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Losartan-teva 100 mg 30 pcs. film-coated tablets

pharmachologic effect

Diuretic, hypotensive.

Composition and release form Losartan-teva 100 mg 30 pcs. film-coated tablets

Tablet - 1 tablet:

Active substance: losartan potassium 100 mg;
Excipients: lactose monohydrate 18 mg, microcrystalline cellulose 158 mg, pregelatinized starch 121 mg, magnesium stearate 3 mg;
composition of the film shell: opadry II85F 18422 white (polyvinyl alcohol (partially hydrolyzed) 4.8 mg, titanium dioxide (E171) 3 mg, macrogol 2.424 mg, talc 1.776 mg).

Tablets 100 mg, in blisters, 30 pieces per pack.

Description of the dosage form

White, oval-shaped, film-coated tablets marked “100”.

Directions for use and doses

The average dose for oral administration is 50 mg 1 time/day. If necessary, the dose can be reduced to 25 mg/day or increased to 100 mg/day, in the latter case it can be used 2 times/day.

Pharmacodynamics

Antihypertensive agent. It is a non-peptide angiotensin II receptor blocker. It has high selectivity and affinity for AT1 type receptors (with the participation of which the main effects of angiotensin II are realized). By blocking these receptors, losartan prevents and eliminates the vasoconstrictor effect of angiotensin II, its stimulating effect on the secretion of aldosterone by the adrenal glands and some other effects of angiotensin II. It is characterized by a long-term effect (24 hours or more), which is due to the formation of its active metabolite.

Pharmacokinetics

After oral administration, losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. Metabolized during the “first pass” through the liver to form a carboxyl metabolite, which has more pronounced pharmacological activity than losartan, and a number of inactive metabolites. Cmax in blood plasma of losartan and the active metabolite is achieved after 1 hour and 3-4 hours, respectively. Plasma protein binding of losartan and the active metabolite is high - more than 98%.

T1/2 of losartan and the active metabolite in the final phase is about 1.5-2.5 hours and 3-9 hours, respectively. Losartan is excreted in the urine and feces (with bile) unchanged and in the form of metabolites. About 35% is excreted in urine and about 60% in feces.

Indications for use Losartan-teva 100 mg 30 pcs. film-coated tablets

Arterial hypertension.

Chronic heart failure with ineffective treatment with ACE inhibitors.

Kidney failure.

Left ventricular hypertrophy.

Contraindications

Pregnancy, lactation, childhood and adolescence under 18 years of age, hypersensitivity to losartan.

Use with caution in case of arterial hypotension, decreased blood volume, water-electrolyte imbalance, bilateral renal artery stenosis or stenosis of the artery of a single kidney, and renal/liver failure.

Application of Losartan-teva 100 mg 30 pcs. film-coated tablets during pregnancy and breastfeeding

Contraindicated.

special instructions

For patients who have fluid and/or sodium deficiency, fluid and electrolyte disturbances should be corrected or a lower initial dose should be used before starting treatment.

In patients with dehydration (for example, those receiving high-dose diuretics), symptomatic hypotension may occur when losartan treatment is initiated.

If renal function is impaired, a dose reduction of losartan may be required.

In patients with a history of liver disease, losartan should be used in low doses. In liver cirrhosis, the concentration of losartan in the blood plasma increases significantly.

During treatment, potassium levels in the blood should be regularly monitored, especially in elderly patients with impaired renal function.

The simultaneous use of losartan with potassium-sparing diuretics should be avoided.

Overdose

Marked decrease in blood pressure, change in heart rate (HR) (tachycardia or bradycardia due to parasympathetic (vagal) stimulation).

Side effects Losartan-teva 100 mg 30 pcs. film-coated tablets

From the hematopoietic system: rarely - anemia, thrombocytopenia.

From the nervous system: often - dizziness, headache, sleep disturbance, insomnia; uncommon - anxiety, drowsiness, memory impairment, peripheral neuropathy, paresthesia, hypoesthesia, migraine, tremor, ataxia, depression, syncope, acute cerebrovascular accident.

From the side of the organ of vision: infrequently - impaired visual acuity, conjunctivitis.

On the part of the hearing organ: infrequently - ringing in the ears.

