Lorista ND, 100 mg+25 mg 60 pcs

hypotensive combination drug (diuretic + angiotensin II receptor antagonist)

Indications

– Arterial hypertension (patients indicated for combination therapy).

– Reduced risk of associated cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy as manifested by cumulative reductions in cardiovascular mortality, stroke and myocardial infarction rates.

Active ingredient

Composition

1 film-coated tablet contains:

Kernel:

Active substances:

Hydrochlorothiazide 25.00 mg

Potassium losartan 100.00 mg

Auxiliary substances:

Pregelatinized starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate

Shell film:

Hypromellose, macrogol-4000, quinoline yellow dye (E104), titanium dioxide (E171), talc

.

How to take, the dosage

The drug Lorista® ND is taken orally regardless of the time of meals, once a day. Lorista® ND can be taken simultaneously with other hypotensive agents.

Arterial hypertension

The starting and maintenance dose is 1 tablet of the drug Lorista® ND once daily. Lorista® ND is indicated if there is no adequate therapeutic effect against combination of hydrochlorothiazide 12.5 mg and losartan 50 mg once daily during 2-4 weeks. Maximal daily dose is 1 tablet of the medicine Lorist® ND once daily.

Cardiovascular risk reduction and mortality in patients with arterial hypertension and left ventricular hypertrophy

The drug Lorista® ND is used in a dose of – 1 tablet once daily. Lorista® ND is indicated for patients who do not achieve the target BP values when taking a combination of hydrochlorothiazide 12.5 mg and losartan 50 mg once daily.

Special patient groups

Patients with impaired renal function or patients on hemodialysis

Lorista® ND should not be used for initial therapy in patients with moderate renal dysfunction (CKD 30-50 ml/min). Lorista®® ND is not recommended for patients on hemodialysis. Lorista® ND should not be used in patients with severe renal dysfunction (CK less than 30 ml/min) (see section “Contraindications”).

Patients with decreased BOD

The drug Lorista® ND should not be used for initial therapy in patients with reduced OBC.

Patients with impaired liver function

The drug Lorista® ND is contraindicated in patients with severe hepatic dysfunction (see Section “Contraindications”).

Elderly patients

The drug Lorista® ND should not be used for initial therapy in elderly patients.

Interaction

Hydrochlorothiazide

Unrecommended drug combinations

Lithium drugs

The simultaneous use of hydrochlorothiazide and lithium drugs reduces renal clearance of lithium, which may result in increased plasma lithium concentrations and increased toxicity. If it is necessary to use hydrochlorothiazide concomitantly, the dose of lithium preparations should be chosen carefully, the concentration of lithium in blood plasma should be controlled regularly, and the dose of the drug should be adjusted accordingly.

Drug combinations requiring special attention

Drugs capable of causing pirouette-type polymorphic ventricular tachycardia

Particular caution should be used with hydrochlorothiazide simultaneously with such drugs as:

-neuroleptics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, fluphenazine), benzamides (amisulpride, sultopride, sulpride, thiapride), butyrophenones (droperidol, haloperidol), pimozide, sertindol;

– antidepressants: tricyclic antidepressants, selective serotonin reuptake inhibitors (citalopram, escitalopram);

– Antibacterials: Fluoroquinolones (levofloxacin, moxifloxacin, sparfloxacin, ciprofloxacin), macrolides (erythromycin when given intravenously, azithromycin, clarithromycin, roxithromycin, spiramycin), co-trimoxazole;

– antifungal agents: azoles (voriconazole, itraconazole, ketoconazole, fluconazole);

– antimalarials (quinine, chloroquine, mefloquine, halofantrine, lumefantrine);

– antiprotozoal agents (pentamidine in parenteral administration);

– antianginal agents (ranolazine, bepridil);

– antineoplastic agents (vandetanib, arsenic trioxide, oxaliplatin, tacrolimus);

– antiemetics (domperidone, ondansetron);

– agents affecting GI motility (cisapride);

– antihistamines (astemisol, terfenadine, misolastin);

– other drugs (anagrelide, vasopressin, difemanil methylsulfate, ketanserin, probucol, propofol, sevoflurane, terlipressin, terodiline, cilostazol).

