Rosvin 10mg

Tablet
Rosuvastatin
Alco Pharma

Other Strength:

Alternative:
- Rosutin 10mg
- ROSTAB 10mg
- RosuvaTM 10mg
- Rovast 10mg
- Rosu 10mg
- Rosetor 10mg
- Cholcut 10mg
- Ruvastin 10mg
- Rolip 10mg



Rosvin
Description:
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.

Composition:
Rosvin 10 Tablet: Each film coated tablet contains Rosuvastatin calcium INN equivalent to Rosuvastatin 10 mg.

Indication/Use:
Heterozygous Hypercholesterolemia (Familial & Nonfamilial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson type IIa & IIb)

Dosage Guideline:
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 factor for myopathy. For patients with marked hypercholesterolemia (LDL-C >190 mg/dl) and aggressive lipid target, 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 of Rosuvastatin 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 hemodyalysis, dosing of Rosuvastatin should be started at 5 mg once daily and not to exceed 10 mg once daily.

Administration:
Rosuvastatin can be taken with or without food, at any time of day.

Side Effects:
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were myalgia, constipation, asthenia, abdominal pain and nausea.

Contraindication:
Rosuvastatin is contraindicated in patients with known hypersensitivity to any components of this product. Rosuvastatin is contraindicated to active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels, pregnant women and women who may become pregnant.

Drug Interaction:
Erythromycin: Co-administration of Erythromycin with Rosuvastatin decreased AUC and Cmax of Rosuvastatin by 20% and 31%, respectively. Itraconazole: Itraconazole resulted in a 39% and 28% increase in AUC of Rosuvastatin after 10 mg and 80 mg dosing, respectively. Fluconazole: Co-administration of Fluconazole with Rosuvastatin resulted in a 14% increase in AUC of Rosuvastatin. Warfarin: Co-administration of Warfarin (25 mg) with Rosuvastatin (40 mg) did not change Warfarin plasma concentrations but increase the International Normalized Ratio (INR). Gemfibrozil: Co-administration of Gemfibrozil (600 mg twice daily for 7 days) with Rosuvastatin (80 mg) resulted in a 90% and 120% increase for AUC and Cmax of Rosuvastatin, respectively. Antacid: Co-administration of an Antacid (Aluminium and magnesium hydroxide combination) with Rosuvastatin (40 mg) resulted in a decrease in plasma concentrations of Rosuvastatin by 54%. Oral contraceptives: Co-administration of oral contraceptives (Ethinyl Estradiol and Norgestrel) with Rosuvastatin resulted in an increase in plasma concentrations of Ethinyl Estradiol and Norgestrel by 26% and 34% respectively.

Use in Pregnancy & Lactation:
Rosuvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued immediately. It is not known whether Rosuvastatin is excreted in human milk.

Precaution:
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness and Rosuvastatin can be discontinued if such signs or symptoms appear. Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Liver enzymes should be monitored before and during treatment.

Therapeutic Class:
Lipid Lowering Agent

Dosage Form:
Tablet

Storage:
Store in a cool and dry place, away from the light. Keep out of the reach of children.





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