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Cardiovascular Agents

Lipistad 20

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

             

Composition:

Each film-coated tablet contains atorvastatin (as atorvastatin calcium) 20 mg.

 

Shelf-life:  

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • 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) hyperlipidaemia (type IIa or IIb hyperlipoproteinaemias), hypertriglyceridaemia (type IV), and dysbetalipoproteinaemia (type III).
  • Atorvastatin can also be effective as adjunctive therapy in patients with homozygous familial hypercholesterolaemia who have some LDL-receptor function.
     
  • Administered orally once daily, without regard to meals.
    The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment with the drug.
  • The drug should be initiated with a lowest effective dose, thereafter dosage of atorvastatin may be adjusted, if necessary, according to individual requirements and response by increased at intervals of no less than 4 weeks. Adverse reactions should be monitored, especially the adverse effects on muscle system.
     
  • The usual initial oral dosage of atorvastatin in adults for the management of primary hypercholesterolemia (heterozygous familial or nonfamilial) and mixed dyslipidemia is 10 or 20 mg once daily. Patients requiring reductions in LDL-cholesterol of more than 45% to achieve their goal may be started on an atorvastatin dosage of 40 mg daily. The usual maintenance dosage of atorvastatin in adults is 10 - 80 mg once daily.
  • The recommended initial dosage of atorvastatin for treatment of heterozygous familial hypercholesterolemia in boys and postmenarchal girls 10 years of age or older is 10 mg once daily; the maximum recommended dosage is 20 mg daily.
  • The usual oral dosage of atorvastatin for the management of homozygous familial hypercholesterolemia is 10 - 80 mg once daily. The drug may be used as an adjunct to other lipid-lowering therapies (e.g., plasma LDL-apheresis) or when such therapies are not available.
  • The dosage of atorvastatin should be adjusted at intervals of no less than 4 weeks until the desired effect on lipoprotein concentrations is observed. Reduction of atorvastatin dosage should be considered in patients whose serum cholesterol concentrations fall below the desired target range.
  • For patients taking drugs that interact with atorvastatin, dose reduction is advised as follows:
    Amiodarone: The dosage of atorvastatin should not exceed 20 mg daily.
    Ciclosporin: Maximum dose 10 mg once daily.
    Clarithromycin: Initial dose 10 mg once daily and maximum dose 20 mg once daily.
    Itraconazole: Initial dose 10 mg once daily and maximum dose 40 mg once daily.
    Tipranavir plus ritonavir, telaprevir: Avoid atorvastatin.
    Lopinavir plus ritonavir: Use with caution and use with the lowest atorvastatin dose necessary.
    Darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, saquinavir plus ritonavir: Do not exceed 20 mg atorvastatin daily.
    Nelfinavir: Do not exceed 40 mg atorvastatin daily.
  • Renal impairment: Because atorvastatin does not undergo substantial renal excretion, dosage modification in patients with renal impairment is not necessary.
  • Hepatic impairment: Because atorvastatin is metabolized predominantly in the liver and potentially may accumulate in the plasma of patients with hepatic impairment, the drug should be used with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease, and such patients should be monitored closely while receiving atorvastatin therapy.


Or as prescribed by physicians.

 

  • Patients who are hypersensitivity to any ingredient of this drug.
  • Patients with active liver disease or unexplained, persistent increases in serum aminotransferase concentrations.
  • Pregnancy and lactation.

     

  • Atorvastatin is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to atorvastatin were constipation, flatulence, dyspepsia, and abdominal pain.
  • The potential for non-serious and reversible side effects, which include: Memory loss and confusion, increased blood glucose, increased hemoglobin A1c levels.

     

  • Before instituting therapy with atorvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems.
  • Liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter.
  • The necessity of creatine kinase measurement should be considered:
    A creatine kinase (CK)  level should be measured before starting treatment in the following situations: Renal impairment, hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity with a statin or fibrate, previous history of liver disease and/or where substantial quantities of alcohol are consumed, in elderly (age > 70 years) with the presence of other predisposing factors for rhabdomyolysis, situations where an increase in plasma levels may occur, such as interactions and special populations. In such situations, the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended. If CK levels are significantly elevated > 5 times upper limit of normal at baseline, treatment should not be started.
    If muscular pain, weaknes or cramps occur whilst a patient is receiving treatment with a statin, their CK levels should be measured.
  • Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins.
  • Atorvastatin 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 (e.g., severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).
  • Safety and efficacy of atorvastatin have not been evaluated in prepubertal children or in children younger than 10 years of age.
  • Pregnancy: Atorvastatin is contraindicated in pregnant women. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking the drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus.
  • Lactation; It is not known whether atorvastatin is distributed into milk in humans. Because of the potential for serious adverse reactions from atorvastatin in nursing infants, the drug is contraindicated in nursing women.
  • Atorvastatin has negligible influence on the ability to drive and use machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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