Crestor 5mg Astrazeneca medicine for hypercholesterolic cholesterol (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Rosuvastatin
Ingredient Atherosclerosis, blood fat, high blood cholesterol

Ingredient

Composition information	Content
Rosuvastatin	5mg

Uses

indications

Crestor 5mg drug is indicated in the following cases:

The treatment of primary blood cholesterol (LLA type including hyperlested heterozygous blood cholesterol) or mixed blood lipid disorders (type IIB): Support when patients do not fully respond to diets and other non -drug -free therapies (such as exercise, weight loss).

Treatment of primary blood lipoprotein beta disorders (hyperplotein type Ill blood lipoprotein): Support diet for patients with beta lipoprotein disorders (increased blood lipoprotein type Ill).

Support treatment for diets in adult patients with increased triglycerides.

Hyper hypercholesteroline hypertension for children from 7-17 years old and adults: diet support and other lipid reduction treatments (such as blood extract) or when these therapies are not appropriate.

Hematopopoeia hypercholesterolinemia (HEFH) for children from 8 to 17 years old: Supporting diet to reduce total cholesterol, LDL -C and APOB in children and adolescents 8 - 17 years old with hyperplastic hypertype hyperplasia if the following factors still exist after treatment with diet: LDL -C> 190 MG/DL Hay/DL HAI 16 and have a family history of cardiovascular disease early or have 2 or more risk factors for cardiovascular disease.

Support treatment for diets to slow down the progression of atherosclerosis in adult patients and reduce total cholesterol along with LDL-C to the target level.

Prevention of primary cardiovascular disease: In patients at risk of cardiovascular disease such as> 50 years old in men,> 60 years old in women, HSCRP> 2mg/l and at least one risk factor for cardiovascular disease: hypertension, low HDL-C, smoking or family history of early coronary artery disease.

Pharmacokology

Rosuvastatin is a selective and competitive inhibitor with HMG-COA-RUDUCTASE (3-Hydroxy-3-Methylutaryl Coezyme A metabolic catalyst into cholesterol's precursor to MeValonate). Rosuvastatin increases the number of LDL receptors on the surface of liver cells, leading to increased absorption and catabolism of LDL, inhibiting VLDL synthesis in the liver, resulting in reducing VLDL and LDL components.

pharmacokinetics

absorption:

Rosuvastatin reaches peak plasma concentrations after drinking about 5 hours. Absolute bioavailability of about 20%.

Distribution:

Rosuvastatin is mainly distributed in the liver. The distribution volume is about 134 L. 90% of rosuvastatin combined with plasma proteins, mainly albumin.

Metabolism:

Only 10% of rosuvastatin is metabolized, mainly through CYP 2C9 and a small part through 2C19, 3A4 and 2D6. The main metabolites are N-Desmethyl and Lactone.

Era:

About 90% of the dose of rosuvastatin excreted intact in the stool and the rest through the urine. Sell waste time in plasma is about 19 hours.

Before taking Crestor 5mg Astrazeneca medicine for hypercholesterolic cholesterol (2 blisters x 14 tablets)

How to use

Before starting the medication, the patient must follow the standard diet to reduce cholesterol and continue to maintain this diet during treatment.

oral drugs at any time of the day, during or away from meals.

Dosage

adults:

Hyper cholesterol treatment:

Initial dose: 1 or 2 tablets/day (equivalent to 5 or 10 mg) x 1 time/day for both patients who have never used Statin groups and patients from using HMG-CAA Reductase inhibitors to Crestor.

The starting dose should be paid to the level of cholesterol of each patient, later cardiovascular risk as well as the possibility of unwanted effects. Adjusting the dose to the next dose can be done after 4 weeks if necessary.

Because the frequency of unwanted effects increases when taking a dose of 40 mg compared to lower doses, the last dose standard to 40 mg should only be considered for patients with severe hypercholesterolemia patients with high risk of cardiovascular disease (especially patients with hypercholesterol family), without achieving treatment goals at 20 mg and these patients need to be monitored regularly.

It is necessary to have a close monitoring of a specialist at the start of a 40 mg dose.

Provisions of cardiovascular events:

4 tablets (equivalent to 20 mg) x 1 time/day.

Children:

Hypothesis hypertopy blood cholesterol:

From 8 to under 10 years old: 1 - 2 capsules (equivalent to 5 - 10 mg)/day.

