Rovatin Korea Prime Pharm reduces total cholesterol, LDL-Cholesterol (4 blisters x 14 tablets)
Dosage form Box of 4 blisters x 14 tablets
Specifications Rosuvastatin
Ingredient
| Composition information | Content |
| Rosuvastatin | 10mg |
Uses
indications
Bodhi for diet to reduce total cholesterol, LDL-Cholesterol, APOB, Nonhdl-C, and Triglyceride (TG) and increase HDL-C in patients with primary blood cholesterol (heterozygous and non-family family), and mixed blood lipid disorders (Fredriekson type ILA and IIB).
Support for diet to treat patients with high serum levels (Fredrickson IV).
To reduce LDL-C, total cholesterol, and apobs in patients with primary cholesterol hyperplation hyperplasia, as a hypocrus, as another supported drug for lipid lowering treatments (for example, decanted LDL-C in the blood) or if this treatment is not effective.
Use in combination with adjusting the diet for patients and then beta lipoprotein (increased blood lipoprotein 1h).
Use in conjunction with adjustment of diet for patients who are slow to the progressive atherosclerosis reduces TC-Total cholesterol and LDL-C to the target threshold.
Prevention of raw cardiovascular disease. In patients without clinical coronary artery disease but increases the risk of cardiovascular disease, including over 50 for men and over 60 for women, HSCRP> 2 mg/l and at least one risk factor for cardiovascular disease such as hypertension, reduction of LDL-C, smoking or family history of people with early coronary artery disease, Rosuvastatin is indicated to reduce risk of hematuria, hemorrhage risk to vascular vessels.
Pharmacokology
Code ATC: C10AA07
Rosuvastatin is a selective and competitive inhibitor of HMG-COA, an enzyme limiting the conversion speed of Coenzyme A 3-Hydroxy-3-MethylGlutaryl into Mevalonate-Premodage of cholesterol. The main effect of rosuvastatin is the liver.
Rosuvastatin increases the number of liver LDL receptors on the cell surface, increases the absorption and metabolism of LDL and inhibits the synthesis of VLDL in the liver thus reducing the total amount of VLDL and LDL seeds. Rosuvastatin reduces total cholesterol, LDL-C, APOB, and NonHDL-C (HDL-C) in patients with primary hypercholesteroline hypercholular hyperplasia and clutches (FH), cholesterol hypercasting without family chat, and mixed blood lipDD disorders.
Rosuvastatin also reduces TG and increases HDL-C. Rosuvastatain Lam TC-Total Cholesterol, LDL-C, VLDL-CHOLesterol (VLDCL-C), APOB, NonHDL-C and TG, and HDL-C increase in patients with hyperllycerides.
pharmacokinetics
absorption
Birth of rosuvastatin is about 20%. The concentration of rosuvastatin in plasma is not different after taking the drug or in the morning. The reduction of LDL-C took place in a way that even when there was or not using rosuvastatin with food, and regardless of the daily use of medication.
Distribution
The average distribution of rosuvastatin in "Durable state is about 134 L. Rosuvastatin binds 88% with protein. Same, the owner is albumin. This link is reversible and depends on plasma concentrations.
Metabolism
Rosuvastatin is not much specialized, about 10% of the dose with radioactive isotope is found in the form of metabolites. The main metabolites are Ndesmethyl Rosuvastatin, created the owner loved by Cytochrom P450 2C9, and the Invitro studies have proven that N-Desmethyl Rosuvastatin has about one-six to half of HMG-COA reducing enzyme that inhibits Rosuvastatin's operation.
Elimination
After drinking, rosuvastatin and its metabolites are mainly excreted in feces (90%). The sale time of Rosuvastatin (t) is about 19 hours.
Before taking Rovatin Korea Prime Pharm reduces total cholesterol, LDL-Cholesterol (4 blisters x 14 tablets)
How to use
This drug is only used as prescribed by a physician. Before starting treatment, patients need to follow a standard diet of cholesterol and maintain during medication.
