Omnadren 250 results derived synthetically from a fermentation product Aspergillus tereus, is an inactive lactone, is hydrolyzed in the body to form the hydroxy-acid derivative. heterozygous familial and non-familial forms of hypercholesterolemia, with mixed hyperlipidemia when elevated cholesterol is a risk factor)
increases the content of high density omnadren 250 results .
onset of effect – 2 weeks from the start of the reception , the maximum therapeutic effect is achieved within 4-6 weeks. Action is maintained with continued treatment, at the termination of therapy cholesterol gradually returned to baseline.
Absorption – high. After oral administration, maximum concentration omnadren 250 results in plasma is reached after 1.3 – 2.4 hours, and reduced by 90% after 12 hours.
Relationship to plasma proteins – 95%.
It is metabolized in the liver, it has a “first pass effect” through the liver (hydrolyzed to form an active derivative – beta-hydroxyacids are found and other active and inactive metabolites). The half-life of the active metabolites is 1.9 hours.
Write mainly with feces (60%) in the form of metabolites.
Approximately 10-15% is excreted by the kidneys in an inactive form.
- Primary Hypercholesterolemia (type IIa and IIb), when poor diet low in cholesterol and other non-drug interventions (exercise and weight reduction) in patients with an increased risk of coronary atherosclerosis;
- combined hypercholesterolemia and hypertriglyceridemia, is not correctable special diet and exercise.
- for prevention of myocardial infarction, for reducing the risk of death, reducing the risk of cardiovascular disorders (stroke or transient ischemic attacks), slowing the progression of coronary atherosclerosis, reduce the risk of revascularization procedures.
- Hypersensitivity to omnadren 250 results or to other components of the preparation (including hereditary lactose intolerance), as well as several other statin drugs (HMG-CoA reductase) in history;
- liver disease in the active phase, a persistent increase in activity of “liver” enzymes of unknown etiology;
- diseases of skeletal muscles (myopathy);
- age of 18 years (effectiveness and safety have been established).
With careful preparation is prescribed to patients who abuse alcohol, transplant patients undergoing immunosuppressive treatment (due to the increased risk of rhabdomyolysis and renal failure); in conditions that can lead to severe renal insufficiency, such as hypotension, acute infectious diseases heavy currents expressed metabolic and endocrine disorders, disorders of water and electrolyte balance, surgery (including dental), or injury; patients with high or low tone of the skeletal muscles of unknown etiology; epilepsy.
Pregnancy and lactation
The drug should not be used during pregnancy. There are several reports of malformations in newborns whose mothers took omnadren 250 results.
Women of childbearing age who take medication should avoid conception. If in the course of treatment became pregnant, the drug should be immediately canceled and the woman warned of the possible danger to the fetus.
The data on the allocation of omnadren 250 results in breast milk are not available. If necessary Aktalipida appointment during lactation should be borne in mind that many drugs are excreted in breast milk, and there is a threat of severe reactions, so breast-feeding during treatment is not recommended.
Dosing and Administration
Before the start of treatment, patients should assign standard, hypolipidemic diet, which must be observed during the treatment.
The drug is administered orally 1 time a day in the evening, drinking plenty of water.
Time of the drug should not be combined with the meal.
The recommended dose for the treatment of hypercholesterolemia varies from 10 to 80 mg 1 time per day in the evening. The recommended starting dose for patients with hypercholesterolemia is 10 mg.
The maximum daily dose -. 80 mg of
change (selection) the dose should be performed at intervals of 4 weeks. In most patients, the optimal effect is achieved by taking the drug at doses up to 20 mg per day.
In patients with homozygous familial hypercholesterolemia recommended daily dose is 40 mg 1 time per day in the evening or 80 mg in three divided doses (20 mg in the morning, 20 mg in the afternoon and 40 mg in the evening).
For the treatment of patients with coronary heart disease (CHD) or at high risk for CHD Aktalipida effective doses are 20-40 mg per day. Therefore, the recommended initial dose in these patients – 20 mg per day. Changes (selection) the dose should be performed at intervals of 4 weeks, if necessary, the dose can be increased to 40 mg per day. If the LDL cholesterol content of less than 75 mg / dL (1,94mmol / L), total cholesterol levels – less than 140 mg / dL (3.6 mmol / l), the dose should be reduced.
