Livazo 4 mg 28 pcs. film-coated tablets

An increase in blood cholesterol levels and the initial stage of atherosclerosis are direct indications for starting therapy. The basis of all medications used in the course of treatment are statins. They reduce the amount of cholesterol produced in the body and significantly improve the patient’s well-being.

One of these drugs is Livazo 2 mg. This medicine is also available in active ingredient quantities of 1 mg and 4 mg, and the specific dosage prescribed depends on the severity of the disease and is at the discretion of the attending physician.

Pharmacological properties

Pharmacodynamic parameters.
pitavastatin is a synthetic lipid-lowering agent that controls cholesterol (c) synthesis by competitively inhibiting the liver enzyme 3-hydroxy-3-methylglutaryl coenzyme a (hmg-coa) reductase. As a result, there is a compensatory increase in the expression of LDL receptors, which contributes to increased LDL catabolism. The structure of pitavastatin, different from other representatives of this group, determines its high affinity for HMG-CoA reductase and a pronounced effect on the level of LDL cholesterol and HDL cholesterol in the blood plasma.

Livazo reduces elevated levels of LDL cholesterol, total cholesterol, TG, apolipoprotein (Apo) B, as well as the TG/HDL and Apo-B/Apo-A1 ratio and increases the content of HDL cholesterol and Apo-A1.

The magnitude of the reduction in LDL cholesterol levels with pitavastatin (2 and 4 mg) is comparable to that with atorvastatin (10 and 20 mg) and simvastatin (20 and 40 mg).

Pitavastatin also increases the plasma level of adiponectin, a protein that has anti-atherosclerotic and anti-inflammatory properties, promotes regression of atherosclerotic plaque (by about 17%).

Pharmacokinetic parameters. Absorption of pitavastatin occurs primarily in the small intestine. Eating does not affect this process. Bioavailability is 51%; time to reach Cmax in blood plasma - 1 hour.

More than 99% of pitavastatin is bound to plasma proteins, mainly albumin and α1-acid glycoprotein.

Pitavastatin is primarily metabolized in the liver. It undergoes glucuronidation by uridine 5-diphosphate glucuronyltransferases (UGT1A3 and UGT2B7) to form the major circulating metabolite, pitavastatin lactone.

The cytochrome P450 system is practically not involved in the metabolism of pitavastatin. The effect is exerted by CYP 2C9 and to a lesser extent by CYP 2C8.

T½ from blood plasma at steady state is almost 9 hours.

It is excreted from the body mainly in feces (79%) and 15% in urine.

The AUC of pitavastatin increases in females, as well as in patients over 65 years of age, which does not affect the safety and effectiveness of the drug.

The content of pitavastatin in the blood plasma 1 hour after administration is dose dependent and has an inverse relationship with body weight, which may indicate higher concentrations of the substance in children.

In the study, the pharmacokinetic parameters of pitavastatin in healthy volunteers of different races (Mongoloids and Caucasians) were similar.

How the drug works

The active substance of the drug Livazo pitavastatin slows down the rate of production of HMG-CoA reductase, thereby reducing the amount of cholesterol produced by liver tissue. As a result, receptors that produce low-density lipoproteins in the liver are activated, and the amount of total cholesterol in the blood plasma decreases.

Pitavastatin is well absorbed by intestinal tissues, and its bioavailability is 51%. After taking a tablet in a dosage of 1, 2 or 4 mg, the maximum concentration of the substance in the blood plasma is observed after 60 minutes. The absorption efficiency of Livazo is not associated with food intake. According to medical statistics, when pitavastatin was taken orally and at the same time consumed fatty foods, the concentration of the substance in the blood decreased to 43%.

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Application

It is necessary to adhere to restrictions on the cholesterol content in the diet both before and during drug therapy.

Use exclusively per os without violating the integrity of the tablet. It is more appropriate in the evening, at the same time. Eating does not affect the effectiveness of the drug.

If it is impossible to swallow the tablet without compromising its integrity, it should be dissolved in water (1 glass) and drunk immediately. And then immediately drink the volume of water used to rinse the specified container.

