Description
The Latin name
ATORVASTATIN-SZ
Release form
Tablets, film-coated pink, round, biconvex in cross section, the core of the tablet is white or almost white.
packaging 30 pcs
Pharmacological action
Hypolipidemic drug. 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 (Ch) in the liver are included in VLDL, enter the blood plasma and are transported to peripheral tissues. LDL is formed from VLDL during interaction with LDL receptors. Atorvastatin reduces plasma levels of cholesterol and lipoproteins, inhibiting HMG-CoA reductase, synthesis of cholesterol in the liver and increasing the number of LDL receptors in the liver on the cell surface, which leads to increased uptake and catabolism of LDL. Reduces the formation of LDL, causes a pronounced and persistent increase in the activity of LDL receptors.
Decreases LDL in patients with homozygous familial hypercholesterolemia, which is usually not amenable to hypolipidemic therapy. Reduces the level of total cholesterol by 30-46%, LDL – by 41-61%, apolipoprotein B – by 34-50% and TG – by 14-33% causes an increase in the level of HDL-C and apolipoprotein A. Dose-dependently reduces the level of LDL in patients with homozygous hereditary hypercholesterolemia, resistant to therapy with other lipid-lowering drugs.
Indications
– in combination with a diet to reduce elevated levels of total Chs, Chs-LDL, apolipoprotein B and TG and increase the levels of Chs-HDL in patients with primary hypercholesterolemia, heterozygous familial and non-familial hypercholesterolemia (combined type II) and IIb Fredrickson)
– in combination with a diet for the treatment of patients with elevated serum TG levels (Fredrickson type IV) and patients with dysbetalipoproteinemia (Fredrickson type III), in which diet therapy does not give an adequate effect of
– to reduce the levels of total Chs and Chs-LDL in patients with homozygous familial hypercholesterolemia, when diet therapy and other non-pharmacological methods of treatment are not effective enough.
Contraindications
– active liver disease
– increased activity of liver enzymes of unclear origin (more than 3 times compared with HBV)
– liver failure (classes A and B on the Child-Pugh scale)
– pregnancy lactation srdlpk – age under 18 years (effectiveness and safety have not been established)
– hypersensitivity to the components of the drug.
Caution should be used in patients with chronic alcoholism, with a history of liver disease, severe electrolyte imbalance, endocrine and metabolic disorders, arterial hypotension, severe acute infections (sepsis), uncontrolled epilepsy, extensive surgery, injuries, skeletal muscle diseases .
Use during pregnancy and lactation
Atorvastatin is contraindicated in pregnancy and lactation (breastfeeding).
It is not known whether atorvastatin is excreted in breast milk. Given the possibility of adverse events in infants, if necessary, use of the drug during lactation should decide on the termination of breastfeeding.
Women of reproductive age should use adequate contraceptive methods during treatment. Atorvastatin can be prescribed to women of reproductive age only if their probability of pregnancy is very low, and the patient is informed about the possible risk of treatment for the fetus.
Composition
1 tab.
atorvastatin (in the form of calcium salt) 10 mg
Excipients: lactose monohydrate (milk sugar) – 62 mg, calcium carbonate – 33 mg, povidone K30 (polyvinylpyrrolidone medium molecular weight) – 6 mg, croscarmellose sodium (primrose), 6.75 mg stearyl fumarate – 1.5 mg, colloidal silicon dioxide (aerosil) – 0.75 mg, microcrystalline cellulose – 30 mg.
Shell composition: Opadry II (polyvinyl alcohol, partially hydrolyzed – 2.2 mg, macrogol (polyethylene glycol) 3350 – 0.6175 mg, talc – 1 mg, titanium dioxide (E171) – 0.9585 mg, soy lecithin (E322) – 0.175 mg, aluminum varnish based on dye indigo carmine – 0.003 mg, aluminum varnish based on dye azorubine – 0.0255 mg, aluminum varnish based on dye crimson [Ponceau 4R] – 0.0205 mg).
Dosage and administration of
Before prescribing atorvastatin, the patient should be advised of a standard lipid-lowering diet, which he must follow throughout the treatment period.
The drug can be taken at any time of the day with food or regardless of the meal time. The dose is selected taking into account the initial levels of LDL-C, the purpose of therapy and the individual effect. At the beginning of treatment and / or during an increase in the dose of Atorvastatin, it is necessary to monitor plasma lipid levels every 2-4 weeks and adjust the dose accordingly.