From the cardiovascular system: often - palpitations, tachycardia, bradycardia, arrhythmia; infrequently - angina pectoris, orthostatic hypotension (dose-dependent).

From the respiratory system: often - cough, upper respiratory tract infections (pharyngitis, rhinitis, sinusitis, bronchitis), swelling of the nasal mucosa; infrequently - dyspnea.

From the digestive system: often - nausea, diarrhea, abdominal pain, dyspeptic disorders; uncommon - taste disturbance, anorexia, dry mouth, vomiting, flatulence, constipation, gastritis, liver dysfunction; rarely - hepatitis.

From the urinary system: uncommon - urinary tract infections, impaired renal function, urinary urgency, acute renal failure.

From the genital organs and mammary gland: infrequently - decreased libido, impotence.

From the skin and subcutaneous tissues: uncommon - dry skin, erythema, skin hyperemia, photosensitivity, increased sweating, alopecia.

From the musculoskeletal system: often - muscle cramps in the lower extremities, myalgia, pain in the back, chest, legs; uncommon - arthritis, arthralgia, fibromyalgia, rhabdomyolysis.

Allergic reactions: rarely - skin rash, urticaria, itching, angioedema (including swelling of the larynx and tongue), Quincke's edema, allergic vasculitis, Henoch-Schönlein purpura.

From laboratory and instrumental data: often - hyperkalemia; infrequently - moderate increase in the concentration of urea and creatinine in the blood serum, hypoglycemia, hyponatremia, hyperuricemia; very rarely - increased activity of liver enzymes, hyperbilirubinemia.

Other: often - asthenia, increased fatigue.

Drug interactions

When used simultaneously with diuretics in high doses, arterial hypotension is possible.

When used simultaneously with potassium preparations and potassium-sparing diuretics, the risk of developing hyperkalemia increases.

When used simultaneously with indomethacin, the effectiveness of losartan may be reduced.

There is a report of the development of lithium intoxication when used simultaneously with lithium carbonate.

When used simultaneously with orlistat, the antihypertensive effect of losartan decreases, which can lead to a significant increase in blood pressure and the development of a hypertensive crisis.

When used simultaneously with rifampicin, the clearance of losartan increases and its effectiveness decreases.

Interactions

Other antihypertensive drugs may enhance the hypotensive effect of losartan. Drugs that can cause hypotension include tricyclic antidepressants, antipsychotics, baclofen, amifostine. The main or side effect of simultaneous use of these drugs with antihypertensive agents may be an increased risk of arterial hypotension.

Losartan is metabolized primarily through the cytochrome P450 (CYP) 2C9 system to form the active carboxylic acid metabolite. Fluconazole (a CYP2C9 inhibitor) has been reported to reduce exposure to the active metabolite by approximately 50%. It has been established that the simultaneous use of losartan and rifampicin (an inducer of metabolic enzymes) leads to a 40% decrease in the concentration of the active metabolite in the blood plasma.

The clinical significance of this effect is unknown.

There is no difference in exposure when losartan is co-administered with fluvastatin (a weak CYP2C9 inhibitor).

As with other drugs that block angiotensin II or its effects, concomitant use of drugs that retain potassium in the body (for example, potassium-sparing diuretics: spironolactone, triamterene, amiloride) or increase potassium levels (for example, heparin), or potassium supplements or salt substitutes, may lead to increased plasma potassium levels. The simultaneous use of such drugs is not recommended.

A reversible increase in plasma lithium concentrations and the occurrence of toxic effects have been reported with simultaneous use of lithium with ACE inhibitors. Also, such manifestations have been very rarely reported with the use of ARAs. Simultaneous treatment with lithium and losartan should be carried out with caution. If use of such a combination is considered necessary, it is recommended to monitor plasma lithium levels during combination treatment.

With the simultaneous use of ARAs and NSAIDs (for example, selective COX-2 inhibitors, acetylsalicylic acid in doses that have an anti-inflammatory effect, non-selective NSAIDs), the antihypertensive effect may be weakened. Concomitant use of ARBs or diuretics with NSAIDs may lead to an increased risk of renal impairment, including the possible development of acute renal failure, as well as an increase in plasma potassium levels, especially in patients with existing renal impairment. This combination should be prescribed with caution, especially in elderly patients. Patients should be appropriately dehydrated, and consideration should be given to monitoring renal function after initiating concomitant drug use and periodically during treatment.