The drug can be used at any time in this, used in meals or away from meals.
Dosage
Adults
The dose for adults is from 5 to 40mg. In case of prevention of primary cardiovascular disease, the dose is 20 mg/day.
The normal starting dose is 5 or 10mg 1 time/day. For patients with primary hypercholesterolemia hyperconders, the starting dose is 20 mg once a day.
Dosage must be individualized according to the patient's treatment and response goals. Selecting the starting dose level to consider the patient's cholesterol levels and cardiovascular risks as well as the risk of unwanted effects.
After 2 to 4 weeks of starting or adjusting dose dose, the test is needed to monitor the blood lipid level and the adjustment to the next dose level can be done after 4 weeks. Due to the frequency of unwanted effects reported at a dose of 40 mg compared to lower doses, the adjustment of the dose to the maximum dose of 40 mg should only be considered when the patient has a serious hypercoles (especially with hypercast blood cholesterol) without achieving treatment effects at a dose of 20 mg, and patients who are monitored regularly.
Children
In patients with hypercondic hypertension hyperlested hypertension, the recommended dose is from 5 to 10 mg oral 1 time/day in patients from 8 to under 10 years old and 5 to 20 mg oral 1 time/day in patients from 10 to 17 years old.
In patients with hyperconded hypertension with homozygous, recommended dose is 20 mg oral 1 time/day in patients from 7 to 17 years old.
Asian patients
In patients with Asians, it is necessary to consider the starting dose of 5 mg once a day due to increased blood rosuvastatin levels.
In case of failing to achieve the goals of treatment, the dose increases to 20 mg/day.
Elderly
The starting dose recommended for people over 70 years old is 5 mg once a day. It is not necessary to conduct other measures to adjust the dose by age.
Patients with liver failure
Rosuvastatin concentration in the blood does not increase in patients with Pugh ≤ 7. In these patients, it is necessary to conduct kidney function assessment. There is no clinical data on the use of drugs in patients with PUGH score over 9. The drug is contraindicated in patients with progressive liver disease.
Patients with renal failure
There is no need to change the dose for patients with mild to moderate renal failure. For patients with average renal failure (CLCR
Used in combination with other drugs
The risk of muscle diseases (including muscle pepper) increases when taking the drug simultaneously with some drugs that increase the concentration of rosuvastatin in the blood (such as ciclosporin and some protease inhibitors include a combination of ritonavir with Atazanavir, Lopinavir, and/or Tipranavir) and Gemfibrozil, other Fibrat blood medications, other fibrine blood groups, niacin fibratoly High doses (> 1 g/day), colchicin.
In case it may be necessary to consider other maintenance measures and if necessary, it may temporarily stop using rosuvasfatin. In case of compulsory combination of these drugs with rosuvastatin, be careful to consider the benefits and risks and adjust the Rosuvastatin bureaucracy. The maximum limit of rosuvastatin dose when coordinated with acacanavir, Atazanavir and Ritonavir, Lopinavir and Ritonavir is 10 mg once a day.
Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of injury, the most serious is muscle pattern, kidney damage leading to kidney failure and can be fatal.
What to do when overdose?
There is no overdose information.
How to handle overdose: There is no specific treatment when overdose Rosuvastatin. In the event of an overdose, patients need to be treated with symptoms and take supportive measures if necessary and should monitor liver and ck function. Dialysis bruises do not increase rods of rosuvastatin.
What to do when forgetting the dose?
If you forget a dose, use it as soon as possible. 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
rosuvastatin is generally tolerated well. The side effects are usually light and transient.
In clinical studies of 10,275 patients, 3.7 % must stop taking the drug due to side effects.
When using rosuvastatin may have muscle pain, constipation, weakness, abdominal pain, and nausea, cognitive impairment (such as memory eyes, confusion ...), hyperglycemia, hbaic increased. The following unexpected effects are listed according to the frequency and organ system.
