Rosuvastatin Savi 10 Medicine Treatment for hypercholesterol primary blood cholesterol (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

indications

Rosuvastatin Savi 10 drug is indicated in the following cases:

Increasing cholesterol (La type, including hyperlested heterozygic blood cholesterol) or mixed blood lipid disorders (1LB type) in adults and children aged 6 and older: is a supportive therapy for diet when the patient does not fully respond to diets and other non -drug -free therapies (such as exercise, weight loss).

Hyperlipitium hyperlested hypertension: Use to support diets and other lipid reduction treatments (such as blood ldl extract) or when these therapies are not appropriate.

Cardiovascular event prophylaxis.

Pharmacokology

Mechanism of impact: Rosuvastatin is a selective inhibitor and competition HMG-Coa Reductase, is a catalyst of the conversion process 3-hydroxy-3-methylutaryl a into Meevalonate, a precursor of cholesterol. The main effect of rosuvastatin is the liver, the target organs reduce cholesterol.

Rosuvastatin increases the amount of low density lipoprotein receptors (LDL: Low Density Lipoprotein) on the surface of the cell in the liver, thus increasing LDL's absorption and catabolism and inhibiting very low lipoprotein synthesis (VLDL: VLDL: Very Low Density Lipoprotein) in the liver, thus reducing VLDL and LDL components.

Pharmacological impact: Rosuvastatin reduces the level of Low Density Lipoprotein - Cholesterol (LDL -C), total cholesterol and triglycerides and increases the high density lipoprotein - cholesterol (HDL -C). The drug also reduces APOB, Non HDL-C, VLDL-C, VLDL-C, VLDL-TG and increases APOA-I. Rosuvastatin also reduces the ratio of LDL-C/HDL-C, C full/HDL-C, Non HDL-C/HDL-C and APOB/APOA-I.

pharmacokinetics

absorption:

Rosuvastatin's peak plasma concentration is about 5 hours after drinking. Absolute bioavailability of about 20%.

Distribution:

Rosuvastatin widely distributed in the liver is the main place for cholesterol and LDL-C clearance. The distribution of rosuvastatin is about 134 liters. 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 cytochrom P450.

CYP2C9 is the main isenzyme involved in metabolism, 2C19, 3A4 and 2D6 participating at a lower level. The main metabolites are identified as N-Desmethyl and Lacton.

N-Desmethyl metabolites are about 50% weaker than rosuvastatin while lacton form is not clinically active. Rosuvastatin accounts for more than 90% of HMG-COA Reductase inhibitors during the circulation.

Era:

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 unchanged urine.

Sell waste time in plasma is about 19 hours. The waste time does not increase when the dose is higher. The average plasma clearance is about 50 liters/hour (the variable coefficient is 21.7%).

Like other HMG-CoA Reductase enzyme inhibitors, the transportation of rosuvastatin through the liver requires the transportation through the OATP-C membrane. This transportation is important in eliminating rosuvastatin through the liver.

Before taking Rosuvastatin Savi 10 Medicine Treatment for hypercholesterol primary blood cholesterol (3 blisters x 10 tablets)

How to use

Take oral use.

Before starting treatment, the patient must follow a standard diet to reduce cholesterol and continue to maintain this regime during treatment. Use current consensus guidelines on the treatment of lipid disorders to adjust the dose of rosuvastatin for each patient according to the patient's treatment and response goals. Rosuvastatin can be used anytime of the day, during or outside the meal.

Dosage

Hyper cholesterol treatment:

The recommended starting dose is 5 mg or 10 mg, orally once a day for both patients who have never used Statin groups and patients who move from HMG-COA Reductase inhibitors to Rosuvastatin. The dose can be adjusted every 4 weeks if needed.

It is necessary to have a monitor of a specialist when starting a 40 mg.

Related between rosuvastatin and muscle atrophy to note

All patients start at a dose of 10 mg/day and only increase to 20 mg if necessary after 04 weeks. Need to closely monitor for cases of 40 mg.

Children:

Children from 6 - 17 years old: Increasing blood cholesterol heterozygous family: The starting dose is usually 5 mg/day.

Children from 6 - 9 years old: The dose is commonly used from 5 - 10 mg, 1 time a day.

Children from 10 - 17 years old: The dose is often used from 5 - 20 mg, 1 time a day. Experience in taking drugs in children with hyperlested family blood cholesterol is limited to a small group of children (≥ 8 years old).

Elderly:

No dose adjustment.

Patients with renal failure:

No dose adjustment in patients with mild to medium renal failure. Contraindicated using rosuvastatin for patients with severe renal impairment.

