Atorvastatin tablets p/o 20mg №10×3

Name:
Atorvastatin.
Description:
: Coated tablets, white or almost white, biconvex. On the surface of the tablet, the unevenness of the film coating is allowed. The main active ingredient is Atorvastatin. Release form Tablets. Dosage 20mg. Pharmacological action Atorvastatin is a lipid-lowering agent from the group of statins. Reduces cholesterol and lipoprotein levels in blood plasma. Reduces LDL levels in patients with homozygous familial hypercholesterolemia, which usually does not respond to lipid-lowering drugs. Reduces total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides; causes an increase in cholesterol levels – high-density lipoprotein and apolipoprotein A. Reduces LDL levels in patients with homozygous hereditary hypercholesterolemia, resistant to therapy with other lipid-lowering drugs. Reduces the risk of ischemic complications (including the development of death from myocardial infarction), the risk of re-hospitalization for angina, accompanied by signs of myocardial ischemia. It does not have a carcinogenic and mutagenic effect. The therapeutic effect is observed 2 weeks after the start of therapy, reaches a maximum after 4 weeks and persists throughout the entire period of treatment. It is metabolized mainly in the liver under the influence of cytochrome CYP3A4, CYP3A5 and CYP3A7 with the formation of active metabolites. It is not excreted during hemodialysis due to intense binding to plasma proteins. With liver failure in patients with alcoholic cirrhosis of the liver, the concentration of the drug in the blood increases significantly. Renal insufficiency does not affect the concentration of the drug in plasma. Indications for use Therapy with atorvastatin should be only one of the components of the complex therapy of patients with multiple risk factors for the development of atherosclerotic vascular lesions associated with hypercholesterolemia. Medical therapy is recommended as an adjunct to diet when response to diet or other non-pharmacological interventions is inadequate. In patients with or without evidence of CAD but with multiple risk factors for CAD, atorvastatin may be given concomitantly with diet. Hyperlipidemia Atorvastatin is indicated: – as an adjunct to the diet in patients with elevated levels of total cholesterol, LDL (low density lipoprotein), apolipoprotein B and triglycerides, as well as to increase HDL (high density lipoprotein) cholesterol in patients with primary hypercholesterolemia (hereditary heterozygous and non-hereditary hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson type IIa and IIb); – for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III) in cases where the diet does not have a sufficient effect; – to lower total cholesterol and LDL cholesterol in patients with homozygous hereditary hypercholesterolemia in addition to other methods designed to lower lipid levels (eg LDL apheresis), or c. where such methods are not available. Use in children (patients aged 10-17 years) Atorvastatin is indicated as an adjunct to diet to lower total cholesterol, LDL (low-density lipoprotein) cholesterol, apolipoprotein B in post-menarche girls and in boys aged 10-17 years with heterozygous a history of hereditary hypercholesterolemia if, after an appropriate trial therapeutic diet, the following indicators are present: a. cholesterol – LDL remains ≥190 mg/dL or b. – LDL cholesterol remains ≥ 160 mg/dL and: – there is a family history of early CVD, or – the children currently have 2 or more other risk factors for CVD. Prevention of cardiovascular complications Patients without clinical signs of cardiovascular disease with or without dyslipidemia, but with multiple risk factors for coronary heart disease, such as smoking, hypertension, diabetes mellitus, low HDL cholesterol (X-HDL), or with early family history of coronary heart disease, atorvastatin is indicated for: – reducing the risk of mortality in coronary heart disease and non-fatal myocardial infarction; – reduce the risk of stroke; – reducing the risk of undergoing revascularization surgery and the risk of developing angina pectoris; – reducing the risk of hospitalization for CHF; – reduce the risk of developing angina pectoris. Dosage and administration Prior to initiation of treatment with atorvastatin, the patient must be put on a lipid-lowering diet, which must be observed during therapy with the drug. The recommended starting dose is 10 mg daily. Depending on the desired effect, the daily dose may be increased to no more than 80 mg. The patient should take