Atorvastatin ALSI tab p / 20 mg of the film 30 pc

$5.75

Atorvastatin ALSI tab p / 20 mg of the film 30 pc

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Description

Composition
Active substance:
atorvastatin calcium trihydrate 21.70 mg, calculated as 20.00 mg atorvastatin
Excipients:
microcrystalline cellulose – 96.00 mg calcium carbonate – 66.00 mg pregelatinized starch (1500) – 65.60 mg of lactose monohydrate (milk sugar) – 47,70 mg colloidal silicon dioxide (Aerosil) – 1.50 mg magnesium stearate – 1.50 mg;
film coating: Opadry II (85 Series) (polyvinyl alcohol – 4.80 mg titanium dioxide – 3.00 mg macrogol (polyethylene glycol) – 2.42 mg talc – 1.78 mg) – 12.00 mg.
Description:
Round, biconvex tablets, film-coated, white color. The cross-sectional view – an inner layer of white or almost white color.
Product form:
Tablets, film-coated, 20 mg.
10 tablets in blisters of PVC film and aluminum foil printed patent.
3 the contour of cellular packaging together with instructions for use placed in a pile of cardboard.
Contraindications
hypersensitivity to the drug;
active liver disease or increased activity “liver” enzymes of unknown origin (more than 3 times compared with the upper limit of normal);
hepatic failure (severity classification Child-Pyuga A and B)
pregnancy;
lactation;
age 18 years (effectiveness and safety have been established).
Caution: alcohol abuse, history of liver disease, severe electrolyte imbalance, endocrine and metabolic disorders, arterial hypotension, severe acute infection (sepsis), uncontrolled epilepsy, extensive surgery, trauma, skeletal muscle diseases.
Dosage
20 mg
Indications
Atorvastatin is used:
in combination with a diet to reduce elevated total cholesterol, cholesterol / LDL, apolipoprotein B and triglyceride levels and increasing HDL cholesterol levels in patients with primary hypercholesterolemia, heterozygous familial and non-familial hypercholesterolemia and combined (mixed) hyperlipidemia (Types IIa and IIb according to Fredrickson);
in combination with a diet for treating patients with elevated serum triglyceride levels (Frederickson Type IV on) and patients with disbetalipoproteinemiey (Type III according to Fredrickson) whose diet therapy does not give adequate effect;
to reduce the levels of total cholesterol and cholesterol / LDL cholesterol in patients with homozygous familial hypercholesterolemia, when diet therapy and other non-pharmacological treatments are not sufficiently effective.
Interaction with other drugs
The risk of myopathy during treatment with other drugs of this class is increased by the simultaneous use of cyclosporine, fibrates, erythromycin, antifungal agents belonging to the azole, and nicotinic acid.
With the simultaneous ingestion of atorvastatin and a slurry containing magnesium hydroxide and aluminum, atorvastatin decreased plasma concentrations of approximately 35%, but the degree of reduction of cholesterol / LDL level without changing.
With simultaneous use of atorvastatin does not affect the pharmacokinetics of antipyrine (phenazone) so interaction with other drugs metabolized by the same cytochrome expected.
With simultaneous application of colestipol atorvastatin plasma concentration decreased by about 25%. However hypolipidemic effect of the combination of atorvastatin and colestipol than that of each drug separately.
Repeated dose digoxin and atorvastatin 10 mg equilibrium concentration of digoxin in plasma did not change. However, the application of digoxin in combination with atorvastatin 80 mg / day. digoxin concentrations increased by approximately 20%. Patients receiving digoxin in combination with atorvastatin, should be observed.
With simultaneous use of atorvastatin and erythromycin (500 mg four times / day) or clarithromycin (500 mg, 2 times / day), which inhibit cytochrome P450 3A4, was an increase atorvastatin plasma concentration.
With simultaneous use of atorvastatin (10 mg 1 time / day) and azithromycin (500 mg 1 time / day) atorvastatin plasma concentration was not changed.
Atorvastatin had no clinically significant effect on the concentration of terfenadine in the blood plasma, which is metabolized primarily by cytochrome P450 3A4; therefore it seems unlikely that atorvastatin can significantly affect the pharmacokinetic parameters of other substrates of cytochrome P450 3A4.
