Ruvastin 10mg Aristopharma reduces the increase in total cholesterol (20 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

Indications

Ruvastin - 10 is indicated in the following cases:

Supports the diet to reduce the increase in total cholesterol levels, LDL - Cholesterol, Apolipoprotein B, non -HDL - C cholesterol and triglycerides and increase HDL - C in patients with primary blood cholesterol (heterozygous family and non -family -owned and mixed blood lipid disorders (IIA groups and IIBs and IIB classifications Fredrickson). LDL filtration measures) or if such treatments do not bring full results. Cholesterol. In vivo studies on animals, and in vitro studies on animal transplanting cells and humans show that Rosuvastatin has high absorption and selection, the impact on the liver is the target organ to reduce cholesterol. In Vivo and In Vitro studies show that RosuVastatin acts on lipid changes in two ways. The first is that it increases the number of low density lipoprotein receptors (LDL) in the liver on the cell surface to increase the absorption and divestment of LDL. Secondly, Rosuvastatin inhibits the synthesis of lipoprotein very low density (VLDL) in the liver, which reduces the total number of VLDL and LDL particles.

Rosuvastatin reduces total cholesterol (c - total), apolipoprotein B (APOB) and non -HDL - C cholesterol (total cholesterol minus HDL - C) in patients with hypertonic hypertension (FH) heterozygous and contractual homozygogy, non -domestic cholesterol and mixed lipid disorders. Rosuvastatin also reduces triglycerides (TG) and increases high density lipoprotein cholesterol (HDL - C). Rosuvastatin reduces total cholesterol, LDL - C, VLDL - Cholesterol (VLDL - C), APOB, non -HDL - C cholesterol and triglyceride and increases HDL - C in special hyperlageceride patients.

pharmacokinetic

absorption

In human clinical pharmaceutical studies, the peak concentration of rosuvastatin plasma is achieved within 3 to 5 hours after drinking. Both peak concentration (CMAX) and area under the concentration curve - plasma time (AUC) increases almost proportional to the dose of rosuvastatin. Rosuvastatin's absolute biological comfort is about 20%. Rosuvastatin concentration in plasma is not different after taking medicine in the evening or morning.

Distribution

The average distribution of rosuvastatin in a stable state is about 134 liters. Rosuvastatin linked to plasma proteins is 88%, mainly with albumin. This cohesion is reversible and does not depend on the concentration of drugs in plasma.

Metabolism

Rosuvastatin is not metabolized much, about 10% of the doses with radioactive isotope are found in the form of metabolites. The main metabolite is N - reducing methyl rosuvastatin, formed mainly by cytochrom P450 2C9, and in vitro studies show that N - reducing methyl rosuvastatin has about 1/6 to 1/2 of HMG - COA inhibitors of Rosvastatin.

Elimination

After drinking, rosuvastatin and its metabolites are excreted mainly in feces (90%). Selling time (t1/2) of rosuvastatin is approximately 19 hours.

Before taking Ruvastin 10mg Aristopharma reduces the increase in total cholesterol (20 tablets)

How to use

This drug is only used as prescribed by a physician.

Ruvastin is taken orally.

Dosage

recommendation to start treatment with the lowest dose that the drug works, then if necessary, can adjust the dose according to the needs and response of each person by increasing the dose each spaced no less than 4 weeks and must monitor the harmful reactions of the drug, especially the harmful reactions to the muscle system.

Related between rosuvastatin and muscular atrophy should note: All patients start treatment at 10 mg/daily dose and only increase to 20 mg if necessary after 4 weeks, need closely monitoring for cases of 40 mg.

According to pharmacokinetic research in the US in Asians, the ability to absorb Rosuvastatin in Asians is 2 times higher than white people, so it should be considered 5 mg to do the time of 5 mg for Asians. Do not use the dose of rosuvastatin 40 mg for Asians.

Patients need to apply standard diets to reduce cholesterol before treatment with rosuvastatin and should maintain this diet during treatment. Rosuvastatin can be used a single dose at any time of the day, with or without food.

Hyper cholesterol (heterozygous and non -family family) and mixed blood lipid disorders (group IIA and ILB according to the classification of Fredrickson)

Rosuvastatin's dose limits are 5 to 40 mg once daily. Therapy with rosuvastatin should be specified for each patient depending on the purpose of treatment and response of the patient. Rosuvastatin's common starting dose is 10 mg once daily. The starting therapy may start at a dose of 5 mg once daily for patients who need less LDL - C or those who have muscle diseases. For patients with significant hypercholesterolemia (LDL - C> 190 mg/dL) and the purpose of attacking lipids can use the starting dose of 20 mg. The dose of Rosuvastatin 40 mg should be used for patients who do not achieve LDL - C goals at the dose of 20 mg. After starting treatment and/or increasing the dose of rosuvastatin, lipid concentration should be monitored for 2 to 4 weeks and adjust the dose accordingly.

