Pharmacological Effects:
Means of lipid-lowering statin group. Selective competitive inhibitor of HMG-CoA reductase – an enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonic acid, a precursor of sterols, including cholesterol. TG and cholesterol in the liver included in the composition of VLDL are delivered to the plasma and transported to peripheral tissues. LDL formed from VLDL during the interaction with LDL receptors. Reduces levels of cholesterol and lipoproteins in the plasma due to the oppression of HMG-CoA reductase, cholesterol synthesis in the liver and increase the number of “liver” of LDL receptors on the cell surface, which leads to increased capture and catabolism of LDL. Reduces LDL, causes marked and persistent increase in activity of LDL receptors. Lowers cholesterol in patients with homozygous familial hypercholesterolemia, which usually defies LS lipid-lowering therapy. Lowers total cholesterol of 30-46%, LDL – by 41-61%, apolipoprotein B – at 34-50% and TG – by 14-33%, a rise in cholesterol, HDL (high density lipoproteins) and apolipoprotein A. dose-dependent decreases the level of LDL in patients with homozygous hereditary hypercholesterolemia resistant to other lipid-lowering therapy LS. Reliably reduces the risk of ischemic complications (including development of death from myocardial infarction) by 16%, the risk of rehospitalization for angina, accompanied by signs of myocardial ischemia – 26%. Not carcinogenic and mutagenic action.
Indications:
The primary hypercholesterolemia (heterozygous familial hypercholesterolemia and non-family, according to Frederickson Type IIa), combined (mixed) hyperlipidaemia (Frederickson types IIb on and III), disbetalipoproteinemiya (by Frederickson Type III) (as an adjunct to diet), family endogenous hypertriglyceridemia (Frederickson on type IV), resistant to dietary treatments. Homozygous hereditary hypercholesterolemia (as a supplement to hypolipidemic therapy, including LDL autohemotransfusion purified from the blood). Diseases of the CAS against the background of dyslipidemia, secondary prevention to reduce the overall risk of death, myocardial infarction and rehospitalization for angina.
Contraindications:
Hypersensitivity, active liver disease (including chronic active hepatitis, chronic alcoholic hepatitis), increased activity of “liver” of transaminases (more than 3 times) of unknown origin, hepatic impairment (severity of A and B on the scale of Child-Pyuga) , pregnancy, laktatsii.C caution. Serious violations of electrolyte balance, endocrine and metabolic disorders, alcoholism, liver disease history, hypotension, severe acute infections, uncontrollable seizures, extensive surgery, trauma, children’s age (efficacy and safety of application is not installed).
Side effects:
From the nervous system: often 2% – insomnia, dizziness, rarely 2% – headache, fatigue, malaise, somnolence, abnormal dreams, amnesia, paresthesia, peripheral neuropathy, amnesia, emotional lability, ataxia, paralysis of the facial nerve, hyperkinesis, depression , hyperesthesia, loss of consciousness. From the senses: at least 2% – amblyopia, tinnitus, dryness of the conjunctiva, disturbance of accommodation, eye hemorrhage, deafness, glaucoma, parosmiya, loss of taste, taste perversion. From the CCC: usually 2% – pain in the chest, rarely 2% – palpitation, vasodilatation, migraine, postural hypotension, increased blood pressure, phlebitis, arrhythmia, angina. The part of the hemopoietic system: at least 2% – anemia, lymphadenopathy, thrombocytopenia. On the part of the respiratory system: often 2% – bronchitis, rhinitis, at least 2% – pneumonia, dyspnea, bronchial asthma, nasal bleeding. From the digestive system: often 2% – nausea, rarely 2% – heartburn, constipation or diarrhea, flatulence, stomachodynia, abdominal pain, anorexia, decreased or increased appetite, dry mouth, eructation, dysphagia, vomiting, stomatitis, esophagitis, glossitis, erosive and ulcerative lesions of the oral mucosa, gastroenteritis, hepatitis, biliary colic, cheilitis, duodenal ulcer 12 ulcers, pancreatitis, cholestatic jaundice, abnormal liver function, rectal bleeding, melena, bleeding gums, tenesmus. The part of the locomotor system: often 2% – arthritis, rarely 2% – spasms of the leg muscles, bursitis, peritendinitis, myositis, myopathy, arthralgia, myalgia, rhabdomyolysis, torticollis, muscular hypertonicity, contracture of joints. On the part of the digestive system: often 2% – urogenital infections, peripheral edema, rarely 2% – dysuria (including thamuria, nocturia, urinary incontinence or urinary retention, compelling urge to urination), 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: at least 2% – skin itching, skin rashes, contact dermatitis, rare – urticaria, angioedema, face edema, photosensitivity, anaphylaxis, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome Lyell). Laboratory findings: at least 2% – hyperglycemia, hypoglycemia, increased serum CPK, albuminuria. Other: at least 2% – weight gain, gynecomastia, mammalgia, exacerbation podagry.Peredozirovka. Treatment: No specific antidote, being symptomatic therapy. Hemodialysis is ineffective.
