Atorlip 20

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Lipid-lowering agent - Statin group
Barcode: 8935206009019
Description

COMPOSITION:
Atorvastatin calcium ............................. 20 mg
Excipients q.s ..................................... 1 tablet
(Lactose monohydrate, avicel, calcium carbonate, hydroxypropyl cellulose,
croscarmellose sodium, polysorbate 80, magnesium stearate).
DOSAGE FORM: Tablet.
PRESENTATION: Box of 3 blisters x 10 tablets.
PHARMACODYNAMICS: Atorlip is a synthetic lipid-lowering agent including active ingredient – atorvastatin calcium. It is a competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, which prevents the conversion of HMG-CoA to mevalonate, a precursor of cholesterol. Atorvastatin lowers the plasma cholesterol and lipoprotein levels by inhibiting hepatic cholesterol synthesis and by increasing the amount of hepatic LDL (Low-Density Lipoprotein) receptors on the cell surface, resulting in enhancing the uptake and catabolism of LDL. Atorvastatin reduces the most LDL cholesterol (25% - 61%) against any drugs taking alone and it is proved to be potential for patients requiring a large reduction of cholesterol; but now this only obtains in case of drug combination. Atorvastatin enhances HDL (High-Density Lipoprotein) cholesterol (5% - 15%) and consequently lowers LDL/ HDL and total cholesterol / HDL. Besides, atorvastatin reduces the plasma triglyceride (10 - 30%) by increasing the clearance of surplus VLDL (Very Low-Density Lipoprotein) by LDL receptor. In clinical studies, the evidences have showed that statins remarkably reduce coronary arterial accidents, every known cardiovascular accidents, and total of death in patients with coronary arterial disease.
PHARMACOKINETICS: Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentrations occur within 1 to 2 hrs. Extent of absorption and concentration increases in proportion to atorvastatin dose. Although food decreases the rate and extent of drug absorption, the therapeutic effect is unchangeable whether atorvastatin is given with or without food. Plasma atorvastatin concentrations are lower following evening drug administration compared with morning. However, the effect of drug is the same whatever the time of day for drug administration.
INDICATIONS: Atorlip is used in the following cases: elevated total cholesterol, LDL-cholesterol, and triglyceride concentrations. Atorlip helps to slow the development of coronary atherosclerosis. Atorlip is used in primary prevention of coronary arteries accidents in patients with hypercholesterolemia: reduction in the risks such as myocardial infarction, operation of coronary arteries reproduction, death due to angiocardiopathy.
CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Active liver disease, which may include unexplained persistent elevations in plasma transaminase levels. Patients receiving treatment of tipranavir and ritonavir, or telaprevir.
PRECAUTIONS: Before starting on the atorvastatin treatment, blood cholesterol should be coordinately controlled by diet, weight loss, exercise, treatment of diseases associated with elevated lipid. Lipid assay should be periodically tested and the dosage can be adjusted according to patient’s response to the drug. Using LDL-C concentration to start treatment and assess treatment response. It is recommended that liver enzyme tests be performed before the initiation of statin and as clinically indicated.
Creatine kinase (CK) should be carefully considered to monitor in cases of:
+ Before treatment: CK test should be carried out in cases of impaired renal function, hypothyroidism, personal history or family history of hereditary myopathy, history of myopathy due to previous statins and fibrates administration, history of hepatic disease and/or consumption of substantial quantities of alcohol, elderly patients (> 70 years of old) with a risk factor of rhabdomyolysis, possibility of drug interactions and some special patient subjects. These cases should be considered the potential interests and risks and clinically monitored before treatment with statins. If result of CK test is over 5 times of the normal level, it is not advised to start treating with statins.
+ During treatment with statins, patients should be advised to inform manifestations including myopathy, muscular cramps, muscular weakness... If these symptoms occur, patients should be performed CK test to provide appropriate intervention methods.
Statins therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Atorvastation should be administered to women of childbearing age only when such patients are highly unlikely to conceive and when patients suffer from very high hypercholesterolemia without response with other drugs.
In patients taking treatment of lopinavir and ritonavir, atorvastatin should be used with caution and if needed with the lowest dose.
PREGNANCY AND LACTATION: The drug should not be administered to pregnant women and nursing mothers.
VEHICLE DRIVERS AND MACHINERY OPERATORS:
The drug should be used with caution in vehicle drivers and machinery operators because of possibility of headache, dizziness.
INTERACTIONS: The risk of muscular damages may be increased by concomitant administration of statin and gemfibrozile, blood cholesterol-lowering agents of other fibrates, high-dose niacin (>1g/day), and colchicine, cyclosporin, erythromycin, itraconazole, and ketoconazole. Concomitant administration of blood lipid-lowering agents of statins and HIV-treated drugs and HCV-treated drugs has been reported to increase risks of muscular damage, including rhabdomyolysis, weak kidneys leading to renal impairment and death. Atorvastatin enhances the effect of warfarin. Prothrombin time should be examined before treatment and followed frequently during the initial treatment period. Co-administration of bile acid resins can reduce clearly the bioavailability of statins; a distant interval should be advised.
ADVERSE EFFECTS: Frequently observed: Digestive system: diarrhoea, constipation, flatulence, abdominal discomfort, nausea. Nervous system: headache, dizziness, vision blurred, insomnia, asthenia. Musculoskeletal system: muscular and arthral pains.
Infrequently observed: myopathy, rash, rhinitis, sinusitis, pharyngitis, cough.
Rarely observed: myositis, rhabdomyolysis leading to secondary acute renal failure caused by myoglobinuria.
Some other adverse effects: impaired awareness (amnesia, forgetfulness), hyperglycemia, increase in HbA1c.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: There is no specific treatment for atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures institutes as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
DOSAGE & ADMINISTRATION:
Patients should be placed on a standard diet before receiving Atorlip and should remain on this diet during treatment with Atorlip.
The drug can be given without regard to meal at any time of the day.
The recommended starting dose is 10 mg once daily. Adjustments should be made at intervals of 4 weeks if needed and tolerated.
The maintenance dose is 10 to 40 mg daily and if necessary can be increased, but not exceeding 80 mg daily.
In patients taking a combination of darunavir plus ritonavir, or fosamprenavir, or fosamprenavir plus ritonavir, or saquinavir plus ritonavir, therapy with Atorlip should be limited to 20 mg daily.
In patients taking nelfinavir, therapy with Atorlip should be limited to 40 mg daily.
Or as directed by the physician.
Read the directions carefully before use.  Shelf-life: 36 months from the manufacturing date
Consult the physician for more information.  Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
This drug is for prescriptions only.   Specifications: Manufacturer's.

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