Due to the increased risk of ventricular arrhythmias, especially polymorphic pirouette-type ventricular tachycardia (hypokalemia is a risk factor), plasma potassium content should be determined and, if necessary, corrected before starting hydrochlorothiazide combination therapy with the above drugs. Monitoring of the patient’s clinical condition, plasma electrolyte content and ECG parameters is necessary. In patients with hypokalemia it is necessary to use agents that do not cause polymorphic ventricular tachycardia of “pirouette” type.

Drugs that can prolong QT interval duration

The concomitant use of hydrochlorothiazide with drugs that can prolong the QT interval should be based on a careful evaluation for each patient of the ratio of expected benefit to potential risk (an increased risk of pirouette-type polymorphic ventricular tachycardia is possible). While using such combinations it is necessary to record ECG regularly (for detection of prolongation of QT interval) as well as to monitor potassium content in blood.

Drugs that can cause hypokalemia: Amphotericin B (when administered intravenously), gluco- and mineralocorticosteroids (when administered systemically), tetracosactide (ACTH), glycyrrhizic acid (carbenoxolone, drugs containing licorice root), laxatives that stimulate bowel motility

Increased risk of hypokalemia when used concomitantly with hydrochlorothiazide (additive effect). Regular monitoring of plasma potassium is necessary, and its correction, if necessary. Against the background of hydrochlorothiazide therapy it is recommended to use laxatives which do not stimulate intestinal motility.

Heart glycosides

Hypokalemia and hypomagnesemia due to thiazide diuretics increase the toxicity of cardiac glycosides. When using hydrochlorothiazide and cardiac glycosides concomitantly, plasma potassium and ECG parameters should be monitored regularly and the therapy should be adjusted if necessary.

Drug combinations requiring attention

Other hypotensive drugs

Potentiation of the antihypertensive effects of hydrochlorothiazide (additive effect). It may be necessary to adjust the dose of simultaneously prescribed hypotensive drugs.

It is recommended to stop taking hydrochlorothiazide 2-3 days before starting ACE inhibitor therapy to prevent symptomatic arterial hypotension. If this is not possible, the initial dose of ACE inhibitors should be reduced.

Ethanol, barbiturates, antipsychotics (neuroleptics), antidepressants, anxiolytics, narcotic analgesics and general anesthetic agents

The antihypertensive effect of hydrochlorothiazide may be enhanced and orthostatic hypotension potentiated (additive effect).

Nedepolarizing myorelaxants (eg, tubocurarin)

The effects of nondepolarizing myorelaxants may be enhanced.

Adrenomimetics (pressor amines)

Hydrochlorothiazide may reduce the effects of adrenomimetics such as epinephrine (adrenaline) and norepinephrine (noradrenaline).

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and high-dose acetylsalicylic acid (> 3 g/day)

NSAIDs may decrease the diuretic and antihypertensive effects of hydrochlorothiazide. With concomitant use, there is a risk of acute renal failure due to decreased FFR. Hydrochlorothiazide may increase the toxic effects of high doses of salicylates on the central nervous system.

Hypoglycemic oral agents and insulin

Thiazide diuretics affect glucose tolerance (hyperglycemia may develop) and decrease the effectiveness of hypoglycemic agents (hypoglycemic dose adjustment may be required).

Hydrochlorothiazide and metformin should be used with caution due to the risk of lactoacidosis due to hydrochlorothiazide-induced renal impairment.

Beta-adrenoblockers, diazoxide

The concomitant use of thiazide diuretics (including hydrochlorothiazide) with beta-adrenoblockers or diazoxide may increase the risk of hyperglycemia.

Drugs used to treat gout (probenecid, sulfinpyrazone, allopurinol)

Dose adjustment of uricosuric medications may be necessary because hydrochlorothiazide increases serum uric acid concentrations. Thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol.

Amantadine

Thiazide diuretics (including hydrochlorothiazide) may decrease amantadine clearance, lead to higher plasma amantadine concentrations, and increase the risk of its adverse effects.

Anticholinergic drugs (choline blockers)

Anticholinergic drugs (e.g., atropine, biperidene) increase the bioavailability of thiazide diuretics by reducing GI motility and gastric emptying rate.

