|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Atorvagen||coated tablets; 20 mg; 30 tabl.||Generics||10.61||
|Atorvagen||coated tablets; 40 mg; 30 tabl.||Generics||20.43||
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
A medicine that reduces blood lipids.
The active substance is Atorvastatin , a drug belonging to the statin group. Statins are used to reduce the levels of lipids (mainly cholesterol) in the blood. The risk of cardiovascular disease is associated with an increased level of blood lipids, especially with an increased concentration of a certain fraction of cholesterol occurring in the form associated with low density lipoproteins (LDL cholesterol). LDL cholesterol higher than or equal to 3 mmol / L (115 mg / dL) is considered to be abnormal. Increased LDL cholesterol in the blood is referred to as hypercholesterolemia. Statins work by inhibiting the activity of a key enzyme involved in the cholesterol synthesis process (this enzyme is reductase of 3-hydroxy-3-methyl-glutaryl-coenzyme A, in short HMG-CoA reductase). Inhibition of this enzyme in liver cells limits the synthesis of cholesterol and stimulates liver cells to increase the uptake of LDL cholesterol molecules from the blood. As a result, blood LDL cholesterol is effectively reduced. Statins are used in the treatment of hypercholesterolemia and prophylactically in people with risk factors for cardiovascular diseases. They reduce the risk of cardiovascular events (myocardial infarction, stroke, death related to ischemic heart disease).
The preparation is indicated:
• in adults, adolescents and children over 10.to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides in the treatment of primary hypercholesterolaemia, familial heterozygous hyperglycerolism or mixed hyperlipidemia, while maintaining diet when diet and other non-pharmacological treatments have proved inadequate;
• in adults to reduce the total cholesterol and LDL cholesterol levels in the treatment of familial homozygous hypercholesterolaemia in combination with diet and other treatments, or when other treatments are not available;
and in the prevention of:
• cardiovascular events in adults at high risk of the first cardiovascular event, in addition to treatments aimed at reducing other risk factors.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients.
The use of the preparation is contraindicated:
• in people with active liver disease or persistent elevations of liver transaminases with an undetermined cause
• in women of childbearing potential who do not use effective methods of preventing pregnancy
• in pregnant women
• in women who are breastfeeding.
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Before and during the treatment, your doctor will recommend regular liver function tests. If any abnormal liver function occurs, your doctor will advise you to perform appropriate check-ups of your liver's functions. The use of the preparation may increase the activity of liver enzymes (aminotransferases) determined in blood laboratory tests. In case of elevated aminotransferase activity, if the value determined is 3 times above the upper limit of normal, a doctor should be consulted who will recommend a dose reduction or discontinuation of the preparation. Exercise caution in the case of people consuming significant amounts of alcohol, as well as in patients who have had liver problems in the past.
Caution should be exercised in people who have recently had a transient ischemic attack or stroke. They are more likely to experience hemorrhagic stroke when using atorvastatin 80 mg. The doctor will individually assess the risk-benefit ratio of these patients and will decide if the preparation is appropriate.
Atorvastatin, like other statin drugs, may cause myopathy, i.e. muscle diseases manifested by pain, weakness or excessive muscle sensitivity to touch. These symptoms are accompanied by increased creatine kinase (CK) activity, detectable in laboratory tests. This kinase is an enzyme important for muscle work and its activity is a biochemical indicator of muscle damage. Myopathy may lead to rhabdomyolysis, a set of symptoms associated with damage and muscle breakdown. Rhabdomyolysis may be life-threatening. Rhabdomyolysis may be accompanied by acute renal failure , in very rare cases leading to death.
The risk of myopathy and / or rhabdomyolysis is dependent on the dose of medicine used.
If during the treatment period you notice increased muscle sensitivity to touch (tenderness), pain, cramps or muscle weakness, you should immediately consult a doctor, especially if the symptoms are accompanied by fatigue or fever. These symptoms may occur without complications but may also be associated with the onset and development of myopathy and may require discontinuation of the preparation.
Some patients have an increased risk of rhabdomyolysis. In these people, it is necessary to determine the CK activity before starting treatment with statins. Particular care should be taken in patients:
• in old age (after 70 years of age)
• with kidney problems
• with muscle diseases or family-related hereditary diseases
• who have previously had statins or fibrates that have caused muscle damage
• in which the blood level of the drug may be increased, for example as a result of interaction with other medicines
• with history of liver disease and / or alcohol abuse
• with specific genetic conditions.
If you know or suspect you are in any of the above groups, inform your prescriber before using this medicine. Your doctor will assess the risk-benefit ratio of treatment. It may recommend you more frequent laboratory tests and strict control.
