Crestor 10mg Astrazeneca medicine for hypercholesterolic blood cholesterol (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Rosuvastatin
Ingredient Astra

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

indications

Crestor 10mg drug treatment for primary cholesterol (type IIA including hyperlyonic hyperlyonic heterozygic) or mixed blood lipid disorders (type IIB): A supportive therapy for diet when patients do not respond to diets and other non -drug therapies (such as physical training, losing weight).

Treatment of primary blood lipoprotein disorders (hyperplotein lipoprotein III): Crestor is indicated as a supplementary therapy for the diet in the treatment of patients with primary blood lipoprotein disorders (increased blood lipoprotein type III).

Crestor is indicated as a supplementary treatment for diets in adult patients with increased triglycerides.

Children from 7 to 17 years old and adults with hyperlest hypercholesteroline hypertension: Use to support diets and other lipid reduction treatments (such as decanting blood LDL) or when these therapies are not appropriate.

Pediatric patients from 8 to 17 years old suffered from heterozygous family blood cholesterol (HEFH): Support diet to reduce total cholesterol, LDL-Cholesterol and Apob in children and teenagers 8 to 17 years old with hyperlemical hypertension if the following elements still exist after treatment with diet mode: LDL-C> 190MG/DL HAY 160mg/dl and have a history of family disease early or have two or more risk factors for cardiovascular disease.

Crestor 10mg is indicated as a supplementary treatment for a diet to slow down the progression of atherosclerosis in adult patients as part of the total treatment strategy to reduce total cholesterol and LDL-C to reach target levels.

Prevention of primary cardiovascular disease.

In individuals without clinical evidence of coronary artery disease but there is a risk of cardiovascular disease such as ≥ 50 years old in men, ≥ 60 years old in women, HSCRP ≥2mg/l and at least one more risk factor for cardiovascular disease such as hypertension, low HDL-C, smoking or family history of early coronary artery disease, Crestor 10mg is indicated.

Reduce the risk of stroke.

Reduce the risk of myocardial infarction. 3-Hydroxy-3-Methylglutaryl Coenzyme A into Mevalonate, a precursor of cholesterol. The main action position of rosuvastatin is the liver, the target organs reduce cholesterol.

Rosuvastatin increases the number of LDL receptors on the cell surface in the liver, thus increasing the absorption and catabolism of LDL and inhibiting VLDL synthesis in the liver, thus reducing VLDL and LDL components.

pharmacokinetic

absorption

Rosuvastatin's peak plasma concentration is about 5 hours after drinking. Absolute bioavailability is 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 L. About 90% of rosuvastatin combined with plasma proteins, mainly with albumin.

Metabolism

Rosuvastatin is less metabolized (about 10%). CYP2C9 is the main enzyme involved in the metabolism, 2C19, 3A4 and 2D6 participating at a lower level. The main metabolites are identified as N-Desmethyl and Lactone. N-Desmethyl metabolites have a weaker activity about 50% than rosuvastatin while lactone form is not clinically active. Rosuvastatin accounts for more than 90% of HMG-COA Reductase inhibitors in circulation.

Elimination

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.

Before taking Crestor 10mg Astrazeneca medicine for hypercholesterolic blood cholesterol (2 blisters x 14 tablets)

How to use

Crestor 10mg can be used at any time of the day, during or away from meals.

Dosage

Adults

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 from using HMG-Coa Reductase inhibitors to Crestor. The selection of the starting dose should be noted that the cholesterol level of each patient, the 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 final dose standard up to 40 mg should only be considered for patients with severe blood cholesterol hyperplasia patients with high risk of cardiovascular disease (especially patients with hypercholesterol family blood), without achieving treatment goals at the dose of 20 mg and these patients need to be monitored regularly. It is necessary to have close monitoring of a specialist at the start of a 40 mg.

Provisions of cardiovascular events:

In studies reducing the risk of cardiovascular events, the dose is 20 mg daily.

Children

Hyperized blood cholesterol hyperlested: The recommended dose is 5 - 10 mg/day orally in patients 8 to 10 years old, dose of 5-20 mg/day on patients from 10 to 17 years old.

Hyper cholesterol hyperliper: Dosage recommended is 20 mg/day orally on children from 7 to 17 years old.

Elderly

Should start at a dose of 5 mg once a day in people over 70 years old.

No need to adjust the dose due to age.

Patients with renal failure

No dose adjustments in patients with mild to medium renal failure.