As a rule, the starting dose of the drug is 1 mg once a day. When adjusting the dose, the interval between changes is ≥4 weeks. Dose selection is carried out on an individual basis and is determined by the content of LDL cholesterol in the blood, the clinical condition of the patient and the treatment regimen. The maximum daily dose is 4 mg.

In elderly patients, the dose is not adjusted.

Use with caution without dose adjustment in patients with mild renal failure.

In patients with mild to moderate renal impairment, pitavastatin is used at a dose of 4 mg exclusively against the background of scrupulous monitoring of renal function after a gradual dose increase.

Pitavastatin at a dose of 4 mg is not used in patients with severe renal impairment.

In patients with mild to moderate hepatic impairment, do not use pitavastatin at a dose of 4 mg. It is possible to use pitavastatin at a dose of 2 mg/day against the background of scrupulous monitoring of liver function indicators.

Children aged 6 years and adolescents with heterozygous familial hypercholesterolemia: initial dose - 1 mg/day. Maximum daily dose: children aged 6–9 years - 2 mg; ≥10 years - 4 mg.

Instructions for use

Therapy with statin drugs requires mandatory adherence to a diet with a reduced amount of plant-based fats in the diet. When using Livazo, preference should be given to plant foods, cereals, grains, vegetables and fruits.

It is necessary to give up table salt and sugar or reduce the amount of their consumption. Prohibited foods are fatty meats and fish, bread, carbonated drinks, baked goods, spicy, over-salted, smoked foods. The dosage of pitavastatin per day required for a particular patient is selected in accordance with the test results.

The patient buys Livazo at the pharmacy exclusively in the dose recommended by the attending doctor. Initially, the patient is prescribed tablets at a dosage of 1 mg, adjusting the recommendation over the next 4 weeks. Practice shows that for most people with elevated blood cholesterol levels, the best option is to take Livazo 2 mg once a day.

Contraindications

Hypersensitivity to the active substance or any of the auxiliary ingredients of the drug, as well as to other statins;

• severe liver dysfunction; active stage of liver pathology or a persistent increase of 3 values ​​of the upper limit of normal (ULN) of aminotransferase activity in the blood serum;

• myopathy;
• combined use with cyclosporine;

• pregnancy;

• breastfeeding period.

Analogues of the drug

If for some reason it is impossible to prescribe pitavastatin to a patient, you can select analogues of Livazo, which are also in the statin group:

• Crestor is a drug belonging to the statin group, based on the active substance rosuvastine (available in dosages of 10, 20 and 40 mg);
• Simvastatin – tablets based on simvastatin, available in the form of 10 and 20 mg dosages;
• Lescol is a drug whose active component is fluvastatin sodium. Sold in the form of capsules containing 21.06 and 42.12 mg of active ingredient;
• Lipobay - tablets consisting of cerivastatin sodium in a dose of 0.2 or 0.4 mg;
• Pravastatin – includes the same name (pravastatin) as the main substance;
• Liprimar is a product containing atorvastatin in dosages of 10, 20, 40 and 80 mg.

Preparations with a similar composition that can replace Livazo

Each of the listed drugs has its own contraindications and side effects, which is why you cannot independently replace Livazo with analogues. Only a specialist can evaluate the medications already taken by the patient, knows the medical history and examination results, and is able to recommend one or another substitute.

Side effects

Anemia; complete lack of appetite despite the body’s objective need for nutrition; insomnia; cephalalgia, dizziness, impaired taste perception, drowsiness, decreased sensitivity to irritants; decreased visual acuity; tinnitus; nausea, vomiting, dyspeptic symptoms, diarrhea, constipation, abdominal pain, xerostomia, glossodynia, acute pancreatitis, gastrointestinal discomfort; increased levels of aminotransferases, intrahepatic cholestasis, impaired liver function, liver pathology; rashes, itching, erythema, urticaria; muscle pain (the most common effect), joint pain, muscle spasms; myopathy (including immune-mediated necrotic), rhabdomyolysis; frequent urination; weakness, fatigue, malaise, peripheral edema.