atorvastatin once at any time of the day, but at the same time each day. The drug is taken regardless of the meal. The therapeutic effect is usually observed after two weeks of treatment, and the maximum effect develops after four weeks. Therefore, the dosage should not be changed earlier than four weeks after the start of the drug in the previous dose. : Hyperlipidemia (hereditary heterozygous and non-hereditary hypercholesterolemia) and combined (mixed) dyslipidemia (Fredrickson type IIa and IIb) The recommended starting dose is 10 mg daily. Depending on the desired effect, the daily dose may be increased to no more than 80 mg. Homozygous familial hypercholesterolemia The dose range is 10-80 mg. In patients with homozygous hereditary hypercholesterolemia, atorvastatin should be used as adjunctive therapy to other therapies or when therapy with other therapies is not possible. Heterozygous hereditary hypercholesterolemia in children (aged 10-17 years) The recommended starting dose of atorvastatin is 10 mg/day. The maximum recommended dose is 20 mg/day (doses above 20 mg have not been reported in studies in this patient population). The dose should be selected individually depending on the recommended goal of treatment. Dose changes should be made at intervals of 4 weeks or more. Prevention of cardiovascular complications In studies on the prevention of cardiovascular complications, a dose of 10 mg per day was used. Higher doses may be needed to achieve desired cholesterol levels. Special groups of patients Patients with renal insufficiency Renal disease does not affect the concentration of atorvastatin or the reduction of LDL-C in plasma. Therefore, there is no need to adjust the dose of atorvastatin in patients with kidney disease. Patients with impaired liver function Caution is required due to the slowdown in the excretion of the drug from the body (see sections “Contraindications” and “Precautions”). The use of the drug in elderly patients When taking the drug in recommended doses, its efficacy and safety in patients over 70 years of age does not differ from those in the general population. Combined use of lipid-lowering agents Atorvastin can be administered with bile acid sequestrants. The combination of HMG-CoA reductase inhibitors and fibrates requires extreme caution (see sections “Precautions” and “Interaction with other drugs”). Dosing in patients taking cyclosporine, clarithromycin, itraconazole, or certain protease inhibitors Patients taking cyclosporine or HIV protease inhibitors (tipranavir + ritonavir) or hepatitis C virus (telaprevir) should avoid atorvastatin therapy. In HIV-infected patients receiving lopinavir in combination with ritonavir, care must be taken when prescribing atorvastatin, and treatment should be carried out at the lowest effective dose. In patients taking clarithromycin, itraconazole, and in HIV-infected patients taking combinations of saquinavir and ritonavir, darunavir and ritonavir, fosamprenavir, or fosamprenavir and ritonavir, the dose of atorvastatin should be limited to 20 mg, and appropriate clinical evaluation is recommended to confirm effectiveness of low doses of atorvastatin. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C virus protease inhibitor boceprevir, the dose of atorvastatin should be limited to 40 mg, and an appropriate clinical evaluation is also recommended to confirm the effectiveness of low doses of atorvastatin (see sections “Precautions” and “Interaction with other drugs”). If you forget to take Atorvastatin, take your tablet as soon as possible before your next appointment is due. If it is time for your next dose of medication, do not take the missed dose. You can not double the dosage of the drug to compensate for the missed! Further, the drug is used according to the recommended dosing regimen. Do not stop taking Atorvastatin without first consulting with your doctor! Use during pregnancy and lactation If you are pregnant or breastfeeding, if you suspect that you are pregnant or do not exclude the possibility of pregnancy, inform your doctor. Women of reproductive age Women of reproductive age should use effective contraceptive methods during therapy. Pregnancy The use of atorvastatin is contraindicated during pregnancy (see section “Contraindications”). There have been reports of congenital malformations after intrauterine exposure to inhibitors of HMG-CoA reductase. Animal studies have demonstrated reproductive toxicity. When a pregnant woman takes atorvastatin, a decrease in fetal levels of mevalonate, which is a precursor of