Surotadina 10mg Adamed medicine treatment for hypercholesterol in blood (14 blisters x 7 tablets)
Dosage form Box of 14 blisters x 7 tablets
Specifications Rosuvastatin
Ingredient
| Composition information | Content |
| Rosuvastatin | 10mg |
Uses
Indications
Surotadina 10 mg Adamed 14x7 drugs are indicated in the following cases:
Hyper cholesterol treatment
Use as a drug that supports diet in the treatment of primary blood cholesterol (type or IIA or mixed blood lipid disorders (type IIB) when the patient does not respond satisfactorily with the diet or other non -drug treatments (such as exercise, weight loss).
Use as a diet support drug and lipid lowering measures (such as LDL separation) in the treatment of hypercholesterol blood cholesterol family when these treatments are inappropriate.
Prevent cardiovascular events
Prevention of cardiovascular events in patients is considered to have a high risk of cardiovascular complications, as a supportive drug to adjust other risk factors.
Pharmacokology
Mechanism of action
Rosuvastatin is a selective competitive inhibitor HMG - COA Reductase, enzyme limiting metabolic speed 3 - hydroxy - 3 - methylglutary coenzyme A into Mevabonate, early stage of cholesterol synthesis.
The main effect of rosuvastatin is at the liver, the target organs of lowering cholesterol. Rosuvastatin increases the number of LDL receptors in the liver on the cell surface, enhances the absorption and catabolism of LDL and inhibits the synthesis of VLDL in the liver, thus reducing the total number of VLDL and LDL fertilizers.
Pharmacological effects
Rosuvastatin reduces LDL - cholesterol, total cholesterol, triglycerides and increases HDLCHolesterol. Rosuvastatin also reduces APOB, NonHDL - C, VLDL - C, VLDL - TG and increases APOA - I. RosuVastatin reduces the LDL - C/HDL - C, GUYS, HDLC and NONHDL - C/CL - C as well as APOB/APOA - I.
The treatment effect is achieved within 1 week after the beginning of treatment and 90% of the maximum response is obtained for 2 weeks. The maximum response is usually achieved after 4 weeks.
Clinical effectiveness
Rosuvastatin is effective when used for adults with hypercholesterolemia, whether or not there is no hyperkemin, regardless of race, gender or age and in special patients such as diabetes patients or hypertension patients with family blood cholesterol.
Gross data from phase clinical tests III shows that RosuVastatin is effective when treating most patients with hypertonic blood cholesterol IIA and IIB (LDL - C concentration of initial average about 4.8 mmol/l), about 80% of patients treated with 10 mg Rosuvastatin dose of LDL -C concentration as directed by European plastic associations (EAS) - C (
In a forced dose detection study, 42 patients with hypercholesterol hyperplation patients have been assessed to respond to Rosuvastatin doses of 20 - 40 mg. In the entire research group, the average reduction rate of LDL - C is 22%.
In clinical trials on a limited number of patients, RosuVastatin has a synergistic effect in lowering triglycerides when used in combination with fenofibrat and increases HDL -Hom when coordinated with Niacin.
Rosuvastatin has not been shown to prevent relevant complications of lipid abnormalities such as coronary artery disease due to research on mortality and incidence rates when using rosuvastatin has not been completed.
In a clinical, double -blind, multicolored study (Meteor research), 984 patients aged 45 to 70 are at risk of low coronary artery disease (defined as the risk of Framingham scale
Rosuvastatin significantly slows down the speed of progression of endocardium of the carotid artery at 12 different positions in the carotid artery compared to the placebo, at a slower speed - 0.0145 mm/year [95% reliability is - 0.0196, - 0.0095; P
The degree of change compared to the original is - 0.0014 mm/year ( - 0.12%/year (without statistical significance)) in the rosvastatin group compared to the increase + 0.0131 mm/year (1.12%/year (P
No proof of any direct connection between a decrease in the peripheral artery thickness and the risk of cardiovascular events. The patient population in Meteor research is at risk of low coronary artery disease and does not represent the target population using Rosuvastatin 40 mg. The 40 mg dose is only prescribed for patients with severe blood cholesterol that is at high risk of cardiovascular disease.
pharmacokinetic pharmacokinetics
absorption: The peak concentration of rosuvastatin in plasma is about 5 hours after use. The absolute bioavailability of the drug is nearly 20%.