With simultaneous use of atorvastatin and oral contraceptive containing norethindrone and ethinyl estradiol, showed a significant increase in AUC of norethindrone and ethinyl estradiol is about 30% and 20% respectively. This effect should be considered when selecting an oral contraceptive for a woman receiving atorvastatin.
The simultaneous use of drugs, which reduce the concentration of endogenous steroid hormones (including cimetidine, ketoconazole, spironolactone), increases the risk of reduction of endogenous steroid hormones (caution).
It has been detected in studying the interaction of atorvastatin with warfarin and cimetidine evidence of clinically significant interaction.
With simultaneous use of atorvastatin 80 mg or amlodipine 10 mg atorvastatin pharmacokinetics in the equilibrium state is not changed.
There were no clinically significant adverse interactions atorvastatin and antihypertensive agents.
The simultaneous use of atorvastatin with protease inhibitors, known as cytochrome P450 3A4 inhibitors, accompanied by an increase atorvastatin plasma concentration.
Pharmaceutical incompatibility is unknown.
Overdose
Treatment: No specific antidote, being symptomatic therapy.
Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
hypolipidemic agent, HMG-CoA reductase inhibitor.
Pharmacodynamics:
Hypolipidemic agent from the group of statins. Selective competitive inhibitor of HMG-CoA reductase – converting enzyme 3-hydroxy-3-methylglutaryl coenzyme A to mevalonic acid which is a precursor of sterols, including cholesterol. Triglycerides (TG) and cholesterol in the liver are included in the very low density lipoproteins (VLDL), enter the blood plasma and transported to peripheral tissues. Low density lipoproteins (LDL) are formed from VLDL during the interaction with the LDL receptor. Atorvastatin reduces the cholesterol levels in blood plasma lipoproteins by inhibiting HMG-CoA reductase, a cholesterol synthesis in the liver and increase the number of “liver” LDL receptors on the cell surface, which leads to increased trapping and catabolism of LDL. Reduces LDL, causes a marked and persistent increase in LDL receptor activity. Lowers LDL cholesterol in patients with homozygous familial hypercholesterolemia, which usually can not be lipid-lowering therapy means. Lowers total cholesterol by 30-46%, LDL – by 41-61%, apolipoprotein B – by 34-50% and TG – by 14-33%; It causes an increase in HDL-cholesterol (HDL) and apolipoprotein A. Dozozawisimo reduces cholesterol in patients with homozygous familial hypercholesterolemia resistant to therapy other hypolipidemic agents.
Pharmacokinetics:
Absorption – high. The maximum concentration (Cmax) is achieved after 1-2 h in plasma, Cmax women above 20%, area under the curve / concentration, time (AUC) – below 10%; Cmax in patients with alcoholic cirrhosis by 16 times, AUC – 11 times higher than normal.
Food somewhat reduces the rate and duration of absorption of the drug (25% and 9% respectively) but LDL cholesterol reduction similar to that in the application of atorvastatin without food. The concentration of atorvastatin in the application in the evening lower than in the morning (approximately 30%). A linear relationship between the degree of absorption and the dose of the drug.
Bioavailability – 12% systemic bioavailability of inhibitory activity against HMG-CoA reductase – 30%. The low systemic bioavailability due to first-pass metabolism in the mucosa of the gastrointestinal tract, and the “first pass” through the liver.
The average distribution volume – 381 liters, the connection with plasma proteins – 98%. Metabolized mainly in the liver by the action of the cytochrome CYP3A4, CYP3A5 and CYP3A7 to produce pharmacologically active metabolites (ortho and paragidroksilirovannyh derivatives, beta-oxidation products). In vitro and ortho paragidroksilirovannye metabolites have an inhibitory effect on HMG-CoA reductase, comparable to that of atorvastatin. The inhibitory effect of the drug against HMG-CoA reductase inhibitor of approximately 70% determined by the activity of circulating metabolites.
Excreted in the bile after hepatic and / or extrahepatic metabolism (not subjected to severe enterohepatic recirculation).