cholesterol biosynthesis, is possible. Atherosclerosis is a chronic process, and, as a rule, the withdrawal of lipid-lowering drugs during pregnancy does not significantly affect the long-term risk associated with primary hypercholesterolemia. In this regard, atorvastatin should not be administered to pregnant women, women who are planning a pregnancy or if pregnancy is suspected. It is necessary to stop taking atorvastatin during pregnancy. Breastfeeding It is not known whether atorvastatin or its metabolites are excreted in human breast milk. In animal studies, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. The use of atorvastatin during breastfeeding is contraindicated, women taking atorvastatin should stop breastfeeding (see section “Contraindications”). Fertility In animal studies, atorvastatin had no effect on male or female fertility. Precautions Impaired liver function It is recommended to monitor liver function (liver enzyme activity) before starting treatment with atorvastatin, and again if clinically indicated. There have been rare post-marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including atorvastatin. If serious liver damage with clinical symptoms and/or hyperbilirubinemia or jaundice develops while taking atorvastatin, treatment should be discontinued immediately. Unless other causes of liver dysfunction are established, atorvastatin should not be restarted. Atorvastatin should be used with caution in patients who drink alcohol and/or have a history of liver disease. Liver disease in the active phase or an increase in transaminase activity with an unknown cause is a contraindication for the appointment of atorvastatin. Prevention of stroke through intensive cholesterol lowering Studies have found that among patients without coronary heart disease, recent stroke or transient ischemic attack, hemorrhagic stroke was observed more often in patients receiving 80 mg of atorvastatin than in patients receiving placebo. In particular, an increased risk was observed in patients who had already suffered a hemorrhagic stroke or lacunar infarction at the time of study entry. In patients with prior hemorrhagic stroke or lacunar infarction, the balance of risk/benefit of atorvastatin 80 mg is unclear; the possible risk of hemorrhagic stroke should be carefully assessed before initiating therapy. Influence on skeletal muscles In the treatment of atorvastatin, as with the use of similar drugs in this group, there have been rare cases of rhabdomyolysis, which were accompanied by acute renal failure resulting from myoglobinuria. A history of renal failure may be a risk factor for the development of rhabdomyolysis. In such patients, more careful monitoring of skeletal muscle function is necessary. Treatment with atorvastatin, as with other statins, can cause myopathy, which is manifested by muscle pain and weakness in combination with an increase in creatine phosphokinase (CPK) activity more than 10 times the upper limit of normal. Concomitant use of high doses of atorvastatin and certain drugs, such as cyclosporine and strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, and HIV protease inhibitors), increases the risk of myopathy/rhabdomyolysis. There are rare reports of the development of immune necrotizing myopathy, autoimmune myopathy, associated with the use of statins. Immune necrotizing myopathy is characterized by proximal muscle weakness and elevated creatine kinase levels that persist after discontinuation of statin treatment; muscle biopsy reveals necrotizing myopathy without significant inflammation; improvement occurs when taking immunosuppressive drugs. Myopathy should be suspected in any patient with diffuse myalgia, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be warned that they should immediately inform the doctor about the appearance of unexplained pain or weakness in the muscles, if they are accompanied by malaise or fever. Therapy with atorvastatin should be discontinued in the event of a marked increase in CPK activity or in the presence of confirmed or suspected myopathy. The risk of myopathy in the treatment of other drugs in this class increased with the simultaneous use of cyclosporine, fibrates, erythromycin, clarithromycin, hepatitis C protease inhibitor telaprevir, a combination of HIV protease inhibitors, including saquinavir and ritonavir, lopinavir and ritonavir, tipranavir and ritonavir, fosamprenavir, fosamprenavir and ritonavir, nicotinic acid, or azole antifungals. When prescribing atorvastatin in combination with fibrates, erythromycin, clarithromycin, a