PMS-Rosuvastatin 20mg Pharmascascience tablet for hypertonic blood cholesterol (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin
Ingredient
| Composition information | Content |
| Rosuvastatin | 20mg |
Uses
Indications
PMS - Rosuvastatin is indicated in the following cases:
Hyper cholesterol hypertrophy
mixed lipid disorders (type IIB): is a supportive therapy for a diet when the patient does not fully respond to the diet and other non -drug therapies (such as exercise, weight loss).
Preventing the main cardiovascular events
In patients without a history of cardiovascular and cerebrovascular events, but at least two common risk factors for cardiovascular disease, PMS - Rosuvastatin are specified to:
Pharmacy
Rosuvastatin is a selective and competitive inhibitor on HMG - Coa Reductase, is the catalyst of the conversion process 3 - Hydroxy - 3 - Methylulutaryl Coenzyme A into Meovalonate, a precursor of cholesterol.
pharmacokinetic
absorption
Rosuvastatin Calcium is used quickly absorbed, reaching the peak concentration in plasma 3-5 hours after taking the drug. Both peak concentrations (CMAX) and area under the curve of drug concentration in plasma over time (AUC) increase proportional to the dose of rosuvastatin. Rosuvastatin's absolute bioavailability is about 20% and there is no accumulation when using the dose repeated. Rosuvastatin calcium can be used or not with food. Using the drug in the morning or evening does not affect the speed and level of absorption as well as the ability to reduce LDL - C of Rosuvastatin.
Distribution
Rosuvastatin widely distributed in the liver is the main place for cholesterol and LDL - c. The distribution of rosuvastatin is about 134 l. About 90% of rosuvastatin combined with plasma proteins, mainly with albumin.
Metabolism
Rosuvastatin is less metabolized (about 10%). In vitro studies on metabolism use liver cells of the person who determines that rosuvastatin is a weak substrate for metabolism through cytochrome P450. CYP2C9 is the main enzyme copper involved in the metabolism, 2C19, 3A4 and 2D6 participating at a lower level. The main metabolites are identified as N - Desmethyl and Lactone. N - Desmethyl metabolites have a weaker activity about 50% than rosuvastatin while lactone form is not clinically active. Rosuvastatin accounts for more than 90% of HMG inhibitors - CoA Reductase in circulation.
Elimination
About 90% of rosuvastatin dose is eliminated in a constant form (including the active ingredient that is absorbed and not absorbed) and the rest is excreted into urine. About 5% are excreted into the urine in the form of air. Selling time for plasma is about 19 hours. The sale time does not increase when using a higher dosage. The average plasma clearance is about 50 liters/hour (the variable coefficient is 21.7%). Like other HMG - coa reductase inhibitors, the elimination of rosuvastatin from the liver is related to the transportation through the OATP film - C. This transportation is important in eliminating rosuvastatin from the liver.
Linear calculation: Rosuvastatin's contact level is calculated by concentration and duration proportional to the dose. There is no change in pharmacokinetic parameters after many dosage doses.
Special patient groups
Age and gender
The impact of age or gender on pharmacokinetics of rosuvastatin is negligible in terms of clinical.
Race
Dynamic studies show that AUC increases about twice in Japanese people living in Japan and Chinese living in Singapore compared to the white Western people. The influence of genetic and environmental factors on this change has not been determined. A pharmacokinetics analysis by population shows that there is no clinical difference in pharmacokinetics in white and black groups.
kidney failure
In research on people with kidney failure at different degrees shows that the kidney disease from mild to medium does not affect the level of rosuvastatin or N - Desmethyl metabolites in plasma. Patients with severe renal impairment (plasma creatinine clearance Hepatic failure
In the study of liver damage to many different levels, there is no evidence of increasing the exposure of rosuvastatin by concentration and time in patients with Child - PUGH ≤ 7. However, 2 patients with Child - Pugh score are 8 and 9 with the contact level of RosuVastatin calculated by concentration and time of minimum of the minimum of the person with a minimum of the person with the minimum of Child - PUGH scores. Inexperienced in patients with Child - Pugh> 9.