In elderly patients and in patients with mild or moderate renal impairment (creatinine clearance less than 30 mL / min) or receiving cyclosporin, danazol, gemfibrozil or other fibrates (except fenofibrate), niacin in lipid-lowering doses (≥ 1g / day) in combination with omnadren 250 results maximum recommended dose should not exceed 10 mg per day.
in patients taking amiodarone or verapamil simultaneously with the drug, the daily dose should not exceed 20 mg.
The digestive system: possible abdominal pain, constipation, flatulence, nausea, diarrhea, pancreatitis, vomiting, hepatitis, increased activity of “liver” enzymes, alkaline phosphokinase, and creatine phosphokinase (CPK). The nervous system and sensory organs: asthenic syndrome, dizziness, headache , insomnia, muscle cramps, paresthesia, peripheral neuropathy, blurred vision, taste disturbance.Allergic and immunopathological reactions: angioedema, polymyalgia rheumatica, vasculitis, thrombocytopenia, increased erythrocyte sedimentation rate, fever, arthritis, rash, photosensitivity, skin redness, flushing, shortness of breath , lupus-like syndrome, eosinophilia. Dermatological reactions: rare skin rash, pruritus, alopecia, dermatomyositis. From the musculoskeletal system: myalgia, myopathy, muscle cramps, weakness, rhabdomyolysis. Other: anemia, palpitation, acute renal failure (due to rhabdomyolysis) , reduced potency.
None of the known cases of overdose (maximum dose of 450 mg adopted) specific symptoms have been identified.
Treatment: Induce vomiting, activated charcoal. Symptomatic therapy. It is necessary to control the function of the liver and kidneys, creatine kinase levels in the blood serum.
With the development of myopathy and rhabdomyolysis with acute renal failure (rare but severe side effects), stop taking the drug and the patient enter a diuretic and sodium bicarbonate (intravenous infusion). If necessary hemodialysis shown.
Rhabdomyolysis can cause hyperkalemia, which can eliminate the intravenous administration of calcium chloride or calcium gluconate, glucose infusion with insulin, or using potassium ion exchangers, in severe cases, by dialysis.
Interaction with other drugs
Cytotoxic agents, antifungal drugs (ketoconazole, itraconazole), fibrates, high doses of nicotinic acid, immunosuppressants, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone increase the risk of myopathy.
Cyclosporin or danazol: risk of myopathy / rhabdomyolysis increases when coadministered cyclosporin or danazol with higher doses of omnadren 250 results.
other lipid-lowering drugs that can cause myopathy development: the risk of myopathy is increased by concomitant use of other lipid-lowering drugs that are not potent inhibitors of CYP3A4, but can cause myopathy in monotherapy conditions. Such as gemfibrozil and other fibrates (except fenofibrate), and niacin (nicotinic acid) at a dose of ≥ 1,0 g per day.
Amiodarone and verapamil: risk of myopathy increased when co-administered with verapamil or amiodarone high doses of omnadren 250 results.
Diltiazem: Risk myopathy slightly increased in patients receiving diltiazem simultaneously with the drug at a dose of 80 mg.
omnadren 250 results potentiates the action of oral anticoagulants (eg phenprocoumon, warfarin) and increases the risk of bleeding, which requires the need for monitoring indicators of coagulation prior to treatment, as well as enough often in the initial period of therapy. Once reached a stable level indicator prothrombin time or international normalized ratio (INR), a further control be carried out at intervals recommended for patients receiving anticoagulant therapy. If you change the dosage or discontinuation of omnadren 250 results should also carry out monitoring of prothrombin time or INR on the above chart.
Therapy with omnadren 250 results did not cause changes in prothrombin time and the risk of bleeding in patients not taking anticoagulants.
It increases levels of digoxin in the blood plasma.