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

Patients with liver failure

The level of contact with rosuvastatin is calculated by concentration and time without increasing 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 scores. In these patients, they should consider the evaluation of kidney function. Inexperienced in patients with Child-Pugh scores on 9. Contraindicated use of Crestor for patients with liver disease developed.

Asian patients

In Asian patients, consider starting with Crestor 5 mg/day/day due to an increase in plasma rosuvastatin levels. Note to increase the level of exposure to drugs in Asian patients without adequate control with a dose of over 20 mg/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? 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 forgetting a dose? Ignore the forgotten dose if it is close to the time for the next expected dose. Do not use additional medicine to create the forgotten dose.

Side Effects

When using Crestor 10mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache, dizziness.

Skin: itching, rash, urticaria.

Rare, ADR

Digestive: Pancreatitis

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

Crestor medicine 10mg contraindicated in the following cases:

Patients with hypersensitivity to rosuvastatin or any excipients of the drug. 30ml/minute).

Patients with muscle disease.

Caution when using

The effect on the kidneys: proteinuria, discovered by the test strip mostly in the form of tube, which has been observed in patients treated with higher doses of Crestor, especially 40 mg, in which it is only transient or occasionally occurs. Proteinuria is not a warning sign of acute or progressive kidney disease. Kidney function assessment should be considered during periodic monitoring patients treated at a dose of 40 mg.

Musculosa effects: Bone muscle effects such as muscle pain, muscle disease and rarely rarely have been reported in patients treated with crestor with all doses and special doses> 20 mg.

measurement of creatine kinase (CK) concentration: Creatine kinase (CK) should not be measured after exertion or when presence a certain cause increases CK, this may falsify the results. If the CK concentration increases significantly before treatment (> 5 x ULN), a test should be done to determine, so within 5-7 days. If the test is repeated, determine the concentration of CK before treatment> 5 x ULN, then do not start treatment with Cresto.

Before treatment:

As well as other HMG-COA Reductase inhibitors, Cresto is at risk of causing harmful reactions to muscle systems such as muscle atrophy, muscle inflammation, need to be cautious while taking Cresto in patients with risk factors that can lead to muscle lesions. These factors include: renal failure; hypothyroidism; personal or family history of genetic muscle disorders; Previous history of muscle poisoning with another HMG-CoA Reductase inhibitor or fibrate; Alcohol abuse; > 70 years old; Situations may occur in plasma concentrations

In these patients, the risk of treatment should be considered related to possible benefits and should be clinically monitored. If CK concentration increases significantly at the original level (> 5 x ULN), it is not advisable to start treatment.

During treatment:

Patients should be required to immediately report the muscle, stiff, muscle weakness or unexplained cramps, especially if they are accompanied by fatigue, fever, dark urine, nausea, vomiting during the use of the drug. CK levels should be measured in these patients. Treatment should be stopped if the concentration of CK increases significantly (> 5 x ULN) or if the symptoms are serious and cause daily discomfort (even if CK ≤ 5 x ULN).

If the symptoms are relieved and the concentration of CK returns to normal, it is advisable to consider using Crestor or a HMG-CoA Reductase inhibitor instead of the lowest doses with close monitoring. Periodic monitoring of CK concentration in patients with no symptoms is not guaranteed. It is very rare for reporting muscle necrosis through the immunity (IMNM) during or after treatment with some statins, including rosuvastatin. IMNM has a clinical characteristic: the weak of the tendon speculators and increased serum creatine kinase, the symptoms continued despite stopping treatment with statin;

Increase the rate of myocarditis and muscle disease that has been seen in patients taking statins with other drugs including:

gemfibrozil

other fibrat blood cholesterol medications

high doses (1g/day)

Colchicin

In clinical trials, there is no increase in skeletal influence in patients using Cresto with other drugs. However, the increase in the incidence of muscle and muscular inflammation has been seen when combining HMG-CoA Reductase inhibitors different from Fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, Azole antifungal, protease inhibitors and macrolid antibiotics. Gemfibrozil increases the risk of muscle disease when used simultaneously with some HMG-CoA reducing enzyme inhibitors. Therefore, the combination of Crestor and Gemfibrozil is not recommended. The benefits of adding lipid concentration by using crestor combining with fibrat or niacin should be carefully considered with the potential risks of such combination.

Crestor should not be used for any patient with acute, serious condition, or tend to develop secondary renal failure after muscle pepper (e.g. infections, hypotension, major surgery, trauma, metabolic disorders, endocrine and severe electrolytes; or uncontrolled convulsions).

affects the liver: Like other HMG-Coa Reductase inhibitors, Crestor should be used carefully for patients who drink too much alcohol and/or a history of liver disease. It is recommended 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 an increase in exposure in Asians compared to white people.

