Livazo tablets p / o 1mg, No. 28

Primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (Fredrickson's type IIa hyperlipidemia) or mixed hypercholesterolemia (Fredrickson's type IIb hyperlipidemia), hypertriglyceridemia (Fredrickson's type IV hyperlipidemia and other treatments for dietary supplementation) e.g. exercise, weight loss) are insufficient.

Inside, the tablets must be swallowed whole.
It is preferable to take the pill at the same time of day, preferably in the evening, in accordance with the circadian rhythm of lipid metabolism. Before and during treatment, patients should adhere to a cholesterol-lowering diet.
The initial dose of the drug is 1 mg per day, once. If necessary, the dose of the drug is increased at intervals of at least 4 weeks to 2 mg per day. The dose should be selected individually according to the LDL-C concentration, the goal of treatment and the patient's response to treatment. Most patients require a 2 mg dose. The maximum daily dose is 4 mg.
Patients with mild to moderate hepatic impairment: a maximum daily dose of 2 mg is recommended.
Patients with impaired renal function:in case of impaired renal function of mild severity (it is desirable to objectively assess this degree with reflection of creatinine clearance or glomerular filtration rate), the drug 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, it is necessary to prescribe a maximum daily dose of 4 mg only with careful monitoring of renal function after a gradual increase in the dose. It is not recommended for patients with severe renal impairment to prescribe 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: dose adjustment is not required.

Active ingredient: Pitavastatin calcium - 1.045 mg, which corresponds to the content of Pitavastatin - 1 mg.

Excipients : lactose monohydrate - 63.085 mg, low-substituted hyprolose - 12.54 mg, hypromellose - 1.33 mg, magnesium aluminometasilicate - 1.6 mg, magnesium stearate - 0.4 mg.

The composition of the film shell: Opadrai white - 3 mg (hypromellose - 1.98 mg, titanium dioxide - 0.8 mg, triethyl acetate - 0.2 mg, colloidal silicon dioxide - 0.02 mg).

• Hypersensitivity to pitavastatin, auxiliary components of the drug and other inhibitors of HMG-CoA reductase (statins).

• Severe liver failure (more than 9 points on the Child-Pugh scale) or class C according to the Child-Pugh classification, liver diseases in the active phase, including a persistent increase in the activity of 'hepatic' transaminases in the blood serum (more than 3 times compared to the upper limit norms (VGN)).

• Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

• Myopathy.

• Simultaneous administration of cyclosporine.

• Pregnancy, breastfeeding period, lack of adequate contraceptive methods in women of childbearing age.

• Age up to 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 a previous history of muscle toxicity with the use of other HMG-CoA reductase inhibitors or fibrates, a history of liver disease or alcohol abuse, age over 70 years ...

Trade name:

Livazo

International non-proprietary name:

pitavastatin

Dosage form:

film-coated tablets

Composition for one tablet:

Active ingredient: Pitavastatin calcium - 1.045 mg, which corresponds to the content of Pitavastatin - 1 mg.

Excipients : lactose monohydrate - 63.085 mg, low-substituted hyprolose - 12.54 mg, hypromellose - 1.33 mg, magnesium aluminometasilicate - 1.6 mg, magnesium stearate - 0.4 mg.

The composition of the film shell: Opadrai white - 3 mg (hypromellose - 1.98 mg, titanium dioxide - 0.8 mg, triethyl acetate - 0.2 mg, colloidal silicon dioxide - 0.02 mg).

Pharmacotherapeutic group:

hypolipidemic agent - HMG-CoA reductase inhibitor.

ATX code:

S10AA08

Pharmacological properties

Pharmacodynamics
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 into 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 readily metabolized to acetyl-CoA, which is involved in many synthesis processes in the body. Livazo has been proven to be effective in reducing the concentration of total cholesterol (TC) in the blood plasma, low-density lipoprotein cholesterol (LDL cholesterol), very low-density lipoprotein cholesterol (VLDL cholesterol), triglycerides (TG) and apolipoprotein B (Apo-B),as well as increasing the concentration of high density lipoprotein cholesterol (HDL cholesterol) and apolipoprotein A1 (Apo-A1)

