EZERVA is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL and Apo B in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.
EZERVA is also indicated for the reduction of elevated total cholesterol and LDL in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
- Hypersensitivity to any component
- Active liver disease or unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
EZERVA is generally well tolerated. Adverse reactions have usually been mild and transient. Occasional undesirable effects include abdominal pain, asthenia, constipation, diarrhoea, dyspnea, flatulence, nausea, headache and myalgia.
DOSAGE & ADMINISTRATION:
The recommended dosage is one tablet once daily.
Dose Titration Guided by Clinical Effect
A patient whose dyslipidemia is not adequately controlled with atorvastatin (or another statin) alone or with ezetimibe alone may be switched to combination therapy with EZERVA.
Dosage in Patients Taking Cyclosporine, Clarithromycin or A Combination of Ritonavir plus Saquinavir or Lopinavir plus Ritonavir In patients taking cyclosporine, therapy should be limited to atorvastatin 10 mg once daily. In patients taking clarithromycin or in patients with HIV taking a combination of ritonavir plus saquinavir or lopinavir plus ritonavir, for doses of atorvastatin exceeding 20 mg appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed.
Boxes of 10, 20 film coated tablets.