Distribution: Rosuvastatin is absorbed by the liver, which is the main organ of cholesterol and LDL - C. The liking of Rosuvastatin's distribution is about 134 L. Nearly 90% of rosuvastatin is attached to plasma proteins, mainly albumin.
Metabolism: Rosuvastatin is less metabolized (about 10%). In vitro metabolic studies that use human liver cells show that rosuvastatin is a weak substrate of the metabolic process thanks to Cytochrome P450. CYP2C9 is the main isenzyme involved in the metabolism of rosuvastatin, in addition to 2C19, 3A4 and 2D6 but at less level. N -Desmethyl metabolites have less than RosuVastatin 50% while lacton is considered to have no clinical activity. Rosuvastatin accounts for more than 90% of HGM inhibitors - CoA Reductase in the circulation.
Elimination: About 90% of the dose of rosuvastatin is excreted intact in the stool (including the active ingredient and is not absorbed), the rest is excreted through the urine. Nearly 5% excreted intact through the urine. The sale time of the drug in plasma is about 19 hours. The sale time does not last when increasing the dose. The average rate of plasma clearance is about 50 liters/hour (the variable coefficient of 21.7%). Similar to other HMG - Coa Reductase inhibitors, RosuVastatin is absorbed into the liver by the transportation of Oatp - C. This substance plays an important role in eliminating rosuvastatin through the liver.
linear: Rosuvastatin ratio is exposed to the body proportional to the dose. There is no change in pharmacokinetic parameters when using daily doses.
Special patient groups
Age and gender: Age and gender does not affect the pharmacokinetics of rosuvastatin.
Race: Pharmacokinetic studies show that the average AUC and CMAX values of Rosuvastatin in Asian patients (Japan, China, Philippines, Vietnam and South Korea) are about 2 times higher than in whites. AUC and CMAX in Indian patients increased by 1.3 times compared to white people. The pharmacokinetic analysis of the population does not detect the clinical differences of pharmacokinetic parameters between the white and black people.
Patients with renal failure: In a study in patients with different levels of renal failure, from mild to medium, no impact of renal failure on rosuvastatin concentration or N - Desmethyl metabolism in plasma. Patients with severe renal impairment (Creatinine clearance
Patients with hepatic failure: In a study in patients with different levels of liver failure, there is no sign that the level of exposure to Rosuvastatin has increased in patients with Child - Pugh is 7 or lower. However, the two patients with the Child - Pugh score are 8 and 9 with the level of exposure to the body of Rosuvastatin, the whole body increases at least 2 times compared to patients with a lower Child - PUGH score. There is no clinical experience for patients with Child - Pugh score over 9.
Before taking Surotadina 10mg Adamed medicine treatment for hypercholesterol in blood (14 blisters x 7 tablets)
How to use
oral drugs. Can take medicine at any time of the day, during or outside the meal.
Dosage
Before starting treatment with rosuvastatin, patients need to follow the standard cholesterol -reducing diet to continue maintaining this diet during treatment. The dosage needs to be individualized for each patient depending on the goals of treatment and response of the patient according to the current instructions.
Hyper cholesterol treatment:
The starting dose is 5 or 10 mg, oral once daily in both patients who have never used statins and patients transferred from a HMG inhibitor - CoA Reductase to use Rosuvastatin. The selection of the starting dose should be based on the cholesterol level of each patient and the future cardiovascular risk as well as the possibility of adverse reactions (see Side effect section).
If necessary, can be adjusted to the next dose level after 4 weeks. Due to the adverse reaction rate recorded when using 40 mg dose increased compared to when using lower doses, the dose should only be up to 40 mg in patients with severe blood cholesterol hypercesting that is highly at risk of cardiovascular disease (especially patients with hypercholesterol blood cholesterol) does not achieve treatment goals when taking the dose of 20 mg and in patients with frequent monitoring later. Patients should be closely monitored at the start of a 40 mg dose.
