Lortenza coated pills 10mg + 100mg N30
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Active ingredients
Amlodipine + Losartan
Release form
Pills
Composition
1 tablet contains: amlodipine besylate (amlodipine besylate) 13.88 mg, equivalent to amlodipine - 10 mg; Losartan A substance (granules) 327.1 mg, contains losartan potassium - 100 mg. Adjuvants: Cellactose 80 (lactose monohydrate - 75%, cellulose - 25%) - 72.9 mg; MCC - 206.02 mg; pregelatinized starch - 54 mg; sodium carboxymethyl starch - 22 mg; iron dye yellow oxide (E172) - 0.4 mg; colloidal silicon dioxide - 2.1 mg; magnesium stearate - 6.6 mg. Coil: Opadry II white (polyvinyl alcohol - 40%, titanium dioxide (E171) - 25%, macrogol - 20.2%, talc - 14.8%) - 29 mg; iron dye yellow oxide (E172) - 1 mg.
Pharmacological effect
Pharmacological action - antihypertensive.
Indications
Arterial hypertension in patients for whom combination therapy is indicated.
Contraindications
hypersensitivity to the active components and / or auxiliary components of the drug; pregnancy and breastfeeding period (see “Use during pregnancy and lactation”); severe hepatic failure (more than 9 points on the Child-Pugh scale); hemodynamically marked aortic stenosis; shock; age up to 18 years (efficacy and safety not established); severe arterial hypotension.
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy, and its reception should be immediately discontinued when pregnancy is established. Toxic and lethal effects on the body of the fetus and newborn AmlodipinLS, directly affecting the RAAS, can cause damage and death to the fetus and newborn when prescribed to pregnant women.Single cases of use of ACE inhibitors during pregnancy are described. The use of drugs that directly affect the RAAS in the second and third trimesters of pregnancy is associated with such injuries of the fetus and newborn as arterial hypotension, neonatal hypoplasia of the skull bones, anuria, reversible and irreversible renal failure, and death. Also reported cases of oligohydramnios, presumably developed as a result of reduced kidney function in the fetus. In these cases, oligohydramnios was associated with contractures of the extremities, craniofacial deformities, and hypoplasia of the fetal lungs. In addition, there were cases of premature birth, intrauterine growth retardation and non-closure of the ductus arteriosus, however, no connection with the effect of the drug was found in these cases. These side effects, apparently, are not the result of the use of the drug in the first trimester of pregnancy. However, pregnant women who took ARA drugs in the first trimester should be informed about the consequences of taking these drugs in the second and third trimesters. Depending on the duration of pregnancy, a stress test for uterine contractions, stress-free tests or an assessment of the biophysical profile of the fetus can be applied. . At the same time, both the doctor and the patient should be aware that oligohydramnios may appear after the development of irreversible damage to the fetus. Children who have undergone in utero history of exposure to ARA drugs should be under medical supervision because of the increased likelihood of arterial hypotension, oliguria, and hyperkalemia. In the case of oliguria, the correction of blood pressure and renal perfusion is necessary first. Exchange hemotransfusion or hemodialysis is necessary for correcting hypotension and / or as a replacement for kidney function. Losartan Using RAAS drugs in the second and third trimesters of pregnancy can cause serious damage or even death to a developing fetus, therefore, when setting pregnancy, taking Losartan should be immediately discontinued Since the renal perfusion of the fetus, which depends on the RAAS, develops from the second trimester of pregnancy; the risk to the fetus increases when taking losartan in the II or III trimesters. It is not known whether amlodipine and / or losartan are excreted into breast milk,but in preclinical studies in animals, significant concentrations of amlodipine and / or an active metabolite of losartan in breast milk were noted. Not recommended for use during breastfeeding.