Cholestyramine and colestipol reduce bioavailability (reception possible drug through 4 hours after administration of the drugs, while noting additive effect).
grapefruit juice contains one or more components which inhibit CYP3A4 and can increase the concentration in the blood plasma means, metabolized by CYP3A4. Increasing the activity of HMG-CoA reductase inhibitors after drinking 250 ml of grapefruit juice per day is minimal and has no clinical significance. However, the larger volume of juice consumption (more than 1 L) while taking omnadren 250 results significantly increases the level of inhibitory activity against HMG-CoA reductase inhibitor in blood plasma. In this connection, to avoid consumption of grapefruit juice in large quantities during ingestion.
At the beginning of therapy Aktalipidom possible transient increase in the level of “liver” enzymes. Before therapy, and further need to perform regular liver function tests (to monitor the activity of “liver” transaminases every 6 weeks during the first 3 months., And then every 8 weeks for the remainder of the first year, and then every six months), and at higher doses should be to carry out a test to determine the liver function. By increasing the dose to 80 mg of the test should be carried out every 3 months. When persistent elevations of transaminases (3 times as compared to baseline) receiving the drug should be discontinued.
Aktalipid, like other inhibitors of HMG-CoA reductase inhibitors, should not be applied at an elevated risk of developing rhabdomyolysis, renal failure (on the background of severe acute infections, hypotension, planned major surgery, trauma, severe metabolic disorders).
Cancel lipid-lowering drugs during pregnancy has no significant impact on the treatment of primary hypercholesterolemia.
due to the fact that inhibitors of HMG-CoA reductase inhibitors inhibit the synthesis of cholesterol and cholesterol and other products of its synthesis plays an important role in fetal development, including synthesis of steroids and cell membranes, omnadren 250 results may have an adverse effect on the fetus in the appointment of his pregnant (women of childbearing age should avoid conception during treatment with the drug). If in the course of treatment became pregnant, the drug should be withdrawn and the woman warned of the possible danger to the fetus. Use of the drug is not recommended for women of childbearing age, not using contraception.
In patients with low thyroid function (gipotirioz) or in the presence of certain diseases of the kidneys (nephrotic syndrome) with an increase in cholesterol levels should first carry out treatment of the underlying disease.
Aktalipid prescribed with caution persons who abuse alcohol and / or have a history of liver disease.
Before and during treatment the patient should be on hypolipidemic diet.
Co-administration of grapefruit juice and medication may enhance the severity of side effects, so you should avoid their simultaneous reception.
Aktalipid not shown in those cases where there is hypertriglyceridemia I, IV, V type.
Treatment of drug can cause myopathy, rhabdomyolysis and leading to kidney failure. The risk of this disease increases in patients receiving simultaneously with the drug, one or more of the following drugs: fibrates (gemfibrozil, fenofibrate), cyclosporine, nefazadon, macrolides (erythromycin, clarithromycin), antifungal agents from “azoles” (ketoconazole, itraconazole) and HIV protease inhibitors (ritonavir). The risk of myopathy is also increased in patients with severe renal insufficiency.
All patients who start therapy with the drug and the patients who need to increase the dose of the drug should be warned of the possibility of myopathy and need immediate treatment to the doctor in case of unexplained pain, pain in muscle flaccidity or muscle weakness, particularly if accompanied by malaise or fever. Drug therapy should be discontinued immediately if myopathy is diagnosed or suspected.
In order to diagnose myopathy is recommended to conduct regular measurements of the CK.
In the treatment of the drug may increase the content of serum CK, which should be considered in the differential diagnosis of chest pain. Drug withdrawal criterion is an increase in serum CPK more than 10 times the upper limit of normal. Patients with myalgia, myasthenia and / or marked increase in CPK drug treatment is stopped.
The drug is effective as a monotherapy, or in combination with bile acid sequestrants.
In case of missing the current drug dose must be taken as soon as possible. If it is time for your next dose, do not double the dose.
Patients with severe renal insufficiency treatment is carried out under the control of renal function.
The duration of the drug is determined by the physician individually.
Driving a car and operating machinery
The adverse effect of the drug on the ability to drive vehicles and work with the mechanisms have not been reported. gen shi labs supplier