Lortenza, 10 mg+100 mg 90 pcs

Hypotensive drug combined (slow calcium channel blocker + angiotensin II receptor antagonist)

Indications

Arterial hypertension (patients who are indicated for amlodipine and losartan combination therapy).

Active ingredient

Amlodipine, Lozartan

Composition

for 1 tablet 5 mg + 50 mg

Kernel:

Active substances:

Amlodipine besylate (amlodipine besylate) 6.94 mg, equivalent to amlodipine 5.00 mg

Lozartan A, 163.55 mg granule substance, contains losartan potassium 50.00 mg

Supplementary substances: 80¹ cellactose, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch, iron oxide yellow dye (E172), colloidal silicon dioxide, magnesium stearate

Shell film:

Opadray II white², iron oxide yellow dye (E172), iron oxide red dye (E172)

for 1 tablet 5 mg + 100 mg

Kernel:

Active substances:

Amlodipine besylate (amlodipine besylate) 6.94 mg, equivalent to amlodipine 5.00 mg

Lozartan A, substance-granules 327.10 mg, contains losartan potassium 100.00 mg

Supplementary substances: cellactose 80¹, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch, iron oxide yellow dye (E172), colloidal silicon dioxide, magnesium stearate

Shell film:

Opadray II white², iron oxide red dye (E172)

for 1 tablet 10 mg + 50 mg

Kernel:

Active substances:

Amlodipine besylate (amlodipine besylate) 13.88 mg, equivalent to amlodipine 10.00 mg

Lozartan A, 163.55 mg substance-granules, contains losartan potassium 50.00 mg

Supplementary substances: cellactose 80¹, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch, iron oxide yellow dye (E172), colloidal silicon dioxide, magnesium stearate

Shell film:

Opadray II white², iron oxide red dye (E172)

for 1 tablet 10 mg + 100 mg

Kernel:

Active substances:

Amlodipine besylate (amlodipine besylate) 13.88 mg, equivalent to amlodipine 10.00 mg

Lozartan A, substance-granules 327.10 mg, contains losartan potassium 100.00 mg

Supplementary substances: cellactose 80¹, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch, iron oxide yellow dye (E172), colloidal silicon dioxide, magnesium stearate

Shell film:

Opadray II white², iron oxide yellow dye (E172)

¹ Cellactose 80: lactose monohydrate, cellulose.

² Opadray II white: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc.

How to take, the dosage

Orally, once daily, regardless of meal time, with a little water.

The recommended dose of Lortense^® is 1 tablet daily.

Lortenza^® in dose 5 mg + 50 mg is indicated for patients who have not adequately controlled BP when using amlodipine 5 mg or losartan 50 mg in monotherapy.

Lortenza^® at a dose of 5 mg + 100 mg is indicated for patients who have not achieved adequate BP control when using losartan 100 mg or Lortenza^® at a dose of 5 mg + 50 mg.

Lortenza^® at a dose of 10 mg + 50 mg is indicated for patients who have not achieved adequate BP control when using amlodipine 10 mg or Lortenza^® at a dose of 5 mg + 50 mg.

Lortenza^® at a dose of 10 mg + 100 mg is indicated for patients who have not achieved adequate BP control when using Lortenza^® at a dose of 5 mg + 100 mg or 10 mg + 50 mg.

The dose is adjusted after previously titrated doses of individual drug components. If it is necessary to change the dose of one of the active substances in the composition of the fixed combined medicine (for example, due to newly diagnosed disease, change in the patient’s condition or drug interaction), individual selection of doses of individual components is necessary.

Maximum daily dose of Lortense^® is 10 mg + 100 mg.

Patients taking losartan and amlodipine concomitantly may be switched to Lortenza^® containing losartan and amlodipine in the same doses.

Kidney function disorder

Dose adjustment is not required for CK of 50 to 20 ml/min.

The drug Lortenza^® is contraindicated in patients with CK less than 20 ml/min and patients on hemodialysis (see section “Contraindications”).

Patients with reduced CPR

In patients with decreased RBC (eg, due to high-dose diuretic treatment, etc.) the starting dose of losartan should be reduced to 25 mg once daily. Due to the unavailability of Lortenza^® containing 25 mg losartan, this dose should be administered in losartan monotherapy.

Before using Lortensa^®, the RBC and plasma sodium content should be restored.

