Losartan Canon pills 100mg, 30pcs

Composition

1 film-coated tablet,100 mg contains:

Active ingredient:

losartan potassium 100 mg;

excipients:  

corn starch 50.8 mg,

croscarmellose sodium 11 mg,

mannitol 60 mg,

magnesium stearate 2 mg,

povidone 6.2 mg,

microcrystalline cellulose 50 mg;

film coated:

 Opadray white 8 mg, including: hypromellose (hydroxypropylmethylcellulose) 2.7 mg, hyprolose (hydroxypropylcellulose) 2.7 mg, talc 1.6 mg, titanium dioxide 1 mg

Pharmacological action

Pharmacotherapeutic group:

Angiotensin II receptor antagonist.

KodATH:  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, which is manifested by a decrease in the frequency of hypercreatininemia, the frequency of end-stage chronic renal failure requiring dialysis or kidney transplantation, mortality rates, and a decrease in proteinuria.

Contraindications

• Hypersensitivity to the Active ingredient or to 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 insufficiency (creatinine clearance less than 60 ml / min).
• Pregnancy, breast-feeding 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).
• Decreased circulating blood volume (BCC).
• Bilateral renal artery stenosis or stenosis of the artery of a single kidney, kidney 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, and coronary heart disease.
• Cerebrovascular diseases.
• Liver failure (less than 9 points on the Child-Pugh scale).
• A history of angioedema.

Side effects

WHO classification of frequency of side effects: very common ≥1/10 appointments (>10%) frequently ≥1/100 to < 1/10 appointments (>1% and < 1/10 appointments (><10%) infrequently ≥1/1000 to <1/100 appointments (>0.1% and <1/100 appointments (><1%) rarely ≥1/10000 to <1/1000 appointments (>0.01% and <1/1000 appointments (>very rare <1/10000 assignments (frequency unknown based on the available data, it is not possible to determine the frequency of occurrence.

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

Immune system disorders: Rare: skin rash, urticaria, pruritus, angioedema (including laryngeal and tongue edema), angioedema, allergic vasculitis, Schonlein-Heinoch purpura.

Nervous system disorders: Common: dizziness, headache, sleep disturbance, insomnia. Infrequently: restlessness, drowsiness, memory disorder, peripheral neuropathy, paresthesia, hypesthesia, migraine, tremor, ataxia, depression, syncope, acute cerebrovascular accident.

Visual disturbances: Infrequently: visual acuity disorder, conjunctivitis.

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

Disorders of the taste organ: Infrequently: taste disorders.

Cardiac disorders: Often: palpitation, tachycardia, bradycardia, arrhythmia. Infrequently: angina pectoris.

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

Respiratory, thoracic and mediastinal disorders: Common: cough, upper respiratory tract infections (pharyngitis, rhinitis, sinusitis, bronchitis), swelling of the nasal mucosa. Infrequently: dyspnoea.

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

Liver and biliary tract disorders: Infrequently: impaired liver function. Rare: hepatitis.

Skin and subcutaneous tissue disorders: Infrequently: dry skin, erythema, hyperemia of the skin, photosensitization, increased sweating, alopecia.

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

Kidney and urinary tract disorders: Infrequently: urinary tract infections, impaired renal function, imperative urination, acute renal failure.

Genital and breast disorders: Infrequently: decreased libido, impotence.

General violations: Often: asthenia, increased fatigue.

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

Interaction

It can be used simultaneously with other antihypertensive agents.

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 plasma concentrations of the active metabolite. The clinical significance of these interactions is still unknown. As with other agents that block the formation of angiotensin II and its effects, concomitant use 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 agents may 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 hypotension, can also enhance the antihypertensive effect of losartan.

Concomitant use of angiotensin II receptor antagonists and nonsteroidal anti-inflammatory drugs (NSAIDs) (including selective cyclooxygenase-2 inhibitors, acetylsalicylic acid as an anti-inflammatory agent) may reduce the antihypertensive effect of losartan. In patients with impaired renal function, concomitant use of angiotensin II antagonists or diuretics and NSAIDs may cause further deterioration of renal function, including acute renal failure and increased serum potassium.

This combination should be used with caution, especially in elderly patients. When lithium was co-administered with ACE inhibitors, a reversible increase in serum lithium concentrations and toxicity was reported; in very rare cases, this was observed with the use of angiotensin II receptor antagonists. Caution should be exercised when lithium is co-administered 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; the combined use of losartan with diuretics causes an additive effect.

Dual blockade of the 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 hypotension, syncope, hyperkalemia, and impaired renal function (including acute renal failure) compared to the use of a single-component RAAS blockade. The question of using a double blockade of the RAAS should be decided in each case individually and with careful monitoring of blood pressure, blood water-electrolyte balance and kidney function.

How to take it, course of use and dosage

Inside, regardless of food intake. Tablets are swallowed without chewing, washed down with water. The frequency of reception 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 (it is possible to use losartan in 25 mg tablets or 50 mg tablets with a risk) 2 times a day or 50 mg 2 times a day.

Reduced 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, low-dose hydrochlorothiazide may be added or the dose of Losartan Canon may be increased to a maximum of 100 mg in one or two doses, taking into account the reduction in blood pressure.

The initial dose for patients with chronic heart failure is 12.5 mg (it is possible to use losartan in tablets of 25 mg with a risk) 1 time / day. The dose is titrated 2 times, depending on the patient’s tolerance to the drug, at weekly intervals, i. e. 12.5 mg/day,25 mg/day,50 mg/day to an average maintenance dose of 50 mg/day. No dose adjustment is required in elderly patients with renal insufficiency.

In patients with type 2 diabetes mellitus with proteinuria, to slow the progression of renal insufficiency, 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 reduction 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 (losartan can be used in tablets of 25 mg or in tablets of 50 mg with a risk).

Patients with hepatic insufficiency (less than 9 points on the Child-Pugh scale), during the hemodialysis procedure, as well as patients over 75 years of age, a lower initial dose of 25 mg is recommended (losartan can be used in 25 mg tablets or 50 mg tablets with a risk) once a day.

There is insufficient experience of using the drug in patients with severe hepatic insufficiency, so the drug is not recommended in this category of patients (see the section “Contraindications”).

No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 20-30 ml / min).

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.

Special instructions

Patients with reduced BCC (for example, those receiving high doses of diuretics) may experience symptomatic hypotension, so 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, if there is a history of liver disease, it should be prescribed in lower doses.

During treatment, plasma potassium 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 these indicators should be especially carefully monitored in patients with heart failure with concomitant renal impairment.

Drugs that affect the RAAS may 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.

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

In patients with severe chronic heart failure, medications 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 fatal outcomes.

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

As with all vasodilating agents, Losartan Canon should be used with caution in 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 monitoring is recommended when titrating the dose.

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

Influence on the ability to drive vehicles and mechanisms

No studies have been conducted to assess the effect of the drug on driving vehicles and mechanisms. It is necessary to keep in mind the possibility of drowsiness and dizziness, so care should 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 vehicles.

Form of production

Tablets are round, biconvex, covered with a film-coated white or almost white color. On a cross-section, it is almost white in color.

Active ingredient

Losartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Heart failure, Prevention of heart attacks and strokes, Hypertension