Cytotoxic (antitumor) drugs

Thiazide diuretics decrease renal excretion of cytotoxic drugs (e.g., cyclophosphamide and methotrexate) and potentiate their myelosuppressive effects.

Methyldopa

Cases of hemolytic anemia have been described when hydrochlorothiazide and methyldopa are used simultaneously.

Antioepileptic drugs (carbamazepine, oxcarbazepine, topiramate)

Risk of developing symptomatic hyponatremia. In concomitant use of hydrochlorothiazide and carbamazepine it is necessary to monitor the patient’s condition and control serum sodium content. When using hydrochlorothiazide and topiramate concomitantly, the content of topiramate in blood serum should also be monitored; if necessary, it is necessary to administer potassium preparations or to adjust topiramate dose.

Selective serotonin reuptake inhibitors

When used concomitantly with thiazide diuretics, hyponatremia may be potentiated. It is necessary to control the sodium content in plasma.

Cyclosporine

The concomitant use of thiazide diuretics and cyclosporine increases the risk of hyperuricemia and gout exacerbation.

Peroral anticoagulants

Tiazide diuretics may decrease the effect of oral anticoagulants.

Iodine-containing contrast agents

Dehydration from thiazide diuretics increases the risk of acute renal failure, especially when high doses of iodine-containing contrast agents are used. Before the use of iodine-containing contrast agents it is necessary to compensate the fluid loss.

Calcium preparations

With concomitant use, an increase in calcium in the blood and the development of hypercalcemia due to decreased excretion of calcium ions by the kidneys is possible. If simultaneous use of calcium containing medicines is necessary, the plasma calcium content should be monitored and the dose of calcium preparations should be corrected.

Anion exchange resins (colestyramine and colestipol)

The anionic exchange resins reduce absorption of hydrochlorothiazide. Single doses of colestyramine and colestipol reduce absorption of hydrochlorothiazide in the GI tract by 85% and 43%, respectively.

Lozartan

No clinically significant interactions of losartan with hydrochlorothiazide, digoxin, warfarin, cimetidine, and phenobarbital have been identified in clinical studies of pharmacokinetic drug interactions. Rifampicin, as an inducer of drug metabolism, reduces the plasma concentration of the active metabolite losartan. Two CYP3A4 isoenzyme inhibitors have been studied in clinical trials: ketoconazole and erithromycin. Ketoconazole had no effect on the metabolism of losartan to the active metabolite after intravenous administration of losartan. Erythromycin had no clinically significant effect when losartan was administered orally. Fluconazole, a CYP2C9 isoenzyme inhibitor, reduces plasma concentrations of the active metabolite of losartan, but the pharmacodynamic significance of concomitant use of losartan and CYP2C9 isoenzyme inhibitors has not been studied. Patients who do not metabolize losartan to an 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 performed by the CYP2C9 isoenzyme rather than the CYP3A4 isoenzyme.

Simultaneous use of losartan, as well as other drugs that block angiotensin II or its effects, with caliberating diuretics (e.g., spironolactone, triamterene, amiloride, eplerenone), potassium-containing supplements, or potassium salts may lead to an increase in serum potassium.

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

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, may decrease the effect of diuretics and other hypotensive agents. Due to this, the antihypertensive effect of ARA II or ACE inhibitors may be weakened when concomitantly used with NSAIDs, including selective COX-2 inhibitors.

In some patients with impaired renal function (e.g., elderly patients or patients with dehydration, including those taking diuretics) receiving NSAID therapy, including selective COX-2 inhibitors, concomitant use of ARA II or ACE inhibitors may cause further impairment of renal function, including development of acute renal failure. These effects are usually reversible, therefore concomitant use of these drugs should be conducted with caution in patients with impaired renal function.

