SUVIKAN 20 MG 14 TAB; rosuvastatin, cardiovascular agents .
ACTIVE-INGREDIENT OF SUVIKAN 20 MG 14 TAB
Each tablet contains: rosuvastatin 20 mg (as calcium salt).
INDICATION OF SUVIKAN 20 MG 14 TAB
Hyperlipidemia and Mixed Dislipidemia : SUVIKAN is indicated: as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, nonHDL-C, and triglycerides and to increase HDL-C in patients with primary hyperlipidiemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholerterol when response to diet and non pharmacological interventions alone has been inadequate. Pediatric patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH): Adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least year post-menarche, 10-17 years of age with heterozygous familial hypercholestorolemia if after an adequate trial of diet therapy The following findings are present: LDL-C>190 mg/dLor > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Hypertriglceridemia: Suvikan is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia): Suvikan is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Homozygous Familial Hyperchloesterolemia. Suvikan is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, ApoB in adult patients with homozygous familial hypercholesterolemia. Slowing of the progression of Atherosclerosis: Suvikan is indicated as adjunctive therapy to diet to slow the progression of Atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. Primary Prevention of cardiovascular disease: In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease at risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, SUVIKAN is indicated to: Reduce the risk of stroke. Reduce the risk of myocardial infarction. Reduce the risk of arterial revascularization procedures. Limitations of Use: Suvikan has not been studied in Fredrickson Type I and V dyslipidemias.
DOSAGE OF SUVIKAN 20 MG 14 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
The dose range of SUVIKAN is 5 to 40 mg orally once daily. The usual dose is 10-20 mg, SUVIKAN can be administered as a single dose at any time of day, with or without food. When initiating SUVIKAN therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate SUVIKAN starting dose should first be utilized, and only then titrated according to the patient’s response an individualized goal of therapy. After initiation or upon titration of SUVIKAN lipidlevels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. The 40 mg dose of SUVIKAN should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose. Heterozygous familial hypercholesterolaemia in pediatric patients ( 10 to 17 years of age ): The usual dose range of SUVIKAN is 5-20 mg /day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studies in this patient patient population). Doses should be individualized according to the recommended goal of therapy . Adjustments should be made at intervals of 4 weeks or more. Homozygous Familial Hypercholesterolemia: The recommended starting dose of SUVIKAN is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels. Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir: In patients taking Cyclosporine, The dose of SUVIKAN should be limited to 5 mg once daily. In patients taking a combination of lopinavir and ritonavir or atazanavir and ritonsvir, The dose of SUVIKAN should be limited to 10 mg once daily. Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when SUVIKAN is used in combination with niacin or fenofibratep a reduction in SUVIKAN dosage should be considered in this setting. Combination therapy with gemfibrozil should be avoided because of an increase in SUVIKAN exposure with concomitant use; If SUVIKAN is used combination with gefibrozil, the dose of SUVIKAN should be limited to 10 mg once daily. Dosage in patients with severe renal impairment: For patients with severe renal impairment (CLcr OVER-DOSAGE OF SUVIKAN 20 MG 14 TAB
There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels should be monitored. Haemodialysis is unlikely to be benefit.
CONTRA-INDICATION OF SUVIKAN 20 MG 14 TAB
Sulvikan is contraindicated : In patients with hypersensitivity to rosuvastatin or to any of the excipients. In patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limity of normal (ULN). In patients with severe renal impairment (creatinine clearance STORAGE OF SUVIKAN 20 MG 14 TAB
Store at temperature not exceeding 25° C in dry place .
PACK OF SUVIKAN 20 MG 14 TAB
A carton box containing 1,2 strips each of 7 film coated tablets and an insert.
SUVIKAN 20 MG 14 TAB MANUFACTURED BY
Hikma Pharmaceuticals Industries S.A.E, 6th of October City – Egypt