The frequency of unexpected effects. Want to get rated according to the following criteria: Common (> 1/100 to
Table 1. Unwanted effect based on clinical studies and after -sales reports
Memory loss
Sleep disorders (including insomnia
and nightmares)
digestive disorders
abdominal pain
Hepatitis
pattern
Unwanted effect on the kidneys
proteinuria, detected by the test strip and most of the renal tubules, have been reported in patients using rosuvastatin. The protein in urine changes from negative or to ++ or more traces that have been reported at
In most cases, proteinuria decreases or disappears when treated. Data from clinical studies and after -sales reports so far have not been determined the relationship between proteinuria and acute or progressive kidney disease.
Affects on skeletal muscles
Unwanted muscle -muscular effects such as muscle pain, muscle disease (including myocarditis) and, rarely, the muscle pattern has or without acute kidney failure has been reported in patients using rosuvastatin with all the dose levels and especially at the dose of over 20 mg.
Increased creatine kinase level depends on the dosage that has been reported in patients using rosuvastatin, most cases are mild, asymptomatic and transient. If Creatine Kinase concentration increases rapidly (over 5 times the threshold above the normal limit), it is necessary to stop using the drug.
influence on the liver
Like other HMG-CoA Reductase inhibitors, increasing transaminase depends on the dose that has been reported in a few patients using rosuvastatin; Most cases are light,
with no symptoms and fleeting.
Other undesirable effects have been reported to some statins:
Increase Creatine Kinase> 10 times on the normal limit and shift symptoms after exercise or increase physical activity reported with greater frequency than adults in a 52 -week clinical study in children and teenagers. For other unwanted effects, data obtained in children and teenagers similar to adults.
Warnings
Contraindicated
Do not indicate drug treatment in the following cases:
Patients with hypersensitivity to any component of the drug.
Patients with progressive liver disease or persistent high serum transaminase unexplained (when serum transaminase concentration increases more than 3 times the upper limit of normal level).
Pregnant or lactating women.
Women may be pregnant without using effective contraception.
Severe renal failure (creatinine clearance
Patients are taking ciclosporin.
Dosage level of 40 mg is contraindicated in patients: medium renal failure (Creatinine clearance Precautions when using
Effects on the kidneys
proteinuria, detected by test strips and most of the renal tubules, have been reported to patients using high -dose rosuvastatin, especially 40 mg, most of them occur transient or interrupted.
proteinuria shows signs of acute or progressive kidney disease. The frequency of reporting serious kidney diseases is higher for a dose of 40 mg. Need to assess kidney function when regular monitoring patients when taking the dose of 40 mg.
Effects on skeletal system
Effects on musculoskeletal systems such as muscle pain, muscle disease and rare muscle pepper have been reported when using rosuvastatin at all special doses, the dose of over 20 mg. Very few cases have been reported when using ezetimibe combined with HMG-CoA Reductase enzyme inhibitors, so they need to be cautious when used in combination. The frequency of muscle pepper is still associated with the use of rosuvastatin higher at the dose of 40 mg.
Patients need to be tested for liver enzyme before starting treatment with rosuvastatin and in case of clinical indications for testing later.
Increased risk of muscle damage when using rosuvastatin simultaneously with the following drugs: Gemfibrozil, other fibrat blood cholesterol medications, high -dose niacin (> 1 g/day), Colchicin.
Consider monitoring Creatin Kinase (CK) in the case:
Before treatment, CK tests should be conducted in the following cases: impaired renal function, hypothyroidism, self -history or family history of genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) with risk factors for muscle patterns, drugs that occur with special patients.
In these cases, the benefits/risks should be considered and monitor patients clinically when treated with statin. If the results of CK test> 5 times the upper limit of normal levels, do not start treatment with statin.
