Atorvastatin 10 mg: White to off-white film-coated tablet, oval shaped, biconvex and plain on both sides.
Atorvastatin 20 mg: White to off-white film-coated tablet, oval shaped, biconvex, bisected on one side and plain on the other side.
Atorvastatin 40 mg: White to off-white film-coated tablet, oval shaped, biconvex, bisected on one side and plain on the other side.
Each film-coated tablet contains: Atorvastatin (as Calcium) 10 mg, 20 mg & 40 mg.
HMG-CoA Reductase Inhibitor.
Pharmacology: Pharmacodynamics: Atorvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (as statin), is a lipid regulating drug with actions on plasma lipids.
Pharmacokinetics: Atorvastatin is rapidly absorbed from the gastrointestinal tract. It has low absolute bioavailability of about 12% due to presystemic clearance in the gastrointestinal mucosa and/or first-pass metabolism in the liver, its primary site of action. Atorvastatin is metabolized by the cytochrome P450 isoenzyme CYP3A4 to a number of compounds which are also active inhibitors of HMG-CoA reductase. The mean plasma elimination half-life of atorvastatin is about 14 hours although the half-life of inhibitory activity for HMG-CoA reductase is approximately 20 to 30 hours due to the contribution of the active metabolites. It is 98% bound to plasma proteins. Atorvastatin is excreted as metabolites, primarily in the bile.
Atorvastatin is used to reduce LDL-cholesterol, apolipoprotein B, and triglycerides, and to increase HDL-cholesterol in the treatment of hyperlipidaemias, including hypercholesterolaemias and combined (mixed) hyperlipidaemias (type IIa or IIb hyperlipoproteinaemias), hyperlipidaemias (type IIa or IIb hyperlipoproteinaemias), hypertriglyceridaemia (type IV), and dysbetalipoproteinaemia (type III). It can also be effective as adjunctive therapy in patients with homozygous familial hypercholesterolaemia who have some LDL-receptor function.
The usual initial dose is 10 mg daily which may be adjusted at intervals of 4 weeks up to a maximum of 80 mg daily or as prescribed by the physician.
There is no specific treatment for statin overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures be instituted, as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance statin clearance.
Statins are contraindicated in active liver disease (on persistently abnormal liver function test), in pregnancy (adequate contraception required during treatment and for one month afterwards) and breast feeding.
Discontinue if markedly creatinine phosphokinase levels occur or myopathy is diagnosed. Temporarily withheld or discontinue in patients with acute serious condition suggestive of myopathy or with risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Increased risk of recurrent hemorrhagic stroke. Increased HbA1c and fasting serum glucose levels. Monitor for increased transaminase levels until abnormalities resolve: signs and symptoms of muscle pain, tenderness or weakness.
Pregnancy: Atorvastatin is contraindicated in pregnancy. Women of childbearing potential should use adequate contraceptive measures. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus.
Lactation: Atorvastatin is contraindicated while breastfeeding. It is not known whether this drug is excreted in human milk. Because of the potential for adverse reactions in nursing infants, women taking atorvastatin should not breastfeed.
The most common adverse effects are gastrointestinal disturbances. Other adverse effects reported include dizziness, insomnia, headache, blurred vision, dysgeusia and skin rashes.
The most serious consequence of drug interactions with Atorvastatin and other statins is the development of myopathy and rhabdomyolysis. Drugs that can cause myopathy when given alone increase the risk of myopathy with all statins: These drugs include fibric acid derivatives (fibrates or gemfibrozil), and nicotinic acid. Atorvastatin is metabolized by cytochrome P450 isoenzyme CYP3A4, as are simvastatin and lovastatin, and interactions may occur with drugs that inhibit this enzyme, including ciclosporin, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV-protease inhibitors, nefazodone, amiodarone, and verapamil; there may also be similar interaction with grapefruit juice.
Store at temperatures not exceeding 30°C.
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Avator FC tab 10 mg
50's (P9.8/film-coated tab)
Avator FC tab 20 mg
50's (P16.25/film-coated tab)
Avator FC tab 40 mg
48's (P22.5/film-coated tab)
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