In the treatment of primary hypercholesterolemia and combined (mixed) dyslipidemia, with the appointment of therapeutic doses, pitavastatin significantly reduced the concentration of LDL cholesterol, TC, non-HDL cholesterol, TG and Apo-B and increased the concentration of HDL cholesterol and Apo-A1. The ratio of total cholesterol / HDL cholesterol and Apo-B / Apo-A1 decreased. When using Livazo at a dose of 2 mg, a decrease in the concentration of LDL cholesterol was achieved by 38-39%, and by 44-45% - when using a dose of 4 mg. In most cases, with the appointment of a dose of 2 mg, the target value for the treatment of LDL cholesterol was achieved according to the recommendations of the European Atherosclerosis Society (EAS).
In the treatment of patients of the older age group with primary hypercholesterolemia and mixed dyslipidemia (?65 years), with the administration of a dose of Livazo 1 mg, 2 mg or 4 mg, LDL cholesterol values ??decreased by 31%, 39.0% and 44.3%, respectively, the target level , established by EAS, was achieved in 90% of patients.
When treating patients with primary hypercholesterolemia or mixed dyslipidemia in combination with 2 or more cardiovascular risk factors, or mixed dyslipidemia in combination with type 2 diabetes, about 80% of patients achieved the EAS LDL-C targets. The level of LDL cholesterol in these groups of patients decreased by 44% and 41%, respectively.
With long-term use of Livazo, the target value set by the EAS was maintained due to a constant stable decrease in the concentration of LDL cholesterol (-30.5%), and the concentration of HDL cholesterol increased sequentially, with a large increase in the concentration of HDL cholesterol in patients with initially lower values ??of this indicator ( <40 mg / dl), from 11.9% after 3 months to 28.9% after 5 years.
Atherosclerosis
In the treatment of patients who underwent percutaneous coronary intervention for acute coronary syndrome under the control of intravascular ultrasound, the administration of pitavastatin at a dose of 4 mg for 8-12 months led to a decrease in the volume of coronary plaques by about 17% and was accompanied by the reverse development of vascular wall remodeling ( from 113.0 to 105.4 mm?).
The beneficial effects on mortality and morbidity have not yet been assessed.
Diabetes mellitus
In patients with hyperlipidemia and impaired glucose tolerance, when Livazo was prescribed in doses of 1 mg / day or 2 mg / day, in addition to recommendations for lifestyle changes, newly diagnosed diabetes mellitus developed less frequently than in patients who did not receive lipid-lowering therapy: 39.9% versus 45.7% over a period of 2.8 years, the risk ratio was 0.82.
Data from a meta-analysis of the safety of pitavastatin in relation to the risk of developing diabetes mellitus demonstrated a neutral effect of Livazo on the risk of developing new cases of diabetes mellitus compared with therapy with other statins.

Pharmacokinetics
Absorption
Pitavastatin is rapidly absorbed in the upper gastrointestinal tract (GIT), the maximum concentration (Cmax) in blood plasma is reached within 1 hour after taking the drug. Food intake does not affect absorption. Cmax of pitavastatin in blood plasma decreases by 43% when taken together with a fat beggar, but the area under the concentration-time pharmacokinetic curve (AUC) remains unchanged. The unchanged drug undergoes enterohepatic recirculation and is well absorbed from the jejunum and ileum. The absolute bioavailability of pitavastatin is 51%.
Distribution
More than 99% of pitavastatin binds to blood plasma proteins, mainly albumin and alpha-1 acid glycoprotein. The average volume of distribution is 133 liters. Pitavastatin actively penetrates into hepatocytes with the help of transport proteins OATP1B1 and OATP1B3. AUC varies within a 4-fold increase from minimum to maximum value. Pitavastatin is not a substrate for P-glycoprotein.
Metabolism
Plasma contains mainly unchanged pitavastatin. The main metabolite is inactive lactone, which is formed from the ester-type pitavastatin glucuronide conjugate with the participation of UDP-glucuronosyltransferases (UGT1A3 and 2B7). Cytochrome P450 has a minimal effect on pitavastatin metabolism. CYP2C9 isoenzyme (and to a lesser extent CYP2C8 isoenzyme) are involved in the metabolism of pitavastatin to minor metabolites.
Withdrawal
Pitavastatin in unchanged form is rapidly excreted from the liver with bile, but undergoes intestinal-hepatic recirculation, which ensures its long-term effect. Less than 5% of Pitavastatin is excreted by the kidneys. The plasma half-life varies from 5.7 hours (single dose) to 8.9 hours (at steady state), the average clearance is 43.4 L / hour after a single oral dose.

