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სამომავლოდ დაგეგმილი პროდუქტები

Cardiovascular System

Amvastan (Tablets)

Film-coated tablets. Tablet contains atorvastatin (as calcium salt) 10, 20, 40 or 80 mg.
PHARMACODYNAMICS. Hypolipidemic agent. Atorvastatin is a selective competitive inhibitor of HMG-CoA-reductase, an enzyme converting 3-hydroxy-3-methyl-glutaryl- CoA into mevalonic acid which is a precursor of sterols, including cholesterol. The drug causes a decrease in the level of total cholesterol, LDL, apolipoprotein B and triglycerides by 34-50%, 30-46%, 41-61% and 14-33%, accordingly; it increases the level of HDL-cholesterol and apolipoprotein A. It does not have carcinogenic and mutagenic action. The therapeutic effect is achieved in 2 weeks after the initiation of therapy, reaches a maximum in 4 weeks and remains stable during the whole period of treatment. PHARMACOKINETICS. Atorvastatin has rapid oral absorption with an approximate time to Cmax of 1-2 hours. The absolute bioavailability is approximately 14%, and the systemic availability for HMG-CoA-reductase inhibiting activity is approximately 30%. Food slightly reduces the rate and extent of the drug absorption (by 25% and 9%, accordingly), however, food does not affect the plasma LDL-cholesterol lowering efficacy. Plasma protein binding is > 98%. Atorvastatin is primarily metabolized in the liver by cytochrome P450 3A4 to form pharmacologically active metabolites. It is eliminated with bile. An approximate elimination half-life is 14 hours. Less than 2% is recovered in the urine. In kidney diseases dose adjustment is not required. Plasma atorvastatin concentrations increase in patients with alcohol-induced liver injuries.
- in combination with diet for lowering of increased total cholesterol, LDL-cholesterol, apolipoprotein B and triglyceride levels, increasing HDL-cholesterol level in patients with primary hypercholesterolemia (heterozygous familial or non-familial) and mixed dyslipidemia;
- for the treatment of patients with increased serum triglyceride levels;
- in patients with dysbetalipoproteinemia who do not achieve proper effect with diet;
- for lowering total cholesterol and LDL-cholesterol levels in patients with homozygous familial hypercholesterolemia in combination with other therapeutic methods;
- for lowering total cholesterol, LDL-cholesterol and apolipoprotein B at the age of 10-17 years with heterozygous familial hypercholesterolemia;
- cardiovascular diseases in patients with risk factors, including those with underlying
- hypersensitivity to the drug components;
- active liver diseases or increased activity of hepatic transaminases (threefold exceeding normal limits) of unknown genesis;
- pregnancy and lactation period, absence of appropriate contraception.
The drug is generally well tolerated.
More frequent (1% and more): Insomnia, headache, asthenic syndrome; nausea, diarrhea, abdominal pain, dyspepsia, flatulence, constipation; myalgia. Less frequent (less than 1 %):
Nervous system: malaise, vertigo, amnesia, paresthesia, peripheral neuropathy. Digestive system: vomiting, anorexia, hepatitis, pancreatitis, cholestatic jaundice. Musculoskeletal system: backache, myotonia, myositis, myopathy, arthralgia, rhabdomyolysis.
Allergic reactions: urticaria, itching, skin rash, anaphylaxis, exudative erythema. Hematopoietic system: thrombocytopenia.
Metabolic system: hypo- or hyperglycemia, increase in serum creatine phosphokinase. Other: impotence, peripheral edema, body weight increase, chest pain, secondary renal impairment, alopecia, tinnitus, fatigue.
The drug is taken orally at any time of day with food or independently of food intake. Hypercholesterolemia (heterozygous familial or non-familial) and mixed dyslipidemia: the recommended initial dose is 10-20 mg once daily. Dosage range: 10-80 mg daily. The doses should be chosen in accordance with the main goals of therapy and patient's response to treatment. Homozygous familial hyper-cholesterolemia: daily dosages of 10-80 mg are administered. The initial dose in the prevention of heart ischemic disease for adults is 10 mg once daily. Heterozygous familial hypercholesterolemia in childhood: the recommended initial dose is 10 mg once daily; the maximum recommended dose is 20 mg once daily.
10 tablets in a blister.
3 blisters in a carton box with enclosed leaflet.
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