Branded Medicine

 
ESVAT

Film-coated tablet

 
:: Compositions ::

ESVAT 5
Each film-coated tablet contains:
Simvastatin 5 mg

ESVAT 10
Each film-coated tablet contains:
Simvastatin 10 mg

ESVAT 20
Each film-coated tablet contains:
Simvastatin 20 mg

 
:: Indications ::
  • Therapy in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
  • As an adjunct to diet when the response to a diet restricted and other nonpharmacologic measures alone has been inadequate.
  • Coronary heart disease:
    • Reduce the risk of total mortality by reducing coronary heart disease deaths.
    • Reduce the risk of non-fatal myocardial infarction.
    • Reduce the need for myocardial revascularization procedures.
  • Hypercholesterolemia:
    Reduce elevated total cholesterol and LDL in patients with primary hypercholesterolemia (type IIa and IIb).
 
:: Contraindications ::
  • Hypersensitivity to simvastatin or drug component.
  • Active liver disease or unexplained persistent elevation of serum transaminases.
  • Pregnancy and lactation.
 
:: Dosage and administration ::
  • Initially 5-10 mg once daily as a night dose.
  • Mild to moderate hypercholesterolemia: Initially 5 mg daily. Doses may be titrated at 4 week intervals to 40 mg once daily as a night dose.
 
:: Warnings and precautions ::
  • Periodic cholesterol monitoring should be done during treatment.
  • Alcoholism or history of liver disease.
  • Acute and severe myopathy or risk of secondary kidney failure due to rhabdomyolysis.
  • Hypertriglyceridemia.
  • Children and adolescents.
 
:: Adverse reactions ::

Abdominal pain, constipation, flatulence, asthenia, headache, myopathy, rhabdomyolysis, angioneurotic edema.
Other adverse reactions:

  • Neurology: cranial nerve dysfunction, tremor, dizziness, vertigo, memory loss, paresthesia, peripheral neuropathy, peripheral nerve palsy.
  • Hypersensitivity reactions: anaphylaxis, angioedema, thrombocytopenia, leucopenia, hemolytic anemia.
  • Gastrointestinal: anorexia, vomiting.
  • Skin: alopecia, pruritus.
  • Reproduction: gynecomastia, loss of libido, erectile dysfunction.
  • Eye: cataract aggravation, ophthalmoplegia.
 
:: Drug interactions ::
  • Immunosuppressants, itraconazole, gemfibrozil, niacin, erythromycin, coumarin.
  • Antipyrine, propranolol, digoxin.
 
:: Presentation ::

ESVAT 5. Box, 5 strips @ 6 film-coated tablets.
Box, 5 blisters @ 10 film-coated tablets.
ESVAT 10. Box, 5 strips @ 6 film-coated tablets.
Box, 5 blisters @ 10 film-coated tablets.
ESVAT 20. Box, 5 strips @ 6 film-coated tablets.
Box, 5 blisters @ 10 film-coated tablets.