Liver function disorder

Patients with a history of liver dysfunction (less than 9 points on the Child-Pugh score) are recommended to use lower doses of losartan. Due to the absence of a Lortenza^® dosage containing 25 mg losartan, this dose should be administered in losartan monotherapy.

The use of the drug Lortenza^® is possible in patients with impaired liver function (less than 9 points by Child-Pugh score) for whom the use of losartan in a dose of 50 mg has been recommended by a physician.

Elderly patients

In elderly patients (>65 years) due to decreased clearance, therapy with amlodipine should be started with a 2.5 mg dose once daily. Since Lortenza^® has no dosage containing 2.5 mg amlodipine, this dose should be administered in amlodipine monotherapy.

Children and teens

The drug Lortenza^® should not be administered to children and adolescents younger than 18 years of age, because there are no data on the effectiveness and safety of use in this group of patients.

Interaction

Antihypertensive effect of the drug Lortenza^® may be enhanced when used simultaneously with other hypotensive agents. Therefore, the simultaneous use of different hypotensive agents should be justified.

Amlodipine

The concomitant use of amlodipine with thiazide diuretics, alpha-adrenoblockers or ACE inhibitors is considered safe.

Unlike other BMCCs, no clinically significant interaction of amlodipine (generation III BMCCs) has been found when used concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs), including indomethacin.

It is possible to enhance the antihypertensive effect of BMCC when used simultaneously with thiazide and “loop” diuretics, ACE inhibitors and nitrates, as well as when used simultaneously with alpha1-adrenoblockers, neuroleptics.

Concomitant use of amlodipine with CYP3A4 isoenzyme inhibitors requires careful monitoring of symptoms of arterial hypotension and peripheral edema. Concomitant use of diltiazem at a dose of 180 mg daily and amlodipine at a dose of 5 mg daily in elderly patients increases the systemic exposure of amlodipine by 60%. Eritromycin concomitant use increases C_max of amlodipine in plasma in younger patients by 22% and by 50% in elderly patients. In contrast, powerful isoenzyme inhibitorsCYP3A4 (ketoconazole, itraconazole, ritonavir) may increase the plasma concentration of amlodipine even more.

With concomitant use of inducers isoenzyme CYP3A4, plasma concentrations of amlodipine may vary. Therefore, BP control and dose adjustment of the drugs taken should be performed both during and after concomitant use, especially in combination with powerfulpowerfulinducers of CYP3A4 isoenzyme (e.g.,Rifampicin,Guarrow preparations).

Beta-adrenoblockers when used concomitantly with amlodipine may cause exacerbation of CHF.

Although no negative inotropic effects have typically been observed in studies of amlodipine, however, some BMCCs may increase the severity of the negative inotropic effects of antiarrhythmic agents that cause QT interval prolongation (e.g., amiodarone and quinidine).

A single administration of 100 mg of sildenafil in patients with AH has no effect on the pharmacokinetic parameters of amlodipine. When amlodipine was taken simultaneously with sildenafil, each drug had its own antihypertensive effect independently.

Repeated use of amlodipine at a dose of 10 mg and atorvastatin at a dose of 80 mg was not accompanied by significant changes in the pharmacokinetics of atorvastatin.

Ethanol (drinks containing alcohol): amlodipine at a single and repeated use in a dose of 10 mg does not affect pharmacokinetics of ethanol.

Neuroleptics and isoflurane enhance the antihypertensive effects of dihydropyridine derivatives.

Intravenous administration of dantrolene with amlodipine therapy may cause collapse, arrhythmias, reduced heart rate and hyperkalemia.

The calcium drugs may decrease the antihypertensive effects of BMCCs.

When concomitant use of amlodipine with the drugs lithium may increase manifestations of neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

It has no effect on the serum digoxin concentration and its renal clearance.

It does not significantly affect the effect of warfarin (in particular, simultaneous use of amlodipine and warfarin does not affect the increase in prothrombin time).

Cimetidine has no effect on amlodipine pharmacokinetics.

In studies under in vitro amlodipine does not affect the binding to plasma proteins of digoxin, phenytoin, warfarin and indomethacin.

The simultaneous administration of 240 mggrapefruit juice and 10 mg amlodipine orally is not accompanied by significant changes in amlodipine pharmacokinetics.

A single administration of aluminum- or magnesium-containing antacids has no significant effect on amlodipine pharmacokinetics.