Dual RAAS blockade with ARA II, ACE inhibitors or aliskiren (renin inhibitor) is associated with an increased risk of arterial hypotension, syncope, hyperkalemia and renal function impairment (including acute renal failure) compared to monotherapy. Regular monitoring of BP, renal function and plasma electrolyte levels is necessary in patients taking Lorist® ND and other drugs that affect the RAAS simultaneously. Concomitant administration of ARA II with aliskiren and drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with 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. Concomitant use of ARA II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Special Instructions

Bilateral renal artery stenosis or stenosis of the artery of a single kidney, hyperkalemia, conditions after kidney transplantation (no experience of use), aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy (HACMI), chronic heart failure (CHF) with associated severe renal impairment, severe heart failure (NYHA functional class IV), CHF with life-threatening arrhythmias, coronary heart disease (CHD), cerebrovascular disease, primary hyperaldosteronism, history of angioneurotic edema, arterial hypotension, liver dysfunction, renal dysfunction water-electrolyte balance disorders, patients with decreased BOD (e.g., those treated with high doses of diuretics) due to the possibility of symptomatic arterial hypotension, hypokalemia, hyponatremia, hypercalcemia, concomitant use of drugs, concomitant use of drugs that may cause polymorphic ventricular tachycardia of “pirouette” type or increase the QT interval duration on ECG, concomitant use of drugs that may cause hypokalemia, cardiac glycosides, history of penicillin allergy, hyperparathyroidism, hyperuricemia, gout, history of nonmelanoma skin cancer (NSCLC) (see sect. See section “Special Indications”).

Persons under 18 years of age are contraindicated (efficacy and safety of use have not been established)

Patients with impaired renal function or patients on hemodialysis

Lorista® ND should not be used for initial therapy in patients with moderate renal dysfunction (CKD 30-50 ml/min). Lorista®® ND is not recommended for patients on hemodialysis. Lorista® ND should not be used in patients with severe renal dysfunction (CK less than 30 ml/min) (see section “Contraindications”).

Patients with decreased BOD

The drug Lorista® ND should not be used for initial therapy in patients with reduced OBC.

Patients with impaired liver function

The drug Lorista® ND is contraindicated in patients with severe hepatic dysfunction (see Section “Contraindications”).

Elderly patients

The drug Lorista® ND should not be used for initial therapy in elderly patients.

The use of Lorista® ND in patients with acute myocardial infarction is not recommended due to insufficient experience in clinical use. Also, Lorista® ND should not be used to control hypertensive crisis.

Drug Lorista® ND

Hypersensitivity reactions

In patients with a history of angioedema (edema of the face, lips, pharynx/larynx and/or tongue) the use of the drug should be monitored (see (see section “Side effects”).

Kidney and liver function disorders

The drug Lorista® ND is contraindicated for use in patients with severe hepatic dysfunction and severe renal dysfunction (CK less than 30 mL/min) (see Section “Contraindications”).

Embryotoxicity

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

Hydrochlorothiazide

Kidney function disorders

In patients with renal impairment, hydrochlorothiazide may cause azotemia. In patients with renal insufficiency, hydrochlorothiazide may cumulate.

In patients with decreased renal function, periodic CK monitoring is necessary. In progression of renal function impairment and/or onset of oliguria (anuria), hydrochlorothiazide should be discontinued.

Liver function disorders

Hepatic encephalopathy may develop when using thiazide diuretics in patients with liver function disorders. In patients with severe hepatic insufficiency or hepatic encephalopathy thiazides use is contraindicated. In patients with mild to moderate hepatic insufficiency and/or progressive liver disease hydrochlorothiazide should be used with caution, since even a slight change of electrolyte-water balance and accumulation of ammonium in blood serum may cause hepatic coma. In case of encephalopathy symptoms the use of diuretics should be immediately stopped.

Water-electrolyte balance and metabolic disorders

Synopsis

Oval, slightly biconvex film-coated tablets from yellow to yellow with a greenish tint.

Breakage appearance: white rough mass with film coating from yellow to yellow with greenish tint.

Contraindications

Side effects

No adverse reactions specific to the combination of hydrochlorothiazide + losartan were observed in clinical trials with the drugs. Adverse reactions were limited to those already reported with losartan and/or hydrochlorothiazide alone. The cumulative incidence of adverse reactions reported with this combination was comparable to that with placebo. The rate of therapy withdrawal was also comparable to that of patients taking placebo.

Overall, treatment with the combination hydrochlorothiazide + losartan was well tolerated. In most cases the adverse reactions were mild, transient, and did not require therapy withdrawal.