Lactose intolerance: Patients with rare genetic problems are galactose intolerance, lapp lactase or glucose-galactose should not use this drug.

Interstitial lung disease: The exception of interstitial lung disease has been reported to some statins, especially when long -term treatment (see the harmful reaction). The characteristics of expression may include shortness of breath, cough without sputum and general health impairment (fatigue, weight loss and fever). If a patient suspects that the patient has developed interstitial lung disease, he should stop treating with statin.

Diabetes: Some evidence suggests that statins are a drug that increases blood sugar and in some patients, has a high risk of future diabetes, which can create a level of hyperglycemia when taking care of the official diabetes. However, this risk is superior due to reducing the risk of blood vessels when using statin and thus is not the reason to stop treating statin. Patients with risk (glucose at 5,6 - 6.9 mmol/l, BMI> 30 kg/m 2, increase triglycerides, hypertension) should be monitored both clinical and biochemical under national instructions.

The ability to drive and operate machinery

Studies to determine the influence of Crestor on driving and operating 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 10mg 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

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

Medicinal interaction

Transport protein inhibitors: Rosuvastatin is a substrate for some transport proteins that include the absorption agent in OatP1B1 liver and BCRP flow. Use, caution and table 8 as follows).

ciclosporin: Crestor increases contact with rosuvastatin and may increase the risk of muscle disease (see Table 8). Therefore, in patients taking ciclosporin, the dose of crestor must not exceed 5 mg x 1 time/day (see the dose & usage and caution at use).

Protease inhibitors: Although the exact interaction mechanism is unknown, the simultaneous use of protease inhibitors can increase the level of exposure to Rosuvastatin. For example, in a pharmacokinetic study, the simultaneous use of 10 mg of Rosuvastatin and a combined product of two protease inhibitors (300 mg Atazanavir/100 mg Ritonavir) in healthy volunteers is related to an increase about three times and seven times in Rosuvastatin AUC and C maximum maximum. 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 exposed to Rosuvastatin (see the dose & usage, caution and Table 8 as follows).

Gemfibrozil and other lipid -reducing products: simultaneously use Crestor and Gemfibrozil, increasing 2 times Rosuvastatin C Max and AUC (see caution at use). 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-COA Reductase inhibitors, maybe because they can cause muscle diseases when used alone. These patients should also start at a dose of 5 mg.

Ezetimibe: simultaneously use 10 mg of Crestor and 10 mg Ezetimibe, increasing the AUC of rosuvastatin to 1.2 times in blood cholesterol objects (Table 8). Can not exclude pharmacological interaction, about adverse effects, between Crestor and Ezetimibe (see the cautious part at use).

Antacisletes: Concomitance Crestor with antacids containing aluminum and magnesium hydroxide reduces the plasma concentration of rosuvastatin about 50%. This effect is slightly reduced when taking antacids 2 hours after Crestor. The clinical involvement of this interaction has not been studied.

Fusidic acid: Interactive studies with rosuvastatin and fusidic acid have not been done. 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: simultaneously use Crestor and Erythromycin, reducing 20% AUC (0-T) and a 30% C Max reduction of Rosuvastatin. This interaction may be caused by increased intestinal motility caused by erythromycin.

enzyme cytochrome P450: Results from in vito and in vivo studies show that Rosuvastatin is not inhibitors nor is the touch substance 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).

Interactive dose adjustment Rosuvastatin: When needed to simultaneously use Crestor with other drug products known to increase contact with rosuvastatin, the Crestor dose should be adjusted. Start with the dose of Crestor 5 mg x 1 time/day if the expected exposure increase (AUC) is approximately 2 times or higher. The maximum daily dose of Crestor should be adjusted so that RosuVastatin exposure is expected to not exceed the maximum daily crestor dose recommended 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 fibrats can cause severe muscleitis and myoglobin urine.

The influence of rosuvastatin on shared medicine products:

Vitamin K antagonistic drugs: As well as other HMG-COA reducing enzyme inhibitors, the start of treatment or adjustment of Crestor dose in patients treated simultaneously with vitamin K antagonists (such as warfarin or another coagulant coagulopular) can lead to an increase in international standardized ratio (INR). Discontinuing or reducing crestor titration 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 have increased Ethinyl estradiol and Norgestrel AUC, respectively 26% and 34%. 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

Do not store over 30 ° C. Store in original packaging.

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