combination of saquinavir and ritonavir, lopinavir and ritonavir, darunavir and ritonavir, fosamprenavir, fosamprenavir and ritonavir, azole antifungals, or niacin at lipid-lowering doses, the expected benefits and risks of treatment should be carefully weighed. monitor patients regularly for any signs or symptoms of muscle pain or weakness, especially during the first months of treatment and during periods of increasing the dose of any drug. Low initial and maintenance doses of atorvastatin should be administered concomitantly with these drugs. In such situations, periodic determination of CPK activity can be recommended, although such monitoring does not prevent the development of severe myopathy. Recommendations for prescribing interacting medicinal products are shown in Table 1. Table 1. Drug interactions associated with an increased risk of myopathy/rhabdomyolysis Interfering medicinal products – Prescribed recommendations Cyclosporine, HIV protease inhibitors (tipranavir + ritonavir), hepatitis C protease inhibitor (telaprevir) – Atorvastatin should be avoided HIV protease inhibitor (lopinavir + ritonavir) – Use with caution. at the lowest possible effective dose Clarithromycin, itraconazole, HIV protease inhibitors (saquinavir + ritonavir *, darunavir + ritonavir, fosamprenavir, fosamprenavir + ritonavir) – Do not exceed a daily dose of 20 mg HIV protease inhibitor (nelfinavir), hepatitis C protease inhibitor (boceprevir ) – Do not exceed the daily dose of 40 mg * Use with caution at the lowest dose. Cases of myopathy, including rhabdomyolysis, have been reported when atorvastatin is co-administered with colchicine, so caution should be exercised in this case. Patients should be warned that they should immediately consult a doctor if unexplained pain or weakness in the muscles occurs, especially if they are accompanied by malaise or fever. Atorvastatin should be used with caution in patients with a predisposition to rhabdomyolysis. The level of CPK should be determined before starting therapy in the following cases: – renal failure; – hypothyroidism; – hereditary muscle diseases in an individual or family history; – previous muscle toxicity due to the use of statins or fibrates; – previous liver disease and/or alcohol abuse; – elderly patients (over 70 years old) – the need for these laboratory tests in this case is also caused by the presence of other predisposition factors for rhabdomyolysis; – cases of elevated plasma concentrations (for example, cases of interaction and use in special populations, including genetic subpopulations). In the cases listed above, the balance between risk and possible benefit should be assessed, clinical observation is recommended. With a significant increase in the concentration of CPK (exceeding the upper limit of the norm by more than 5 times) at the initial level, treatment should not be started. Measurement of CPK levels CPK levels should not be measured after strenuous exercise or in the presence of other factors responsible for the increase in CPK levels, as this will complicate the interpretation of the results of the analysis. If the initial levels of CPK are markedly increased (more than 5 times compared to the upper limit of the norm), it is necessary to re-analyze the results after 5-7 days to confirm the results. Endocrine function Increases in HbAlc and fasting serum glucose have been reported with HMG-CoA reductase inhibitors, including atorvastatin. Statins affect the synthesis of cholesterol and theoretically can inhibit the production of hormones of the adrenal cortex and / or sex steroid hormones. Clinical studies have shown that atorvastatin does not reduce basal plasma cortisol levels and does not adversely affect adrenal reserve. The effect of statins on male fertility has not been studied in sufficient numbers of patients. Effects, if any, on the pituitary-gonadal system in premenopausal women are unknown. Caution must be exercised when prescribing statins with drugs that can decrease the level or activity of endogenous steroid hormones, such as ketoconazole, spironolactone, and cimetidine. Diabetes mellitus Statins, as a class, are capable of elevating blood glucose, and in some patients at high risk of developing diabetes, they can cause hyperglycemia requiring standard diabetes management. At the same time, the reduction in CV risk with statins outweighs the risk of diabetes, so discontinuation of statin therapy is not required. Patients at risk of developing diabetes (fasting glucose 5.6-6.9 mmol / l, body mass index> 30 kg / m2, elevated