Lozarel Plus, 12.5mg+50 mg 30 pcs

LOZAREL is an antihypertensive agent.

It is a non-peptide blocker of angiotensin II receptors. It has high selectivity and affinity to AT1 receptors (with the participation of which the main effects of angiotensin II are realized).

Blocking these receptors losartan prevents and eliminates vasoconstrictor effect of angiotensin II, its stimulating effect on adrenal aldosterone secretion and some other effects of angiotensin II.

It is characterized by prolonged action (24 hours or more) due to the formation of its active metabolite.

Indications

Arterial hypertension.

Reduced risk of associated cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy, manifested by a combined reduction in the incidence of cardiovascular mortality, stroke and myocardial infarction.

Kidney protection in patients with type 2 diabetes mellitus with proteinuria – slowing the progression of renal failure, manifested by a decrease in the incidence
hypercreatininemia, incidence of end-stage chronic renal failure requiring hemodialysis or kidney transplantation,
mortality rates, as well as a decrease in proteinuria.

Chronic heart failure with ineffective treatment with ACE inhibitors.

Pharmacological effect

LOSAREL is an antihypertensive drug.

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.

Special instructions

Drugs that affect the RAAS system can increase serum concentrations of urea and creatinine in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney.

In patients with dehydration (for example, those receiving treatment with high doses of diuretics), symptomatic arterial hypotension may occur at the beginning of treatment with Losarel (dehydration should be corrected before prescribing Losarel or treatment should be started with a lower dose).

Regular monitoring of potassium levels in the blood plasma is necessary in patients taking the drug Losarel for a long time.

Use in pediatrics

The safety and effectiveness of the drug in children have not been established.

Impact on the ability to drive vehicles and operate machinery

Losartan does not affect the ability to drive a car or use machinery.

Active ingredient

Hydrochlorothiazide, Losartan

Composition

1 tablet contains:

Active substance:

losartan potassium 50 mg.

Excipients:

microcrystalline cellulose,

lactose monohydrate,

pregelatinized starch,

anhydrous colloidal silicon dioxide,

magnesium stearate.

Film shell composition:

hypromellose, hyprolose, macrogol 400, titanium dioxide (E171), talc.

Contraindications

Pregnancy, lactation, hypersensitivity to losartan.

Side Effects

Typically, side effects are mild and transient and do not require discontinuation of treatment.

Determination of the frequency of adverse reactions: very often (> 10%), often (> 1% 0.1% 0.01% < 0.1%) and very rarely, including isolated reports (< 0.01%).

From the cardiovascular system: sometimes – orthostatic hypotension (dose-dependent), nosebleeds, palpitations, tachycardia, bradycardia, arrhythmias, angina pectoris, myocardial infarction, vasculitis.

From the digestive tract: often – nausea, diarrhea, dyspeptic symptoms, abdominal pain; sometimes – anorexia, taste disturbance, dry mouth, toothache, vomiting, flatulence, gastritis, constipation, hepatitis, liver dysfunction.

Dermatological reactions: sometimes – dry skin, erythema, subcutaneous hemorrhages, photosensitivity, increased sweating, alopecia.

Allergic reactions: sometimes – urticaria, skin rash, itching, angioedema.

From the hematopoietic system: sometimes – anemia, thrombocytopenia, eosinophilia, thrombocytopenic purpura (Henoch-Schönlein disease).

From the musculoskeletal system: often – cramps, myalgia, pain in the back, chest, legs; sometimes – arthralgia, arthritis, fibromyalgia; rarely – rhabdomyolysis.

From the central nervous system and sensory organs: often – dizziness, asthenia, headache, fatigue, insomnia; sometimes – anxiety, sleep disturbance, drowsiness, memory disorders, peripheral neuropathy, paresthesia, hypoesthesia, tremor, ataxia, depression, syncope, tinnitus, visual impairment, conjunctivitis, migraine.

From the respiratory system: often – nasal congestion, cough, upper respiratory tract infections, pharyngitis, dyspnea, bronchitis, swelling of the nasal mucosa.

From the urinary system: sometimes – imperative urge to urinate, urinary tract infections, impaired renal function.

From the reproductive system: sometimes – decreased libido, impotence.

Laboratory indicators: often – hyperkalemia (potassium level in blood plasma more than 5.5 mmol/l); sometimes – an increase in the level of urea and residual nitrogen or creatinine in the blood serum; very rarely – moderate increase in the activity of liver transaminases (AST, ALT), hyperbilirubinemia.

Other: gout.

Interaction

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.

Overdose

Symptoms: marked decrease in blood pressure and tachycardia; as a result of parasympathetic (vagal) stimulation, bradycardia may develop.

Treatment: forced diuresis, symptomatic therapy.

Hemodialysis is not effective because… losartan and its active metabolite are not excreted from the body through hemodialysis.

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

2 years

Manufacturer

Lek d.d., Slovenia