Χώρα: Σιγκαπούρη
Γλώσσα: Αγγλικά
Πηγή: HSA (Health Sciences Authority)
FLUVASTATIN SODIUM
NOVARTIS (SINGAPORE) PTE LTD
C10AA04
80 mg
TABLET, FILM COATED
FLUVASTATIN SODIUM 80 mg
ORAL
Prescription Only
Siegfried Barbera, S.L.
ACTIVE
2001-04-26
LESCOL / LESCOL XL HMG-CoA reductase inhibitor DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Capsules and prolonged release tablets for oral administration. ACTIVE SUBSTANCE [R*,S*-(E)]-( )-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6- heptenoate (fluvastatin sodium) One capsule of Lescol contains 21.06 mg or 42.12 mg fluvastatin sodium equivalent to 20 mg or 40 mg fluvastatin free acid. One prolonged release tablet of Lescol XL contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid. Certain dosage strengths and dosage forms may not be available in all countries. EXCIPIENTS LESCOL 20 MG AND 40 MG CAPSULES Magnesium stearate; sodium hydrogen carbonate; talc; cellulose microcrystalline, pregelatinised starch, calcium carbonate; titanium dioxide; iron oxide red, iron oxide yellow, gelatine; shellac. LESCOL XL 80 MG TABLETS Cellulose microcrystalline; hypromellose; hydroxypropyl cellulose; potassium hydrogen carbonate; povidone; magnesium stearate; iron oxide yellow; titanium dioxide; macrogol 8000. Pharmaceutical formulations may vary between countries. 2 INDICATIONS DYSLIPIDEMIA ADULTS Lescol/Lescol XL is indicated as an adjunct to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B) and triglycerides (TG) levels and for the increase of high-density lipoprotein cholesterol (HDL-C) in adults with primary hypercholesterolaemia and mixed dyslipidaemia (Fredrickson Types IIa and IIb). OTHER INDICATIONS Lescol/Lescol XL is indicated to slow the progression of coronary atherosclerosis in adults with primary hypercholesterolaemia, including mild forms, and coronary heart disease. Lescol/Lescol XL is also indicated for the secondary prevention of major adverse cardiac Διαβάστε το πλήρες έγγραφο
1 LESCOL XL HMG-CoA reductase inhibitor DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Capsules and prolonged release tablets for oral administration. ACTIVE SUBSTANCE Fluvastatin sodium One prolonged release tablet of Lescol XL contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid. Certain dosage strengths and dosage forms may not be available in all countries. ACTIVE MOIETY Fluvastatin EXCIPIENTS LESCOL XL 80 MG TABLETS Cellulose microcrystalline; hypromellose; hydroxypropyl cellulose; potassium hydrogen carbonate; povidone; magnesium stearate; iron oxide yellow; titanium dioxide; macrogol 8000. Pharmaceutical formulations may vary between countries. INDICATIONS DYSLIPIDEMIA ADULTS Lescol XL is indicated as an adjunct to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B) and triglycerides (TG) levels and for the increase of high-density lipoprotein cholesterol (HDL-C) in adults with primary hypercholesterolaemia and mixed dyslipidaemia (Fredrickson Types IIa and IIb). OTHER INDICATIONS Lescol XL is indicated to slow the progression of coronary atherosclerosis in adults with primary hypercholesterolaemia, including mild forms, and coronary heart disease. 2 Lescol XL is also indicated for the secondary prevention of major adverse cardiac events in adults with coronary heart disease after coronary transcatheter therapy. DOSAGE REGIMEN AND ADMINISTRATION Lescol XL can be administered as a single dose at any time of the day with or without food. Lescol XL must be swallowed whole with a glass of water. The maximum lipid-lowering effect with a given dose of the drug is achieved within 4 weeks. Doses should be adjusted according to the patient's response and dose adjustment made at intervals of 4 weeks or more. The therapeutic effect of Lescol XL is maintained with prolonged administration. GENERAL TARGET POPULATION ADULTS Prior to initiating treatment with Lescol XL, the patient should be placed on a standa Διαβάστε το πλήρες έγγραφο