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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:losartan
The drug is available on prescription
What is Apo-Lozart?
The drug from the group of angiotensin II receptor antagonists, which, like all preparations in this group, limits the action of angiotensin II, a substance that causes vasoconstriction and aldosterone-stimulating release.
What does Apo-Lozart contain and how does it work?
The active substance is Losartan
belonging to a group of medicines called angiotensin II receptor antagonists or sartans. The common mechanism of action of drugs in this group is the blocking of angiotensin II receptors which prevents them from binding to angiotensin II and inhibits its action (drugs from this group are often indicated by the abbreviation ARB, which comes from the English nameAngiotensin II Receptor Blockers
). Agiotensin II plays an important role in the pathophysiology of hypertension. The effect of angiotensin II is vasoconstriction and the increase in the release of aldosterone, which leads to increased blood pressure. The action of losartan, like other sartans, effectively counteracts the effects of angiotensin II and leads to a decrease in blood pressure. Unlike drugs from the angiotensin-converting enzyme inhibitors, sartans do not exacerbate the effects of bradykinin-dependent, for example, cough. Sartans are used as medicines to lower blood pressure and to treat and prevent diseases of the cardiovascular system. In patients with heart failure
, they reduce vascular resistance, which improves hemodynamic conditions, increases exercise capacity and improves the clinical condition. They have a protective effect on the kidneys, slow down the rate of development associated with high blood pressure and diabetes renal dysfunction.
Losartan lowers blood pressure without affecting heart rate. Lowering blood pressure after taking a single dose of losartan persists for 24 hours. Full development of antihypertensive activity usually requires 3.-6. weeks of use and persists during long-term use.
When should I use Apo-Lozart?
The preparation is indicated:
· In the treatment of primary hypertension in adults and in children and adolescents 6.-18. age
· In the treatment of kidney disease in patients with hypertension and type 2 diabetes mellitus with proteinuria not less than 0.5 g / day in combination with other antihypertensive agents
· In the treatment of chronic heart failure in patients over 60 years of age, if the use of angiotensin converting enzyme inhibitors (ACE inhibitors) is inappropriate due to side effects, especially cough or contraindicated; ejection fraction of the left ventricle not more than 40%, the clinical condition should be stabilized during treatment of chronic heart failure
· To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, documented in the ECG.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used.You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients.
The preparation is contraindicated in people with severe hepatic impairment.
The preparation is contraindicated in the second and third trimester of pregnancy and during breastfeeding. It is not recommended during the first trimester of pregnancy.
Take special care with Apo-Lozart?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
The preparation may cause angioneurotic edema
(swelling of the lips, tongue, throat, larynx that may impede breathing and may be life-threatening). In the event of the first symptoms of edema, stop using the preparation and seek medical help immediately. People who have ever had angioneurotic edema should remain under close medical supervision.
Caution should be exercised because symptomatic hypotension may occur, especially in patients with circulating, dehydrated or sodium deficient circulating blood (eg, people who have previously received high doses of diuretics, low salt diets, diarrhea or vomiting). Before starting treatment, electrolyte deficits should be leveled and adequate hydration should be ensured. It may be necessary to reduce the initial dose and adjust the dosage by your doctor.
Water-electrolyte imbalance, which should be compensated before treatment, often occurs in patients with impaired renal function and in patients with diabetes with co-existing renal dysfunction. Regular monitoring of creatinine and potassium in the blood is recommended, especially in patients with heart failure and in patients with impaired renal function.
The use of a preparation and medicines to increase the level of potassium in the blood is not recommended. The preparation may cause hyperkalaemia (increase in potassium in the blood). Hyperkalaemia may cause serious arrhythmias. Your doctor will monitor the level of potassium in your blood, especially if you are at increased risk for hyperkalemia.
If you have liver problems, your doctor will consider reducing your dose. The preparation is contraindicated in the presence of severe hepatic impairment. It is not recommended for use in children with impaired hepatic function.
In patients at higher risk of renal dysfunction, in which renal function depends on the activity of the renin-angiotensin-aldosterone system (eg in patients with severe heart failure, bilateral renal artery stenosis or renal artery stenosis of the sole active kidney) use of drugs acting on the renin-angiotensin-aldosterone system may be associated with the risk of oliguria, increased urea and creatinine in the blood. These disorders usually disappear spontaneously after discontinuation of the preparation. Caution should be exercised and treatment should be under special medical supervision. Blood creatinine must be checked regularly.
