Detailed information
COMPOSITION:
Each capsule contains : 42.16mg Fluvastatin sodium equivalent to 40 mg Fluvastatin Each capsule contains : 21.06mg Fluvastatin sodium equivalent to 20 mg Fluvastatin
PROPERTIES:
Fluvastatin sodium is a hypolipidaemic agent . It is a competitive inhibitor of 3 - hydroxy - 3 - methyl glutaryl coenzyme A reductase (HMG-COA reductase) the enzyme for cholesterol synthesis.
It reduces total cholesterol, low-density lipoprotein (LDL)-cholesterol , and very low-density lipoprotein (VLDL)-cholesterol concentrations in plasma. It also tends to reduce triglycerides and to increase high-densitylipoprotein (HDL)-cholesterol concentrations.
Fluvastatin sodium is absorbed rapidly and completely following oral administration , with peak concentrations reached in less than 1 hour.
INDICATIONS:
-Fluvastat is used as an adjunct to diet in the treatment of elevated total cholesterol and LDL-C levels in patients with primary hypercholesterolemia (Type IIa and IIb)
-Fluvastat is used to slow progression of coronary atherosclerosis in patients with coronary heart disease.
CONTRAINDICATIONS:
-Hypersensitivity to any component of this drug.
-Active liver disease or unexplained,persistent raised serum -aminotransferase concentrations.
-Pregnancy and lactation.
SIDE EFFECTS:
Nausea .dizziness, headache, vertigo, muscle cramps, myalgia, arthralgia, urticaria, hepatitis, peripheral neuropathy, and elevated transaminases and alkaline phosphatase.
PRECAUTIONS:
-Caution should be taken in patients with a history of liver disease or heavy alcohol.
-The liver function tests should be performed before initiating the treatment and after 6 and 12 weeks of treatment. Tests should also be conducted in cases of dose increase .and periodically thereafter.
-Fluvastat should be discontinued if marked increase in serum - aminotransferase or creatine - phosphokinase concentrations occurs.
-Patients should be advised to report promptly unexplained musculor pain, tenderness or weakness, particularly if accompanied by malaise or fever.
DRUG INTERACTIONS:
-Concomitant therapy with Fluvastat and gemfibrozil , erythromycin and immunosuppressive drugs is not recommended.
-Concomitant administration of Fluvastat with cimetidine, ranitidine and omeprazole results in a significant increase in the Fluvastat maximum concentrations.
DOSAGE AND ADMINISTRATION:
-The dose may be taken without regard to meals.
-The starting dose is 20-40 mg once daily at bedtime.
-The dosing range is 20-80 mg daily.
-The daily regimen of 80 mg should be administered in divided doses.
-Dosage adjustment may be made at intervals of 4 weeks.
PRESENTATION:
Boxes of 20 cap. 20 mg Boxes of 10 cap. 40 mg |
