Preparation
Rovex 5 Tablet:
Each film coated tablet contains Rosuvastatin Calcium INN equivalent to 5 mg
Rosuvastatin.
Rovex 10 Tablet:
Each film coated tablet contains Rosuvastatin Calcium INN equivalent to 10 mg
Rosuvastatin.
Indication
Heterozygous Hypercholesterolemia (Familial and Nonfamilial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
Contraindication
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Active liver disease, which may include
unexplained persistent elevations in hepatic transaminase levels
Dosage & Administration
Heterozygous
Hypercholesterolemia (Familial and Nonfamilial) and Mixed Dyslipidemia
(Fredrickson Type IIa and IIb)
The usual recommended starting dose of Rosuvastatin is 10 mg
once daily. Initiation of therapy with 5 mg once daily may be considered for
patients requiring less aggressive LDL-C reductions or who have predisposing
factors for myopathy. For patients with marked hypercholesterolemia (LDL-C >
190 mg/dL) and aggressive lipid targets, a 20 mg starting dose may be
considered. The 40 mg dose of Rosuvastatin should be reserved for those patients
who have not achieved goal LDL-C at 20 mg. After initiation and/or upon
titration of Rosuvastatin, lipid levels should be analyzed within 2 to 4 weeks
and dosage adjusted accordingly.
Homozygous
Hypercholesterolemia (Familial)
The recommended starting dose of Rosuvastatin is 20 mg once
daily in patients with homozygous FH.The maximum recommended daily dose is 40
mg. Rosuvastatin should be used in these patients as an adjunct to other
lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are
unavailable.
Patients with renal
insufficiency
No modification of dosage is necessary for patients with
mild to moderate renal insufficiency. For patients with severe renal impairment
(CLcr<30 mL/min/1.73 m2) not on hemodialysis, dosing of Rosuvastatin should
be started at 5 mg once daily and not to exceed 10 mg once daily.
Dosage in Asian
Patients
In Asian patients, consider initiation of Rosuvastatin
therapy with 5 mg once daily due to increased Rosuvastatin plasma
concentrations. The increased systemic exposure should be taken into
consideration when treating Asian patients not adequately controlled at doses
up to 20 mg/day.
Use with
Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir
In patients taking Cyclosporine, the dose of Rosuvastatin
should be limited to 5 mg once daily. In patients taking Lopinavir and
Ritonavir or Atazanavir and Ritonavir the dose of Rosuvastatin should be
limited to 10 mg once daily.
Side Effect
Rosuvastatin is generally well tolerated. The adverse events
seen with Rosuvastatin are generally mild and transient. Most commonly
occurring side-effects are headache, myalgia, asthenia, constipation,
dizziness, nausea, abdominal pain. Uncommonly pruritus, rash and urticaria may
occur. Myopathy (including myositis), hypersensitivity reactions (including
angioedema), rhabdomyolysis, pancreatitis etc are the rarely occurring
side-effects of Rosuvastatin.
Precaution
Caution should be takenin patients with thyroid problem,
have family history of muscular disorder, had any past problems with muscles
(pain, tenderness), after using an HMG-CoA reductase
Inhibitor (statin) such as atorvastatin, fluvastatin, lovastatin, pravastatin
or simvastatin or have developed an allergy or Intolerance to them.
Drug Interaction

Erythromycin: Co-administration of Erythromycin with
Rosuvastatin decreased AUC and Cmax of Rosuvastatin. Itraconazole: Itraconazole
increases the AUC of Rosuvastatin. Fluconazole: Co-administration of
Fluconazole with Rosuvastatin increases the AUC of Rosuvastatin. Warfarin: The
pharmacokinetics of Warfarin is not significantly affected following
co-administration with Rosuvastatin. Cyclosporin: Co-administration of
Rosuvastatin with cyclosporin resulted in no significant changes in Cyclosporin
plasma concentration. Gemfibrozil: Concomitant use of Rosuvastatin and
Gemfibrozil resulted in a two-fold increase in Cmax and AUC. Antacid: The
simultaneous dosing of Rosuvastatin with an antacid suspension containing
Aluminium and Magnesium hydroxide resulted in a decrease in Rosuvastatin plasma
concentration of approximately 50%. There are no clinically significant
interactions with an oral contraceptive, Digoxin, Fenofibrate, antihypertensive
agents, antidiabetic agents and hormone replacement therapy.