The use of the preparation is not recommended in children with a glomerular filtration rate of less than 30 ml / min / 1.73 m2.
The use of the preparation may cause worsening of renal function, especially in patients with an increased risk of renal dysfunction (eg if there is a fever, dehydration). In these patients, the doctor will recommend regular determination of parameters characterizing kidney function.
The use of ACE inhibitors and adducts is not recommended because of the increased risk of side effects, especially renal dysfunction.
There are no data on the use of the preparation in patients after kidney transplantation.
It is not recommended to use the preparation in patients with primary hyperaldosteronism, because the effect of the preparation in this group of patients is not effective.
In people with ischemic heart disease or cerebrovascular disease (people with coronary artery stenosis or narrowing of the cerebral vessels) a significant reduction in blood pressure may result in a heart attack or stroke.
In people with heart failure in whom vascular tone and renal function depends on the activity of the renin-angiotensin-aldosterone system, the use of the preparation may be associated with the risk of a rapid fall in blood pressure and acute renal failure
Due to the lack of sufficient clinical experience, caution should be exercised when using the preparation in patients:
· With heart failure associated with acute renal failure
· With severe heart failure (NYHA grade IV)
· With heart failure and symptomatic arrhythmias.
Caution should be exercised if beta-blockers are used in parallel.
Caution should be used if the preparation is used in patients with impaired left ventricular outflow (aortic or mitral stenosis), hypertrophic cardiomyopathy).
In black people, the preparation may be less effective in lowering blood pressure.
Additional information about the other ingredients of the preparation:
· The product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of Glucose
-galactose should not use this preparation.
Does this preparation affect the ability to drive vehicles?
There is no evidence of effects on the ability to drive vehicles and operate machinery / equipment. However, it should be taken into account that the preparation may cause dizziness, drowsiness or other symptoms in some people, which may impair psychophysical fitness and the ability to drive and use machines and machines, especially at the beginning of treatment or during dose escalation.
Dosage of Apo-Lozart
The preparation is in the form of coated tablets. It is intended for oral use. The tablets can be taken with or without a drink, with a glass of water. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
Hypertension: initial dose 50 mg once daily, maintenance dose 50-100 mg once daily. Full antihypertensive effect is achieved during the 3rd-6th. weeks of treatment. It can be used in conjunction with other antihypertensive agents, especially with hydrochlorothiazide (a diuretic).
Kidney disease in patients with hypertension and type 2 diabetes mellitus with proteinuria: initial dose 50 mg once daily. Then, if necessary, after about 4 weeks, your doctor may increase the dose to 100 mg once a day. The preparation can be used in parallel with other antihypertensive agents (eg diuretics, Calcium
channel blockers, alpha or beta blockers, drugs affecting the central nervous system) as well as with antidiabetic agents (insulin, sulphonylureas, glitazones, glucosidase inhibitors).
Heart failure: the initial dose is 12.5 mg once a day and the treatment can only be started under close medical supervision; then the doctor will double the dose at weekly intervals up to the usual maintenance dose, which is 50 mg once a day.
Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy: initial dose of 50 mg once daily. Your doctor may then increase the dose to 100 mg once a day or to take a diuretic (hydrochlorothiazide) for treatment.
In patients with a reduced volume of circulating blood (eg treated with high doses of diuretic medicines), your doctor may recommend a reduction of the initial dose to 25 mg once a day.
There is no need to adjust the starting dose of the drug in patients with impaired renal function and in patients undergoing hemodialysis.
In patients with hepatic impairment, it is necessary to reduce the initial dose and further adjust the dosage by the doctor. The preparation is contraindicated in the presence of severe hepatic impairment.
Children and adolescents: data on the safety and efficacy of the preparation in the treatment of hypertension in children and adolescents 6.-18. years of age are limited. In each case, an individual doctor will recommend the appropriate dosage.For children with a body weight of 20-50 kg who can swallow tablets, the recommended dose is 25 mg once a day; if the body weight is greater than 50 kg, the recommended dose is 50 mg once daily. It is not recommended for use in children under 6 years of age. It is not recommended for children with a glomerular filtration rate of less than 30 ml / min / 1.73 m2 and in children with hepatic insufficiency.