The half-life – 14 hours. The inhibitory activity against HMG-CoA reductase persists for about 20-30 hours due to the presence of active metabolites. Less than 2% of the dose of an oral preparation is defined in the urine. Not output during hemodialysis.
Pregnancy and breast-feeding
Atorvastatin is contraindicated during pregnancy and lactation (breastfeeding).
It is not known whether atorvastatin is excreted in breast milk. Given the potential for adverse effects in infants, if necessary, use during lactation should decide the issue of termination of breastfeeding.
Women of reproductive age during treatment should use adequate contraception methods. Atorvastatin can be administered to women of childbearing age only when the probability of pregnancy are very low and the patient informed of the potential risk of treatment to the fetus.
Conditions of supply of pharmacies
On prescription.
side effects
From the nervous system – often 2% – insomnia, dizziness; less than 2% – headache, asthenia, malaise, drowsiness, nightmares, paresthesia, peripheral neuropathy, amnesia, emotional lability, ataxia, facial paralysis, hyperkinesia, migraine, depression, hypoesthesia, loss of consciousness.
From the senses: less than 2% – amblyopia, tinnitus, dryness of the conjunctiva, disturbance of accommodation, bleeding in the retina of the eye, deafness, glaucoma, parosmiya, loss of taste, taste perversion.
With the cardiovascular system: often 2% – pain in the chest; less than 2% – palpitation, vasodilatation symptoms of orthostatic hypotension, increased blood pressure, phlebitis, arrhythmia, angina pectoris.
From hemopoiesis system: less than 2% – anemia, lymphadenopathy, thrombocytopenia.
From respiratory system: often 2% – bronchitis, rhinitis; less than 2% – pneumonia, dyspnea, exacerbation of asthma, nasal bleeding.
From the digestive system: often 2% – nausea; less than 2% – heartburn, constipation or diarrhea, flatulence, gastralgia, abdominal pain, decrease or increase in appetite, dry mouth, regurgitation, dysphagia, vomiting, stomatitis, esophagitis, glossitis, erosive and ulcerative lesions of the oral mucosa, gastroenteritis, hepatitis, biliary colic, cheilitis, duodenal ulcer a 12-ulcer, pancreatitis, cholestatic jaundice, hepatic dysfunction, rectal bleeding, melena, gum bleeding, tenesmus.
On the part of the musculoskeletal system: often 2% – arthritis; less than 2% – spasms of the leg muscles, bursitis, tenosynovitis, myositis, myopathy, arthralgia, myalgia, rhabdomyolysis, torticollis, muscular hypertonicity, contracture of joints.
With the genitourinary system: often 2% – urogenital infections, peripheral edema; less than 2% – dysuria (including pollakiuria, nocturia, urinary incontinence or urinary retention, urgency to urinate), nephritis, hematuria, vaginal bleeding, nefrourolitiaz, metrorrhagia, epididymitis, decreased libido, impotence, abnormal ejaculation.
For the skin: often 2% – alopecia, dermatoxerasia, increased sweating, eczema, seborrhea, ecchymosis, petechiae.
Allergic reactions: less than 2% – itching, skin rash, contact dermatitis, rarely – urticaria, angioedema, swelling of face, photosensitivity, anaphylaxis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome Lyell).
Laboratory findings: less than 2% – hyperglycemia, hypoglycemia, increased serum CPK, albuminuria.
Others: less than 2% – weight gain, gynecomastia, mammalgia, exacerbation of gout.
special instructions
Before therapy with atorvastatin patient must assign a standard hypolipidemic diet, which he must comply during the entire treatment period.
Use of inhibitors of HMG-CoA reductase to reduce the level of lipids in the blood can lead to changes in biochemical parameters that reflect liver function. liver function should be monitored before treatment and after 6 weeks, 12 weeks after the start of atorvastatin and improve after each dose, and periodically, e.g., every 6 months. Increased activity of “liver” enzymes in the blood serum may occur during therapy with atorvastatin. Patients who have received elevated enzymes should be kept under control until the enzyme levels return to normal. In that case, if the values ​​of alanine aminotransferase (ALT) or asparaginaminotransferazy (AST) is more than 3 times higher than the level of the upper allowable limit, it is advisable to reduce the dose of atorvastatin or discontinue treatment.