When concomitantly used with amlodipine, there is a risk of increased plasma tacrolimus concentrations, but the pharmacokinetic mechanism of this interaction is not fully understood. To prevent toxic effects of tacrolimus when used concomitantly with amlodipine, plasma tacrolimus concentrations should be monitored and the dose should be adjusted if necessary.

Clarithromycin is an inhibitor of CYP3A4 isoenzyme. Concomitant use of amlodipine and clarithromycin increases the risk of arterial hypotension. Close medical monitoring of patients receiving amlodipine concomitantly with clarithromycin is recommended.

Inhibitors of the mechanistic target for rapamycin in mammals (mTOR🙂 mTOR inhibitors, such as sirolimus, temsirolimus and everolimus, are substrates of the CYP3A isoenzyme. Amlodipine is a weak inhibitor of CYP3A isoenzyme. When used concomitantly with inhibitorsmTOR amlodipine may increase their exposure.

Drug interaction studies using cyclosporin and amlodipine in healthy volunteers or other patient groups have not been performed, except in kidney transplant patients who have had variable minimum concentrations (mean values: 0-40%) of cyclosporin. Concomitant use of amlodipine with cyclosporin may increase plasma concentrations of cyclosporin. When concomitant use of amlodipine in patients who have undergone kidney transplantation, plasma concentrations of cyclosporin should be monitored, and if necessary, its dose should be reduced.

Clinical interaction studies have shown that amlodipine does not affect the pharmacokinetics of atorvastatin, digoxin orwarfarin.

Simultaneous repeated use of amlodipine at a dose of 10 mg and simvastatin at a dose of 80 mg results in a 77% increase in simvastatin exposure. The dose of simvastatin when used concomitantly with amlodipine should not exceed 20 mg once daily.

Lozartan

As with other agents that block angiotensin II formation and its effects, the simultaneous use of caliberating diuretics (e.g., ), potassium preparations and potassium-containing salt substitutes may lead to increased serum potassium content.

As with other drugs that affect sodium excretion, losartan may decrease excretion of lithium, therefore, when concomitant use of drugs lithium and ARA II, serum lithium concentration should be monitored closely.

In some patients with impaired renal function (e.g., elderly patients or patients with dehydration, including those taking diuretics) who have been treated with DNAPs, including sselective cyclooxygenase-2 (COX-2) inhibitors, concomitant use of ACE inhibitors and/or ARAII, including losartan, may cause further deterioration of renal function up to and including acute renal failure (ARF). This effect is usually reversible. NSAIDs, including selective COX-2 inhibitors, may reduce the effect of APA II, including losartan. Therefore, the antihypertensive effect of ARA II may be impaired by concomitant use of NSAIDs, in particular selective COX-2 inhibitors. Thus, concomitant use of amlodipine/lozartan combination with DNAPs should be performed with caution in patients with impaired renal function.

Dual RAAS blockade is possible only in individual cases under close monitoring of BP, renal function and plasma electrolyte content. In patients with atherosclerosis, CHF or diabetes with target organ damage, dual RAAS blockade is associated with a higher incidence of arterial hypotension, syncope, hyperkalemia, and renal function impairment (including ARF) compared to one of the above groups.

The concomitant use of ARA II, including losartan, with drugs containing aliskiren is contraindicated in patients with diabetes and/or moderate to severe renal function impairment (FFR less than 60 ml/min/1.73 m² body surface area) and is not recommended in other patients.

Simultaneous use of ARA II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Two CYP3A4 isoenzyme inhibitors have been studied in clinical trials. Ketoconazole did not affect the metabolism of losartan to the active metabolite after intravenous administration of losartan. Eritromycin had no clinically significant effect on the pharmacokinetics of losartan when administered orally.

Fluconazole, a inhibitor of the isoenzyme CYP2C9.decreases the concentration of the active metabolite of losartan and increases the plasma concentration of losartan, but the pharmacodynamic significance of concomitant use of losartan and inhibitors ofem>inhibitors of the isoenzyme CYP2C9 has not been established. Patients who do not metabolize losartan to the active metabolite have been shown to have a very rare and specific defect in the CYP2C9 isoenzyme. These data suggest that the metabolism of losartan to the active metabolite is mediated primarily by the CYP2C9 isoenzyme rather than the CYP3A4 isoenzyme.

