Atorvastatin

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Atorvastatin

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Before prescribing Atorvastatin, the patient should be advised to recommend a standard lipid-lowering diet, which he must continue to follow throughout the entire period of therapy.

The drug is taken orally, at any time of the day with food, or regardless of meal times.

The dose is selected based on baseline levels of cholesterol / LDL, goals of therapy and individual effect. The initial dose is an average of 10 mg 1 time / day. The dose varies from 10 to 80 mg 1 time / day.

At the beginning of treatment and / or during the dose increase of the drug Atorvastatin, it is necessary every 2-4 weeks to control the content of lipids in the blood plasma and adjust the dose accordingly.

In case of primary hypercholesterolemia and mixed hyperlipidemia, as well as Fredrickson type III and IV hyperlipidemia, in most cases it is enough to administer the drug in a dose of 10 mg 1 time / day. A significant therapeutic effect is observed, as a rule, after 2 weeks; The maximum therapeutic effect is usually observed after 4 weeks. With long-term treatment, this effect persists.

With homozygous familial hypercholesterolemia, the drug is prescribed in a dose of 80 mg (4 tab. 20 mg) 1 time / day.

The use of the drug in patients with renal insufficiency and kidney disease does not affect the level of atorvastatin in the blood plasma or the degree of cholesterol / LDL cholesterol in its use, therefore, changing the dose of the drug is not required.

With hepatic insufficiency, the dose must be reduced.

When using the drug in elderly patients, there were no differences in safety, efficacy, or achievement of lipid-lowering therapy goals in comparison with the general population.

Adverse reactions

On the part of the nervous system: most often 2% - insomnia, dizziness; less than 2% - headache, asthenia, malaise, drowsiness, nightmares, paresthesias, peripheral neuropathy, amnesia, emotional lability, ataxia, facial paralysis, hyperkinesis, migraine, depression, hypoesthesia, loss of consciousness.

On the part of the senses: less often 2% - amblyopia, tinnitus, dry conjunctiva, accommodation disturbance, hemorrhage into the retina, deafness, glaucoma, parosmia, loss of taste, taste perversion.

Since the cardiovascular system: usually 2% - chest pain; less than 2% - palpitations, vasodilation symptoms, orthostatic hypotension, increased blood pressure, phlebitis, arrhythmia, angina pectoris.

From the hematopoietic system: less often 2% - anemia, lymphadenopathy, thrombocytopenia.

On the part of the respiratory system: more often 2% - bronchitis, rhinitis; less often 2% - pneumonia, dyspnea, exacerbation of bronchial asthma, nasal bleeding.

On the part of the digestive system: usually 2% - nausea; less 2% - 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, abnormal liver function, rectal bleeding, melena, gingival bleeding, tenesmus.

From the musculoskeletal system: usually 2% - arthritis; less often 2% - leg muscle spasms, bursitis, tendosynovitis, myositis, myopathy, arthralgia, myalgia, rhabdomyolysis, torticollis, muscle hypertonia, joint contractures.

On the part of the urinary system: usually 2% - peripheral edema; less often 2% - dysuria (including pollakiuria, nocturia, urinary incontinence or urinary retention, imperative urination to urinate, nephritis, hematuria, nephrorolithiasis.

On the part of the genital organs and the mammary gland: most often 2% are urogenital infections; less than 2% - vaginal bleeding, metrorrhagia, epididymitis, decreased libido, impotence, impaired ejaculation, gynecomastia, mastodynia.

On the part of the skin and subcutaneous tissues: more often 2% - alopecia, xerodermia, increased sweating, eczema, seborrhea, ecchymosis, petechiae.

Allergic reactions: less than 2% - pruritus, skin rash, contact dermatitis "rarely - urticaria, angioedema, swelling of the face, photosensitization, anaphylaxis, erythema multiforme exudative (includingStevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

On the part of laboratory parameters: less often 2% - hyperglycemia, hypoglycemia, increased serum CPK, albuminuria.

Other: less than 2% - weight gain, exacerbation of gout.

Contraindications

- active liver disease or increased activity of liver enzymes of unclear genesis (more than 3 times compared with VGN);

- liver failure (severity according to the Child-Pugh A and B classification);

- pregnancy;

- lactation period;

- age up to 18 years (efficacy and safety have not been established);

- Hypersensitivity to the drug.

Precautions should be prescribed for alcohol abuse, history of liver diseases, severe electrolyte imbalance, endocrine and metabolic disorders, hypotension, severe acute infections (sepsis), uncontrolled epilepsy, extensive surgical interventions, injuries, and skeletal muscle diseases.

Drug interactions

The risk of myopathy during treatment with other drugs of this class increases with the simultaneous use of cyclosporine, fibrates, erythromycin, antifungal agents related to azoles, and nicotinic acid.

With simultaneous use of the drug inside atorvastatin and a suspension containing magnesium and aluminum hydroxide, plasma concentrations of atorvastatin decreased by about 35%, but the degree of decrease in the concentration of cholesterol / LDL did not change.

With simultaneous use of atorvastatin does not affect the pharmacokinetics of antipyrine (phenazone), therefore, interaction with other drugs metabolized by the same cytochrome isoenzymes is not expected.

With simultaneous use of colestipol, the concentration of atorvastatin in the blood plasma decreased by approximately 25%. However, the lipid-lowering effect of the combination of atorvastatin and colestipol was superior to that of each drug separately.

With repeated administration of digoxin and atorvastatin in a dose of 10 mg Css of digoxin in the blood plasma did not change. However, when using digoxin in combination with atorvastatin at a dose of 80 mg / day, the concentration of digoxin increased by about 20%. Patients receiving digoxin in combination with atorvastatin should be monitored.

With simultaneous use of atorvastatin and erythromycin (500 mg 4 times / day) or clarithromycin (500 mg 2 times / day), which inhibit cytochrome CYP3A4, an increase in plasma concentration of atorvastatin was observed.

With simultaneous use of atorvastatin (10 mg 1 time / day) and azithromycin (500 mg 1 time / day), the concentration of atorvastatin in the blood plasma did not change.

Atorvastatin did not have a clinically significant effect on the concentration of terfenadine in the blood plasma, which is metabolized mainly by cytochrome CYP3A4; therefore, it seems unlikely that atorvastatin can significantly affect the pharmacokinetic parameters of other CYP3A4 substrates.

With simultaneous use of atorvastatin and a oral contraceptive containing norethindrone and ethinyl estradiol, there was a significant increase in the norethindrone and ethinyl estradiol AUC by about 30% and 20%, respectively. This effect should be considered when choosing an oral contraceptive for a woman receiving atorvastatin.

Simultaneous use with drugs that reduce the concentration of endogenous steroid hormones (including cimetidine, ketoconazole, spironolactone) increases the risk of reducing endogenous steroid horomones (caution should be exercised).

When studying the interaction of atorvastatin with warfarin and cimetidine signs of clinically significant interaction was not found.

With simultaneous use of atorvastatin 80 mg and amlodipine 10 mg, the pharmacokinetics of atorvastatin in an equilibrium state did not change.

No clinically significant undesirable interaction of atorvastatin and antihypertensive agents was noted.

The simultaneous use of atorvastatin with protease inhibitors, known as CYP3A4 inhibitors, was accompanied by an increase in plasma atorvastatin concentrations.

Pharmaceutical incompatibility is unknown.

Pregnancy and Lactation

Special instructions

Overdosage

• Brand name: Atenolol
• Active ingredient: Atenolol
• Dosage form: pills white or white with a grayish or creamy shade of color; light marbling is allowed.
• Manufacturer: PFK Obnovlenie
• Country of Origin: Russia