ATHERO Rosuvastatin 20mg Film-Coated Tablet 1's
RXDRUG-DRP-7993-1pc
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Features
Brand
Athero
Full Details
Dosage Strength
20mg
Drug Ingredients
- Rosuvastatin
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Rosuvastatin
Dosage Form
Film-Coated Tablet
Registration Number
DRP-7993
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Hyperlipidemia and Mixed Dyslipidemia: Rosuvastatin is indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApB, non HDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non pharmacological interventions alone has been inadequate, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non pharmacological interventions alone has been inadequate.
Hypertriglyceridemia: Rosuvastatin is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
Homozygous Familial Hypercholesterolemia: Rosuvastatin 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, and ApoB in adult patients with homozygous familial hypercholesterolemia.
Showing of the Progression of Atherosclerosis: Rosuvastatin 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.
Hypertriglyceridemia: Rosuvastatin is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
Homozygous Familial Hypercholesterolemia: Rosuvastatin 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, and ApoB in adult patients with homozygous familial hypercholesterolemia.
Showing of the Progression of Atherosclerosis: Rosuvastatin 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.
Dosage/Direction for Use
General Dosing Information: The dose range of rosuvastatin is 5 to 40 mg orally once daily.
LDNIL can be administered as a single dose at anytime of the day with or without food. Before using this medication, tell the doctor or pharmacist of all prescription and non-prescription/herbal products if the patient may use, especially of antacids, birth control pills, cyclosporine, daptomycin, atazanavir, fosamprenavir, lopinavir/ritonavir, nelfinavir and warfarin.
The documents does not contain all possible interactions. Therefore, before using this product, tell the doctor or pharmacist of all the products the patient uses. Keep a list of all the medications with the patient, and share the list with the doctor and pharmacist.
LDNIL can be administered as a single dose at anytime of the day with or without food. Before using this medication, tell the doctor or pharmacist of all prescription and non-prescription/herbal products if the patient may use, especially of antacids, birth control pills, cyclosporine, daptomycin, atazanavir, fosamprenavir, lopinavir/ritonavir, nelfinavir and warfarin.
The documents does not contain all possible interactions. Therefore, before using this product, tell the doctor or pharmacist of all the products the patient uses. Keep a list of all the medications with the patient, and share the list with the doctor and pharmacist.
Overdosage
There is no specific treatment in the event of overdose. In the event of overdose, patient should be treated symptomatically and supportive measure instituted as required. Hemodialysis dose not significantly enhance to rosuvastatin.
Administration
May be taken with or without food.
Contraindications
Rosuvastatin is contraindicated in the following conditions: Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin.
Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
Women who are pregnant or may become pregnant. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy, and safety in pregnant women has not been established. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the luck of known clinical benefit with continued use during pregnancy.
Nursing mothers. Because another drug in this class passes into breast milk, and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require rosuvastatin treatment should be advised not to nurse their infants.
Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
Women who are pregnant or may become pregnant. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy, and safety in pregnant women has not been established. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the luck of known clinical benefit with continued use during pregnancy.
Nursing mothers. Because another drug in this class passes into breast milk, and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require rosuvastatin treatment should be advised not to nurse their infants.
Special Precautions
Before taking rosuvastatin tell the doctor or pharmacist if the patient is allergic to it, or other "stains"; or if the patient has any other allergies.
Use In Pregnancy & Lactation
Rosuvastatin is contraindicated in the following conditions: Women who are pregnant or may become pregnant. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy, and safety in pregnant women has not been established. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the luck of known clinical benefit with continued use during pregnancy.
Nursing mothers. Because another drug in this class passes into breast milk, and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require rosuvastatin treatment should be advised not to nurse their infants.
Nursing mothers. Because another drug in this class passes into breast milk, and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require rosuvastatin treatment should be advised not to nurse their infants.
Storage
Store at temperatures not exceeding 30°C.
Action
Antihyperlipidaemic.
Pharmacology: 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. In-vivo studies in animals, and in-vitro studies in cultured animal and human cells have shown rosuvastatin have a high uptake into, and selectivity for action in the liver, the target organ for cholesterol lowering. In in-vivo and vitro studies. Rosuvastatin produces its lipid modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and particles.
Pharmacokinetics: Absorption: In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing. Both Cmax and AUC increased in approximately proportion to rosuvastatin dose. The absolute bioavailability rosuvastatin is approximately 20%. Administration of rosuvastatin with food did not effect the AUC of rosuvastatin. The AUC of rosuvastatin does not differ following evening or morning drug administration.
Distribution: Mean volume of distribution state of rosuvastatin is approximately 134 liters, rosuvastatin is 88% bound to plasma proteins mostly albumin. The binding is reversible and independent of plasma concentrations.
Metabolism: Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is covered as metabolite. The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 2C9 and in-vitro studies have demonstrated that N-desmethyl rosuvastatin has approximately one-sixth to one half the HMG-CoA reductase inhibitory activity of the parent compound. Overall, greater than 90% of active plasma HMG-CoA reductase inhibitory activity us accounted for by parent compound.
Excretion: Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%). The elimination half-life of rosuvastatin is approximately 19 hours after an intravenous dose, approximately 28% of total body clearance was via the renal route and 72% by the hepatic route. When initiating rosuvastatin therapy, the appropriate rosuvastatin starting dose should first be utilized, and only then titrated according to the patients response and individualized goal of therapy. The 40 mg dose of rosuvastatin should be use for those patients who have not achieve their LDL C goal utilizing the 20 mg dose.
Pharmacology: 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. In-vivo studies in animals, and in-vitro studies in cultured animal and human cells have shown rosuvastatin have a high uptake into, and selectivity for action in the liver, the target organ for cholesterol lowering. In in-vivo and vitro studies. Rosuvastatin produces its lipid modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and particles.
Pharmacokinetics: Absorption: In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing. Both Cmax and AUC increased in approximately proportion to rosuvastatin dose. The absolute bioavailability rosuvastatin is approximately 20%. Administration of rosuvastatin with food did not effect the AUC of rosuvastatin. The AUC of rosuvastatin does not differ following evening or morning drug administration.
Distribution: Mean volume of distribution state of rosuvastatin is approximately 134 liters, rosuvastatin is 88% bound to plasma proteins mostly albumin. The binding is reversible and independent of plasma concentrations.
Metabolism: Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is covered as metabolite. The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 2C9 and in-vitro studies have demonstrated that N-desmethyl rosuvastatin has approximately one-sixth to one half the HMG-CoA reductase inhibitory activity of the parent compound. Overall, greater than 90% of active plasma HMG-CoA reductase inhibitory activity us accounted for by parent compound.
Excretion: Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%). The elimination half-life of rosuvastatin is approximately 19 hours after an intravenous dose, approximately 28% of total body clearance was via the renal route and 72% by the hepatic route. When initiating rosuvastatin therapy, the appropriate rosuvastatin starting dose should first be utilized, and only then titrated according to the patients response and individualized goal of therapy. The 40 mg dose of rosuvastatin should be use for those patients who have not achieve their LDL C goal utilizing the 20 mg dose.
MedsGo Class
Dyslipidaemic Agents
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