When combined with protease inhibitors (Atazanavir, Atazanavir + Ritonavir, Lopinavir + Ritonavir), the maximum dose is recommended as 10 mg x 1 time/day.
Prevent cardiovascular events: In a study on the risk of cardiovascular events, the dose used is 10 mg daily.
Used for pediatric patients: Used for pediatric patients should only be performed by a specialist.
Children under 10 years of age: Experience in children under 10 years of age limited to a few children (ages 8 to 10) with hyperlesto blood cholesterol. Therefore, Surotadina 10 mg Adamed 14x7 is not recommended for children under 10 years old.
Used for elderly patients: The starting dose of 5 mg should be used for 5 70 years old. No need to adjust the dose by age in this patient group.
Dosage for elderly patients with renal failure: No need to adjust the dose for elderly patients with mild to medium to medium renal failure. The initial dose suggested for medium renal failure (the rate of creatinine clearance
Dosage for patients with liver failure:
There is no increase in the exposure of Rosuvastatin in patients with Child - PUGH scores from 7 or less. However, the increase in the exposure of Rosuvastatin has been recorded in patients with Child - PUGH scores 8 and 9. In these patients, it is necessary to conduct kidney function assessment. There is no experience in treating patients with Child - PUGH score over 9. Contraindicated Surotadina 10 mg Adamed 14x7 for patients with liver disease.
Race:
The phenomenon of increased exposure to Rosuvastatin has been recorded in Asian patients. The starting dose suggested to Asian patients is 5 mg. Contraindicated 40 mg for these patients.
Dosage for patients carrying risk factors:
The starting dose suggested to patients with risk factors for muscle disease is 5 mg. Contraindicated 40 mg for some patients of this group.
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? When an overdose occurs, symptomatic treatment and supportive treatment. Need to monitor liver function and ck concentration. Hematopause is usually not too effective in the drug from circulation.
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 Surotadina 10 mg Adamed 14x7, you may experience unwanted effects (ADR).
The adverse reactions recorded by the use of rosuvastatin are usually mild and transient. In control clinical studies, less than 4% of patients treated with RosuVastatin must stop the drug due to adverse reactions.
Based on data from clinical studies and post -marketing experiences, the adverse reactions of Rosuvastatin are presented as below. The adverse reactions are separated by frequency and organs.
Common (1/100 Uncommon (1/1000 Rare (1/10000 The immune system: Hypersensitivity reaction includes angels. Very rare (ADR Unknown frequency Systemic: edema. Similar to other IMG - Coa Reductase inhibitors, the frequency of adverse reactions tends to depend on the dose. Effects on the kidneys: proteinuria, detected with intact urine and renal tubules recorded in patients treated with rosuvastatin. Change the results of urine protein tests from negative or ++ or higher marks that have been recorded in Proteinuria increases slightly or converted from negative or + + observed by 20 mg. In most cases, proteinuria drops or disappears by self -treatment. Data from clinical studies and post -marketing monitoring so far not show that the causal relationship between proteinuria and acute kidney disease or progress. Hematuria has been recorded in patients treated with rosuvastatin. Data from clinical trials shows that the frequency of the urinary hematuria is low. Muscle effects: The effect of musculoskeletal muscles such as muscle pain, muscle disease (such as myocarditis) and rarely is still or not accompanied by acute renal failure recorded in patients treated with rosuvastatin at all dose levels, especially with the dose> 20 mg. The increase in CK depends on the dose recorded in patients using rosuvastatin; Most cases are only mild, not symptomatic and transient. If the concentration of CK increases (> 5 x ULN), it is necessary to stop the drug. Effects on the liver: Similar to other HMG - Coa Reductase inhibitors, the status of transaminase increases depends on the dose recorded in a small number of patients using rosuvastatin; Most cases are only mild, not symptomatic and transient. Metabolic disorders: hyperglycemia, HBA1C. The following adverse reactions have been reported to some statins: Penal condition, heavy events in the kidneys and liver (mainly increased the liver transaminase) is more common when using 40 mg. 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
Surotadina 10 mg Adamed 14x7 contraindications in the following cases:
Patients with muscle disease.