Effect
Mechanism of impact
Rosuvastatin is a selective and competitive inhibitor on HMG - CoA Reductase, is the catalyst of conversion 3 - Hydroxy - 3 - Methylglutaryl Coenzyme A into Mevalonate, a precursor of cholesterol. The main acting position of rosuvastatin is the liver, the target organs reduce cholesterol.
Rosuvastatin increases the number of LDL receptors on the cell surface in the liver, thus increasing the absorption and catabolism of LDL and inhibiting VLDL synthesis in the liver, thus reducing VLDL and LDL components.
Pharmaceutical impact
Rosuvastatin reduces LDL - cholesterol levels, total cholesterol and triglycerides and increases HDL - cholesterol. The drug also reduces APOB, Non HDL - C, VLDL - C, VLDL - TG and increases APOA - I. Rosuvastatin also reduces the ratio of LDL - C/HDL - C, Non/HDL - C, C total/HDL - C, Non HDL - C/HDL - C and APOB/APOA - I.
Before taking PMS-Rosuvastatin 20mg Pharmascascience tablet for hypertonic blood cholesterol (3 blisters x 10 tablets)
How to use
PMS - Rosuvastatin is taken orally.
Before starting treatment, the patient must follow a standard diet to reduce cholesterol and continue to maintain this regime during treatment. Use consensus instructions for lipid disorders to adjust the dose of rosuvastatin for each patient according to the patient's treatment and response goals.
Rosuvastatin can be used at any time of the day, during or away from meals.
Dosage
The recommended starting dose is Rosuvastatin 10 mg, taken once a day and most patients are controlled at this starting dose.
If necessary, the dose can be increased to 20 mg after 4 weeks. Increasing the dose to 40 mg should only be used for patients with severe hypercholesterolemia that is at high risk of cardiovascular disease (especially patients with hypertension in the family) without achieving treatment goals at a dose of 20mg and these patients need to be monitored regularly.
Consider taking drugs in special subjects
Children
Safety and efficiency in children have not been set up. Experience in using drugs in children is limited to a small group of children (> 8 years old) with hypertension hypertension. Therefore, Rosuvastatin is not recommended for children during this time.
Elderly
No dose adjustment.
Patients with renal failure
No dose adjustment in patients with mild to medium renal failure. Contraindicated use of rosuvastatin for patients with severe renal failure.
Patients with liver failure
The level of contact with rosuvastatin by concentration and time does not increase in patients with Child - Pugh ≤ 7. However, the level of exposure to the increased drug has been recorded in patients with Child - Pugh 8 and 9 scores. Inexperienced in patients with Child - Pugh scores over 9. Contraindicated use of rosuvastatin for patients with liver disease developing.
Race
Increase the level of exposure to drugs calculated by concentration and time seen in Japanese and Chinese patients. This should be considered when deciding the dose for Japanese and Chinese -based patients.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? If the drug is overdose, the patient needs to be treated with symptoms and supportive measures to set up as required. Hemodialysis does not significantly increase the clearance of rosuvastatin.
For monitoring an overdose, contact the Detail Control Center immediately.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using PMS - Rosuvastatin, you may experience unwanted effects (ADR).
Rosuvastatin calcium is usually well tolerated. The side effects of rosuvastatin calcium are usually light and transient. However, some unwanted effects occur such as:
Hyperglycemia.
Unexpectedly unexpected effects (
Frequency of side effects in clinical trials and are considered possible, capable or firmly relevant as follows:
Popular (> 0.1% and
Itching, rash, joint pain, muscle weakness, arthritis, constipation, nausea, gastrointestinal dysplasia, gastroesophageal reflux disease, hyperplation, increased creatin phosphokinase, liver enzyme, increased creatinine, abnormal, tremor, general pain, sinusitis, sinusitis, insomnia, abnormal liver function, dizziness, diabetes.