Dosage and administration:
Inside, take at any time of day, regardless of the meal. Initial dose – 10 mg 1 time per day. Change dose at intervals of not less than 4 weeks. The maximum daily dose – 80 mg in 1 step. When the primary hypercholesterolemia and combined (mixed) hyperlipidemia appoint 10 mg 1 time a day. The effect is manifested within 2 weeks, the maximum effect is observed within 4 weeks. In homozygous familial hypercholesterolemia prescribed 80 mg 1 time per day (reduced cholesterol content of 18-45%). Before therapy the patient must assign a standard hypocholesterolemic diet, which he must comply during treatment.
Cautions:
Atorvastatin may cause an increase in serum CPK, which should be taken into account in the differential diagnosis of retrosternal pain. Should regularly monitor liver function tests before starting treatment, at 6 and 12 weeks after the start of the drug or after increasing the dose, and periodically during the entire period of application (to the complete normalization of the patients whose transaminase levels higher than normal). Improved performance of “liver” of transaminases is observed mainly in the first 3 months of treatment. It is recommended to cancel or reduce the dose of medication at higher rates AST and ALT more than 3 times. Should temporarily halt the use of atorvastatin in the development of clinical symptoms, implying the presence of acute myopathy, or in the presence of factors predisposing to the development of acute renal failure on the background of rhabdomyolysis (severe infection, hypotension, traumatic surgical interventions, trauma, metabolic, endocrine, or electrolyte disturbances expressed). Patients should be warned that they should immediately seek medical attention at the appearance of unexplained pain or weakness in muscles, especially if accompanied by malaise or fever. Women of childbearing age should use reliable methods of contraception. Children experience with atorvastatin at a dose of 80 mg / day is limited. Controlled studies in children are not held, but adverse reactions when using the drug in 8 children older than 9 years old when the family homozygous hypercholesterolemia at a dose of 80 mg / day for 1 year were not found.
Interaction:
When concomitant administration of cyclosporin, fibrates, erythromycin, clarithromycin, immunosuppressive, anti-LS (relating to azoles) and nicotinamide concentration of atorvastatin in plasma (and the risk of myopathy) increases. Antacids reduce the concentration of 35% (effect on LDL cholesterol level does not change). Concomitant use of atorvastatin with the protease inhibitors, known as inhibitors of cytochrome CYP3A4, accompanied by an increase in plasma concentrations of atorvastatin. In the application of digoxin in combination with atorvastatin at a dose of 80 mg / day of digoxin concentration increased by approximately 20%. Increases the concentration of 20% (in the appointment with atorvastatin at a dose of 80 mg / day) oral contraceptive containing norethindrone and ethinyl estradiol. Lipid-lowering effect of the combination with colestipol than that for each drug separately.
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