Dosage and administration
Inside, 1 time / day, regardless of the time of reception, write, drank a small amount of water. The recommended dose of the drug Lortenza - 1 tab. / Day. Lortenza drug at a dose of 5 mg + 50 mg is prescribed to patients who have not achieved adequate blood pressure control when using amlodipine at a dose of 5 mg or losartan at a dose of 50 mg in monotherapy. Lortenza drug at a dose of 5 mg + 100 mg is prescribed to patients who have not achieved adequate control of blood pressure when using losartan at a dose of 100 mg or Lawtenza at a dose of 5 mg + 50 mg. Lortenza drug at a dose of 10 mg + 50 mg is prescribed to patients who have not achieved adequate blood pressure control when using amlodipine at a dose of 10 mg or Lortenza drug at a dose of 5 mg + 50 mg. Lortenza drug at a dose of 10 mg + 100 mg is prescribed to patients who have not achieved adequate blood pressure control with Lortenza at a dose of 5 mg + 100 mg or 10 mg + 50 mg. The dose is selected after the previously conducted titration of doses of individual components of the drug. If you need to change the dose of one of the active ingredients in the composition of a fixed combination drug (for example, due to a newly diagnosed disease, a change in the patient’s condition or drug interactions), an individual selection of doses of individual components is necessary. The maximum daily dose is 10 mg + 100 mg. Patients taking losartan and amlodipine at the same time can be transferred to the drug Lortenza containing losartan and amlodipine in the same doses. In patients with impaired renal function with QC from 50 to 20 ml / min, dose adjustment is not required. Lortenza is contraindicated in patients with CC less than 20 ml / min and in patients on hemodialysis. In patients with impaired liver function (less than 9 points on the Child-Pugh scale) in history, lower doses of losartan are recommended. In connection with the lack of a dosage of drug Lortenza containing 25 mg of losartan, this dose should be prescribed in losartan monotherapy. Use of the drug Lortenza is possible in patients with impaired liver function (less than 9 points on the Child-Pugh scale), who are recommended by the doctor to use losartan in a dose of 50 mg. In patients with reduced BCC (for example, due to treatment with high doses of diuretics, etc.), the initial dose of losartan should be reduced to 25 mg 1 time / day.In connection with the lack of a dosage of drug Lortenza containing 25 mg of losartan, this dose should be prescribed in losartan monotherapy. Before using the drug Lortenza, it is necessary to restore the BCC and the sodium content in the blood plasma. Elderly patients do not require dose adjustment of Loretenza, however, it is necessary to increase the dose carefully. Lawtenza should not be prescribed to children and adolescents under the age of 18, because There are no data on the efficacy and safety of use in this group of patients.
Side effects
Side effects (PE), observed during the study of the drug, are presented in accordance with the WHO classification of the frequency of occurrence: very often (more than 1/10); often (more than 1/100, less than 1/10); infrequently (more than 1/1000, less than 1/100); rarely (more than 1/10000, less than 1/1000) and very rarely (less than 1/10000), including individual messages; frequency is unknown (it is impossible to estimate the frequency according to the available data). From the nervous system: often - dizziness, headache; infrequently - drowsiness. General disorders and disorders at the injection site: infrequently - asthenia, discomfort or pain in the chest, feeling of fullness in the abdomen, peripheral edema. On the part of the skin and subcutaneous tissues: infrequently - pruritus, urticaria. On the CVS side: infrequently - palpitations, rush of blood to the skin of the face, orthostatic hypotension. On the side of the respiratory system, chest organs and mediastinum: rarely - shortness of breath. with luha and labyrinth disorders: infrequently - systemic dizziness. From the kidneys and urinary tract: infrequently - increased frequency of urination. PE, noted when taking components (amlodipine and losartan), can also serve as its potential PE, despite the fact that PE data were not noted in clinical trials and in the post-registration period of the drug use. Amlodipine For the CNS: often - headache (especially at the beginning of treatment), dizziness, fatigue, drowsiness; infrequently - general malaise, hyperesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, unusual