Pharmacokinetics in different groups of patients
Elderly patients: when assessing the pharmacokinetics of pitavastatin in elderly patients over 65 years of age, the AUC of pitavastatin was 1.3 times higher. This did not affect efficacy or safety.
Liver failure: in patients with mild liver dysfunction (Child-Pugh class A) AUC was 1.6 times higher than in healthy volunteers, while in patients with moderate hepatic dysfunction (Child-Pugh class B) Pugh) AUC was 3.9 times higher. In case of severe liver dysfunction, the use of pitavastatin is contraindicated.
Renal failure: in patients with moderate renal failure and on hemodialysis, there was an increase in AUC of 1.8 times and 1.7 times, respectively.
Sex differences: there was an increase in AUC in women compared with men by 1.6 times in a study of healthy volunteers, which did not affect the efficacy and safety of Livazo.
Race: according to the results of pharmacokinetic analysis of data obtained from healthy volunteers of different races (Japanese and Caucasian populations), factors such as gender and age did not affect the pharmacokinetics of pitavastatin.

Indications for use

Primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (Fredrickson's type IIa hyperlipidemia) or mixed hypercholesterolemia (Fredrickson's type IIb hyperlipidemia), hypertriglyceridemia (Fredrickson's type IV hyperlipidemia and other treatments for dietary supplementation) e.g. exercise, weight loss) are insufficient.

Contraindications

• Hypersensitivity to pitavastatin, auxiliary components of the drug and other inhibitors of HMG-CoA reductase (statins).

• Severe liver failure (more than 9 points on the Child-Pugh scale) or class C according to the Child-Pugh classification, liver diseases in the active phase, including a persistent increase in the activity of 'hepatic' transaminases in the blood serum (more than 3 times compared to the upper limit norms (VGN)).

• Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

• Myopathy.

• Simultaneous administration of cyclosporine.

• Pregnancy, breastfeeding period, lack of adequate contraceptive methods in women of childbearing age.

• Age up to 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 a previous history of muscle toxicity with the use of other HMG-CoA reductase inhibitors or fibrates, a history of liver disease or alcohol abuse, age over 70 years ...

Application during pregnancy and during breastfeeding

Pregnancy
The use of the drug Livazo during pregnancy is contraindicated. Women of childbearing age should use reliable methods of contraception when treating Livazo. Since cholesterol and other cholesterol biosynthetic products are required for fetal development, the potential risk of inhibition of HMG-CoA reductase outweighs the benefits of drug treatment 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 the drug 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 discontinued.

Method of administration and dosage

Inside, the tablets must be swallowed whole.
It is preferable to take the pill at the same time of day, preferably in the evening, in accordance with the circadian rhythm of lipid metabolism. Before and during treatment, patients should adhere to a cholesterol-lowering diet.
The initial dose of the drug is 1 mg per day, once. If necessary, the dose of the drug is increased at intervals of at least 4 weeks to 2 mg per day. The dose should be selected individually according to the LDL-C concentration, the goal of treatment and the patient's response to treatment. Most patients require a 2 mg dose. The maximum daily dose is 4 mg.
Patients with mild to moderate hepatic impairment: a maximum daily dose of 2 mg is recommended.
Patients with impaired renal function:in case of impaired renal function of mild severity (it is desirable to objectively assess this degree with reflection of creatinine clearance or glomerular filtration rate), the drug 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, it is necessary to prescribe a maximum daily dose of 4 mg only with careful monitoring of renal function after a gradual increase in the dose. It is not recommended for patients with severe renal impairment to prescribe 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: dose adjustment is not required.

