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ETC / RX - Anti-diabetics - Atovas 10, 20

COMPOSITION:

Atorvastatin: 10 mg; 20 mg.
Per each film coated caplets


INDICATIONS:

Atorvastatin is indicated in treatment of hypercholesterolemia, hyperlipoproteinemia and hypertriglyceridemia:

  • As an adjunct to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, and triglyceride (TG) levels and to increase high-density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson Types IIa and IIb)
  • As an adjunct to diet for the treatment of patients with hypertriglyceridemia (Fredrickson Type IV)
  • For the treatment of patients with primary dys- beta-lipoproteinemia (Fredrickson Type III) who do not respond adequately to diet
  • As an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) to reduce total cholesterol and LDL-C in patients with homozygous familial hypercholesterolemia.

ADMINISTRATION AND DOSAGE:

The recommended starting dose of atorvastatin is 10 mg once daily.

The dosage range is 10-80 mg PO once daily. Atorvastatin may be administered as a single dose at any time during the day and without regard to meals.

The maximum recommended dose is 80 mg/day.

The maximum dose is 20 mg/day when concomitantly using with amiodarone.


CONTRAINDICATIONS:

Hypersensitivity to any component of this product.

Active liver disease of unexplained persistent elevations of serum transaminases.

Pregnancy and lactation.


WARNINGS AND PRECAUTIONS:

  • Liver function test should be performed during therapy with atorvastatin.
  • Atorvastatin should be used with caution in patients who consumes alcohol and/or have a past history of liver disease.
  • Atorvastatin should be used with caution in patients with the risk of myopathy. Atorvastatin may cause side effects on muscle system including myasthenia, myositis, particularly in patients with the risks such as the elderly (> 65 years), hypothyroidism, renal failure. These side effects should be observed carefully when using atorvastatin. Patients should be advised to report promptly any unexplained muscle pain, tenderness or weakness, if accompanied by malaise or fever.
  • Take care when driving or operating machinery until you know how atorvastatin affects you.

SIDE EFFECTS:

Atorvastatin is generally well tolerated. Side effects have usually been mild and transient. These were nausea, diarrhea, constipation, abdominal discomfort, dizziness, insomnia, malaise, rhabdomyolysis.


INTERACTIONS:

  • Co-administration with CYP3A4 enzyme inhibitors (eg, cyclosporine, mibefradil, itraconazole, ketoconazole. erythromycin, clarithromycin and nefazodone) or with fibric acid derivatives or niacin may increase plasma concentrations of atorvastatin lead to increasing the risk of myopathy and rhabdomyolysis. When concomitantly using with amiodarone, should not exceed 20 mg daily due to increasing the risk of rhabdomyolysis. For patient who must use atorvastatin at doses higher than 20 mg daily, physician should choose other statin (e.g. pravastatin).
  • Plasma concentrations of atorvastatin decreasedwhen atorvastatin was co-administered with antacid.

PRESENTATION:

Box of 1 blister x 7 film coated tablets.
Box of 1 blister x 10 film coated tablets.
Box of 3 blisters x 10 film coated tablets