Rare (> 0.01% and
Muscle disease (including muscle inflammation), muscle pattern, and hypersensitivity reaction including angioedema. The following additional side effects have been reported in controlled clinical trials, regardless of the cause: accident, injury, back and chest pain, influenza syndrome, infection, urinary tract infection, diarrhea, flatulence, gastritis, hypertension, bronchitis, cough, rhinitis and sore throat.
In the Rosuvastatin Calcium clinical trial control has been shown to have no harmful effects on the eyewear lenses.
Abnormal hematology and clinical chemical detection: As with HMG inhibits - CoA Reductase, an increase in liver enzyme and CK has been observed in a few patients using Rosuvastatin.
Experienced analysis of urine analysis (positive protein on Dipstick) has been seen in a small number of patients using Rosuvastatin calcium and other HMG - coa reductase inhibitors. Protein detected mainly in the essence.
In most cases, proteinuria decreases or disappears treatment and is not a prediction of acute kidney disease.
Monitor the adverse reaction of the drug
In addition to the above report events, the following side effects have been reported in monitoring experience with Rosuvastatin Calcium.
Bone impact
Very rare: joint pain.
Liver disorders
Very rare: jaundice, hepatitis.
Nervous system disorders
Very rare: Memory loss.
Other
Sleep disorders, including insomnia and nightmares.
Disorders related to mood such as depression.
The case of erectile dysfunction has been reported in combination with the use of statin.
Interstitial lung disease: The very rare case of interstitial lung disease, especially with long -term treatment. If the patient is suspected of developing interstitial lung disease, the drug should be stopped.
Instructions on how to handle ADR
When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
PMS - Rosuvastatin contraindicated in the following cases:
Patients with acute liver disease or prolonged increase in unknown cause of serum transaminases concentration more than 3 times limited to normal levels. Pregnant and lactating women. Cholesterol and other products of cholesterol biosynthesis are essential ingredients for fetal development (including synthesis of steroids and cell membranes), PMS - Rosuvastatin should be used for women of reproductive age only when patients are difficult to conceive and have been notified of harmful effects. If the patient is pregnant while using PMS - Rosuvastatin must immediately stop the drug and the patient informs the potentials that cause harm to the fetus. Vascular atherosclerosis is a chronic process, stopping lipid exchange drugs during pregnancy that has very little effect on long -term treatment results of primary hypercholesterol. Before conducting treatment with Rosuvastatin Canci, it is necessary to control cholesterol hypertrophy with appropriate dietary diet, weight loss in overweight patients and other basic medical problems and related cardiovascular risk factors. The patient was promoted to notify the subsequent doctors of the use of Rosuvastatin Canci or any other previous blood lipid lipid agent. cardiovascular co-enzyme Q10 (Ubiquinone) Ubiquinone levels are not measured in Rosuvastatin clinical trials. The significant decrease in Ubiquinone fluid circulation in patients treated with other statin groups has been observed. The clinical significance of statin deficiency caused Ubiquinone's long -term potential was not established. It has been reported that reducing myocardial Ubiquinone levels can lead to weakened heart function in patients with congested heart failure. endocrine and metabolism Endocrine function: Patients treated with rosuvastatin that have clinical evidence of endocrine dysfunction should be properly evaluated. Be cautious if a HMG-CoA Reductase inhibitor or other substance is used to reduce the amount of cholesterol used for patients with other drugs (such as ketoconazol, spironolacton or cimetidine) that can reduce endogenous steroid hormones. Gleeding: In Jupiter test, Rosuvastatin 20 mg observed that increasing blood sugar levels, sufficient to change some predicated objects to diabetes. Lipoprotein (A): In some patients, the beneficial effect of total cholesterol reduction and LDL - C may be partially reduced by the increase simultaneously in the level of lipoprotein (A) [LP (A)]. The current recognition shows the importance of