In controlled clinical trials in the treatment of arterial hypertension, dizziness was the only adverse reaction associated with taking the drug with a frequency greater than 1% higher than when taking placebo.

As has been shown in controlled clinical trials, losartan in combination with hydrochlorothiazide is generally well tolerated in patients with arterial hypertension and left ventricular hypertrophy. The most common adverse reactions were systemic and non-systemic dizziness, weakness/increased fatigue.

The following additional adverse reactions have been reported during post-registration use of this combination, clinical trials conducted, and/or post-registration use of individual active ingredients of the combination.

Blood and lymphatic system disorders:thrombocytopenia, anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis.

Immune system disorders: Anaphylactic reactions, angioedema, including laryngeal and vocal fold edema with development of airway obstruction, and/or edema of the face, lips, pharynx, and/or tongue in patients taking losartan were rarely observed (≥0.01% and < 0.1% of cases), some of these patients had a history of developing angioedema when using other medications, including ACE inhibitors.

Metabolic and nutritional disorders:anorexia, hyperglycemia, hyperuricemia, blood electrolyte imbalances, including hyponatremia and hypokalemia.

Mental disorders: insomnia, anxiety.

Nervous system disorders:dysgeusia, headache, migraine, paresthesia.

Visual organ disorders: xanthopsia, transient visual focusing disorder.

cardiac disorders:sensation of palpitations, tachycardia.

vascular disorders:dose-dependent orthostatic effects, necrotizing angiitis (vasculitis), cutaneous vasculitis.

Disorders of the respiratory system, thorax and mediastinum:cough, nasal congestion, pharyngitis, sinus disorders (sinusitis), upper respiratory tract infections, adult respiratory distress syndrome (including pneumonitis and pulmonary edema).

Digestive system disorders:dyspepsia, abdominal pain, esophageal reflux, gastrointestinal colic, diarrhea, constipation, nausea, vomiting, pancreatitis, sialadenitis.

Hepatic and biliary tract disorders:hepatitis, jaundice (intrahepatic cholestatic jaundice).

Skin and subcutaneous tissue disorders:skin rash, itching, purpura (including Schönlein-Genoch purpura), toxic epidermal necrolysis, urticaria, erythrodermia, photosensitization, lupus-like syndrome.

Muscular and connective tissue disorders: back pain, muscle cramps, muscle spasms, myalgia, arthralgia.

Renal and urinary tract disorders:glucosuria, impaired renal function, interstitial nephritis, renal failure.

Gender and mammary gland disorders: erectile dysfunction/impotence.

General disorders and disorders at the injection site:breast pain, edema, malaise, fever, weakness.

Laboratory and instrumental findings:disorders of liver function (rarely increased plasma alanine aminotransferase activity).

Laboratory findings

In controlled clinical trials, clinically significant changes in standard laboratory parameters have rarely been observed with the hydrochlorothiazide + losartan combination. Hyperkalemia (serum potassium > 5.5 mEq/L) was observed in 0.7% of patients, but in these studies there was no need to cancel the combination hydrochlorothiazide + losartan due to the occurrence of hyperkalemia. An increase in plasma alanine aminotransferase activity was rarely observed and usually returned to normal after discontinuation of therapy.

Overdose

There are no data on the specific treatment of overdose with the combination of hydrochlorothiazide + losartan. Treatment is symptomatic and supportive. Lorista® ND should be discontinued and the patient should be monitored. If the drug has been taken recently, provocation of vomiting is recommended, as well as elimination of dehydration, water-electrolyte disturbances, hepatic coma and BP reduction by standard methods.

Hydrochlorothiazide

Symptoms

The most common manifestation of hydrochlorothiazide overdose is increased diuresis accompanied by acute fluid loss (dehydration) and electrolyte disturbances (hypokalemia, hyponatremia, gnpochloremia). Overdose with hydrochlorothiazide may manifest as the following symptoms:

Treatment

In overdose, symptomatic and supportive therapy is given. If the drug has been taken recently, induction of vomiting or gastric lavage are indicated for excretion of hydrochlorothiazide. Absorption of hydrochlorothiazide may be reduced by ingestion of activated charcoal. In case of BP decrease or shock it is necessary to replenish BCC (by administering plasma exchange fluids) and electrolyte deficit (potassium, sodium). In case of respiratory failure, oxygen inhalation or artificial lung ventilation is indicated. Water-electrolyte balance (especially serum potassium) and renal function should be controlled until their normalization. There is no specific antidote. Hydrochlorothiazide is excreted by hemodialysis; however, the extent of its excretion has not been determined.