In elderly patients, there is usually no need to adjust the dosage, sometimes, especially in people over 75, the doctor may recommend a reduction of the initial dose to 25 mg once a day.
Can I use Apo-Lozart during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
The preparation should not be used during the first trimester of pregnancy. The use of the preparation in the second and third trimester of pregnancy is contraindicated. If a woman plans to become pregnant she should consult a doctor because it is recommended to change the way of antihypertensive treatment. If you suspect or confirm pregnancy during the period of taking the preparation, you should consult a doctor as soon as possible because immediate discontinuation of the preparation is required. Your doctor will prescribe other antihypertensive agents.
Do not use the product during breast-feeding.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Other antihypertensive agents may increase the hypotensive effect of the preparation.
Diuretics and other medicines that can lower blood pressure (eg, Nitroglycerin
e and other nitrates, tricyclic antidepressants, antipsychotics, baclofen, amifostine) increase the risk of hypotension.
Fluconazole and rifampicin reduce the concentration of the active metabolite in the blood, although it is not known if this is clinically relevant.
Parallel use of drugs that affect the level of potassium in the blood (potassium sparing diuretics, such as spironolactone, triamteren, amiloride, potassium supplements, Heparin
) and potassium-containing salt substitutes may lead to increased levels of potassium in the blood (hyperkalemia). The use of losartan in parallel with the preparations mentioned above is not recommended.
The preparation, like angiotensin-converting enzyme (ACE inhibitors), may increase the toxic effects of lithium salts. The simultaneous use of lithium is not recommended, and if necessary, combination therapy should be used with caution and control of the concentration of lithium in the blood.
Non-steroidal anti-inflammatory drugs (eg Acetylsalicylic acid
, indomethacin) may reduce the antihypertensive effect of the preparation and cause renal dysfunction and increase in potassium in the blood. Adequate hydration and regular renal function should be ensured. Caution should be exercised, especially in elderly patients.
Due to the risk of renal dysfunction, including acute renal failure, the concomitant use of ACE inhibitors and medicinal products should be limited to individual cases where renal function is monitored.
What side effects can occur?
Like all medicines, Apo-Lozart can cause side effects, although they will not occur in all patients who use this product. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Common or not always possible: dizziness, balance disorders, weakness, fatigue, edema, increase in potassium in the blood (hyperkalemia), hypoglycaemia (in diabetic patients), drowsiness, headaches, sleep disorders, palpitations, angina pectoris, symptoms caused by hypotension, including orthostatic hypotension (orthostatic hypotension), abdominal pain, constipation, urticaria, pruritus, rash. Rare: hypersensitivity and Anaphylactic reactions
, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in sporadic cases that may cause narrowing of the airways, impede breathing and threaten life), vasculitis, increase in liver enzymes.In addition, in patients with chronic heart failure, often: increased creatinine
and urea in the blood, kidney problems, renal failure, anemia; uncommon: shortness of breath, cough, diarrhea, nausea and vomiting; rarely: paresthesia (sensory disturbances, tingling and numbness), fainting, atrial fibrillation, cerebrovascular accident. In addition, possible other side effects for which their incidence has not been determined: anemia, thrombocytopenia, depression, MIG
raine, disturbed taste, tinnitus, cough, diarrhea, pancreatitis, hepatitis, liver dysfunction, renal dysfunction, urticaria, pruritus , rash, sensitivity to light, muscle and joint pain, rhabdomyolysis, sexual dysfunction (impotence), malaise, low blood sodium (hyponatraemia).
Other preparations on the Polish market containing losartan
Cozaar (coated tablets)
Lakea (coated tablets)
Loreblok (coated tablets)
Lorista (coated tablets)
Losacor (coated tablets)
Losagen (coated tablets)
Losartan Bluefish (coated tablets)
Losartan Genoptim (coated tablets)
Losartan KRKA (coated tablets)
Losartanum 123ratio (coated tablets)
Losartic (coated tablets)
Lozap 50 (coated tablets)
Presartan (coated tablets)
Rasoltan 50 mg (coated tablets)
Xartan (coated tablets)
Zeprez (coated tablets)