During statin treatment, patients need to notify when there are muscle manifestations such as muscle pain, stiffness, muscle weakness ... When these manifestations, patients need to do CK test to take appropriate interventions.
Effects on the liver
Be careful when taking the drug with patients who drink a lot of alcohol and/or have a history of liver disease. The testing of liver function is recommended before and after 3 months of starting treatment with rosuvastatin. It is necessary to take the drug or reduce the dose when the concentration of transaminase in the blood is tripled by the above limit. The frequency of reporting of dangerous liver diseases (mainly liver transaminase increases) higher than the dose of 40 mg.
In patients with secondary hypercholesteroline hypercholesterol caused by hypothyroidism or nephrotic syndrome, it is necessary to treat these diseases before starting to use rosuvastatin. The race of pharmacokinetics studies shows the increase in blood rosuvastatin levels in Asian people when taking drugs compared to white skin patients.
Pregnant and lactating women
Atherosclerosis is a chronic process and stopping the lipid lipid drug during pregnancy has little effect on long -term treatment results for increased primary blood cholesterol.
Cholesterol and other substances of cholesterol biosynthesis are essential for fetal development (including sterol synthesis and cell membranes). Because HMG-CoA Reductase inhibitors reduce cholesterol synthesis and the ability to synthesize the biological derivatives of cholesterol, it can harm the fetus for pregnant women. Therefore, HMG-CoA Reductase inhibitors are contraindicated during pregnancy and lactation.
Rosuvastain is only used for women during childbirth when the patient has no intention of pregnancy and has been notified of the risks may be encountered. If a patient is pregnant during this medication, the treatment should be stopped immediately and the patient must be notified of the possible risks to the embryo.
Lactose tolerance
Patients with genetic problems in lactose tolerance, lactase lactase lack of lactase or malposive glucose - galactose should not use this drug.
Protease inhibitors
Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leading to kidney failure and may be fatal.
Interstitial lung disease
Some cases of interstitial lung disease have been reported when using statins, especially for long -term use. Signs include: shortness of breath, health impairment (fatigue, weight loss and fever). If the patient is suspected of interstitial lung disease, it is necessary to stop using statin.
pancreatic diabetes
Some evidence suggests that statins may increase blood sugar. However, the effect of reducing the risk of the circuit of statins is superior to the risk of hyperglycemia, so there is no need to use the statin. Patients with risk (thrilling blood sugar from 5.6 to 6.9 mmol/l, body mass index (BMI)> 30 kg/m, increased triglycerides, hypertension) should be monitored both clinically and test indicators according to treatment instructions.
Children
Review height, weight, body mass index (BMI) and secondary characteristics of gender maturity in children from 6 to 17 years old using Rosuvastatin are limited for 2 years. After 2 years, there is no influence on height, weight, BMI or mature gender detected.
affects the ability to drive and operate machinery
Studies on the effects of drugs on driving and operating machinery have not been conducted. However, according to pharmacological effects, the drug has little effect on this ability. Caution should be careful when driving and operating machinery during medication because it can be dizzy.
Pregnant and lactating women
Pregnant women: not for pregnant women.
Lactating women: Do not use for breastfeeding women.
Drug interaction
Transport protein inhibitors
Rosuvastatin is the substrate of some shipping proteins including OATPI1BI and BCRP. Simultaneous use of rosuvasatin with drugs that inhibit these transport proteins can increase the level of rosuvastatin in the blood and increase the risk of muscle diseases.
Protease inhibitors
Increased blood rosomastatin levels have been reported in patients with simultaneous use of rosuvastatin with protease inhibitors in combination with ritonavir. The simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leads to kidney failure and can be fatal.
gemfibrozil and other lipid medications
Increased risk of muscle damage when using rosuvastatin simultaneously with the following drugs: Gemfibrozil, other fibrat blood cholesterol medications.
ezetimibe
Simultaneous use of Rosuvastatin 10mg and Ezetimibe 10 mg increases Rosuvastatin 1.2 times the patients with hypercholesterol.
antacid
Simultaneous use of rosuvastatin with an aluminum -containing antacid -containing antacid -hydroxyd -shaped antacid that reduces the blood's rosmastatin levels by 50%. Utacid should be used for 2 hours after using rosuvastatin.
erythromycin
Simultaneous use of 2 drugs reduces 20% AUC and 30% CMAX of RosuVastatin. This interaction may be due to erythromycin increasing intestinal motility.