There is also the possibility of developing negative effects inherent to the statin class.

Livazo 4 mg 28 pcs. film-coated tablets

pharmachologic effect

Pitavastatin is a competitive inhibitor of HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase.
an enzyme that catalyzes the initial stage of cholesterol synthesis - the formation of mevalonic acid from HMG-CoA. Since the conversion of HMG-CoA to mevalonic acid is the initial stage of cholesterol synthesis, the use of pitavastatin does not cause the accumulation of potentially toxic sterols in the body. HMG-CoA is easily metabolized to acetyl-CoA. which is involved in many synthesis processes in the body. Clinical studies have shown the effectiveness of Livazo in reducing the concentration of total cholesterol (OXC) in the blood plasma and low-density lipoprotein cholesterol (LDL-C). very low density lipoprotein cholesterol (VLDL cholesterol). triglycerides (TG) and apolipoprotein B (Apo-B). as well as increased concentrations of high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A1 (Apo-A1) (see Table 1). Table 1. Dose responses in patients with primary hypercholesterolemia (adjusted mean percent change from baseline)

*uncorrected

In controlled clinical studies involving 1687 patients with primary hypercholesterolemia and combined (mixed) dyslipidemia, including 1239 patients receiving therapeutic doses (average initial LDL cholesterol concentration of about 4.8 mmol/l), pitavastatin significantly reduced the concentration of LDL cholesterol and total cholesterol. non-HDL-C, TG and Apo-B and increased the concentration of HDL-C and Apo-A1. The ratios of TC/HDL cholesterol and Apo-B/Apo-A1 decreased.

The concentration of LDL cholesterol decreased by 18-39% when using Livazo at a dose of 2 mg and by 44-45% when using a dose of 4 mg. Most patients receiving a dose of 2 mg. achieved the LDL cholesterol treatment target according to the recommendations of the European Atherosclerosis Society (EAS) (

Composition and release form Livazo 4 mg 28 pcs. film-coated tablets

Tablets - 1 tablet:

• Active substance: pitavastatin calcium 4.18 mg, which corresponds to the content of pitavastatin 4 mg.
• Excipients: lactose monohydrate, low-substituted hyprolose, hypromellose, magnesium aluminometasilicate, magnesium stearate.
• Film shell composition: Opadry white, including hypromellose, titanium dioxide, triethyl acetate, colloidal silicon dioxide.

14 pcs. - blisters (2) - cardboard packs.

Description of the dosage form

Tablets, film-coated, white, round, biconvex, with a white core in cross section; on one side of the tablet there is an engraving “KC”, on the other there is an engraving “2”.

Directions for use and doses

Inside, tablets must be swallowed whole.

It is preferable to take the tablet at the same time of day, preferably in the evening, in accordance with the circadian rhythm of lipid metabolism. Before starting treatment and during the process, patients should adhere to a cholesterol-lowering diet.

The initial dose of the drug is 1 mg/day once. If necessary, the dose of the drug is increased at intervals of at least 4 weeks to 2 mg/day. The dose should be individualized based on LDL-C concentrations, the goal of treatment, and the patient's response to treatment. Most patients require a dose of 2 mg. The maximum daily dose is 1 mg.

Patients with mild to moderate liver dysfunction: A maximum daily dose of 2 mg is recommended.

Patients with impaired renal function: in case of mild renal impairment (it is advisable to objectively assess this degree by reflecting CC or glomerular filtration rate), Livazo should be used with caution. Data on the use of a maximum daily dose of 4 mg for renal impairment of any severity are limited, therefore, a maximum daily dose of 4 mg should be prescribed only with careful monitoring of renal function after a gradual dose increase. It is not recommended that patients with severe renal impairment be prescribed a maximum daily dose of 4 mg; It is recommended to consider limiting the maximum daily dose to 2 mg in severe renal impairment.

Elderly patients: no dose adjustment is required.