Patients with liver failure:

The level of contact with rosuvastatin by concentration and time does not increase in patients with Child-Pugh scores ≤ 7. However, the level of exposure to the drug has been recorded in patients with Child-Pugh 8 and 9 (see pharmacokinetic). Inexperienced in patients with Child-Pugh scores over 9. Contraindicated use of rosuvastatin for patients with progressive liver disease (see contraindicated).

Race

Increase the level of exposure to drugs calculated by concentration and time recorded in Asian patients, this should be considered when deciding the dose for Asian -based patients. Contraindicated to use 40 mg dose in these patients.

recommendations on drug interactions between rosuvastatin and protease inhibitors of HIV and HCV

Rosder limit Rosuvastatin maximum 10 mg/day when used simultaneously with Atazanavir, Atazanavir + Ritonavir, Lopinavir + Ritonavir.

Note: For 5 mg dose: Use other preparations with the appropriate content (Savi Rosuvastatin 5 film tablets).

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 do

do when overdose? There is no specific treatment when overdose. If an overdose occurs, symptomatic treatment and supportive measures need to be applied. Hemorrhage does not significantly increase the clearance of rosuvastatin.

What to do when forgetting 1 dose?

Not recorded.

Side Effects

When using Rosuvastatin Savi 10, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Endocrine system: diabetes;

Nervous system: headache, dizziness;

Digestive system: constipation, nausea, abdominal pain;

Muscle system, connective tissue and bone: muscle pain;

Systemic: weakness.

Uncommon, 1/1000

Skin and subcutaneous tissue: itching, rash, urticaria.

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

Rosuvastatin Savi 10 drug contraindicated in the following cases:

Patients with hypersensitivity to rosuvastatin or any excipients of the drug.

Patients with progressive liver disease, including prolonged increased serum transaminase and unknown cause, and when serum transaminase concentration increases more than 3 upper limits of normal levels (Uln: upper Limited of Normal).

Patients with severe renal impairment (Creatinine clearance

Patients with muscle disease.

Patients who are taking cyclosporin.

Pregnant and lactating women, women may be pregnant without using appropriate contraception.

Dosage 40 mg/day Contraindications for cases: Average renal failure (Clcr

Caution when using

Effects on the kidneys:

proteinuria, detected by the test strip and the main origin from the renal tubules, has been recorded in patients treated with high doses of rosuvastatin, especially at 40 mg, most of this condition is transient or occasionally occurs.

It is necessary to consider when taking drugs belonging to the statin group for patients with risk factors leading to muscle damage. The statin group is at risk of harmful reactions to muscle systems such as muscle atrophy, muscleitis, especially for patients with risk factors such as patients over 65 years old, patients with untreated thyroid defect, patients with kidney disease. Need to closely monitor the harmful reactions during the use of the drug.

The muscle effects such as causing muscle and muscle pain and some rare cases of muscle pattern have been recorded in patients treated with rosuvastatin at all doses and especially at 20 mg.

Avoid simultaneous use with the following drugs: Gemfibrozil, blood cholesterol, other fibrat groups, high doses (> 1g/day), Colchicin due to increased risk of muscle damage.

Be cautious when taking statin lipid medications with HIV and hepatitis C (HCV) because it can increase the risk of muscle damage, most serious is muscle pattern, kidney damage leads to kidney failure and can be fatal (see drug interaction).

measure the concentration of creatin kinase (ck):

It is not advisable to measure creatin kinase levels after exertion or when there is a certain cause that can increase CK because this may falsify the results. If the test is repeated, determine the CK level before treatment is still greater than 5 times ULN, it should not start treatment with rosuvastatin.

Consider tracking Creatin Kinase in the case:

Before treatment:

CK tests should be conducted in the following cases: impaired renal function, hypothyroidism, self -history or family history of infectious diseases, 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, special patients.

In these cases should consider benefits/risks 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, muscle stiffness, muscle weakness ... When there are these manifestations, patients need to test CK to take appropriate interventions.

In clinical trials, no increase in skeletal effects in a small number of patients using rosuvastatin simultaneously with other drugs. However, the increase in the incidence of muscle and muscle disease has been noticed in patients using other HMG-CoA Reductase inhibitors simultaneously with the derivatives of fibric acid including gemfibrozil, cyslosporin, nicotinic acid, antifungal group Azol, enzyme inhibitors and macrolid group antibiotics.

Gemfibrozil increases the risk of disease sometimes simultaneously with some HMG-CoA Reductase enzyme inhibitors. Therefore, the combination of rosuvastatin and gemfibrozil is not recommended. The use of a combination of rosuvastatin with fibrat or niacin has achieved further change of lipid levels, so it is carefully considered between benefits and risks that may occur due to these combinations.