dreams, hyperexcitability, anxiety; very rarely - migraine, apathy, agitation, ataxia, amnesia,asthenia, increased sweating. On the mental side: infrequently - mood lability, depression. On the part of the digestive system: often - nausea, abdominal pain; infrequently - vomiting, constipation or diarrhea, flatulence, dyspepsia, anorexia, dryness of the oral mucosa, thirst; rarely - gingival hyperplasia, increased appetite; very rarely - pancreatitis, gastritis, jaundice (due to cholestasis), hyperbilirubinemia, increased activity of hepatic transaminases, hepatitis. For CVS: often - a sensation of heartbeat; infrequently - excessive decrease in blood pressure; very rarely, fainting, shortness of breath, vasculitis, orthostatic hypotension, development or aggravation of chronic heart failure, heart rhythm disturbances (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, pulmonary edema, lower extremity edema. side of the hematopoietic and lymphatic systems: very rarely - thrombocytopenic purpura, leukopenia, thrombocytopenia. From the urinary system: infrequently - frequent urination, painful urination, nits ria; very rarely - dysuria, polyuria. From the genitals and mammary gland: infrequently - gynecomastia, impotence. From the respiratory system: infrequently - shortness of breath, rhinitis; very rarely - cough. From the musculoskeletal system: infrequently - muscle cramps, myalgia, arthralgia, back pain, arthrosis; rarely - myasthenia. From the skin: often - rush of blood to the skin of the face; rarely - exfoliative dermatitis, Stevens-Johnson syndrome; very rarely - alopecia, xeroderma, cold sweat, impaired skin pigmentation. Allergic reactions: very rarely - pruritus, rash (including erythematous, maculopapular, urticaria), angioedema, erythema multiforme, photosensitivity reactions. On the part of the senses : infrequently - tinnitus, diplopia, disturbance of accommodation, xerophthalmia, conjunctivitis, pain in the eyes; very rarely - parosmia. Metabolism: very rarely - hyperglycemia. Others: infrequently - weight loss, weight gain, nosebleeds. Lozartan CNS side effects: often - dizziness, asthenia, headache, fatigue, increased weakness, insomnia; infrequently - cerebrovascular accident, sleep disorders, drowsiness, memory disorder,peripheral neuropathy, paresthesia, hyperesthesia, tremor, ataxia, systemic dizziness, memory impairment, migraine, nervousness. General disorders and disorders at the injection site: edema of the face, fever, asthenia, increased weakness. For the gastrointestinal tract: often nausea, diarrhea, dyspepsia , abdominal pain; infrequently - anorexia, a violation of taste, constipation, toothache, dry mouth, flatulence, gastritis, hepatitis, abnormal liver function, pancreatitis. On the side of the skin and subcutaneous tissues: rarely - alopecia, dry skin, skin rash, redness of the skin, Schonlein purpura Genoha, photosensitization, pruritus, increased sweating. Allergic reactions: infrequently - urticaria, angioedema. On the cardiovascular system: infrequently - myocardial infarction, angina pectoris, arrhythmias (atrial fibrillation, sinus bradycardia, tachycardia, tachycardia, tachycardia, tachycardia, tachycardia, tachycardia, rhythm disorders ventricular fibrillation), palpitations, orthostatic hypotension, syncope, arterial hypotension, vasculitis. From the blood and lymphatic system: infrequently - anemia; rarely - thrombocytopenia. On the part of the respiratory system, chest and mediastinal organs: often - shortness of breath, bronchitis, dry cough, discomfort in the throat, nasal bleeding, rhinitis, laryngitis, chest pain. On the part of the organ of hearing and labyrinth disorders: infrequently - ringing in the ears. From the side of the kidneys and urinary tract: infrequently - violation of the frequency of urination, nocturia, urinary tract infection; very rarely - renal failure. Psychiatric disorders: infrequently - anxiety, anxiety disorder, confusion, depression, unusual dreams, panic disorder. On the part of the organ of vision: infrequently - blurred vision, burning / injection in the eye, conjunctivitis, visual acuity. On the part of the genital organs and the mammary gland: infrequently - decreased libido, impotence. On the part of metabolism and nutrition: infrequently - gout. On the part of musculoskeletal and connective tissue: often - convulsions, musculoskeletal pain, apne archery of joints, stiffness of joints; infrequently - arthralgia, arthritis, fibromyalgia; rarely - rhabdomyolysis.