Before starting treatment, and if you suspect myopathy, your doctor will prescribe blood creatine kinase (CK) in your blood. This examination should not be performed after considerable physical effort. If the CK activity significantly (more than 5 times) exceeds the upper limit of normal values, the measurement should be repeated after 5-7 days to confirm the results. In the case of significantly increased CK activity, no atorvastatin treatment should be initiated. In patients undergoing treatment, the doctor may recommend discontinuation of the preparation. If symptoms suggestive of myopathy disappear and CK activity returns to normal, your doctor may recommend continuing with the lowest dose and with particular caution.
The risk of myopathy and rhabdomyolysis increases significantly in the case of parallel use of drugs that strongly inhibit CYP3A4 enzyme activity, such as Itraconazole , ketoconazole, HIV protease inhibitors, delavirdine, HCV protease inhibitors, Erythromycin , Clarithromycin , telithromycin, nefazodone, stiripentol, and also in the case of parallel use of gemfibrozil and other fibrates, niacin, cyclosporine, ezetimibe. Whenever possible, your doctor will recommend the use of alternative medicines that do not interact with atorvastatin or special precautions (eg, reduction of the dose of atorvastatin, clinical monitoring).
The simultaneous use of atorvastatin and fusidic acid is not recommended. Statin therapy should be discontinued while using fusidic acid; re-use of statins can be started 7 days after the last dose of fusidic acid,
When the preparation is used or after its completion, necrotic myopathy with an immune base can very rarely occur. Its symptoms are muscle weakness and increased blood creatinine kinase, which persists despite the end of treatment. Exercise caution and consult a physician if muscle weakness occurs.
There is insufficient data on the effects of the preparation on the development of children.
The use of statin preparations may be associated with the occurrence of interstitial lung disease, especially during long-term use. If you experience symptoms that may indicate the development of interstitial pneumonia (shortness of breath, cough without expectoration, deterioration of general health, dizziness, weight loss and fever), please consult your doctor. Your doctor will consider the need to stop using the product.
Statin drugs may increase blood Glucose , and in some patients with a high risk of developing diabetes in the future, they may cause hyperglycaemia, even if properly managed. However, the benefits of statin reduction in vascular risk outweigh this threat. People with a high risk of diabetes (fasting glucose 5.6-6.9 mmol / l, BMI greater than 30 kg / m2, increased triglycerides, hypertension) should be subject to special clinical and biochemical monitoring.
Additional information about the other ingredients of the preparation:
• the product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use this preparation.
Does this preparation affect the ability to drive vehicles?
The preparation has no significant effect on the ability to drive vehicles and operate machinery / machines.
The preparation is in the form of coated tablets. It is intended for oral use. Do not exceed the recommended doses, because it will not increase the effectiveness of the drug and may harm your health and life.If you have any doubts about the use of the preparation, consult your doctor.
The tablets should be taken once a day, regardless of the time of day, regardless of the meal. The doctor will determine the individual dose depending on the clinical situation (baseline and target LDL cholesterol) and the patient's response to treatment. The usual starting dose is 10 mg a day. If necessary, the doctor may then gradually increase the dose. The maximum dose is 80 mg per day. During the treatment period, you should use (continue) a standard low cholesterol diet as well as maintain adequate physical activity.
Primary hypercholesterolaemia and mixed hyperlipidemia:
A daily dose of 10 mg is usually sufficient in the majority of patients. The effects of the preparation usually occur within 2 weeks of treatment, reaching a maximum within 4 weeks of treatment, after which they remain constant during the maintenance treatment.
Family heterozygote hypercholesterolemia:
The starting dose is usually 10 mg 1 once a day; then your doctor will adjust your dose individually (your doctor may gradually increase your dose to 40 mg, and in some cases to a maximum daily dose of 80 mg or a 40-mg dose a day including a bile acid-binding medicine).
Familial homozygous hypercholesterolemia:
The doctor will individually adjust the dosage (10-80 mg daily).
Prevention of cardiovascular events:
The starting dose is usually 10 mg 1 once a day; if necessary, the doctor will gradually increase the dose.
In patients with impaired renal function, there is no need to modify the dosage.
Patients with hepatic impairment should be cautious. In patients with active liver disease, the use of the preparation is contraindicated.
Elderly patients do not need to adjust their dosage.
Children and adolescents after the age of 10:
In this age group, treatment may only be conducted under the supervision of a specialist doctor experienced in the treatment of hyperlipidemia in children. The usual starting dose is 10 mg a day. If necessary, your doctor may increase the dose to 20 mg a day. There are no full data on the safety and efficacy of using higher doses.
Atorvastatin should not be used in children under 10 years of age.
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or planning to become pregnant, please inform your prescribing physician about this medicine.
The use of the preparation is contraindicated in pregnant women, women trying to get pregnant, women who suspect that they are pregnant and breast-feeding women.
If you suspect you are pregnant, consult your doctor, as treatment should be interrupted during pregnancy.