Atorvastatin should be used with caution in patients who abuse alcohol and / or have liver disease. Active liver disease or persistent elevation of transaminases unclear origin are contraindications to atorvastatin purpose.
Atorvastatin treatment can cause myopathy. Diagnosis myopathy (pain and weakness in the muscles in combination with increased activity of creatine phosphokinase (CK) more than 10 times compared with the upper limit of normal) should be discussed in patients with advanced myalgia, pain, or muscle weakness, and / or a marked increase of CPK activity. Patients should be warned that they should immediately inform your doctor about the appearance of unexplained pain or weakness in muscles, if accompanied by malaise or fever. Atorvastatin therapy should be discontinued if expressed CPK increase or in the presence of confirmed or suspected myopathy. The risk of myopathy in the treatment of other drugs in this class are increased while the use of cyclosporine, fibrates, erythromycin, nicotinic acid or azole antifungals. Many of these drugs inhibit metabolism mediated by cytochrome P450 3A4 and / or transport of drugs. Atorvastatin is biotransformed by the action of CYP 3A4. Assigning atorvastatin in combination with fibrates, erythromycin, immunosuppressive agents, azole antifungals or niacin in lipid-lowering doses should carefully weigh the potential benefits and risks of treatment and regularly monitor patients to detect pain or weakness in muscles, especially during the first months of treatment and in periods of high dose of any drug. In such situations, we can recommend periodic determination of CPK activity, although such control does not prevent the development of severe myopathy.
In the application of atorvastatin, as well as other agents of this class are described cases of rhabdomyolysis with acute renal failure caused by myoglobinuria. Atorvastatin should be suspended or completely cancel when the signs of a possible myopathy or presence of risk factors for renal failure with rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).
Before therapy with atorvastatin is necessary to try to gain control of hypercholesterolemia by adequate dietary therapy, physical activity, weight loss in obese patients, and the treatment of other conditions.
Patients should be warned that they should seek medical advice immediately if the appearance of unexplained pain or weakness in muscles, especially if accompanied by malaise or fever.
Effect on driving ability and work with the mechanisms
On the adverse effects of atorvastatin on the ability to drive and work with the mechanisms have not been reported.
Storage conditions
At a temperature of not higher than 25 degrees in the original packaging.
Keep out of the reach of children.
Dosing and Administration
Before the appointment of atorvastatin patient should be advised to standard lipid-lowering diet, which he must continue to observe during the treatment period.
The initial dose is an average of 10 mg of 1 time / day. The dose varies from 10 to 80 mg 1 time / day.
The drug can be taken at any time of the day with food or whatever mealtime. Dose picked for baseline cholesterol / LDL levels, the goal of therapy and individual effect. At the beginning of the treatment and / or when increasing the dose of atorvastatin is necessary every 2-4 weeks to monitor lipid levels in the blood plasma and accordingly correct the dose.
The primary hypercholesterolemia and mixed hyperlipidemia, and type III and IV according to Fredrickson.
In most cases, a destination dose of 10 mg drug Atorvastatin 1 time per day. Significant therapeutic effect is observed after 2 weeks, as a rule, the maximum therapeutic effect is usually seen within 4 weeks. With long-term treatment of this effect is maintained.
Homozygous familial hypercholesterolemia.
Назначают в дозе 80 мг (4 таблетки по 20 мг) 1 раз в сутки.
Применение препарата у больных с почечной недостаточностью и заболеваниями почек не оказывает влияние на уровень Аторвастатина в плазме крови или степень снижения содержания холестерина/ЛПНП при его применении, поэтому изменение дозы препарата не требуется.
При печеночной недостаточности дозы необходимо снижать (см. раздел «С осторожностью» и «Особые указания»).
При применении препарата у пожилых пациентов различий в безопасности, эффективности или достижении целей гиполипидемической терапии в сравнении с общей популяцией не отмечалось.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

ALSI PHARMA

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