triglycerides, arterial hypertension) need clinical observation and biochemical tests. Interstitial lung disease Interstitial lung disease has been very rarely observed during therapy with some statins, especially during long-term therapy. Manifestations of the disease include symptoms such as dyspnea, dry cough and deterioration in general health (fatigue, weight loss and fever). If interstitial lung disease is suspected, statin therapy should be discontinued. Special information on the excipients of the medicinal product Atorvastatin contains lactose. This medicinal product is not suitable for patients with rare hereditary problems of galactose intolerance, lactase enzyme deficiency or glucose-galactose malabsorption syndrome. Use in Elderly Patients Older age (65 years and older) is a predisposing factor for myopathy, so atorvastatin should be used with caution in elderly patients. Interaction with other drugs If you are currently or have recently taken other drugs, tell your doctor. Effect of concomitant medicinal products on atorvastatin Atorvastatin is metabolized by cytochrome P450 3A4 (CYP3A4) and is a substrate for transporter proteins such as the hepatic uptake transporter OATP1B1. Concomitant use of atorvastatin and inhibitors of the CYP3A4 isoenzyme or carrier proteins can lead to an increase in plasma concentrations of atorvastatin and an increased risk of myopathy. This risk may also increase with the simultaneous use of atorvastatin with other drugs that can cause the development of myopathy, such as fibric acid derivatives and ezetemibe (see section “Precautions”). CYP3A4 Inhibitors Potent CYP3A4 inhibitors are known to result in significant increases in atorvastatin concentrations (see Table 2 and specific information below). Concomitant use of potent CYP3A4 inhibitors (eg, cyclosporine, telithromycin, clarithromycin, delavirdine, styripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors, including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.) should be avoided whenever possible. .). Therefore, if co-administration of these drugs with atorvastatin cannot be avoided, it is recommended to use lower initial and lower maximum doses of atorvastatin, as well as to carry out appropriate clinical monitoring of the patient’s condition (see table 2). Moderate inhibitors of the CYP3A4 isoenzyme (for example, erythromycin, diltiazem, verapamil and fluconazole) can increase plasma concentrations of atorvastatin (see table 2). When using erythromycin in combination with statins, there was an increased risk of developing myopathy. Interaction studies evaluating the effect of amiodarone or verapamil on atorvastatin have not been conducted. Both amiodarone and verapamil are known to inhibit CYP3A4 activity, and their concomitant use with atorvastatin may lead to increased exposure to atorvastatin. Thus, when using atorvastatin and moderate inhibitors of CYP3A4, it is recommended to prescribe lower maximum doses of atorvastatin, as well as to carry out appropriate clinical monitoring of the patient’s condition. After the start of the use or dose adjustment of the inhibitor, proper clinical monitoring of the patient’s condition should be organized. CYP3A4 inducers Co-administration of atorvastatin with inducers of cytochrome P450 3A (eg, efavirenz, rifampin, St. John’s wort) may result in a variable decrease in plasma concentrations of atorvastatin. Due to the dual mechanism of action of rifampin (induction of cytochrome P450 3A and inhibition of the transporter protein OATP1B1, which provides uptake by hepatocytes), the simultaneous use of atorvastatin and rifampin is recommended, since the delayed use of atorvastatin after rifampin was associated with a significant decrease in the concentration of atorvastatin in blood plasma. However, it is not known whether the use of rifampin affects the concentration of atorvastatin in liver cells. Therefore, if the simultaneous use of atorvastatin and rifampin cannot be avoided, proper monitoring of the condition of patients should be organized. Carrier protein inhibitors When using inhibitors of transport proteins (eg, cyclosporine), there may be an increase in systemic exposure to atorvastatin (see table 2). The influence of the process of inhibition of transporters involved in hepatic uptake on the concentration of atorvastatin in liver cells is unknown. If simultaneous use is unavoidable, clinical observation should be organized to evaluate the effectiveness (see table 2). Gemfibrozil/Fibric Acid Derivatives Rare cases of muscle disorders, including