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Cardiovascular System

Amvastan (Tablets)
(Atorvastatin)



CONTENT:
Film-coated tablets. Tablet contains atorvastatin (as calcium salt) 10, 20, 40 or 80 mg.
 
PHARMACOLOGICAL PROPERTIES:
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.
 
THERAPEUTIC INDICATIONS:
- 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
dyslipidemia.
 
CONTRAINDICATIONS:
- 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.
 
SIDE EFFECTS:
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.
 
DOSAGE AND ADMINISTRATION:
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.
 
PACKAGING:
10 tablets in a blister.
3 blisters in a carton box with enclosed leaflet.
 
 
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