Pharmacokinetics

Suction

Pitavastatin is rapidly absorbed in the upper gastrointestinal tract, Cmax in blood plasma is achieved within 1 hour after taking the drug. Eating does not affect absorption. Cmax of pitavastatin in blood plasma decreases by 43% when taken together with fatty foods, but AUC remains unchanged. The unchanged drug undergoes enterohepatic circulation and is well absorbed from the jejunum and ileum. The absolute bioavailability of pitavastatin is 51%.

Distribution

More than 99% of pitavastatin is bound to plasma proteins, mainly albumin and alpha-1 acid glycoprotein. Average Vd 133 l. Pitavastatin actively penetrates into hepatocytes using the transport proteins OATP1B1 and OATP1B3. AUC varies within a 4-fold increase from minimum to maximum values. Pitavastatin is not a substrate for P-glycoprotein.

Metabolism

Plasma contains mainly unchanged pitavastatin. The main metabolite is an inactive lactone, which is formed from the ether-type pitavastatin glucuronide conjugate with the participation of UDP-glucuronosyltransferases (UGT1A3 and 2B7). Cytochrome P450 has a minimal effect on the metabolism of pitavastatin. The CYP2C9 isoenzyme (and to a lesser extent the CYP2C8 isoenzyme) is involved in the metabolism of pitavastatin to minor metabolites.

Removal

Pitavastatin, unchanged, is rapidly excreted from the liver with bile, but undergoes enterohepatic recirculation, which ensures its long-lasting effect. Less than 5% of pitavastatin is excreted by the kidneys. T1/2 from plasma varies from 5.7 hours (single dose) to 8.9 hours (at steady state), the average clearance is 43.4 l/h after a single oral dose.

Pharmacokinetics of different groups of patients

Elderly patients: In clinical studies of the pharmacokinetics of pitavastatin, it was shown that in elderly patients over 65 years of age, the AUC of pitavastatin was 1.3 times higher. This did not affect efficacy or safety.

Hepatic impairment: in patients with mild hepatic impairment (Child-Pyot class A), the AUC was 1.6 times higher than in healthy volunteers, while in patients with moderate hepatic impairment (Child-Pyot class B) the AUC was 1.6 times higher than in healthy volunteers. AUC was 3.9 times higher. In cases of severe liver dysfunction, the use of pitavastatin is contraindicated.

Renal failure: in patients with moderate renal failure and on hemodialysis, an increase in AUC was observed by 1.8 times and 1.7 times, respectively.

Gender differences: there was a 1.6-fold increase in AUC in women compared to men in a study of healthy volunteers, which did not in any way affect the effectiveness and safety of the drug Livazo.

Race: According to the results of pharmacokinetic analysis of data obtained from healthy volunteers of different races, factors such as gender and age did not affect the pharmacokinetics of pitavastatin.

Indications for use Livazo 4 mg 28 pcs. film-coated tablets

Primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (Fredrickson type IIa hyperlipidemia) or mixed hypercholesterolemia (Fredrickson type IIb hyperlipidemia), hypertriglyceridemia (Fredrickson type IV hyperlipidemia) as an adjunct to diet, when diet and other non-drug treatments ( for example, physical exercise, weight loss) are insufficient.

Contraindications

• Hypersensitivity to pitavastatin, auxiliary components of the drug and other HMG-CoA reductase inhibitors (statins);
• severe liver failure (more than 9 points on the Child-Pugh scale) or class C according to the Child-Pugh classification, liver disease and active phase, including a persistent increase in the activity of “liver” transaminases in the blood serum (more than 3 times compared with the upper limit norms (ULN));
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
• myopathy;
• simultaneous use of cyclosporine;
• pregnancy, breastfeeding, lack of adequate methods of contraception in women of childbearing age;
• age under 18 years (efficacy and safety have not been established).

Carefully

If there is a risk of developing myopathy/rhabdomyolysis - renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and previous history of muscle toxicity when using other HMG-CoA reductase inhibitors or fibrates, excessive alcohol consumption, age over 70 years, history of liver disease .