Alcohol abuse.
Simultaneously used with fibrat, high doses of niacin (> 1 g/day), Colchicin, Gemfibrozil.
Caution when used
Effects on the kidneys: proteinuria, detected by intact urine and renal tubules that have been recorded in patients treated with high doses of rosuvastatin, especially when using a dose of 40 mg. This condition is often transient and interrupted in most patients. Proteinuria is a sign of acute or progressive renal disease prediction. The proportion of serious disadvantages on the kidneys is increased by the postpartum report when using 40 mg. Need to evaluate the kidney function during monitoring in patients with a dose of 40 mg.
Muscle effects
The skeletonal effects such as muscle pain, muscle disease and rarely are the muscle pepper has been recorded in patients treated with rosuvastatin at all dosage levels, especially with the doses of> 20 mg. Very rarely the case of muscle pattern has been reported when used in combination with Ezetimibe along with HMG - Coa Reductase inhibitors. It is impossible to eliminate pharmacokinetic interaction between these two drugs and need to be cautious when combining two drugs. Similar to other HMG - Coa Reductase inhibitors, the ratio of muscle patterns is reported to the Marketing postpartum when using the dose of Rosuvastatin 40 mg.
When using simultaneously rosuvastatin with gemfibrozil, other fibrat blood cholesterol medications, high -dose niacin (> 1 g/day), colchicine and protease inhibitors in HIV treatment and viral hepatitis C (Atazanavir, Atazanavir + Ritonavir, Lopinavir + Ritonavir) increase the risk of skeleton surplus. Combination of protease inhibitors (Atazanavir, Atazanavir + Ritonavir, Lopinavir + Ritonavir) and Rosuvastatin in the most serious case that can lead to muscle pattern, kidney damage leading to kidney failure and death. Therefore, the maximum dose when combined with protease inhibitors is 10 mg/1 day/1 day.
Quantifying Creatinin Kinase: Do not conduct a quantitative creatinin kinase (CK) after trying exercise or when there are other causes to increase CK, affecting test results. If CK concentration increases significantly compared to normal (> 5 times on normal), it is necessary to conduct a test to confirm in 5-7 days. If conducting a repeated test but CK still> 5 times ULN, do not start using RosuVastatin.
Before treatment
Similar to other HMG - Coa Reductase inhibitors, be careful when prescribing Surotadina 10 mg Adamed 14x7 for patients with risk factors for muscle disease/muscle disease. These factors include:
Simultaneously used with fibrat and drugs that can cause interaction.
In these patients, it is important to pay attention to the risks of taking the drug besides the benefit of the drug and need to monitor Creatinin Kinase clinically. If CK concentration increases significantly compared to normal (> 5 x ULN), do not start treatment with rosuvastatin.
During treatment
It is necessary to ask the patient to immediately notify the pain, muscle weakness or unknown cramps, especially if accompanied by discomfort or fever. It is necessary to check the concentration of CK in these patients. Should stop taking the drug if the concentration of CK increases significantly (> 5 x ULN) or if the symptoms are in severity and cause daily discomfort (even if the concentration of CK
In clinical trials, there is no sign of increased effect on skeletal muscle in a small number of patients using Surotadina 10 mg Adamed 14x7 and simultaneous medications. However, the increase in the incidence of muscle and muscular inflammation has been detected in patients using other HMG - Coa Reductase inhibitors along with the derivatives of fibric acid such as gemfibrozil, ciclosporin, nicotinic acid, antifungal drugs, protease inhibitors and macrolid antibiotics. Gemfibrozil increases the risk of muscle disease when used simultaneously with HMG - COA Reductase inhibitors.