high levels of LPA is a risk factor for coronary heart disease. Therefore, the desire to maintain and strengthen lifestyle changes in high -risk diseases placed on Rosuvastatin treatment. liver/ bile/ pancreas Liver influence Rosuvastatin is contraindicated in patients with acute liver disease or the prolonged increase in unknown cause of serum transaminase concentration more than 3 times limited to normal. Hepatic failure Different liver injury subjects have no evidence of increased exposure to rosuvastatin than the two subjects with the most serious liver disease (Child - Pugh 8 and 9). Among these subjects, the system exposure is increased by at least 2 times compared to the subjects with lower Child - Pugh. Mechanical effects The rare case of pattern with secondary acute renal failure Myoglobinuria, has been reported to Rosuvastatin calcium and other HMG - CoA Reductase inhibitors. Skilled muscle effects such as muscle pain, muscle diseases and sometimes, pattern pepper has been reported in patients treated with Rosuvastatin calcium at all doses and especially with 40 mg. Muscle diseases, defined as muscle pain or muscle weakness combined with increased creatin kinase (CK) worth ten times larger than the upper limit of normal levels, should be considered in any patient with spreading muscle pain, muscle pain or weakness and/or significantly increased CK. Patients need advice to promptly report any cause of muscle causes, pain or weakness, especially if related to instability or fever. Patients with any signs or symptoms suggest muscle disease should measure their CK level. Rosuvastatin calcium should be discontinued if the ck concentration is highly high> 10 x ULN) is determined or muscle disease is diagnosed or restless. Risk factors for muscle disease/muscle disease Rosuvastatin calcium, as with other HMG - Coa Reductase inhibitors, must be carefully regulated in patients with risk factors for muscle/muscle disease. Therefore, before treatment, Creatin Kinase is required in the following cases: individual or family history of genetic muscle disorders. over 70 years old History of muscle toxicity with a Reductase inhibitor HMG - COA. kidney failure Simultaneous use of fibrat or niacin. Hepatic failure Hypothyroidism Diabetes with fatty liver. Alcohol abuse. Surgery and injury. Exercise too much. Weak condition. Sacrifice that the increase in agriculture Rosuvastatin calcium may occur. In the above cases, the benefits/risks should be considered and monitor patients clinically when treated with rosuvastatin. If the results of Creatin Kinase> 5 times are limited to normal, should not be treated with rosuvastatin. During RosuVastatin treatment, patients need to notify when there are muscle manifestations such as muscle pain, muscle stiffness, muscle weakness ... When there are these manifestations, the patient needs to test Creatin Kinase for appropriate interventions. Kidney Renal failure: The object of severe renal failure (CrCl Sensitive /resistance Hypersensitivity: A clear hypersensitivity syndrome has been reported rarely for HMG - COA Reductase. This has included one or more of the following features: anaphylaxis, angioedema, syndrome like lupus erythematosus, muscle pain due to rheumatism, vascular inflammation, hemorrhage, platelets, leukopenia, hemolytic analogy, positive antibodies (ANA), sedimentation blood rate (ESR) increased, Eosin cells, Eosin, arthritis, stainless, painful, painful, painful, painful, painful, painful, pain Fatigue, shortness of breath, poisoned epidermal necrosis and diverse roses include Stevens - Johnson syndrome. Should stop the drug if hypersensitive. Special subjects Pregnant women Contraindicated Rosuvastatin Calcium during pregnancy. breastfeeding women It is not known whether Rosuvastatin is excreted in breast milk. Because the potential for adverse reactions in children, women using rosuvastatin should not be breastfeeding. Pediatrics ( Experience treatment with Rosuvastatin Calcium in a children's population is limited to 8 patients with genetic hypercholesterol. None of these patients are under 8 years old. Teenage women need advice on appropriate contraception when treating Rosuvastatin Calcium. Geriatrics (65 years old) There is no significant clinical difference between young patients and the elderly (> 65 years old). However, older patients may be more sensitive to muscle disease. They The results