.

Drugs that affect the RAAS can increase the concentration of blood urea and serum creatinine in patients with bilateral renal stenosis or stenosis of a solitary kidney artery.

There is no experience of using losartan in patients after kidney transplantation.

In patients with severe chronic heart failure, drugs that affect the RAAS can lead to severe arterial hypotension and acute renal failure. There are isolated reports of the development of oliguria and / or increasing azotemia and acute renal failure, including fatal ones.

There is insufficient experience with the use of losartan in patients with heart failure with concomitant severe renal failure, in patients with severe chronic heart failure (NYHA functional class IV), in patients with heart failure with life-threatening arrhythmias. In these groups, the drug Losartan Canon with beta-blockers should be used with caution.

Like all drugs with a vasodilating effect, the drug Losartan Canon should be prescribed with caution in patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

In patients with cerebrovascular ischemic diseases, an excessive decrease in blood pressure can lead to stroke. Medical supervision is recommended when titrating the dose.

Caution should be exercised when prescribing Losartan Canon to patients with a history of indications of previous angioedema, including when taking other medications, including ACE inhibitors.
Patients with primary hyperaldosteronism usually do not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, it is not recommended to use the drug Losartan Canon for the treatment of such patients.

Influence on the ability to drive vehicles and mechanisms

There have been no studies to assess the effect of the drug on the management of vehicles and mechanisms.
It should be borne in mind the possibility of drowsiness and dizziness, therefore, care must be taken when performing work requiring increased attention, especially at the beginning of treatment, when increasing the dose of the drug and when driving.

Release form

Tablets are round, biconvex, film-coated, white or almost white. In cross section, it is almost white.