Interaction with other drugs
The antihypertensive effect can be amplified when used simultaneously with other antihypertensive drugs, so the simultaneous appointment of various antihypertensive drugs should be justified. Amlodipine Can be safely used for the treatment of arterial hypertension along with thiazide diuretics, α-adrenergic blockers or ACE inhibitors.Unlike other BPCs, clinically significant interaction of amlodipine (III generation BPC) was not found when used together with NSAIDs, incl. with indomethacin. It is possible to enhance the hypotensive effect of BPC when used together with thiazide and loop diuretics, ACE inhibitors and nitrates, as well as enhancing their hypotensive action when used together with α1-adrenergic blockers, neuroleptics. Combined use of amlodipine with CYP3A4 inhibitors requires careful monitoring of the symptoms of hypotension and peripheral drugs. With the simultaneous appointment of diltiazem at a dose of 180 mg per day and amlodipine at a dose of 5 mg per day in elderly patients, systemic exposure to amlodipine is increased by 60%. When used together, erythromycin increases amlodipine Cmax in young patients by 22% and in elderly by 50%. At the same time, strong inhibitors of CYP3A4 (ketoconazole, itraconazole, ritonavir) can increase the concentration of amlodipine in plasma to an even greater degree. Despite the fact that an accurate quantitative assessment of the interaction of amlodipine and CYP3A4 inducers (for example rifampicin, St. John's wort) is not obtained, the background joint use is recommended continuous monitoring of blood pressure. β-adrenergic blockers with simultaneous administration with amlodipine can cause an exacerbation of the course of heart failure. While studying amlodipine, a negative inotropic effect is usually not observed, however some BPCs can increase the severity of the negative inotropic effect of antiarrhythmic agents causing prolongation of the QT interval (for example, amiodarone and quinidine) A single dose of 100 mg of sildenafil in patients with arterial hypertension does not affect the parameters of amlodipine pharmacokinetics. Repeated The use of amlodipine at a dose of 10 mg and atorvastatin at a dose of 80 mg is not accompanied by significant changes in the pharmacokinetics of atorvastatin. Ethanol (drinks containing alcohol): amlodipine with a single and repeated use at a dose of 10 mg does not affect the pharmacokinetics of ethanol. Neuroleptics and isoflurane: strengthening hypotension actions of dihydropyridine derivatives. With intravenous dantrolene administration during treatment with amlodipine, collapse, arrhythmias, a decrease in heart rate and hyperkalemia can occur. s effect BKK.Pri joint application of amlodipine with preparations of lithium may be increased neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor,tinnitus). Amlodipine does not alter the pharmacokinetics of cyclosporine. It does not affect the serum concentration of digoxin and its renal clearance. It does not significantly affect the effect of warfarin (PT). Cimetidine does not affect the pharmacokinetics of amlodipine. In in vitro studies, amlodipine does not affect on binding to plasma proteins of digoxin, phenytoin, warfarin and indomethacin. Grapefruit juice: simultaneous single dose of 240 mg of grapefruit juice and 10 mg of amlodipine orally is not accompanied by a significant change in pharmac kinetics of amlodipine. Aluminum- or magnesium-containing antacids: their single dose does not significantly affect the amlodipine pharmacokinetics. and potassium-containing salt substitutes, can lead to an increase in the content of potassium in the blood serum. In some patients with impaired renal function who have been treated with NSAIDs, including selective COX-2 inhibitors, co-administration of ACE inhibitors and / or ARA drugs, including losartan, may cause further deterioration of renal function up to the development of acute renal failure. Usually this effect is reversible. NSAIDs, including selective COX-2 inhibitors, can reduce the effect of angiotensin II receptor blockers, including losartan. Therefore, the hypotensive effect of angiotensin II receptor antagonists may be weakened with simultaneous use of NSAIDs, in particular selective COX-2 inhibitors. Thus, the simultaneous use of the drug with NSAIDs should be carried out with caution in patients with impaired renal function. Double RAAS blockade: it has been found that patients with atherosclerosis, heart failure or diabetes with target organ damage have a double RAAS blockade (simultaneous use of ACE inhibitors and drugs ARA) is associated with more frequent complications of therapy in the form of arterial hypotension, syncope, hyperkalemia, and renal dysfunction (including acute renal failure) n compared to a monotherapy each drug.In this regard, the combined treatment with ACE inhibitors and ARA drugs requires an individualized approach and constant monitoring of the functional activity of the kidneys. Pharmacokinetically significant drug interactions with drugs such as hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital have not been noted. Receive rifampin, an inducer of drug metabolism, concentrations of losartan and its active metabolite. In humans, 2 inhibitors have been studied, CYP3A4 isoenzyme. Ketoconazole has no effect on the biotransformation of losartan is administered in / to an active metabolite, and erythromycin has no clinically significant effect on the pharmacokinetics of losartan when receiving vnutr.Flukonazol inhibitor isoenzyme CYP2C9, reduces the concentration of the active metabolite of losartan and increases the concentration in blood plasma, however pharmacodynamic significance of the combined use of losartan and CYP2C9 isoenzyme inhibitors has not been established. It has been shown that persons whose body does not convert losartan into an active metabolite have a very rare and specific defect of the isoenzyme CYP2C9. These data suggest that the biotransformation of losartan to the active metabolite is mediated predominantly by the CYP2C9 isoenzyme, and not CYP3A4.