Side effect

In controlled clinical trials, when taking the recommended doses, less than 4% of patients treated with Livazo were excluded from the study due to the development of adverse reactions. The most common was myalgia.
Depending on the frequency of occurrence, the following adverse reactions are isolated in accordance with the classification of the World Health Organization: very often:? 10, often: from? 1/100 to <1/10, infrequently: from? 1/1000 to <1/100, rarely : from? 1/10000 to <1/1000, very rare: <1/10000 and the frequency is unknown (available data do not allow determining the frequency).
From the side of hematopoiesis
Uncommon: anemia
From the side of metabolism
Uncommon: anorexia
Mental disorders:
Often:insomnia
On the part of the nervous system
Often: headache
Uncommon: dizziness, taste disturbance, drowsiness
On the part of the sensory organs
Uncommon: ringing in the ears
Rarely: decreased visual acuity
On the part of the skin
Uncommon: skin itching, rash
Rarely: urticaria, erythema
On the part of the musculoskeletal locomotor system
Often: myalgia, arthralgia
Uncommon: muscle spasms
Frequency unknown: immune-mediated necrotizing myopathy
From the urinary system
Uncommon: pollakiuria
From the digestive system
Often: constipation, diarrhea, dyspepsia, nausea
Uncommon: abdominal pain, dryness of the oral mucosa, vomiting
Rarely: glossodynia, acute pancreatitis, cholestatic jaundice
Laboratory parameters
Uncommon: increased activity of 'liver' transaminases - aspartate aminotransferase (ACT), aluminotrans ), increased activity of creatine phosphokinase (CPK).
In clinical studies, after taking Livazo, an increase in CPK activity was observed 3 times higher than VGN in 49 out of 2800 patients (1.8%). Levels of excess VGN of 10 times or more with concomitant muscle symptoms were rare, and were observed in only one patient out of 2406 patients who received 4 mg Livazo (0.04%) in the program of clinical trials.
Other
Uncommon: asthenia, malaise, fatigue, peripheral edema

Post-marketing experience
A two-year prospective study of post-marketing follow-up of 20,000 patients in Japan was conducted. The vast majority of these patients received 1 or 2 mg pitavastatin, but not 4 mg. In 10.4% of patients, adverse reactions were registered, 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 of the adverse reactions were mild. Over the course of 2 years, the frequency of adverse reactions was higher in patients with a history of drug allergy (20.4%) or liver or kidney disease (13.5%).
Adverse reactions and the frequency of their occurrence, observed in a prospective study of post-marketing observation, but not in international controlled clinical trials, when using the drug in recommended doses, are given below.
On the part of the liver and biliary tract
Rarely: impaired liver function, liver disease
On the part of the musculoskeletal system
Rarely: myopathy, rhabdomyolysis
In a post-registration observation study, there were two reports of rhabdomyolysis, in which patients needed 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.
There were also spontaneous reports of the following adverse reactions (the frequency is based on cases observed in post-registration studies):
From the nervous system
Uncommon: hypesthesia
From the digestive system
Rarely: abdominal discomfort
Adverse events with the use of other statins:
- sleep disturbance, including nightmares dreams;
- amnesia;
- sexual dysfunction;
- depression;
- interstitial lung disease;
- diabetes mellitus: the frequency of occurrence depends on the presence or absence of risk factors (fasting blood glucose concentration of 5.6 mmol / l, body mass index> 30 kg / m2, increased concentration of triglycerides, history of arterial hypertension);
- increased glycosylated hemoglobin.

Overdose

There is no specific treatment for overdose.
It is necessary to carry out symptomatic therapy, to monitor the activity of CPK and liver function. Hemodialysis is ineffective.