From 10 to 17 years old: 1 - 4 capsules (equivalent to 5 - 20 mg)/day.

Hydropectic hypertension of homozygous family type:

From 7 to 17 years old: 4 tablets (equivalent to 20 mg) x 1 time/day.

Elderly (over 70 years old):

Starting dose: 1 tablet (5 mg) x 1 time/day.

No dose is based on age.

Patients with renal failure:

No dose adjustment in patients with mild to medium renal impairment.

The recommended starting dose for patients with medium renal impairment (creatinine clearance

40 mg dose is contraindicated for patients with medium renal failure.

Contraindicated use Crestor for patients with severe renal impairment.

Patients with liver failure:

Kidney while using Crestor 5mg for this object. Evaluation of the patient's kidney function with Child -Pugh 8 - 9 before prescribing.

Contraindicated Crestor 5mg for patients with progressive liver disease.

Asian patients:

Start at a dose of 5 mg/time/day. Be cautious when the dose is over 20 mg/day.

Medicine coordination:

When using simultaneously Crestor 5mg with Gemfibrozil, Atazanavir and Ritonavir, Lopinavir and Ritonavir or Simeprevir:

Starting dose: 5 mg/time/day.

Maintenance dose: not exceeding 10 mg/time/day.

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?

There is no specific treatment for overdose. When an overdose, patients should be treated with symptoms and applied supportive measures when necessary. Should monitor liver function and ck concentration. Blood decomposition may not benefit.

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

Common, ADR> 1/100

endocrine: diabetes.

Neurology: headache, dizziness.

Digestive: constipation, nausea, abdominal pain.

musculoskeletal muscle: muscle pain.

Body: weakness.

Uncommon, 1/1000

Skin: itching, rash, urticaria.

Rare, ADR

Digestive: Pancreatitis.

Liver: increased transaminase liver enzymes.

Osteoarthritis: muscle disease (including muscle inflammation), muscle pilot.

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

Contraindicated

hypersensitivity to rosuvastatin or any excipients of the drug.

Progressive liver disease, increased serum transaminase for unknown cause, serum transaminase increases more than 3 times the upper limit of normal level (ULN).

Severe renal failure (creatinine clearance

There is muscle disease.

Using cyclosporin.

Pregnant and lactating women.

Contraindicated 40 mg for patients with risk factors for muscle disease/muscle pilot, including:

Moderate kidney failure (Creatinine clearance

Hypothyroidism.

Family history or yourself with genetic muscle disease.

Previous history of muscle lesions caused by other HMG-COA Reductase inhibitors or fibrats.

Alcoholism.

The condition increases the blood concentration in the blood.

Asian patients.

Use Fibrat combination.

Caution when using

Effects on the kidneys:

Patients may have proteinuria when treated with crestor at high doses (40 mg). This situation is mostly transient and occasionally occurs but it is necessary to assess the kidney function regularly when prescribing high -dose crestor.

Muscle effects:

Muscle effects such as muscle pain and muscle disease and rarely are muscle pepper have been recorded in patients treated with crestor at all doses and especially at> 20 mg.

Do not measure the level of Creatin Kinase (CK) after exertion or when there is the presence of a certain cause that can increase CK because it may falsify the results. If CK concentration increases significantly before treatment (> 5 Uln), a test should be performed to redefine within 5-7 days. If the test is repeated to determine the CK concentration before treatment is still greater than 5 Uln, it should not start treatment with Crestor.

Before treatment

Like HMG-CoA Reductase inhibitors, Crestor is at risk for harmful reactions to the muscle system such as muscle atrophy, muscle inflammation, and caution when using Crestor in patients with risk factors that can lead to muscle injury, muscle/muscle pilot diseases; CK tests should be conducted in cases;

Advice on kidney function.

Armor.

History of yourself or a family history of genetic muscle disease.

History of muscle disease due to the use of statin or fibrat before.

History of liver disease and/or drink a lot of alcohol.

Elderly patients (> 70 years old) have risk factors for muscle and muscle.

Conditions can cause increased drug concentration in plasma.

Simultaneously used with fibrats.

The 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 CK test results> 5 Uln, do not start statin treatment.

during treatment

Need to closely monitor harmful reactions during the use of the drug. The patient should immediately report to the doctor the phenomenon of muscle pain, stiffness, muscle weakness or unexplained crust, especially if there is fatigue, fever, dark urine, nausea or vomiting during the use of the drug.