rhabdomyolysis, have been reported with fibrate monotherapy. The risk of developing these phenomena may increase with the simultaneous use of fibric acid derivatives and atorvastatin. If simultaneous use cannot be avoided, it is recommended to use the minimum dose of atorvastatin to achieve the therapeutic goal, and appropriate monitoring of the condition of patients should be organized (see section “Precautions”). Ezetemibe When monotherapy with ezetimibe, cases of the development of muscle disorders, including rhabdomyolysis, have been noted. Therefore, the risk of developing these phenomena may increase with the simultaneous use of ezetimibe and atorvastatin. In such patients, appropriate clinical monitoring is recommended. Colestipol: Co-administration of atorvastatin with colestipol resulted in a decrease in plasma concentrations of atorvastatin and its active metabolites (approximately 25%). However, with the combined use of Liprimar and colestipol, the lipid effects were more pronounced than in the case of the corresponding monotherapies. Fusidic acid Interaction studies between atorvastatin and fusidic acid have not been conducted. As with other statins, muscle disorders, including rhabdomyolysis, have been reported during post-marketing surveillance with concomitant use of atorvastatin and fusidic acid. The mechanism of this interaction is unknown. These patients are closely monitored and may require temporary discontinuation of atorvastatin. Colchicine Although interaction studies between atorvastatin and colchicine have not been conducted, cases of myopathy have been reported with the simultaneous use of atorvastatin and colchicine. Caution should be exercised when atorvastatin is co-administered with colchicine. Effects of atorvastatin on other medicinal products Digoxin Co-administration of multiple doses of digoxin and 10 mg atorvastatin showed a slight increase in steady state concentrations of digoxin. Patients taking digoxin should be monitored appropriately. Oral contraceptives With the combined use of atorvastatin and oral contraceptives, an increase in the concentration of norethindrone and ethinyl estradiol in blood plasma was observed. Warfarin In a clinical study in patients on long-term warfarin therapy, co-administration of atorvastatin 80 mg daily with warfarin resulted in a slight decrease in prothrombin time (approximately 1.7 seconds) during the first 4 days of treatment, which returned to normal within 15 days of atorvastatin therapy. Although clinically important anticoagulant interactions have been reported extremely rarely, prothrombin time determination should be performed prior to initiation of atorvastatin in patients taking coumarin anticoagulants and repeated frequently early in therapy to confirm that there is no significant change in this indicator. After documented stabilization of the prothrombin time, you can continue to monitor it at the intervals adopted in the treatment of coumarin anticoagulants. When changing the dosage of atorvastatin or stopping its use, the same procedure should be repeated. During therapy with atorvastatin in patients not taking anticoagulants, there were no cases of bleeding or changes in prothrombin time. Children Drug interaction studies have only been conducted in adult patients. The degree of drug interaction in pediatric patients. Table 2. Effect of concomitantly used drugs on the pharmacokinetics of atorvastatin (see instructions) Table 3. Effect of atorvastatin on the pharmacokinetics of concomitant drugs (see instructions) Contraindications Hypersensitivity; active liver disease; increased activity of “liver” transaminases (more than 3 times) of unknown origin; women of reproductive age who do not use adequate methods of contraception; pregnancy; lactation period; children under 18 years of age (efficacy and safety have not been established), with the exception of the treatment of heterozygous hereditary hypercholesterolemia; co-administration with HIV protease inhibitors (telaprevir, tipranavir + ritonavir). Atorvastatin should only be given to a woman of reproductive age if she is known to be not pregnant and has been informed of the potential hazard to the fetus. With caution: alcoholism, a history of liver disease, severe electrolyte imbalance, endocrine and metabolic disorders, arterial hypotension, hemorrhagic stroke, severe acute infections (sepsis), uncontrolled epilepsy, major surgery, trauma. Composition Each coated tablet contains: active substance – atorvastatin 20 in the form of atorvastatin calcium salt; excipients: lactose monohydrate, microcrystalline cellulose (E-460), croscarmellose sodium (E-468), hypromellose 2910 (E-463), polysorbate 80 (E-433), calcium stearate (E-470), calcium carbonate (E -170), titanium dioxide (E-171), talc (E-553). OverdoseSymptoms: specific signs of overdose have not been established. Possible symptoms may be pain in the liver, acute renal failure; with prolonged use – myopathy and rhabdomyolysis. Treatment: there is no specific antidote, symptomatic therapy and measures to prevent further absorption (gastric lavage and activated charcoal). Atorvastatin is largely bound to plasma proteins, as a result of which hemodialysis is ineffective. With the development of myopathy with subsequent rhabdomyolysis and acute renal failure (rarely) – immediate withdrawal of the drug and the introduction of a diuretic and sodium bicarbonate solution. Rhabdomyolysis can lead to the development of hyperkalemia, the elimination of which requires intravenous administration of calcium chloride or calcium gluconate, infusion of glucose with insulin, the use of potassium ion exchangers, or in severe cases, hemodialysis. Side effects Side effects that may occur during treatment with atorvastatin are divided into the following groups according to the frequency of occurrence: very frequent (≥1 / 10); frequent (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); unknown (according to the available data, it is not possible to determine the frequency of occurrence). Infections and infestations: common: nasopharyngitis, urinary tract infections. Hematopoietic system disorders: rare: thrombocytopenia. Immune system disorders: common: allergic reactions; very rare: anaphylaxis. Metabolic and nutritional disorders: common: hyperglycemia; infrequent: hypoglycemia, weight loss, anorexia. Mental disorders: infrequent: nightmares, insomnia. Nervous system disorders: common: headache; infrequent: dizziness, paresthesia, hypesthesia, dysgeusia, amnesia; rare: peripheral neuropathy. On the part of the organ of vision: infrequent: deterioration in visual acuity; rare: visual disturbances. Disturbances from the organ of hearing and the labyrinth system: infrequent: tinnitus (tinnitus); very rare: hearing loss. Respiratory, thoracic and mediastinal disorders: Common: sore throat, epistaxis. Hepatobiliary disorders: infrequent: hepatitis; rare: cholestasis; very rare: liver failure. Gastrointestinal disorders: common: nausea, flatulence, dyspepsia, constipation, diarrhea; infrequent: vomiting, abdominal pain, belching, pancreatitis. Skin and subcutaneous tissue disorders: infrequent: urticaria, skin rash, pruritus, alopecia; rare: angioedema, bullous rash (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). Musculoskeletal disorders: common: myalgia, arthralgia, back pain, pain in the extremities, muscle spasms, joint swelling; infrequent: neck pain, muscle fatigue; rare: myopathy, myositis, rhabdomyolysis, tendinopathy, sometimes complicated by ruptures; unknown: immune-mediated necrotizing myopathy. Reproductive system and breast disorders: very rare: gynecomastia. General disorders: infrequent: asthenia, peripheral edema, malaise, chest pain, fatigue, fever. , Laboratory findings: common: abnormal liver function tests, elevated blood creatinine kinase (CK) levels; infrequent: positive results of the analysis for leukocytes in the urine. As with other HMG-CoA reductase inhibitors, elevated serum transaminase levels have been reported in patients treated with atorvastatin. These changes were, as a rule, weak, transient and did not require interruption of therapy. Clinically significant (more than 3 times the upper limit of normal) elevated serum transaminase levels were observed in Q.8% of patients treated with atorvastatin. These deviations were dose-dependent and reversible in all patients. Elevated creatine kinase (CK) levels greater than 3 times the upper limit of normal were observed in 2.5% of patients treated with atorvastatin; similar results have been observed with other HMG-CoA reductase inhibitors in clinical trials. Levels greater than 10 times the upper limit of normal were observed in 0.4% of patients taking atorvastatin. The following adverse events have been observed with the use of individual statins: sexual dysfunction, depression, rare cases of interstitial lung disease, especially with long-term therapy, diabetes mellitus. If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not listed in this package insert. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Atorvastatin tablets p/o 20mg No. 10x3