Interaction with other medicinal products

ѕитавастатин активно транспортируетс¤ в гепатоциты человека многочисленными печеночными транспортерами (включа¤ транспортный полипептид органических анионов [ќј“–]), которые могут быть включены в некоторые из следующих взаимодействий.
?иклоспорин: одновременный прием однократной дозы циклоспорина с питавастатином в равновесном состо¤нии приводит к 4,6-кратному увеличению AUC питавастатина. ¬ли¤ние равновесного состо¤ни¤ циклоспорина на равновесное состо¤ние питавастатина неизвестно. ѕрепарат Ћивазо противопоказан пациентам, получающим лечение циклоспорином.
Ёритромицин: одновременный прием эритромицина с питавастатином приводит к 2,8-кратному увеличению AUC питавастатина. –екомендовано временное прекращение приема питавастатина во врем¤ лечени¤ эритромицином или другими антибиотиками группы макролидов.
vемфиброзил и другие фибраты: в редких случа¤х монотерапию фибратами св¤зывали с развитием миопатии. ќдновременное применение фибратов со статинами св¤зывали с увеличением частоты возникновени¤ миопатии и рабдомиолиза. —ледует соблюдать осторожность при одновременном применении питавастатина с фибратами. ¬ исследовани¤х фармакокинетики одновременное применение питавастатина с гемфиброзилом приводило к 1,4-кратному увеличению AUC питавастатина и увеличению AUC фенофибрата в 1,2 раза.
Ќикотинова¤ кислота (в липидснижающие дозах): исследование взаимодействи¤ при лечении питавастатином и никотиновой кислоты в липидснижающих дозах (более 1 г/сутки) не проводилось. ѕрименение никотиновой кислоты в монотерапии св¤зывали с развитием миопатии и рабдомиолиза. ѕоэтому при одновременном применении с никотиновой кислотой в липидснижающих дозах (более 1 г/сутки) препарат Ћивазо следует назначать с осторожностью.
‘узидова¤ кислота: были зарегистрированы т¤желые мышечные нарушени¤, такие как рабдомиолиз, которые приписывали взаимодействию между фузидовой кислотой и статинами. ¬о врем¤ лечени¤ фузидовой кислотой рекомендовано временно прекратить применение Ћивазо.
–ифампицин: одновременное назначение с питавастатином привело к 1,3-кратному увеличению AUC питавастатина вследствие снижени¤ накоплени¤ в печени.
»нгибиторы протеазы ¬»„: одновременное назначение с питавастатином привело к незначительным изменени¤м AUC питавастатина.
Ёзетимиб и его глюкуронидный метаболит ингибируют всасывание пищевого и билиарного холестерина. ќдновременное применение питавастатина не оказывало вли¤ни¤ на плазменные концентрации эзетимиба или его глюкуронидного метаболита, и эзетимиб не оказывал вли¤ни¤ на плазменные концентрации питавастатина.
»нгибиторы изофермента CYP3A4: исследовани¤ взаимодействи¤ с итраконазолом и грейпфрутовым соком, известными ингибиторами изофермента CYP3A4, не вы¤вили клинически значимого воздействи¤ на плазменные концентрации питавастатина.
?игоксин, известный субстрат –-гликопротеина (Pgp), не взаимодействует с питавастатином. ѕри совместном применении не отмечено существенных изменений концентраций питавастатина или дигоксина в плазме крови.
¬арфарин: равновесное состо¤ние фармакокинетики и фармакодинамики (ћЌќ [ћеждународное нормализованное отношение] и ѕ¬ [протромбиновое врем¤]) варфарина у здоровых добровольцев не измен¤лось при совместном применении варфарина с питавастатином в дозе 4 мг ежедневно. “ем не менее, как и при применении других статинов, у пациентов, получающих варфарин, при добавлении к лечению питавастатина следует контролировать ѕ¬ и ћЌќ.