When there are these manifestations, patients need to test CK to take appropriate interventions. Crestor should be discontinued if the CK concentration increases significantly (> 5 Uln) or has severe muscle symptoms and daily discomfort (even if the concentration of CK

If these symptoms are no more and the CK concentration returns to normal, consider the use of Crestor or use another HMG-CoA Reductase inhibitor at the lowest dose and closely monitor. There are very rare reports on muscle necrosis through the immune intermediaries (IMNM) during or after the treatment process with the Statins group, including rosuvastatin.

IMNM clinical characteristics are proximal muscle and increased serum creatin, these symptoms continued despite stopping the statin.

Periodic monitoring of CK concentrations in patients with no symptoms that are not guaranteed to detect muscle disease.

Increase the risk of muscle damage when using statin simultaneously with the following drugs:

gemfibrozil.

Other fibrat blood cholesterol medications.

High doses (> 1 g/day).

colchicin.

Increased incidence of muscle and muscle disease has been seen in patients using other HMG - Coa Reductase inhibitors simultaneously with the derivatives of fibric acid including gemfibrozil, cyclosporin, nicotinic acid, antifungal group Azole, protease inhibitors and macrolid antibiotics.

Gemfibrozil increases the risk of muscle disease when used simultaneously with HMG-CoA Reductase inhibitors. Therefore, the coordination between Crestor and Gemfibrozil is not recommended. The use of Crestor combination with fibrat or niacin to achieve further change of lipid levels should be carefully considered between benefits and risks.

Do not use Crestor for patients with acute serious condition, suspicion caused by muscle disease or may lead to secondary renal failure due to muscle pilot (such as hypotension infection, large surgery, injury, electrolyte disorders, endocrine and severe conveys; or uncontrolled convulsions).

affect the liver:

As well as other HMG-Coa Reductase inhibitors, Crestor should be used carefully for patients who drink too much alcohol and/or have a history of liver disease.

recommend that liver function tests are done before and 3 months after the beginning of treatment. Crestor should stop using the dose if the serum transaminase level is greater than 3 times the upper limit of the normal level. The rate of reporting on serious liver events (including mainly increasing liver transaminase) when using post -marketing drugs higher than at 40 mg.

In patients with secondary hypercholester hyperchemicals due to hypothyroidism or nephrotic syndrome, basic disease should be treated before starting crestor treatment.

Race:

Pharmacokinetic studies show that an increase in the level of exposure to drugs calculated by concentration and time in Asians compared to white people.

Endocrine effects:

may be increased HBA1C and blood glucose concentration when using HMG-CoA Reductase inhibitors, including Crestor. In some cases, this increase may exceed the threshold to identify diabetes (diabetes).

Protease inhibitors:

Simultaneous use of crestor with protease inhibitors to treat HIV, hepatitis C (HCV) may increase the risk of muscle damage, muscle eligibility and lead to deadly kidney damage. It is not recommended to be used with some protease inhibitors unless there is a adjustable dose of Crestor dose.

Glucose intolerance:

Not only only crestor for patients with galactose intolerance, lactase deficiency or malposure - galactose.

Pediatric:

Be cautious when indicating Crestor for children and teenagers because they may experience similar adults in adults.

The ability to drive and operate machinery

Studies to determine the effect of Crestor on the ability to drive and operate the machine has not been done. However, based on the pharmaceutical properties, Crestor cannot affect these possibilities. When driving or operating the machine should note that dizziness may occur during treatment.

Pregnancy

Crestor 5mg contraindicated in pregnant women.

Women may be pregnant should use appropriate contraceptive measures.

Because cholesterol and other cholesterol biosynthesis are necessary for fetal development, the potential risk due to HMG-COA Reductase inhibitors will dominate the benefits of Crestor treatment during pregnancy. Animal studies show that there are evidence of limited toxicity on the reproductive system. If the patient is pregnant during crestor treatment, the drug should be stopped immediately.

breastfeeding period

Contraindicated Crestor 5mg for breastfeeding women.

Drug interaction

Transport protein inhibitors:

Rosuvastatin is a substrate for some transport proteins including the absorption agent in the OATP1B1 liver and the BCRP flow.