The initial dose is on average 10 mg 1 time / day and subsequently varies from 10 mg to 80 mg 1 time / day.
With simultaneous use with cyclosporine, the daily dose of atorvastatin should not exceed 10 mg.
With primary hypercholesterolemia and mixed hyperlipidemia with an increase in serum TG (Fredrickson type IV), as well as with dysbetalipoproteinemia (Fredrickson type III), in most cases, a dose of 10 mg 1 time / day is sufficient. A significant therapeutic effect is usually observed after 2 weeks, the maximum therapeutic effect is usually observed after 4 weeks. With prolonged treatment, this effect persists.
With homozygous familial hypercholesterolemia, the drug is prescribed in a dose of 80 mg (4 tablets of 20 mg) 1 time / day.
In patients with renal failure and kidney disease, the concentration of atorvastatin in the blood plasma does not change, the degree of decrease in the content of LDL-C is maintained, therefore, a dose change is not required.
In case of liver failure, the dose should be reduced.
When using the drug in elderly patients, there were no differences in safety, effectiveness or achievement of the goals of lipid-lowering therapy in comparison with the general population.
Side effects of the
From the nervous system:> 1% – insomnia, dizziness <1% - headache, asthenia, malaise, drowsiness, nightmares, paresthesias, peripheral neuropathy, amnesia, emotional lability, ataxia, paralysis of the face , migraine, depression, hypesthesia, loss of consciousness. On the part of the sensory organs: <1% - amblyopia, tinnitus, dry conjunctiva, disturbed accommodation, hemorrhage in the retina, deafness, glaucoma, parosmia, loss of taste, perversion of taste. From the cardiovascular system:> 1% – chest pain <1% - palpitations, vasodilation symptoms, orthostatic hypotension, increased blood pressure, phlebitis, arrhythmia, angina pectoris. From the hemopoietic system: <1% - anemia, lymphadenopathy, thrombocytopenia. From the respiratory system:> 1% – bronchitis, rhinitis <1% - pneumonia, dyspnea, exacerbation of bronchial asthma, nosebleeds. From the digestive system:> 1% – nausea <1% - heartburn, constipation or diarrhea, flatulence, gastralgia, abdominal pain, decreased or increased appetite, dry mouth, belching, dysphagia, vomiting, stomatitis, esophagitis, glossitis, erosive and ulcerative lesions of the oral mucosa, gastroenteritis, hepatitis, biliary colic, cheilitis, duodenal ulcer, pancreatitis, cholestatic jaundice, impaired liver function, rectal bleeding, melena, bleeding gums, tenesmus. From the musculoskeletal system:> 1% – arthritis <1% - leg muscle cramps, bursitis, tendosynovitis, myositis, myopathy, arthralgia, myalgia, rhabdomyolysis, torticollis, muscle hypertonicity, joint contracture, joint swelling, tendonopathy (in some cases with tendon rupture). From the genitourinary system:> 1% – urogenital infections, peripheral edema <1% - dysuria (including pollakiuria, nocturia, urinary incontinence or urinary retention, mandatory urination), leukocyturia, nephritis, hematuria, vaginal bleeding , nephrourolithiasis, metrorrhagia, epididymitis, decreased libido, impotence, impaired ejaculation. Dermatological reactions:> 1% – alopecia, xeroderma, photosensitivity, increased sweating, eczema, seborrhea, ecchymosis, petechiae.
From the endocrine system: <1% - gynecomastia, mastodynia. From the side of metabolism: <1% - increase in body weight, exacerbation of gout. Allergic reactions: <1% - itchy skin, rash, contact dermatitis, rarely - urticaria, angioedema, facial edema, anaphylaxis, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome ) Laboratory indicators: <1% - hyperglycemia, hypoglycemia, increased serum CPK, albuminuria. overdose Treatment: no specific antidote, symptomatic therapy is performed. Hemodialysis is ineffective. Storage conditions The drug should be stored out of the reach of children, in a dry, dark place, at a temperature not exceeding 25 ° C. Expiration 3 years. Deystvuyuschee substances Atorvastatin from pharmacies Prescription dosage form dosage form tablets Northern Star, Russia