Therefore, it is not recommended to use rosuvastatin combination with gemfibrozil. It is necessary to carefully consider the benefits of lowering lipid levels by combining rosuvastatin with fibrat or niacin with potential risks of drug coordination. Contraindicated Rosuvastatin combination dose of 40 mg with fibrat. Surotadina 10 mg Adamed 14x7 should not be used for any patient in the risk of acute, serious or secondary renal failure or muscle disease progression (such as blood infections, hypotension, large surgery, trauma, metabolic disorders, hormonal disorders and electrolytes or uncontrolled epilepsy).
influence on the liver
Similar to other HMG - Coa Reductase inhibitors, be careful when using Surotadina 10 mg Adamed 14x7 for patients who are drinking large amounts of alcohol and/or a history of liver disease.
It is necessary to conduct liver enzyme tests before starting rosustatin treatment and in case of clinical indications for testing later. Surotadina 10 mg adamed 14x7 should be stopped or the dose is reduced if the transaminase concentration in serum is more than 3 times higher than the normal limit. The serious incident rate on the liver (including mainly increasing the liver transaminase) increases in a 40 mg dose. In patients with secondary cholesterol hyperthyroidism due to thyroid weakness or nephrotic syndrome, it is necessary to treat these diseases before starting to use Surotadina 10 mg Adamed 14x7.
Race: Pharmacokinetic studies show that there is an increase in the level of drug exposure in Asian patients compared to white people.
Protease inhibitors: Do not recommend the use of protease inhibitors with rosuvastatin.
Lactose intolerant: Patients with rare genetic problems such as galactose intolerance, lactase deficiency or glucose - galactose absorption should not be used.
Interstitial pneumonia: Some rare cases of interstitial pneumonia are reported to some statins, especially when treated for prolonged treatment. Some of the characteristics of expression include shortness of breath, cough without sputum and general health decline (such as fatigue, weight loss, fever). If the patient is suspected of interstitial pneumonia, it is recommended to stop treating with statin.
diabetes
Some evidence suggests that statins increases blood sugar and in some patients at risk of diabetes, can increase blood sugar that it needs an official care regime for people with diabetes. However, the effect of reducing the risk of vascular use is superior to the risk of hyperglycemia, so this risk cannot be a reason for stopping treatment with statin. Patients with risk (blood sugar when hungry 5.6 - 6.9 mmol/l, BMI> 30 kg/m2, increased triglycerides, hypertension) should be closely monitored in clinical response and biochemical tests according to instructions in each country.
In Jupiter study, the general frequency reported on pancreatic diabetes is 2.8% for statins and 2.3% for placebo, mainly in patients with blood sugar when hungry from 5.6 to 6.9 mmol/l).
The ability to drive and operate machinery
has not conducted research on the effects of the drug on driving and operating hook. However, based on the pharmacological properties of the drug, Rosuvastatin does not seem to affect this ability. When driving or operating machinery, it should be noted because during treatment with drugs may occur dizzy.
Pregnancy
Contraindicated Surotadina 10 mg Adamed 14x7 during pregnancy.
Women of reproductive age need to apply appropriate contraception.
Due to cholesterol and products of the cholesterol biosynthesis necessary for the development of the fetus, the risk from the use of HMG inhibitors - CoA Reductase is superior to the benefits of the drug when used during pregnancy. Animal studies only provide evidence of toxicity limit to reproduction. If the patient is pregnant while taking the drug, it is necessary to stop taking the drug immediately.
Breastfeeding period
Contraindicated Surotadina 10 mg Adamed 14x7 during breastfeeding.
Rosuvastatin is secreted into mouse milk. There is no data on the elimination of the drug into breast milk.
Drug interaction
ciclosporin: When using rosvastatin combination with ciclosporin, the AUC value of rosuvastatin is 7 times higher than in healthy volunteers. Simultaneous use of these 2 drugs does not affect the concentration of ciclosporin in plasma.