Special Instructions

Bilateral renal artery stenosis or stenosis of the artery of a single kidney, post kidney transplantation (no experience of use), coronary heart disease (CHD), heart failure with life-threatening arrhythmias, cerebrovascular disease, primary hyperaldosteronism, history of angioedema, unstable angina pectoris, use in patients with low circulating blood volume (CBC) (e.g., when using high doses of diuretics, severe diarrhea, vomiting and other conditions leading to hypovolemia) – symptomatic hypotension may occur, in patients on a diet with restriction of table salt, hyperkalemia, arterial hypotension, liver failure (less than 9 points by Child-Pugh scale), sinus node weakness syndrome (marked bradycardia, tachycardia), heart failure with concomitant severe renal dysfunction, severe CHF of non-ischemic etiology (functional class III-IV by NYHA classification), aortic and/or mitral stenosis, hypertrophic obstructive cardiomyopathy (HICMP), acute myocardial infarction (and within 1 month after the infarction), concomitant use with CYP3A4 inhibitors and inducers, electrolyte-water balance disorders, renal failure (mild and moderate degree), use in elderly patients.

The drug Lortenza^® should not be used in children and adolescents under 18 years of age because there are no data about effectiveness and safety in this group of patients.

Kidney function disorder

Dose adjustment is not required for CK of 50 to 20 ml/min.

The drug Lortenza^® is contraindicated in patients with CK less than 20 ml/min and in patients on hemodialysis.

Liver function disorder

Patients with a history of liver dysfunction (less than 9 points on the Child-Pugh score) are recommended to use lower doses of losartan. Due to the absence of a Lortenza^® dosage containing 25 mg losartan, this dose should be administered in losartan monotherapy.

The use of the drug Lortenza^® is possible in patients with impaired liver function (less than 9 points by Child-Pugh score) for whom the use of losartan in a dose of 50 mg has been recommended by a physician.

Elderly patients

In elderly patients (>65 years) due to decreased clearance, therapy with amlodipine should be started with a 2.5 mg dose once daily. Since Lortenza^® has no dosage containing 2.5 mg amlodipine, this dose should be administered in amlodipine monotherapy.

Patients with decreased CPR or severe aortic stenosis

Special directions and precautions related to amlodipine

Due to the long T_1/2 vasodilation developed as a result of amlodipine administration may persist after its withdrawal. Thus, the use of another vasodilator after amlodipine withdrawal should be performed with caution, individual evaluation of dose, dosing interval and active monitoring of the patient’s condition are necessary.

During treatment, body weight and dietary salt consumption should be controlled and appropriate diet prescribed. It is necessary to maintain dental hygiene and visit the dentist often (to prevent soreness, bleeding, and hyperplasia of the gums).

Unstable angina and myocardial infarction

Unstable angina and acute myocardial infarction may develop after starting therapy or increasing the amlodipine dose, especially in patients with severe GOCMP.

Special directions and precautions related to losartan

Hyperkalemia (plasma potassium > 5.5 mmol/L) was noted in 1.5% of patients taking losartan as monotherapy. None of these cases required drug withdrawal. The concomitant use of potassium-saving diuretics (e.g., spironolactone, triamterene, amiloride, eplerenone), potassium supplements, potassium salt substitutes, and drugs that can increase plasma potassium (e.g., heparin), with losartan should be justified (especially in elderly patients with impaired renal function) and plasma potassium should be monitored.

Patients should not take potassium medications or food salt substitutes containing potassium while taking losartan without first consulting their physician.

Transient hypotension accompanied by shock, syncope and shortness of breath may result from taking losartan.

The drug Lortense^® should be used with caution in patients:

– with reduced CER;

– being on diet with restriction of table salt.

Hypersensitivity reactions

In patients with a history of angioedema (swelling of the larynx, vocal cords, face, lips, pharynx and/or tongue), close monitoring of Lortenza^® (see section “Side effects”) is necessary.

Embiotoxicity

The use of drugs affecting RAAS in the second to third trimesters of pregnancy reduces fetal renal function and increases the frequency of fetal and newborn morbidity and mortality. The development of oligohydramnios may be associated with fetal lung hypoplasia and skeletal deformity. Possible adverse events in neonates include skull bone hypoplasia, anuria, arterial hypotension, renal failure, and death. If pregnancy is diagnosed, the drug Lortenza^® should be immediately discontinued (see section “Use in pregnancy and during breastfeeding”).

Water-electrolyte balance disorder

Aque-electrolyte balance disruption is common in patients with impaired renal function with or without diabetes, so these patients should be monitored closely. In clinical studies involving patients with type 2 diabetes mellitus with proteinuria, the incidence of hyperkalemia was greater in the group taking losartan than in the group taking placebo. Several patients discontinued therapy due to the occurrence of hyperkalemia (see section “Side effects. Laboratory and instrumental data”).

Aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy

As with all drugs with vasodilatory effects, ARA II should be used with caution in patients with aortic or mitral stenosis, GOCMP.

Chronic heart failure

As with other drugs acting on the RAAS, patients with CHF and with or without impaired renal function are at risk of developing severe arterial hypotension or acute renal dysfunction.

As there is not enough experience of using losartan in patients with CHF and concomitant severe renal dysfunction, in patients with severe heart failure (NYHA functional class III-IV), and in patients with heart failure and symptomatic life-threatening arrhythmias, Lortenza^® should be used with caution.

Ischemic heart disease and cerebrovascular disease

As all drugs with vasodilatory action, ARA II should be used with caution in patients with coronary heart disease or cerebrovascular disease, because a significant decrease of BP in this group of patients may lead to myocardial infarction or stroke.

Primary hyperaldosteronism

Since patients with primary hyperaldosteronism do not usually have a positive response to therapy with hypotensive agents that act by inhibiting the RAAS, the use of Lortenza^® is not recommended in this group of patients.

Patients with liver failure

Pharmacokinetic studies indicate that patients with cirrhosis have significant increases in the plasma concentration of losartan. Lortenza^® should not be used in patients with severe hepatic impairment (greater than 9 on the Child-Pugh scale) and in patients with hepatic impairment (less than 9 on the Child-Pugh scale) who are recommended to reduce the dose of losartan to 25 mg daily (see sections “Pharmacological properties. Pharmacokinetics”, “Contraindications”, “Dosage and administration”).

Since amlodipine is primarily metabolized in the liver and the T_1/2 in patients with impaired liver function is 56 hours, when administering amlodipine to patients with severe hepatic impairment, dose titration should be done gradually.

Patients with renal failure

Due to RAAS inhibition, some predisposed patients taking losartan had reversible changes in renal function when the drug was withdrawn.

In patients whose renal function may depend on RAAS activity (e.g., in NYHA functional class III-IV CHF), use of ACE inhibitors was accompanied by oliguria and/or increasing azotemia and, rarely, by ARF and/or lethal outcome. A similar pattern has been observed with losartan in these patients. Some ARF-acting drugs can increase plasma urea and serum creatinine concentrations in patients with bilateral renal artery stenosis or renal artery stenosis of a single kidney. A similar effect was observed when taking losartan in this group of patients; it was reversible when the drug was withdrawn. Lortenza^® should be used with caution in patients with bilateral renal artery stenosis or renal artery stenosis of the single kidney.

Double RAAS blockade

The concomitant use of ARA II, including losartan, with drugs containing aliskiren is contraindicated in patients with diabetes and/or moderate to severe renal function impairment (FFR less than 60 mL/min/1.73 m² body surface area) and is not recommended in other patients.

Simultaneous use of ARA II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Hypertensive crisis

Efficacy and safety of use in hypertensive crisis have not been established.

Special patient groups

Children and adolescents

The efficacy and safety of Lortensa^® in children and adolescents under 18 years of age have not been established.

If neonates whose mothers have taken Lortenza^® during pregnancy develop oliguria or arterial hypotension, symptomatic therapy to maintain BP and renal perfusion is necessary. Blood transfusion or dialysis may be required to prevent the development of arterial hypotension and/or maintain renal function.

Elderly patients

Clinical studies have not shown any specific findings regarding the safety and efficacy of losartan in elderly patients (>65 years). In elderly patients, due to decreased clearance resulting in an increase in AUC of amlodipine by approximately 40-60%, therapy with amlodipine is usually recommended to start with a dose of 2.5 mg once daily. Since Lortenza^® does not have a dose containing 2.5 mg amlodipine, this dose should be administered in amlodipine monotherapy.

Special information about excipients

The drug Lortenza^® contains lactose, so it should not be used in the following conditions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Cautions should be taken when driving vehicles and operating other technical devices requiring high concentration and quick psychomotor reactions, taking into account the risk of dizziness.

Synopsis

Tablets 5 mg + 50 mg:

Oval, slightly biconvex, film-coated tablets with light brown with orange tint.

Breakage appearance: a rough mass consisting of two layers – white or nearly white and pale yellow in color with light brown-orange film coating.

Tablets 5 mg + 100 mg:

Oval, biconvex, film-coated tablets in pink.

Breakage appearance: a rough mass consisting of two layers – white or almost white and pale yellow with a pink film coating.

Tablets 10 mg + 50 mg:

Oval, slightly biconvex, red-brown film-coated tablets.

Breakage appearance: a rough mass consisting of two layers – white or almost white and pale yellow with a red-brown film coating.

Tablets 10 mg + 100 mg:

Oval, biconvex, film-coated tablets of pale brownish-yellow color.

Fracture appearance: a rough mass consisting of two layers – white or almost white and pale yellow with a film coating of pale brownish-yellow color.

Contraindications

– Hypersensitivity to active ingredients and/or excipients of the drug.

– Pregnancy and breastfeeding (see “Use in pregnancy and breastfeeding”).

– Severe liver failure (more than 9 points on the Child-Pugh scale).

– Left ventricular outflow tract obstruction (for example, hemodynamically pronounced aortic stenosis).

-Hemodynamically unstable heart failure after acute myocardial infarction.

– Shock (including cardiogenic shock).

– Age under 18 (effectiveness and safety not established).

– Severe arterial hypotension (systolic BP less than 90 mm Hg).

– Severe renal function impairment (CK less than 20 ml/min), use in patients on hemodialysis.

• Simultaneous use with aliskiren and drugs containing aliskiren in patients with diabetes and/or moderate to severe renal function impairment (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m² body surface area).
• Simultaneous use with ACE inhibitors in patients with diabetic nephropathy.

– Lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Overdose

There are no known cases of overdose with the fixed amlodipine/ losartan combination. Below are data on overdose of amlodipine and losartan taken separately.

Pregnancy use

Pregnancy

The use of Lortense^® is contraindicated in pregnancy; if pregnant, the drug should be stopped immediately.

Drugs (drugs) that affect the RAAS can cause damage and death to the fetus and the newborn when used in pregnant women. Single cases of ACE inhibitors use during pregnancy have been described.

Depending on gestational age, stress test, nonstress test or fetal biopsy profile determination may be used to assess functional status. Patients and the physician should be aware that oligohydramnios develops when there is irreversible fetal damage. Newborns whose mothers have taken APA II during pregnancy should be under medical supervision, given the risk of developing arterial hypotension, oliguria and hyperkalemia. If oliguria develops, BP and renal perfusion should be corrected first. Exchange hemotransfusion or hemodialysis is necessary to correct arterial hypotension and/or to replace renal function.

Amlodipine

The safety of amlodipine in pregnancy has not been established. In animal experiments, signs of reproductive toxicity have been observed with high doses of amlodipine. The use of amlodipine during pregnancy is possible in the absence of safe hypotensive alternative therapy, and if the potential benefit to the mother exceeds the possible risk to the fetus.

Lozartan

The use of RAAS-acting drugs in the second and third trimesters of pregnancy can cause serious damage or even fetal death, so losartan should be discontinued during pregnancy planning or at pregnancy onset and, if necessary, transferred to alternative hypotensive therapy taking into account the safety profile. RAAS-dependent renal perfusion in the fetus develops from the second trimester of pregnancy, so the risk to the fetus increases when losartan is taken in the second and third trimesters of pregnancy.

Breastfeeding period

In preclinical studies, significant concentrations of amlodipine and/or the active metabolite losartan in breast milk were reported in animals.

Amlodipine is excreted with breast milk. The fraction of the maternal dose received by the infant varies from 3-7% to a maximum of 15%. The effect of amlodipine on infants is unknown.

The use of Lortense^® is contraindicated during breastfeeding.

Fertility

Amlodipine

C reversible biochemical changes in the sperm head were observed in some patients when BMCC was used. Clinical data on the potential effect of amlodipine on fertility are scarce. Side effects on fertility in male rats have been reported in a rat study.

Lozartan

No mutagenic properties of losartan were found in in vitro and in vivo studies. Fertility and reproductive function of male rats receiving oral doses up to 150 mg/kg/day were not altered. When female rats were administered doses of 100 mg/kg/day or more, a decrease in the number of yellow bodies, embryos, and fetuses was observed.

Similarities

Lortenza, Lortenza, Lozap AM