Products

Atoreza Tablets

Ezetimibe 10 mg/Atrovastatin 10 mg
Ezetimibe 10 mg/Atrovastatin 20 mg

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Active ingredient

Ezetimibe 10 mg/Atrovastatin 10 mg
Ezetimibe 10 mg/Atrovastatin 20 mg
 

Indications

  • As adjunctive therapy to diet for the reduction of elevated total-C, LDL-C not reaching their target LDL –C.
  • As an adjunct to diet for the treatment of patient with elevated serum TG levels.
  • For achieving the LDL target of <100 mg/dl in CHD and CHD risk equivalents.
  • For Homozygous familial hypercholesterolemia.

Dosage and Administration

The recommended dose of ATOREZA once daily.

Contraindication

  • Hypersensitivity to Ezetimibe or Atorvastatin.
  • Active liver disease or unexplained persistent elevations of serum transaminases.
  • Pregnant and nursing women.

Side effects

• ATOREZA is generally well-tolerated.
• Upper respiratory tract infection, headache, myalgia, back pain, arthralgia, Sinusitis, Pharyngitis, abdominal pain, diarrhea and fatigue.

Drug Interaction

  • The risk of myopathy during treatment which is increased with concurrent administration of cyclosporine, fibric acid derivates, niacin, erythromycin, and antifungals.
  • Oral contraceptives: Administration of atorvastatin with an oral contraceptive containing norethindrone and ethinyl oestradiol produces increased plasma concentrations of norethindrone and ethinyl oestradiol. These increases should be considered when selecting an oral contraceptive for a woman taking ATOREZA.
  •  Digoxin: Administration of multiple doses of atorvastatin with digoxin increases the steady state plasma digoxin concentration by approximately 20%; patients taking digoxin and ATOREZA should be monitored appropriately.

Pregnancy and Lactation

  • ATOREZA is contraindicated during pregnancy and in nursing mothers.
  • ATOREZA 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.

Warning and Precaution

  • Concurrent administration with erythromycin may result in higher plasma concentrations of atorvastatin.
  • ATOREZA should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
  • ATOREZA 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.
  •  Caution should be exercised if ATOREZA is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones, such as ketoconazole, spironolactone and cimetidine because HMG-CoA reductase inhibitors interfere with cholesterol synthesis and theoretically might blunt adrenal and/or gonadal steroid production.

Package and Storage

  • Carton box containing 1 or 2 or 3 (Al foil/PVC) of 7 Film Coated Tablets and insert leaflet.
  • Stored below 25 ºC in a dry place.

Mother Company

Manufactured by Marcyrl