Simultaneous use of Crestor 5mg with drugs inhibiting these shipping proteins can increase the level of rosuvastatin in plasma and increase the risk of muscle disease.

ciclosporin:

Crestor 5mg increases contact with rosuvastatin and can increase the risk of muscle disease. Therefore, in patients taking ciclosporin, the dose of crestor must not exceed 5 mg x once/day.

Protease inhibitors:

Although the exact interaction mechanism is not well known, the simultaneous use of protease inhibitors can increase the level of exposure to Rosuvastatin. The simultaneous use of Crestor and some Protease inhibitors can be considered after careful consideration of adjusting the Crestor dose based on the expected increase when in contact with Rosuvastatin.

gemfibrozil and other products that reduce lipids:

Simultaneous use Crestor 5mg and Gemfibrozil increases 2 times Rosuvastatin CMAX and AUC. Based on data from specific interactive studies, there is no expected interaction related to pharmacokinetics with fenofibrate, however, pharmacological interactions may occur.

gemfibrozil, fenofibrate, other fibrats and lipid dose (> or equal to 1g/day) of niacin (nicotinic acid) increase the risk of muscle disease when used simultaneously with HMG-CAA Reductase inhibitors, maybe they can cause muscle disease when used alone. These patients should also start at a dose of 5 mg.

ezetimibe:

Simultaneous use of 10 mg Crestor and 10 mg Ezetimibe has increased Rosuvastatin's AUC to 1.2 times in blood cholesterol objects. Can not exclude pharmacological interaction, about adverse effects, between Crestor and Ezetimibe.

antacids:

Concomitance Crestor with an aluminum anti -acid mixture and magnesium hydroxide reduces the plasma concentration of rosuvastatin by about 50%. This effect is slightly reduced when taking antacids 2 hours after Crestor.

Fusidic acid:

Like other statins, mechanical events, including muscle pepper, have been reported in experience after marketing when using simultaneously rosuvastatin and fusidic acid. Patients need to be closely monitored and may suspend treatment with rosuvastatin.

erythromycin:

Simultaneous use of Crestor and Erythromycin reduces 20% AUC (0-T) and reduces 30% CMAX of RosuVastatin. This interaction may be caused by increased intestinal motility caused by erythromycin.

enzyme cytochrome p450:

Rosuvastatin is not an inhibitor nor is the induction of the isoenzyme cytochrome P450. In addition, Rosuvastatin is a poor substrate for these isenzymes. Therefore, drug interactions due to metabolism through cytochrom P450 are not expected.

There is no clinical interaction that is recorded between rosuvastatin and fluconazole (CYP2C9 and CYP3A4 inhibitors) or ketoconazole (CYP2A6 and CYP3A4 inhibitors).

Interactions need to adjust the dose of rosuvastatin:

When needed to simultaneously use Crestor with other drug products known to increase contact with rosuvastatin, the dose of Crestor should be adjusted. Start with the dose of Crestor 5 mg 1 time/day if the expected exposure increase (AUC) is approximately 2 times or higher.

Crestor's maximum daily dose should be adjusted so that RosuVastatin exposure is expected to not exceed the maximum daily Crestor dose proposed to use without interacting with drug products. For example, the recommended dose of Crestor is 20 mg; The dose of Crestor is used in combination with Ritonavir/Atazanavir (up 3.1 times) not exceeding 5 mg, and the dose of Crestor used with Gemfibrozil (up 1.9 times) must not exceed 10 mg.

Other drugs:

Simultaneous use of fibrat can cause severe muscleitis and myoglobin.

The influence of rosuvastatin on shared medicine products:

As well as other HMG-COA reducing enzymes inhibitors, the start of treatment or adjustment of Crestor dose in patients treated simultaneously with vitamin K antagonists (such as Warfarin or another coagulants) can lead to an increase in international standardized ratio (INR). Discontinuing or reducing crestor dose may reduce the INR. In such situations, it is necessary to monitor Inr appropriately.

Oral contraceptives/hormone replacement therapy (HRT):

Simultaneous use of Crestor and a contraceptive pills that increased Ethinyl Estradiol and Norgestrel AUC corresponding to 26% and 34% respectively. These hyperplasia concentrations should be considered when choosing the dose of birth control pills. There is no pharmacokinetic data in objects that simultaneously use Crestor and HRT and therefore cannot exclude the same effect. However, the combination has been widely used in women in clinical trials and well tolerated.

Storage

Store in a dry place, temperature below 300C.

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.