Do not use rosuvastatin for patients with acute serious condition, suspicion due to or may lead to secondary renal failure due to muscle pilot (such as blood infections, hypotension, surgery, injury, electrolyte disorders, endocrine and uncontrolled constraints).

influence on the liver:

Like other HMG-CoA Reductase inhibitors, caution should be used when using rosuvastatin in severe alcoholic patients and/or a history of liver disease.

Exzy liver enzyme test before starting statin treatment and in case of clinical indications for testing later. Rosuvastatin should be discontinued if the serum transaminase concentration is 3 times the upper limit of normal levels.

In patients with secondary cholesterol growth due to thyroid discharge or nephrotic syndrome, these diseases must be treated before starting to use rosuvastatin. Patients with rare genetic problems such as galactose intolerance, Lapp Lactase deficiency or Glucose - Galactose should not use this product.

The ability to drive and operate machinery

studies to determine the effect of rosuvastatin on driving and operating machinery has not been done. However, based on the characteristics of force, rosuvastatin cannot affect these possibilities. When driving or operating the machine, note that dizziness may occur during treatment. Notify the doctor the unwanted effects when using the drug

Pregnancy

Rosuvastatin is contraindicated in pregnant and lactating women.

Women may be pregnant, so they should use appropriate contraceptive measures.

Animal studies show that there are evidence of limited toxicity on the reproductive system. If the patient is pregnant while treating with rosuvastatin, the drug should be stopped immediately.

The period of breastfeeding

In mice, Rosuvastatin excreted in milk. There is no corresponding data on human excretion.

Drug interaction

HIV -resistant protease and gold inhibitors:

Simultaneously used with: Atazanavir, combining Atazanavir + Ritonavir, Lopinavir + Ritonavir: Limit the dose of rosuvastatin up to 10 mg once a day.

cyclosporin:

Simultaneously use rosuvastatin with cyclosporin, the AUC values of rosuvastatin are 7 times higher than that of this value in healthy volunteers. Simultaneous use of rosuvastatin and cyclosporin does not affect plasma cyclosporin levels.

Vitamin K antagonists:

Like other HMG-CA Reductase enzyme inhibitors, when starting to treat or increase the dose of rosuvastatin in patients treated simultaneously with vitamin K antagonists (such as warfarin) can increase the Inr (International Normalized Ratio) value. Stopping or reducing the dose of rosuvastatin may reduce the INR. In such cases, the Inr value should be monitored.

gemfibrozil, other fibrat blood cholesterol, high doses (> 1g/ day), Colchicin:

Increases the risk of muscle damage when used simultaneously with statin. Simultaneous use of rosuvastatin with gemfibrozil 2 times the CMAX and AUC indicators of Rosuvastatin. Based on data from specialized drug interactive studies, there is no significant pharmacokinetic interaction with Fenofibrat, but the pharmaceutical interaction may occur.

antacids:

Use Rosuvastatin simultaneously with aluminum antacids and Magnesi Hydroxid, which reduces about 50% of the plasma rosuvastatin levels. When taking antacids 2 hours after using rosuvastatin, the plasma rosuvastatin levels will be reduced less. The clinical correlation of this interaction is still unclear.

erythromycin:

Simultaneous use of rosuvastatin with erythromycin reduces 20% AUC (0 - 1) and 30% cmax of rosuvastatin. This interaction may be due to erythromycin increasing intestinal motility.

Hormone replacement contraceptives (HRT: Hormone Replacement Therapy):

Simultaneous use of rosuvastatin with birth control pills increases 26% AUC of Ethinyl Estradiol and 34% of Norgestrel. It should be noted that increasing the concentration of these substances in plasma when choosing oral contraceptives. There is no pharmacokinetic data on patients using rosuvastatin and HRT simultaneously and therefore cannot exclude the same possibility. However, this combination has been widely used in women in clinical trials and has been well tolerated.

digoxin:

Based on data from specialized drug interactive studies, there is no clinical interaction when used with digoxin.

enzyme cytochrom p450:

Results from In vitro and in vivo testing proves that rosuvastatin is not an inhibitor or an enzyme that cytochrom P450. Moreover, Rosuvastatin is a weak substrate for these isenzymes. There is no clinical interaction between rosuvastatin and fluconazole (CYP2C9 and CYP3A4 inhibitors) or ketoconazole (CYP2A6 and CYP3A4 inhibitors). Simultaneous use of otraconazole (CYP3A4 inhibitor) and rosuvastatin increases 28% AUC of rosuvastatin. This increase is not considered clinical significance. Therefore, there is no drug interaction due to metabolism through cytochrom P450.

Storage

In the dry place, the temperature does not exceed 30 ° C. Avoid light.

Other drugs

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.