Hyper cholesterol is homozygous

Rosuvastatin's recommended dose is 20 mg once daily for patients with hypercholesteroline hypertension with homozygous family. The maximum daily dose is 40 mg. Rosuvastatin should be used for these patients as a support for other lipid therapies (such as LDL filtration methods) or if such treatments do not bring full results. It is advisable to estimate the treatment from LDL - C levels before filtering.

Dosage for patients who are taking cyclosporin

In patients who are taking cyclosporin, treatment with rosuvastatin should be limited at the dose of 5 mg once daily.

Dosage for patients who are taking protease inhibitors

In patients who are taking Atazanavir, Atazanavir and Ritonavir, Lopinavir and Ritonavir should be limited to the maximum of the maximum dose of Rosuvastatin at 10 mg/day.

Lipid lowering therapy at the same time

The effect of rosuvastatin on LDL - C and total cholesterol can increase when used in combination with a resin (plastic) bonds. If you have to use a combination of rosuvastatin with gemfibrozil, the dose of rosuvastatin should be limited to 10 mg once a day. Increased risk of muscle damage when using statin simultaneously with gemfibrozil.

Dosage for patients with renal failure

No need to adjust the dose for patients with mild to medium to medium renal failure. For patients with severe renal impairment (CLCR

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?

No specific treatment in case of overdose. If overdose, symptomatic treatment and necessary support measures for patients. Hemorrhage does not increase the clearance of rosuvastatin.

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 Ruvastin - 10, you may experience unwanted effects (ADR). The side effects are usually light and transient. The most frequent side effects related to rosuvastatin are muscle aches, constipation, weakness, abdominal pain and nausea, cognitive impairment (such as memory loss, confusion ...), hyperglycemia, HBA1C.

ADR ≥ 2%: Sore throat, headache, diarrhea, indigestion, nausea, muscle pain, weakness, back pain, flu syndrome, urinary tract infection, rhinitis, sinusitis.

Common, ADR> 1/100

Body: abdominal pain, transient damage, chest pain, infection, pain, pelvic pain and neck pain.

Cardiovascular system: high blood pressure, angina, vasodilation and suspense.

Digestive system: constipation, gastritis, vomiting, flatulence, periodontal abscess and gastritis. Endocrine: Diabetes.

Blood and lymphatic system: Anemia and bruises.

Disorders of metabolism and nutrition: peripheral edema.

Muscle system: arthritis, joint pain and pathology (bone) pathology.

Nervous system: dizziness, insomnia, increased tone, paresthesia, weakness, anxiety, dizziness and nerve pain.

Respiratory system: Bronchitis, shortness of breath, pneumonia and asthma.

Skin and appendages: rash and itching.

Testing abnormalities: In the Rosuvastatin clinical trial program, proteinuria positive with test strips and urinary hemorrhagic observed in patients treated with rosuvastatin, mostly patients taking the dose in excess of the recommended dose limit (such as 80 mg). Other abnormal test values are reported to increase the level of creatin phosphokinase, transaminase, hyperglycemia, glutamyl transpeptidase, alkaline phosphate, bilirubin, and thyroid function abnormalities.

Uncommon, 1/1000

Body: arrhythmia, hepatitis. Hypersensitivity reactions (such as face edema, reducing the amount of urination, leukopenia, blisters, urticaria and angioedema), kidney failure, fainting, muscle weakness, muscle inflammation, pancreatitis, light sensitivity reaction, muscle disease and muscle pattern.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Ruvastin - 10 contraindications in the following cases:

Patients who know how hypersensitivity to any ingredients of the drug.

rosuvastatin contraindicated in patients with progressive liver disease or increased persistent serum transaminase concentration.

Pregnant and lactating women: Atherosclerosis is a process of satisfaction and when stopping lipid lowering drugs during pregnancy, it will affect the consequences of long -term treatment of primary cholesterol. Cholesterol and other products of cholesterol biosynthesis are essential ingredients for fetal growth (including steroids and cell membranes). Because HMG - COA inhibitors reduce cholesterol synthesis and may reduce the synthesis of other biological activity derivatives from cholesterol, they can be harmful to the fetus when used for pregnant women. Therefore, contraindicated use of HMG - CO inhibitors for pregnant and lactating women.

Patients with severe renal impairment (CLCR,

Patients who are taking ciclosporin.

Caution when using

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

Patients should immediately notify the doctor to treat signs and symptoms of muscle pain, fatigue, fever, dark urine, nausea or vomiting during the use of the drug.

Liver enzymes

As some other lipid remedies, HMG - CO inhibitors inhibitors cause abnormalities in liver function. The ratio of persistent serum transaminase (> 3 times the upper limit of normal levels at two or more tests) occurs in studies at the appropriate dose of 0.4, 0, 0 and 0.1 % of patients taking the doses of Rosuvastatin, respectively 5.10, 20 and 40 mg.