Studies have shown that as a result of dual blockade of the RAAS, concomitant use of ACE inhibitors, ARBs or aliskiren is associated with a higher incidence of adverse effects such as hypotension, hyperkalemia and changes in renal function, including acute renal failure, compared with the use of a single RAAS agent. .

Application

Losartan tablets should be taken with a glass of water. the use of the drug does not depend on food intake.

AG. Typically the initial and maintenance dose for most patients is 50 mg once daily. The maximum antihypertensive effect is achieved 3–6 weeks after the start of treatment. For some patients, it may be beneficial to increase the dose of the drug to 100 mg once a day (in the morning).

Losartan can be used in combination with other antihypertensive drugs, especially diuretics (eg hydrochlorothiazide).

Patients with hypertension and type II diabetes mellitus with proteinuria ≥0.5 g/day. The recommended starting dose is 50 mg once daily. The dose can be increased to 100 mg 1 time per day, depending on what the blood pressure levels are 1 month after the start of treatment. Losartan can be used with other antihypertensive drugs (for example, diuretics, calcium channel blockers, α- or β-adrenergic blockers and centrally acting drugs), as well as insulin and other hypoglycemic drugs (for example, sulfonylureas, glitazones and glucosidase inhibitors).

Heart failure. For patients with chronic heart failure, an initial dose of losartan of 12.5 mg once daily is recommended. As a rule, the dose is titrated at weekly intervals (namely: 12.5; 25; 50, 100 mg 1 time per day to a maximum dose of 150 mg 1 time per day) depending on individual tolerance.

Reduced risk of stroke in patients with hypertension and left ventricular hypertrophy, as documented by ECG. The recommended starting dose is 50 mg of losartan once a day. Depending on changes in blood pressure levels, a low dose of hydrochlorothiazide should be added to treatment and/or the dose of losartan should be increased to 100 mg once daily.

Use in patients with reduced blood volume. Patients with reduced blood volume (for example, due to treatment with high doses of diuretics) should begin therapy with a dose of 25 mg 1 time per day.

Use in patients with impaired renal function and patients undergoing hemodialysis sessions. When prescribing losartan to patients with impaired renal function and those undergoing hemodialysis sessions, no initial dose adjustment is necessary.

Use in patients with impaired liver function. For patients with a history of liver dysfunction, consideration should be given to prescribing the drug at a lower dose. There is no experience in treating patients with severe liver dysfunction, therefore losartan is contraindicated in this group of patients.

Use in children. Data on the effectiveness and safety of the use of losartan in children over 6 years of age for the treatment of hypertension are limited.

For children who can swallow tablets and whose body weight is 20 and 50 kg, the recommended dose is 25 mg once daily. In exceptional cases, the dose can be increased to a maximum of 50 mg once a day. The dose should be adjusted depending on the effect on blood pressure.

In patients weighing 50 kg, the usual single dose is 50 mg once a day. In exceptional cases, the dose can be increased to a maximum of 100 mg once a day. Doses exceeding 1.4 mg/kg (or 100 mg) per day have not been studied in children. Losartan is not recommended for use in children under 6 years of age, since there is insufficient data on the use of the drug in this group of patients.

The drug is not recommended for use in children with a glomerular filtration rate (GFR) of 30 ml/min/1.73 m2, since there are no relevant data on its use. Losartan is also not recommended for use in children with impaired liver function.

Use in elderly patients. As a rule, there is no need to adjust the initial dose for elderly patients, although the possible administration of the drug in an initial dose of 25 mg in patients over 75 years of age should be considered.

Indications

Treatment of essential hypertension in adults, as well as in children over 6 years of age; treatment of kidney disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥0.5 g/day - as part of combination antihypertensive therapy; treatment of chronic heart failure in adults, when the use of ACE inhibitors is considered impossible due to incompatibility, especially with cough, or is contraindicated. Patients with heart failure who are stabilized on an ACE inhibitor should not be treated with losartan. when treating chronic heart failure, the patient's left ventricular ejection fraction should be ≤40%, the condition should be clinically stable; reducing the risk of stroke in adult patients with hypertension and left ventricular hypertrophy documented by ecg.