ќсобые указани¤

¬оздействие на мышечную ткань
 ак и при применении других ингибиторов vћv- ој редуктазы (статинов), существует веро¤тность развити¤ миалгии, миопатии и, в редких случа¤х, рабдомиолиза. —ледует предупредить пациентов о необходимости сообщать о любых мышечных симптомах. јктивность  ‘  следует определ¤ть у любого пациента, сообщающего о мышечной боли, болезненности мышц при пальпации или слабости, особенно если это сопровождаютс¤ недомоганием или лихорадкой.
јктивность  ‘  не следует определ¤ть после физических нагрузок или при наличии каких-либо других возможных причин повышени¤  ‘ , которые могут исказить результат. ѕри повышении активности  ‘  (в 5 раз выше ¬vЌ), в течение 5-7 дней следует выполнить контрольный анализ.
ќтмечены очень редкие случаи иммуноопосредованной некротизирующей миопатии (»ќЌћ) во врем¤ лечени¤ или при прекращении приема статинов. »ќЌћ клинически про¤вл¤етс¤ в виде стойкой слабости проксимальных мышц и повышени¤ активности  ‘  в сыворотке крови, которые сохран¤ютс¤ несмотр¤ на отмену статинов.
?о лечени¤
 ак и все статины, Ћивазо следует с осторожностью назначать пациентам, имеющим предрасполагающие факторы развити¤ рабдомиолиза. —ледует определить активность  ‘  дл¤ установлени¤ контрольного исходного значени¤ в следующих случа¤х:
Х почечна¤ недостаточность,
Х гипотиреоз,
Х личный или семейный анамнез наследственных мышечных заболеваний,
Х предшествующий анамнез мышечной токсичности при лечении фибратами или другими статинами,
Х наличие в анамнезе заболеваний печени или злоупотреблени¤ алкоголем,
Х пациентам старше 70 лет с другими предрасполагающими факторами риска развити¤ рабдомиолиза.
¬ таких случа¤х рекомендован клинический мониторинг, и риск лечени¤ следует рассматривать в зависимости от возможной пользы. Ћечение Ћивазо нельз¤ начинать, если активность  ‘  в 5 раз превышает ¬vЌ.
¬о врем¤ лечени¤
—ледует рекомендовать пациенту немедленно сообщать врачу о мышечной боли, слабости или судорогах. —ледует определить активность  ‘ , и лечение прекратить, если активность  ‘  повышена (в 5 раз выше ¬vЌ). —ледует рассмотреть вопрос о прекращении лечени¤ при возникновении т¤желых мышечных симптомов, даже если активность  ‘  не превышает ¬vЌ в 5 раз. ѕри разрешении симптомов и возвращении активности  ‘  к норме, может быть рассмотрен вопрос о повторном назначении Ћивазо в дозе 1 мг при соблюдении тщательного контрол¤.
¬оздействие на печень
 ак и все статины, Ћивазо следует с осторожностью назначать пациентам, имеющим в анамнезе заболевани¤ печени, или пациентам, регул¤рно употребл¤ющим избыточное количество алкогол¤. ѕеред началом лечени¤ Ћивазо и затем периодически во врем¤ лечени¤ следует проводить функциональные печеночные пробы. ѕациентам со стойким повышением активности Ђпеченочныхї трансаминаз (јЋ“ и ACT), превышающим ¬vЌ в 3 раза, следует прекратить лечение Ћивазо.
¬оздействие на почки
Ћивазо следует с осторожностью назначать пациентам с почечной недостаточностью умеренной или т¤желой степени. ѕовышать дозу следует только при тщательном контроле. ?оза 4 мг не рекомендована пациентам с т¤желой почечной недостаточностью.
—ахарный диабет
Ќекоторые данные свидетельствуют о том, что статины, как класс, привод¤т к увеличению уровней глюкозы в крови, повыша¤ риск развити¤ сахарного диабета в будущем, а у некоторых пациентов с высоким риском развити¤ сахарного диабета могут привести к уровню гипергликемии, при котором становитс¤ показанным формальное лечение сахарного диабета. “ем не менее, эта опасность перевешиваетс¤ снижением сосудистого риска при лечении статинами, и поэтому не должна ¤вл¤тьс¤ причиной дл¤ прекращени¤ лечени¤ статинами. «а пациентами, имеющими риск развити¤ гипергликемии (концентраци¤ глюкозы натощак от 5,6 до 6,9 ммоль/л, индекс массы тела (»ћ“) >30 кг/м?, повышенную концентрацию “v, артериальную гипертензию), необходим клинический и биохимический контроль в соответствии с национальными рекомендаци¤ми. ¬месте с тем, по результатам как постмаркетинговых наблюдений дл¤ оценки безопасности, так и проспективных исследований не было вы¤влено никаких подтверждЄнных сигналов о риске сахарного диабета при применении питавастатина.
»нтерстициальные заболевани¤ легких
–едкие случаи интерстициальных заболеваний легких регистрировали при применении некоторых статинов, особенно при длительной терапии.
Ќаблюдаемые клинические признаки включают одышку, непродуктивный кашель и ухудшение общего состо¤ни¤ здоровь¤ (повышенна¤ утомл¤емость, потер¤ массы тела и лихорадка). ѕри подозрении на развитие интерстициального заболевани¤ легких терапию статинами следует прекратить.

¬ли¤ние на способность управл¤ть транспортными средствами, механизмами

Ќеобходимо соблюдать осторожность при управлении транспортными средствами или выполнении другой работы, требующей повышенного внимани¤, поскольку возможно развитие таких нежелательных реакций как головокружение и сонливость.

‘орма выпуска

Film-coated tablets 1 mg, 2 mg and 4 mg.
For a dosage of 1 mg: 7, 14, 15 tablets in AL / PVC blister, 1 or 2 blisters with instructions for use in a cardboard box.
For a dosage of 2 mg: 7, 10, 14, 15, 20 tablets in AL / PVC blister, 1, 2, 3 or 5 blisters each with instructions for use in a cardboard box.
For a dosage of 4 mg: 7, 10, 14, 15 tablets in AL / PVC blister, 1, 2, 3 blisters each with instructions for use in a cardboard box.

Storage conditions

Store in a dark place at a temperature not exceeding 25 ? C. Keep out of the reach of children.

Shelf life

4 years. Do not use after the expiration date.

Vacation conditions

Dispensed by prescription.