Losartan Canon, 50 mg 60 pcs

Pharmacotherapeutic group:

Angiotensin II receptor antagonist.

Chronic 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.

Pharmacological effect

Pharmacotherapeutic group:

Angiotensin II receptor antagonist.

ATX code: C09CA01

Special instructions

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

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

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

Drugs that affect the RAAS may increase blood urea and serum creatinine concentrations in patients with bilateral renal stenosis or arterial stenosis of a solitary kidney.

There is no experience with the use of losartan in patients after kidney transplantation.

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

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 should be used with beta-blockers with caution.

Like all drugs that have a vasodilating effect, Losartan Canon should be administered with caution to patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

In patients with ischemic cerebrovascular 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 angioedema, including when taking other medications, including ACE inhibitors.
Patients with primary hyperaldosteronism usually do not respond to antihypertensive agents that act through inhibition of the renin-angiotensin system. Therefore, it is not recommended to use the drug Losartan Canon to treat such patients.

Impact on the ability to drive vehicles and machinery

No studies have been conducted to evaluate the effect of the drug on driving vehicles and machinery.
The possibility of drowsiness and dizziness should be borne in mind, so care must be taken when performing work that requires increased attention, especially at the beginning of treatment, when increasing the dose of the drug and when driving.

Active ingredient

Losartan

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 cover:

Opadry 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.

Contraindications

Hypersensitivity to the active substance or other components of the drug.
Arterial hypotension.
Severe liver failure (more than 9 points on the Child-Pugh scale).
Primary hyperaldosteronism.
Concomitant 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).

With caution

Violation of the water-electrolyte balance of the blood (hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia, hyperkalemia).
Decrease in circulating blood volume (CBV).
Bilateral renal artery stenosis or stenosis of the artery of a single kidney, renal failure.
Condition after kidney transplantation (no experience of 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, coronary heart disease.
Cerebrovascular diseases.
Liver failure (less than 9 points on the Child-Pugh scale).
History of angioedema.

Side Effects

WHO classification of the incidence of side effects:
very often ≥1/10 prescriptions (>10%)
often from ≥1/100 to 1% and <10%)
uncommon ≥1/1000 to 0.1% and <1%)
rarely from ≥1/10000 to 0.01% and <0.1%)
very rare <1/10000 prescriptions (<0.01%)
frequency unknown Based on available data, it is not possible to determine the frequency of occurrence.

Disorders of the blood and lymphatic system:
Rarely: anemia, thrombocytopenia.

Immune system disorders:
Rarely: skin rash, urticaria, itching, angioedema (including swelling of the larynx and tongue), Quincke’s edema, allergic vasculitis, Henoch-Schönlein purpura.

Nervous system disorders:
Common: dizziness, headache, sleep disturbance, insomnia.
Uncommon: anxiety, drowsiness, memory impairment, peripheral neuropathy, paresthesia, hypoesthesia, migraine, tremor, ataxia, depression, syncope, acute cerebrovascular accident.

Visual disorders:
Uncommon: impaired visual acuity, conjunctivitis.

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

Disorders of the organ of taste:
Uncommon: taste disturbance.

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

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

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

Gastrointestinal disorders:
Common: nausea, diarrhea, abdominal pain, dyspeptic disorders.
Uncommon: anorexia, dry mouth, vomiting, flatulence, constipation, gastritis.

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

Skin and subcutaneous tissue disorders:
Uncommon: dry skin, erythema, skin hyperemia, photosensitivity, increased sweating, alopecia.

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

Renal and urinary tract disorders:
Uncommon: urinary tract infections, renal dysfunction, urinary urgency, acute renal failure.

Disorders of the genital organs and breast:
Uncommon: decreased libido, impotence.

General violations:
Often: asthenia, increased fatigue.

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

Interaction

Can be used simultaneously with other antihypertensive drugs.

There were no clinically significant drug interactions between losartan and hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin. Rifampicin and fluconazole have been reported to reduce plasma concentrations of the active metabolite. The clinical significance of these interactions is currently 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 may lead to an increase in the content of potassium ions in the blood serum.

Antihypertensive drugs can increase the antihypertensive effect of losartan. Tricyclic antidepressants, antipsychotics, baclofen, amifostine, which reduce blood pressure as a main or side effect and may increase the risk of developing arterial hypotension, can also enhance the antihypertensive effect of losartan.

With simultaneous use of angiotensin II receptor antagonists and nonsteroidal anti-inflammatory drugs (NSAIDs) (including selective cyclooxygenase-2 inhibitors, acetylsalicylic acid as an anti-inflammatory agent), the antihypertensive effect of losartan may be reduced. In patients with impaired renal function, concomitant use of angiotensin II antagonists or diuretics and NSAIDs may cause a 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 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 used when lithium is used concomitantly with losartan. If this combination is necessary, it is recommended to monitor the concentration of lithium in the blood serum.

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

Dual blockade of the RAAS (eg, by combining an angiotensin II receptor antagonist with an ACE inhibitor or aliskiren) in patients with established atherosclerosis, heart failure, or diabetes mellitus with target organ damage is associated with a higher incidence of hypotension, syncope, hyperkalemia, and renal dysfunction (including the development of acute renal failure) compared with single-component blockade of the RAAS. The issue of using double blockade of the RAAS should be decided in each case individually and with careful monitoring of blood pressure, water-electrolyte balance of the blood and renal function.

Overdose

Symptoms: marked decrease in blood pressure (BP), tachycardia. Bradycardia may occur due to parasympathetic (vagal) stimulation.

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

Manufacturer

Kanonpharma production CJSC, Russia