In most cases, this increase is fleeting and resolving or improving when the therapy continues or after treatment.

Be cautious when using rosuvastatin in patients who drink a lot of alcohol and/or have a history of liver disease. The persistent progression of liver or increased transaminase is not explained as contraindicated for the use of rosuvastatin. The liver enzyme test should be performed before starting treatment with rosuvastatin and in case of clinical indications for testing later. Liver enzyme changes usually occur in the first 3 months of treatment with rosuvastatin. Patients with increased transaminase levels should be monitored until these abnormalities are resolved. If ALT or AST increases in excess of the upper limit of the persistent normal level, the dose should be reduced or stop using rosuvastatin.

Consider monitoring Creatin Kinase (CK) in the case of

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 pattern, special possibility of drug interactions and some 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.

muscle/muscle disease

Cases of rare patterns with secondary acute renal failure to myoglobin urinated have been reported to rosuvastatin and other drugs in this group.

Factors that make patients susceptible to muscle diseases with HMG - CO inhibitors inhibitors include older (> 65 tu), weak thyroid and kidney failure. The incidence of muscle disease increases in rosuvastatin doses in excess of the recommended dose limit.

Therefore:

Should be cautious when prescribing rosuvastatin for patients with factors susceptible to muscle disease such as kidney failure, large tu -tu and weak thyroid.

advise patients to immediately report to the doctor when muscle pain, sensitivity or muscle weakness are not explained, especially if accompanied by discomfort or fever. Rosuvastatin should be discontinued if Creatine Kinase (CK) increases significantly or if identified or suspected of muscle disease.

The risk of muscle disease during treatment with rosuvastatin may increase when used simultaneously with other lipid medications or with cyclosporin. The benefits of changing lipid concentration further when used in combination with rosuvastatin with fibrate or niacin should be carefully considered about the potential risks of this combination. Typically, avoid combination of rosuvastatin with gemfibrozil.

The risk of muscle disease during treatment with ros fingastatin may increase in cases that increase rosuvastatin levels.

Rosuvastatin treatment should also temporarily reduce the dose in any patient with severe, acute or acute muscle disease, or have the risk of developing secondary renal impairment (such as infection, hypotension, surgery, metabolic disorders, endocrine and severe electrolytes, or uncontrolled seizures).

General caution

Before conducting treatment with rosuvastatin, trying to control hyperchemical blood cholesterol with appropriate diet and exercise, weight loss in obese patients and other basic diseases.

The ability to drive and operate machinery

No.

Pregnancy

Atherosclerosis is a process of satisfaction and when stopping lipid lowering during pregnancy will affect the consequences of long -term treatment of primary cholesterol.

Cholesterol and other products of cholesterol biosynthesis are essential ingredients for fetal growth (including steroids and cell membranes). Because HMG-CoA reducing enzymes inhibitors reduce cholesterol synthesis and may reduce the synthesis of other biological activity derivatives from cholesterol, they can be harmful to the fetus when used for pregnant women. Therefore, contraindicated use of HMG-COA reducing enzyme inhibitors for pregnant and lactating women.

Breastfeeding period

Contraindicated use of HMG - CO inhibitors for nursing women.

Drug interaction

Increased risk of muscle lesions when using rosuvastatin simultaneously with the following drugs:

gemfibrozil.

Other fLBrat blood cholesterol medications.

High doses (> 1 g/day). colchicin.

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.

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

Statin

Protease inhibitors with interaction

Statistics recommendations

rosuvastatin

Atazanavir

Atazanavir + Ritonavir

lopinavir + ritonavir

Maximum Rosuvastatin dose limit 10 mg/day

However, CMAX and AUC of Rosuvastatin increased by 11 and 7 times respectively, compared to the data when used individuals in healthy people.

gemfibrozil and other blood lipid medications: simultaneous use of gemfibrozil with rosuvastatin increases twice the AUC and CMAX books of Rosuvastatin. Based on specialized drug interactive research data, there is no significant pharmacokinetic interaction with fenofibrat, but the pharmaceutical interaction may occur. Gemfibrozil, fenofibrat, other fibrats and niacin (acid nicotinic) at doses of lipid lowering (> 1g/day) increase the risk of muscle disease when used simultaneously with HMG - CoA Redutase inhibitors, maybe because these drugs can cause muscle disease when used individually. If coordinated with fibrat, contraindicated dose of 40 mg. Aluminum and Magiesi Hydroxid 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. Combined with Protease inhibitors such as Lopinavir/Ritonavir and Atazanavir/Ritonavir increases the AUC value of Rosuvastatin triple. For these combinations, the dose of rosuvastatin should be limited to 10 mg. Combined with tipranavir/ritonavir or fosamprenavir/ritonavir changes small or unchanged rosuvastatin effect. Caution should be careful when using rosuvastatin with protease inhibitors in combination with Ritonavir.

Storage

Store in a cool dry place. Avoid light, less than 30 ° C, out of reach of children.

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.