Lozartan

The information about overdose is limited.

Symptoms

The most likely manifestation of overdose is a marked decrease in BP and tachycardia; bradycardia may occur due to parasympathetic (vagus) stimulation.

Treatment

Symptomatic therapy, in case of symptomatic arterial hypotension development the supporting therapy is indicated.

Losartan and its active metabolite are not excreted by hemodialysis.

Pregnancy use

Pregnancy

The use of Lorista® ND is contraindicated in pregnancy.

There is limited experience with hydrochlorothiazide during pregnancy (especially in the first trimester). Preclinical data regarding safety are insufficient. Hydrochlorothiazide penetrates the placental barrier and is detected in umbilical cord blood. Given the mechanism of pharmacological action of hydrochlorothiazide, its use in the second and third trimesters of pregnancy may disrupt the feto-placental perfusion and lead to the development in the fetus and the newborn of such complications as jaundice, electrolyte-water balance disorders and thrombocytopenia. Cases of thrombocytopenia have been described in newborns whose mothers received thiazide diuretics.

The use of hydrochlorothiazide during pregnancy is contraindicated. Hydrochlorothiazide should not be used for the treatment of gestosis in the second half of pregnancy (edema, arterial hypertension, or preeclampsia), as it increases the risk of decreased BOD and placental hypoperfusion, but does not have a beneficial effect on the course of these pregnancy complications. Diuretics do not prevent the development of gestosis.

Drugs acting directly on the RAAS may cause serious damage and death to the developing fetus, so Lorista® ND should be stopped immediately if pregnancy is diagnosed.

Although there is no experience with Lorista® ND in pregnant women, preclinical animal studies have shown that administration of losartan causes serious fetal and neonatal damage and fetal or offspring death. The mechanism of these phenomena is thought to be due to the effect on the RAAS.

Fetal renal perfusion dependent on the development of RAAS appears in the second trimester, so the risk to the fetus is increased if Lorista® ND is used in the second or third trimester of pregnancy.

The use of drugs affecting the RAAS in the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and mortality. The development of oligohydramnios may be associated with fetal lung hypoplasia and skeletal deformities. Possible adverse events in newborns include skull bone hypoplasia, anuria, arterial hypotension, renal failure, and death.

The above adverse outcomes are usually caused by the use of drugs affecting the RAAS in the second and third trimesters of pregnancy. Most epidemiological studies of fetal abnormalities after the use of hypotensive drugs in the first trimester of pregnancy have found no differences between RAAS-acting drugs and other hypotensive agents. When prescribing hypotensive therapy to pregnant women, it is important to optimize possible outcomes for the mother and fetus.

If alternative therapy cannot be chosen to replace therapy with drugs acting on the RAAS, the patient should be informed about the possible risk of therapy to the fetus. Periodic ultrasound examinations to assess the intra-amniotic space should be performed. If oligohydramnion is detected, Lorist® ND must be discontinued unless it is vital for the mother. Depending on the week of pregnancy, appropriate fetal tests should be performed. Patients and physicians should be aware that oligohydramnios may not be detected until irreversible fetal damage has occurred. Newborns whose mothers have taken Lorista® ND during pregnancy should be closely monitored to control arterial hypotension, oliguria and hyperkalemia.

Breastfeeding

The use of Lorista® ND is contraindicated during breast-feeding.

Hydrochlorothiazide penetrates into breast milk, therefore its use during breastfeeding is contraindicated. If the use of hydrochlorothiazide during lactation is absolutely necessary, breastfeeding should be stopped.

It is unknown whether losartan is excreted with breast milk. Since many drugs are excreted with breast milk and there is a risk of possible adverse effects in a breastfed baby, a decision should be made to stop breastfeeding or to discontinue Lorist® ND taking into account the need for its administration to the mother.

Similarities