Other interactions
Increased risk of muscle lesions when using rosuvastatin simultaneously with high -dose niacin (> 1 g/day), Colchicin. Rosuvastatin interacts with alcohol, neutralizing acids in the stomach, birth control pills,
iTraconazole, enzymes (cholestin, supplements), warfarin.
The dose adjustments
When it is necessary to adjust the dose, the starting dose of rosuvastatin is 5 mg once a day if it is likely to increase the scope about 2 times or higher. The maximum dosage of rosuvastatin should be adjusted to amount of rosuvastatin into the body without an overdose of 40 mg used once a day when not in use with other drugs, for example 20 mg of rosuvastatin with gemfibrozil (an increase of 1.9 times), and 10 mg of rosuvastatin in combination with Ritonavir/Atazanavir (an increase of 3.1 times). clopidogrel 300 mg initially, then 75mg at 24 hours gemfibrozil 600 mg 2 times/day, 7 days tipranavir 500 mg/ritonavir 200 mg 2 times/day, 11 days Symbols: Increase "↑", do not change "↔", decrease "↓". ** Some interactive studies have been conducted in different dose modes rosuvastatin, in the table of presentation with the thought. Vitamin K anti -vitamin k Like other HMG-COA Reductase inhibitors, when starting to treat or adjust the rising dose of rosuvastatin in patients who use simultaneous anti-vitamin K (such as wafarin or other Coupharin anticoagulants) can increase the international normal chemical ratio (INR). Stop or reduce the dose of rosuvastatin may reduce the INR. In these cases, it is necessary to apply appropriate Inr control measures. Oral contraceptives/hormone alternative therapy Simultaneous use of rosuvastatin and oral contraceptives increases Ethinyl estradiol and Norgestrel, respectively 26 and 34%respectively. Increasing the concentration of these substances in the blood should be considered when choosing oral contraceptive dose. There is no sufficient dynamic data in patients using rosuvastatin simultaneously and hormone replacement therapy and therefore cannot exclude the same effect of rosuvastatin. However, the combination of rosuvastatin and hormone replacement therapy has been widely used in women participating in clinical trials and well tolerated. digoxin Based on drug interactive studies, there is no clinical interaction between digoxin and rosuvastatin. Fusidic acid Interactive studies between rosuvastatin and fusidic acid have not been conducted. Like other statins, muscle -related effects, including muscle pepper, have been reported on after -sales reports with rosuvastatin and fusidic acid when used simultaneously. Therefore, simultaneous use of fusidic acid and rosuvastatin are not recommended. If possible, it is advisable to stop using rosuvastatin. If required to be used simultaneously, it is necessary to closely monitor patients. Children Research on drug interactions has only been conducted in adults. The level of influence of the above drug interactions in children is not known. Notify the doctor about all drugs that are in use, including non -prescribing drugs, nutritious figs or herbal products. should also notify the doctor while using caffeine or alcoholic beverages, smoking or banned drugs. These can affect the treatment process. Check before stopping or starting any drug.
Storage
Store at a temperature not exceeding 30 ° C.
Other drugs
- ACECLOFENAC 100MG TABLETS
- BRUFEN SYRUP 100MG/5ML
- LIPOSIC EYE GEL 2MG/G EYE GEL
- NICORIL 10MG TABLETS
- SULPIRIDE TABLETS 200MG
- TAMUREX 400 MCG PROLONGED RELEASE CAPSULES
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions