Atorvastatin-Teva
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Prices in online pharmacies:
from 176 rub.
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Atorvastatin-Teva is a lipid-lowering drug that inhibits HMG-CoA reductase.
Release form and composition
Dosage form - film-coated tablets: almost white or white, capsule-like, engraved on both sides: on one side - "93", on the other - "7310", "7311", "7312" or "7313" (10 pcs. in a blister, in a carton box of 3 or 9 blisters).
1 tablet contains:
- active substance: atorvastatin calcium - 10.36 mg, 20.72 mg, 41.44 mg or 82.88 mg, which is equivalent to 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin, respectively;
- auxiliary components: eudragit (E100) (copolymer of dimethylaminoethyl methacrylate, butyl methacrylate, methyl methacrylate), lactose monohydrate, alpha-tocopherol macrogol succinate, povidone, croscarmellose sodium, sodium stearyl fumarate;
- composition of the film shell: opadry YS-1R-7003 (polysorbate 80, hypromellose 2910 3cP (E464), titanium dioxide, hypromellose 2910 5cP (E464), macrogol 400).
Indications for use
- heterozygous familial and nonfamilial hypercholesterolemia, primary hypercholesterolemia, and mixed (combined) hyperlipidemia (types IIa and IIb according to Fredrickson's classification) in combination with a hypolipidemic diet aimed at lowering elevated levels of total cholesterol, low-density lipoprotein cholesterol, triple lipoprotein (LDL) cholesterol (LDL) increased high-density lipoprotein (HDL) cholesterol;
- dysbetalipoproteinemia (type III according to Fredrickson's classification), increased serum triglycerides (type IV according to Fredrickson's classification) - with ineffective diet therapy;
- homozygous familial hypercholesterolemia - to lower LDL cholesterol and total cholesterol levels with insufficient effectiveness of diet therapy and other non-pharmacological treatments.
Contraindications
- liver failure (classes A and B according to the Child-Pugh classification);
- active liver pathologies, increased activity of liver enzymes (more than 3 times higher than the upper limit of normal) of unknown origin;
- the period of pregnancy and breastfeeding;
- age up to 18 years;
- hypersensitivity to the components of the drug.
It is recommended to prescribe Atorvastatin-Teva with caution if a history of liver disease is indicated, patients with arterial hypotension, alcohol dependence, metabolic and endocrine disorders, severe electrolyte imbalance, severe acute infection (sepsis), skeletal muscle diseases, uncontrolled epilepsy, major surgical interventions, injuries.
Method of administration and dosage
The tablets are taken orally 1 time per day, regardless of food intake at any time of the day.
The doctor prescribes the dose individually, taking into account the initial level of LDL cholesterol, the goal of therapy and the patient's response to the drug.
Taking Atorvastatin-Teva should be accompanied by regular (1 time every 2-4 weeks) monitoring of plasma lipids, based on the data obtained, adjust the dose.
Dose adjustments should be made no more than once every 4 weeks.
The maximum daily dose is 80 mg.
Recommended daily dosage:
- heterozygous familial hypercholesterolemia: the initial dose is 10 mg, adjusting the dose every 4 weeks, it should be gradually increased to 40 mg. When treating at a dose of 40 mg, the drug is taken in combination with a bile acid sequestrant, with monotherapy, the dose is increased to 80 mg;
- primary hypercholesterolemia and mixed (combined) hyperlipidemia: 10 mg, as a rule, the dose provides the necessary control of lipid levels. A significant clinical effect usually occurs after 4 weeks and persists during long-term use of the drug;
- homozygous familial hypercholesterolemia: 80 mg.
With ischemic heart disease and a high risk of cardiovascular complications, treatment is recommended with the following lipid correction goals: total cholesterol less than 5 mmol / L (or less than 190 mg / dL) and LDL cholesterol less than 3 mmol / L (or less than 115 mg / dl).
With hepatic impairment, the patient may need to prescribe lower doses or discontinue the drug.
In renal failure, dose adjustment is not required, since the drug does not change the concentration in the blood plasma.
Side effects
- from the nervous system: often - headache; infrequently - a violation of taste, dizziness, insomnia, paresthesia, amnesia, nightmares, hypesthesia; rarely, peripheral neuropathy; frequency unknown - depression, decreased or loss of memory, sleep disturbance;
- from the immune system: often - allergic reactions; very rarely - anaphylactic shock, angioedema;
- from the gastrointestinal tract: often - nausea, dyspepsia, diarrhea, flatulence, constipation; infrequently - abdominal pain, belching, pancreatitis, vomiting;
- on the part of the musculoskeletal system and connective tissue: often - pain in the limbs, swelling in the joints, myalgia, back pain, arthralgia, muscle spasm; infrequently - muscle weakness, neck pain; rarely - rhabdomyolysis, myopathy, myositis, tendinopathy with tendon rupture; frequency unknown - immune-mediated necrotizing myopathy;
- from the hepatobiliary system: infrequently - hepatitis; rarely - cholestasis; very rarely - liver failure;
- from the lymphatic system and the blood system: rarely - thrombocytopenia;
- from the respiratory system, chest and mediastinal organs: often - nosebleeds, pain in the pharyngeal-laryngeal region, nasopharyngitis; frequency unknown - interstitial lung pathology;
- laboratory parameters: often - an increase in the activity of creatine kinase in the blood serum, hyperglycemia; infrequently - hypoglycemia, leukocyturia, increased activity of liver enzymes; the frequency is unknown - an increase in the level of concentration of glycosylated hemoglobin;
- from the organ of hearing, labyrinth disorders: infrequently - tinnitus; very rarely - hearing loss;
- on the part of the organ of vision: infrequently - decreased vision clarity; rarely - visual impairment;
- dermatological reactions: infrequently - itchy skin, rash, alopecia, urticaria; rarely - erythema multiforme, bullous dermatitis; very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome;
- from the reproductive system: very rarely - gynecomastia; frequency unknown - sexual dysfunction;
- general disorders: infrequently - weakness, asthenia, fever, chest pain, peripheral edema, weight gain, lethargy, anorexia.
special instructions
Preliminary hypercholesterolemia should be controlled by diet therapy, increased physical activity, in obese patients - by reducing body weight and treating other conditions.
The use of Atorvastatin-Teva involves adherence to the standard hypocholesterol diet, which is prescribed by the doctor simultaneously with the drug.
Inhibitors of HMG-CoA reductase can affect changes in the biochemical parameters of liver function throughout therapy. Therefore, treatment should be accompanied by monitoring of liver function with the following frequency: before starting therapy, after each dose increase, then 6 and 12 weeks after the start of admission, then every six months. Patients with elevated enzyme levels should be monitored by a physician until levels return to normal. If the values of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are persistently exceeded by more than 3 times the upper limit of the norm, it is recommended to reduce or cancel the drug.
An undesirable effect of taking atorvastatin may be the development of myopathy, its symptoms include an increase in creatine phosphokinase (CPK) by 10 times or more compared to the upper limit of the norm in combination with pain and muscle weakness. Patients should be informed about the need for immediate medical attention in case of unexplained pain and weakness in the muscles, accompanied by fever and malaise. Therapy should be discontinued if a marked increase in CPK activity persists or a suspected or confirmed myopathy is present.
Against the background of the use of atorvastatin, rhabdomyolysis may develop with acute renal failure caused by myoglobinuria. In case of severe acute infection, arterial hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disturbances, uncontrolled convulsions, or the appearance of other risk factors for the development of renal failure in rhabdomyolysis, therapy with Atorvastatin-Teva is recommended to be discontinued.
Taking the drug does not affect the patient's ability to drive vehicles and mechanisms.
Drug interactions
The combination of HMG-CoA reductase inhibitors with fibrates, cyclosporine, macrolide antibiotics (including erythromycin), nicotinic acid, azole antifungal agents increases the risk of myopathy or can cause rhabdomyolysis, accompanied by renal failure due to myoglobinuria. Therefore, it is recommended to make a balanced decision, comparing the benefits and risks of therapy, to prescribe atorvastatin simultaneously with the indicated agents.
It is recommended to prescribe with extreme caution in combination with cyclosporine, HIV protease inhibitors, macrolide antibiotics (including erythromycin, clarithromycin), azole antifungal drugs, nefazodone and other inhibitors of the CYP3A4 isoenzyme, since it is possible to increase the concentration of atorvastatin in the blood plasma and develop symptoms of drug interactions …
With the simultaneous use of Atorvastatin-Teva:
- cimetidine, ketoconazole, spironolactone and other drugs that reduce the concentration of endogenous steroid hormones increase the risk of a decrease in the level of endogenous steroid hormones;
- oral contraceptives containing ethinyl estradiol and norethisterone significantly increase the concentration of active substances in the blood plasma;
- suspensions containing aluminum hydroxide and magnesium, reduce (by about 35%) the concentration of atorvastatin in the plasma, without changing the degree of decrease in the level of LDL;
- digoxin can increase the level of its concentration in blood plasma;
- warfarin causes a slight decrease in prothrombin time at the beginning of therapy, during the next 15 days the indicator is restored to normal;
- cyclosporine and other P-glycoprotein inhibitors can increase the bioavailability of atorvastatin;
- terfenadine does not alter plasma concentration.
Combination therapy with colestipol has a more pronounced effect on lipids than taking either drug alone, although the level of atorvastatin in blood plasma is reduced by about 25%.
You should limit the intake of grapefruit juice during treatment, since a large amount of juice increases the concentration of atorvastatin in plasma.
The drug does not affect the pharmacokinetics of phenazone and other drugs metabolized by the same cytochrome isoenzymes.
The effect of rifampicin, phenazone and other drugs inducing the CYP3A4 isoenzyme on Atorvastatin-Teva has not been established.
Consideration should be given to the possibility of a clinically significant interaction with the use of class III antiarrhythmics (including amiodarone).
Studies have not revealed the interaction of atorvastatin with cimetidine, amlodipine, antihypertensive drugs.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Atorvastatin-Teva: prices in online pharmacies
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Drug name Price Pharmacy |
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Atorvastatin-Teva 10 mg film-coated tablets 30 pcs. RUB 176 Buy |
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Atorvastatin-Teva tablets p.p. 10mg 30 pcs. 203 r Buy |
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Atorvastatin-Teva 20 mg film-coated tablets 30 pcs. 247 r Buy |
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Atorvastatin-Teva 40 mg film-coated tablets 30 pcs. 509 RUB Buy |
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Atorvastatin-teva tab. p.p. 40mg n30 558 r Buy |
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