Women of childbearing potential using the preparation should strictly consult a physician regarding the use of an effective method of contraception during the treatment period.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
In particular, inform your doctor if you use:
• drugs that strongly inhibit CYP3A4 enzyme activity, such as itraconazole, ketoconazole, HIV protease inhibitors, delavirdine, HCV protease inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone, stiripentol
• gemfibrozil, other fibrates
• niacin (nicotinic acid)
• fusidic acid
• efavirenz, rifampicin, preparations containing St John's wort
• oral contraceptives
• anticoagulants such as Warfarin , phenprocoumon, acenocoumarol.
Atorvastatin is metabolised by the cytochrome P450 3A4 isoenzyme. Parallel use of drugs that inhibit cytochrome P450 3A4 isoenzyme activity such asitraconazole, ketoconazole, HIV protease inhibitors, delavirdine, HCV protease inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone, stiripentol significantly increase blood levels of atorvastatin and the risk of myopathy and rhabdomyolysis. If possible, your doctor will prescribe alternative medicines that do not interact with atorvastatin or take special precautions (eg reducing the dose of atorvastatin used, clinical monitoring).
It is possible that atorvastatin interacts with other drugs that affect the activity of the cytochrome P450 isoenzyme 3A4. The concomitant use of amiodarone, diltiazem or verapamil may increase the concentration of atorvastatin in the blood and thus increase the risk of myopathy and rhabdomyolysis. If you need to use diltiazem in parallel, your doctor will recommend clinical monitoring.
During the treatment period, grapefruit juice should be avoided (grapefruit juice inhibits the activity of the cytochrome P450 3A4 isoenzyme).
The use of atorvastatin with drugs that increase the activity of the cytochrome P450 3A4 isoenzyme (eg efavirenz, rifampicin, St. John's wort) may cause a decrease in atorvastatin levels in the blood.
If it is necessary to use ciclosporin in parallel, the dose of atorvastatin should not exceed 10 mg daily and the patient should be monitored.
The concurrent use of gemfibryzol or other fibrates increases the risk of myopathy and rhabdomyolysis. If it is necessary to use it in parallel, the patient should remain under strict control.
When used in parallel, ezetimibe may increase the risk of myopathy. If it is necessary to use it in parallel, the patient should be closely monitored.
Colestipol may reduce the concentration of atorvastatin and its active metabolites in the blood.
Parallel fusidic acid may significantly increase the risk of rhabdomyolysis. Patients should be closely monitored, it may be necessary to temporarily stop using atorvastatin (as prescribed by a doctor).
Parallel application of atorvastatin and colchicine increases the risk of myopathy; be careful.
The parallel use of digoxin and atorvastatin requires proper monitoring of the patient.
Parallel use of oral contraceptives may result in increased levels of steroid hormones in the blood (progesterone and estrogen derivatives). Consult your doctor (dosage may need to be changed).
Atorvastatin may increase the effect of anticoagulants of coumarin derivatives (eg warfarin); in patients using such combination therapy it is necessary to determine the blood coagulation parameters (prothrombin time) at the frequency recommended by the physician (often at the beginning of treatment and when the dose of atorvastatin is changed or when atorvastatin is discontinued).
The above data on the interaction of the preparation with other medicines come from studies conducted in adults. The interaction of the preparation with other medicines in children has not been studied.
Like all medicines, Atorvagen can also cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Common side effects may include gastrointestinal disturbances (constipation, bloating, indigestion, nausea, diarrhea), hyperglycemia, laryngeal and laryngeal pain, nosebleeds, throat and nasal mucous membranes, insomnia, headaches, reactions allergic reactions (skin rash and pruritus), muscle and joint pain, back pain, swelling of the joints, muscle spasms and increased hepatic transaminases detected in laboratory tests, increased creatine kinase (CK) activity. Uncommon: lack of appetite, vomiting, hypoglycemia, weight gain, pancreatitis, hepatitis, abdominal pain, memory problems, nightmares, insomnia, sensory disturbances, stinging or tingling sensation (paresthesia), dizziness, taste disturbances, blurred vision , tinnitus, neck pain, muscle fatigue, alopecia, urticaria, rash, pruritus, impotence, chest pain, weakness, peripheral edema, fever, fatigue, the presence of white blood cells in the urine.Rare: thrombocytopenia, peripheral neuropathy, visual disturbances, angioneurotic edema (swelling of the face, tongue, throat that may impede breathing), severe skin reactions (Stevens and Johnson syndrome, erythema multiforme and toxic melanoma), myositis, myopathy (muscle diseases), rhabdomyolysis (a set of symptoms associated with the breakdown of muscle tissue), bile retention (cholestasis). Very rare: Anaphylactic reactions that may be life threatening, hearing loss, liver failure, gynecomastia. Isolated cases of interstitial lung disease. In addition, necrotic myopathy with an immune base can occur with unknown frequency.
Data on the occurrence of side effects in children are limited. Probably their type and frequency are similar to those in adults.
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