of pharmacokinetics research, including a major study conducted in North America, proved twice as higher than the average contact with Asians (Philippines, China, Japan, South Korea, Vietnam or Asia - India) when compared to a whites control group. This increase should be considered when making rosvastatin decisions for Asian patients and a dose of 40 mg is contraindicated in these patients. Studies to determine the effectiveness of rosuvastatin on driving capacity and using machines have not been done. However, based on pharmacological properties, Rosuvastatin is unlikely to affect this ability. When driving and operating machinery, it can cause dizziness during treatment. Rosuvastatin Calcium is contraindicated in pregnant women. Rosuvastatin Calcium is contraindicated in breastfeeding women. OVERVIEW In Rosuvastatin Calcium clinical trial has no evidence of an increase in skeletal effects when Rosuvastatin is taken in dosage with any simultaneous treatment. However, Rosuvastatin calcium and other HMG - Coa Reductase inhibitors may cause an increase in the dose of transaminase and CK concentrations. The increase in the incidence of muscle inflammation and muscle disease has been seen in patients using other HMG-COA Reductase inhibitors simultaneously with cyclosporin, fibric acid of derivatives (including gemfibrozil), nicotinic acid, antifungal group Azol and macrolid antibiotic. Cytochrom P450 inhibitors: In vitro and in vivo data indicates that RosuVastatin interactor clinical interactions Cytochrom P450 does not make sense (such as surfaces, inhibitors or induction). Therefore, there is very little ability to interact with drugs when used with drugs metabolized by Cytochrom P450. Rosuvastatin clearance does not depend on the metabolic process by Cytochrom P450 3A4 a significant clinical level. This has been confirmed in studies with Cytochrom P450 3A4 inhibitors (ketoconazol, erythromycin, iTraconazole). Simultaneous treatment with other lipid metabolism: simultaneous use of fenofibrat and rosuvastatin calcium 10 mg does not lead to a significant clinical change in plasma concentrations of both drugs. Protease inhibitors Lopinavir/Ritonavir: In a pharmacokinetics study, used with Rosuvastatin Calcium and a combination product of two protease inhibitors (400 mg Lopinavir/100 mg Ritonavir) in healthy volunteers involved with an increase of about 2 times and 5 times in the state of Rosuvastatin Calcium AUC (0 - 24) and CMAX. Increased system contact for Rosuvastatin has been observed in the objects using rosuvastatin calcium with different protease inhibitors in combination with Ritonavir. It is necessary to consider both the benefit of lowering lipids by using Rosuvastatin calcium in HIV patients who receive protease inhibitors and the ability to increase rosuvastatin levels at the beginning and increase the dose of Rosuvastatin calcium in patients treated with protease inhibitors. combined treatment without significant clinical interactions Bile acid plastic: Rosuvastatin calcium can be used in combination with bile acid plastic (eg cholestyramin). Ketoconazole: Concomitance Ketoconazole with rosuvastatin calcium leads to unchanged in plasma concentrations of Rosuvastatin calcium. erythromycin: simultaneously use erythromycin with rosuvastatin calcium, resulting in reduced low concentration in plasma of rosuvastatin. The decreases are not clinically significant. Itraconazole: simultaneously use Itraconazole with rosuvastatin calcium, resulting in an increase of 28% AUC of Rosuvastatin Calcium. This small change is not considered clinical significance. fluconazole: simultaneously use fluconazole with rosuvastatin calcium, resulting in an increase of 14% AUC of rosuvastatin calcium. This small change is not considered clinical significance. Digoxin: Concomitance of Digoxin and Rosuvastatin Calcium does not lead to any clinical interaction. Interaction between drugs and drugs Increased risk of muscle damage when using rosuvastatin simultaneously with the following drugs: Concomitance the use of rosuvastatin with HIV and hepatitis C (HCV) can cause the risk of injury, kidney damage leading to kidney failure and may cause death. Precautions when used
The ability to drive and operate machinery
Pregnancy
Breastfeeding period
Drug interaction
Storage
temperature below 300C. Avoid light and moisture.
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