Vitamin K antagonists: Similar to other HMG - Coa Reductase inhibitors, start using or increased the dose of rosuvastatin in patients treated simultaneously with vitamin K antagonists (such as warfarin or other coagulants) can increase international standard ratio (INR). Stopping the drug or reducing the dose of rosuvastatin may reduce the INR. In these cases, it is necessary to monitor INR.
Gemfibrozil and other lipid remorters: simultaneously use rosuvastatin and gemfibrozil to increase CMAX and AUC of rosuvasatin about 2 times.
Based on data obtained from specific interactive studies, no pharmacokinetic interaction between rosuvastatin and fenofibrat, however, pharmacological interactions may appear. Gemfibrozil, Fenofibrat, other fibrats and lipid levels (> 1 g/day) of niacin (nicotinic acid) increase the risk of muscle disease when used simultaneously with HMGCOA Reductase inhibitors, may be because these drugs themselves also cause muscle disease when used alone. Contraindicated 40 mg of Rosuvastatin is used simultaneously with a fibrate. These patients should also start the starting dose of 5 mg.
Ezetimibe: Use simultaneously rosuvastatin along with Ezetimibe does not change the AUC and CMAX of each drug. However, it is not possible to eliminate pharmacological interaction between 2 drugs, expressed through adverse effects.
Colchicin: When using simultaneously rosuvastatin and colchicin increases the risk of musculoskeletal damage.
Protease inhibitors: Although the exact mechanism of interactions between rosuvastatin and protease inhibitors has not been well understood, simultaneous use of these two drugs may increase the ratio of Rosuvastatin exposure and increase the risk of muscle damage, the most serious is pattern, kidney damage leading to kidney failure and may cause death. In a pharmacokinetic study, simultaneously used 20 mg of Rosuvastatin with a combination of 2 protease inhibitors (400 mg of Lopinavir/100 mg Ritonavir) in healthy volunteers increasing AUC (0 - 24h), and CMAX of Rosuvastatin in a stable state twice and 5 times. Therefore, it is not recommended to use Rosuvastatin dynamic for HIV patients and hepatitis C being treated with protease inhibitors (Atazanavir, Atazanavir + Ritonavir, Lopinavir + Ritonavir).
Antacid: simultaneously use rosuvastatin along with an aluminum an aluminum and Magnesi hydroxid -containing chaos that reduces rosophers in plasma rosomes by about 50%. This interaction decreases slightly when using antacid 2 hours before using rosuvastatin. Clinical significance of this interaction has not been studied.
erythromycin: simultaneously use rosuvastatin along with erythromycin, reducing 20% AUC (0 - T) and 30% cmax reduction of rosuvastatin. This interaction may be due to the increase in intestinal motility due to the use of erythromycin.
Oral contraceptives/oral hormone replacement therapy: simultaneous use of rosuvastatin and oral contraceptives that increase the AUC values of Ethinyl Estradiol and Norgestrel to 26% and 34% respectively. It should be noted this condition when choosing the dose of birth control pills. There is no pharmacokinetic data on simultaneous use of rosuvastatin with hormone replacement therapy and therefore cannot exclude similar interactions. However, the coordination of these drugs has been widely used for women in clinical trials and well -tolerated drugs.
Other drugs: Based on data obtained from specific interactive studies, not recorded clinical interactions between rosuvastatin and digoxin.
Cytochrom P450 enzymes: Results from in vitro and in vivo studies show that RosuVastatin may be inhibitors or induction of cytochrom P450 isoenzyme. In addition, Rosuvastatin is a weak substrate of these isenzymes. No clinical interaction has not been recorded between rosuvastatin and fluconazole (a CYP2C9 and CYP3A4 inhibitors) or Ketoconazole (a CYP2A6 and CYP3A4 inhibitors). Simultaneous use of otraconazole (CYP3A4 inhibitors) and rosuvastatin increases 28% AUC of rosuvastatin. This small increase is not clinical significance. Thus, drug interactions due to metabolism through cytochrom P450 are not waiting.
Storage
Store in closed boxes at temperatures below 30 ° C. Avoid light and moisture. Outside of children's reach and observation.
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