Application of Livazo 4 mg 28 pcs. film-coated tablets during pregnancy and breastfeeding

Pregnancy

The use of Livazo during pregnancy is contraindicated. Women of childbearing age should use reliable methods of contraception when treating Livazo. Because Since cholesterol and other products of cholesterol biosynthesis are necessary for fetal development, the potential risk of inhibition of HMG-CoA reductase outweighs the benefit of treatment with the drug during pregnancy. Animal studies have shown that pitavastatin has reproductive toxicity but no teratogenic potential. If the patient is planning a pregnancy, treatment should be discontinued at least one month before conception. If pregnancy occurs while using Livazo. treatment should be stopped immediately.

Breastfeeding period

The use of Livazo during breastfeeding is contraindicated. Pitavastatin is excreted in the milk of lactating rats. There are no data on the excretion of pitavastatin in breast milk. If it is necessary to use the drug Livazo during lactation, breastfeeding should be stopped.

Use in childhood

The use of the drug in patients under the age of 18 is prohibited (since the effectiveness and safety have not been established).

special instructions

Effect on muscle tissue

As with the use of other HMG-CoA reductase inhibitors (statins). there is a possibility of developing myalgia, myopathy and, in rare cases, rhabdomyolysis. Patients should be warned to report any muscle symptoms. CPK activity should be determined in any patient reporting muscle pain, muscle tenderness or weakness, especially if accompanied by malaise or fever.

CPK activity should not be determined after physical exercise or in the presence of any other possible reasons for the increase in CPK that may distort the result. If CPK activity increases (5 times higher than ULN), a control analysis should be performed within 5-7 days.

Before treatment

Like all statins, Livazo should be prescribed with caution to patients with predisposing factors for the development of rhabdomyolysis. CPK activity should be determined to establish a reference baseline value in the following cases:

• renal failure;
• hypothyroidism;
• personal or family history of hereditary muscle diseases;
• previous history of muscle toxicity during treatment with fibrates or other statins;
• a history of liver disease or alcohol abuse;
• elderly patients (over 70 years of age) with other predisposing risk factors for the development of rhabdomyolysis.

In such cases, clinical monitoring is recommended and the risk of treatment should be considered in relation to the potential benefit. Treatment with Livazo cannot be started if CK levels are 5 times higher than the ULN.

During the flow

The patient should be advised to immediately report muscle pain, weakness or cramps to the doctor. CPK activity should be determined, and treatment should be stopped if CPK activity is elevated (5 times the ULN). Consideration should be given to discontinuing treatment if severe muscle symptoms occur, even if CPK activity does not exceed 5 times the ULN. When symptoms resolve and CPK activity returns to normal, re-prescribing Livazo at a dose of 1 mg may be considered, subject to careful monitoring.

Effects on the liver

Like all statins, Livazo should be prescribed with caution to patients with a history of liver disease or to patients who regularly drink excessive amounts of alcohol. Before starting treatment with Livazo and then periodically during treatment, liver function tests should be performed. Patients with a persistent increase in the activity of “liver” transaminases (ALT and AST), exceeding ULN by 3 times, should stop treatment with Livazo.

Effects on the kidneys

Livazo should be administered with caution to patients with moderate or severe renal impairment. The dose should be increased only with careful monitoring. The 4 mg dose is not recommended for patients with severe renal impairment.

Diabetes

Some data suggests that. that statins, as a class, cause an increase in blood glucose concentrations and, in some patients at high risk of developing diabetes mellitus, can lead to a level of hyperglycemia at which appropriate diabetes treatment is necessary. However, this risk is offset by the reduction in vascular risk with statin treatment and should therefore not be a reason to discontinue statin treatment. Patients at risk of developing hyperglycemia (fasting glucose concentration from 5.6 to 6.9 mmopi/l, BMI>30 kg/m2, elevated TG concentrations, arterial hypertension) should be subjected to clinical and biochemical monitoring in accordance with national recommendations.

Interstitial lung disease

Rare cases of interstitial lung disease have been reported with the use of some drugs, especially with long-term therapy.

Observed clinical signs include shortness of breath, nonproductive cough, and deterioration in general health (fatigue, weight loss, and fever). If interstitial lung disease is suspected, statin therapy should be discontinued.

Impact on the ability to drive vehicles and maintain moving mechanisms

Caution must be exercised when driving vehicles or performing other work that requires increased attention, as undesirable reactions such as dizziness and drowsiness may develop.

Overdose

There is no specific treatment for overdose.

It is necessary to carry out symptomatic therapy, monitor CPK activity and liver function. Hemodialysis is ineffective.

Side effects of Livazo 4 mg 28 pcs. film-coated tablets

In controlled clinical studies, when taking recommended doses, less than 4% of patients treated with Lnvaso. was excluded from the study due to the development of adverse reactions. The most common was myapgia.

Depending on the frequency of occurrence, the following adverse reactions are distinguished in accordance with the WHO classification: very often: ≥10, often: from ≥1/100 to

From the hematopoietic organs: infrequently - anemia.

From the side of metabolism: infrequently - anorexia.

Mental disorders: often - insomnia.

From the nervous system: often - headache; infrequently - dizziness, taste disturbance, drowsiness.

From the senses: infrequently - ringing in the ears; rarely - decreased visual acuity.

From the skin: infrequently - itchy skin, soup; rarely - urticaria, erythema.

From the musculoskeletal system: often - myalgia, arthralgia; infrequently - muscle spasms.

From the urinary system: infrequently - pollakiuria.

From the digestive system: often - constipation, diarrhea, dyspepsia, nausea; infrequently - abdominal pain, dryness of the oral mucosa, vomiting; rarely - glossodynia, acute pancreatitis, cholestatic jaundice.

Laboratory indicators: infrequently - increased activity of liver transaminases AST, ALT, increased activity of creatine phosphokinase (CPK).

In clinical studies, after taking Livazo, an increase in CK activity was observed 3 times higher than the ULN in 49 patients out of 2800 (1.8%). Levels of 10 times or more ULN with associated muscle symptoms were rare and were observed in only one patient out of 2406 patients receiving 4 mg Livazo (0.04%) in the clinical trial program.

Other: infrequently - asthenia, malaise, increased fatigue, peripheral edema.

Post-marketing experience

A 2-year prospective post-marketing follow-up study was conducted on approximately 20,000 patients in Japan. The vast majority of these patients received pitavastatin 1 or 2 mg rather than 4 mg. In 10.4% of patients, adverse reactions were reported in which a causal relationship with pitavastatin cannot be excluded, and 7.4% of patients discontinued treatment due to the development of adverse reactions. The incidence of myalgia was 1.08%. Most adverse reactions were mild. Over a 2-year period, the incidence of adverse reactions was higher in patients with a history of drug allergies (20.4%) or liver or kidney disease (13.5%).

Adverse reactions and their incidence observed in a prospective post-marketing surveillance study, but not in international controlled clinical studies, with the use of the drug and recommended doses are listed below.

From the liver and biliary tract: rarely - impaired liver function.

From the musculoskeletal system: rarely - myopathy, rhabdomyolysis.

In the post-marketing surveillance study, there were two reports of rhabdomyolysis requiring hospitalization (0.01% of patients).

In addition, there are spontaneous reports of musculoskeletal effects, including myalgia and myopathy, in patients treated with Livazo at all recommended doses. There have also been reports of rhabdomyolysis with and without acute renal failure, including fatal rhabdomyolysis.

Spontaneous reports of the following adverse reactions have also been received (frequency based on incidence observed in post-marketing studies).

From the nervous system: infrequently - hypoesthesia.

From the digestive system: rarely - abdominal discomfort.

Adverse events when using other statins:

• sleep disturbances, including nightmares;
• amnesia;
• sexual dysfunction;
• depression;
• interetitial lung disease;
• diabetes mellitus: the incidence depends on the presence or absence of risk factors (fasting blood glucose concentration ≥5 mmol/l, BMI>30 kg/m2, elevated TG concentration, history of arterial hypertension);
• increase in glycosylated hemoglobin.

Drug interactions

Pitavastatin is actively transported into the human hepatocyte by numerous hepatic transporters (including organic anion transport polypeptide (OATP)), which may be involved in some of the following interactions.

Cyclosporine: Co-administration of a single dose of cyclosporine with pitavastatin at steady state results in a 4.6-fold increase in pitavastatin AUC unknown. Livazo is contraindicated in patients receiving treatment with cyclosporine.

Erythromycin: Concomitant administration of erythromycin with pitavastatin results in a 2.8-fold increase in the AUC of pitavastatin. It is recommended to temporarily discontinue taking pitavastatin during treatment with erythromycin or other macrolide antibiotics.

Gemfibrozole and other fibrates have rarely been associated with fibrate monotherapy with the development of myopathy. Concomitant use of fibrates with statins has been associated with an increased incidence of myopathy and rhabdomyolysis. Caution should be exercised when using pitavastatin concomitantly with fibrates. In pharmacokinetic studies, coadministration of pitavastatin with gemfibrozil resulted in a 1.4-fold increase in pitavastatin AUC and a 1.2-fold increase in fenofibrate AUC.

Nicotinic acid (at lipid-lowering doses): interaction studies have not been conducted during treatment with pitavastatin and nicotinic acid at lipid-lowering doses (more than 1 g/day). The use of nicotinic acid in monotherapy has been associated with the development of myopathy and rhabdomyolysis. Therefore, when used simultaneously with nicotinic acid in lipid-lowering doses (more than 1 g/day), Livazo should be prescribed with caution.

Fusidic acid: Severe muscle disorders, such as rhabdomyolysis, have been reported and have been attributed to an interaction between fusidic acid and statins. During treatment with fusidic acid, it is recommended to temporarily stop using Livazo.

Rifampicin: Coadministration with pitavastatin resulted in a 1.3-fold increase in pitavastatin AUC.

Ezetimibe and its glucuronide metabolite inhibits the absorption of dietary and biliary cholesterol. Concomitant use of pitavastatin had no effect on plasma concentrations of pitavastatin.

CYP3A4 inhibitors: Interaction studies with itraconazole and grapefruit juice, known inhibitors of the CYP3A4 isoenzyme, did not reveal a clinically significant interaction on plasma concentrations of pitavastatin.

Digoxin, a known P-glycoprotein (Pgp) substrate, does not interact with pitavastatin. When used together, there were no significant changes in plasma concentrations of pitavastatin or digoxin.

Warfarin: Steady-state pharmacokinetics and pharmacodynamics (INR and prothrombin time (PT)) of warfarin in healthy volunteers were not affected by coadministration of warfarin with pitavastatin 4 mg daily. However, as with other statins, PT and INR should be monitored in patients receiving warfarin when pitavastatin is added to treatment.

special instructions

The patient must immediately inform the doctor regarding any disorder of the muscular system that has arisen. in any case, with the development of muscle weakness, pain or soreness, especially against the background of increased body temperature or malaise, it is necessary to determine the level of creatine kinase in the blood.

Prescribed with caution to patients with a high risk of rhabdomyolysis.

Therapy is not started if creatinine clearance is 5 values ​​of ULN.

Stop therapy if the level of creatine kinase in the blood increases to 5 values ​​​​of the ULN, as well as if the level of creatine kinase in the blood is 5 values ​​\u200b\u200bof the ULN, but there are pronounced muscle disorders. In case of regression of symptoms and normalization of creatine kinase levels, it is possible to resume taking the drug (daily dose 1 mg) with careful monitoring of the patient's condition.

The use of pitavastatin is resumed 1 week after discontinuation of fusidic acid. As an exception, if long-term use of fusidic acid is necessary after a thorough analysis, combined use with pitavastatin is possible against the background of careful medical monitoring of the patient's condition.

Prescribe with caution to patients with liver pathology or alcohol abuse.

Monitoring of liver function is required before and during pitavastatin therapy.

Therapy is canceled in the case of a persistent increase in the activity of aminotransferases in the blood plasma of 3 values ​​of ULN.

Prescribe with caution to patients with moderate and severe renal impairment. The dose is increased gradually and exclusively against the background of scrupulous monitoring of renal function. Pitavastatin 4 mg is not used in patients with severe renal impairment.

Monitoring of the clinical condition and biochemical parameters is required in patients who have an increased likelihood of hyperglycemia.

If the patient is suspected of having diffuse parenchymal lung disease, it is necessary to discontinue treatment with the drug.

Due to the lactose content in Livazo tablets, the drug should not be taken by patients with galactosemia, Lapp lactase deficiency or glucose-galactose malabsorption syndrome.

Do not use in pregnant women or during breastfeeding.

There is currently no information on the effect on fertility.

While taking Livazo, you should avoid driving vehicles or operating other machinery.

Therapy for patients aged 6–18 years is carried out exclusively under the supervision of a specialist with experience in the treatment of such lipid metabolism disorders and with constant monitoring of the patient’s condition.

Girls and women of childbearing age should follow contraceptive measures while using Livazo.

The safety and effectiveness of Livazo have not been studied in children under 6 years of age.

Reviews

It should be noted that the majority of patients who were prescribed the drug Livazo, and doctors who work with these tablets, leave only positive reviews. Doctors prescribe pitavastatin due to the quickly onset effect of administration and the good tolerability of Livazo in most patients. Naturally, before prescribing tablets, a complete examination is necessary, and during therapy, monitoring of body functions and blood counts is necessary.

Svetlana, 54 years old: When the doctor prescribed me Livazo 2 mg tablets, I started reading information about them on medical websites. I was afraid of a lot of side effects. But in fact, my body tolerated the pills well, especially since I need to take them once a day. At the same time, I followed a diet that I still maintain today. After 2 months, my blood cholesterol levels dropped and I began to feel much better.

Olga, 48 years old: Livazo tablets were prescribed to me by my doctor after my blood cholesterol rose sharply due to excess weight. At the same time, I was prescribed therapeutic exercise sessions, a diet and walks in the evenings. Now I try to eat healthy food, provide myself with physical activity, and take Livazo 2 mg once a day. The last time I took tests, the doctor said that there were significant improvements.

Vasily, 56 years old: I really like Livazo, it gives results within a month. You feel much better, and the doctor says that tests confirm progress in therapy. One disadvantage of the tablets is their high cost for me. But my sister, who lives in Germany, says that Livazo is a very effective drug; it has been widespread among them for 10–15 years. Therefore, I follow the doctor’s orders; health is still more expensive than pills.

Interactions

Do not combine with cyclosporine.

In the case of using macrolide antibiotics, as well as fusidic acid, Livazo therapy should be discontinued for this period.

Use with caution in combination with vitamin B3 and fibric acid derivatives.

The AUC of pitavastatin increases when used concomitantly with rifampicin and changes slightly when combined with protease inhibitors.

In case of combined use with warfarin, monitoring of the hemostatic system (prothrombin time or INR) is required.

There is no interaction with the P-glycoprotein substrate digoxin and no clinically significant changes in the content of pitavastatin in the blood plasma when combined with CYP3A4 inhibitors.

Cross interaction

During the period of use of pitavastatin, it is necessary to take into account the use of drugs that were previously recommended to the patient to eliminate signs of concomitant diseases. Below is a list of pharmacological groups with which you must be careful when interacting with Livazo:

• Cyclosporine - simultaneous use of statins is prohibited due to a sharp increase in AUC;
• Erythromycin and other macrolide antibiotics give the same reaction as taking statins while taking Cyclosporine, so they cannot be used;
• fibrates – simultaneous therapy with statins leads to the development of myopathy and rhabdomyolysis with severe muscle damage (requires selection of the correct dose and caution);
• Niacin and fusidic acid also lead to the formation of gross disorders of muscle tissue;
• Rifampicin and protease inhibitors - reduce the absorption of pitavastatin by liver tissue;
• Warfarin - when taken simultaneously with Livazo 4 mg, monitoring of prothrombin time is necessary.

Drugs such as Digoxin, inhibitors of CYP3A4, OATP1B1 do not affect the concentration of pitavastatin in the blood, so their use simultaneously with Livazo is allowed by doctors.

Note!

Description of the drug Livazo table. p/o 4 mg No. 30 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.