Statinagi medicine 20 Agimexpharm treat hypercholesterol blood cholesterol (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin

Ingredient

Composition information	Content
Atorvastatin	20mg

Uses

indications

Statinagi® 20 drugs are indicated in the following cases:

Indications for hypercholesteroline treatment:

Atorvastatin is assigned to support diets to reduce total cholesterol (partial), low density lipoprotein cholesterol (LDL-C), apolipoprotein B and triglycerides in adults, adolescents and children aged 10 and older with increased primary blood cholesterol including hyperlyonic hyperlipidemia (corresponding to type IIA and IIB according to the classification of Fredrickson), when the patient responds incomplete with the diet and other non -drug therapies.

Atorvastatin is also indicated to reduce the part and LDL-C in adult patients with hyperlested hypercholesteroline hypertension as a supportive therapy for other lipid treatments (for example, blood LDL olion) or if those treatments are not available.

Cardiovascular Prevention:

Prevention of cardiovascular complications in adult patients is considered to be at high risk of early -stage cardiovascular complications, as a supportive drug to adjust other risk factors.

Pharmacokology

Atorvastatin is a selective inhibitor and competition for reducing enzymes HMG-CoA, a decision to inhibit the metabolism of 3-hydroxy-3-methyl-glutaryl-coenzyme A into Meovalonate, a precursor of sterols, including cholesterol.

Dynamic pharmacokinetics

Atorvastatin is quickly absorbed after oral, the peak concentration of plasma is achieved within 1 to 2 hours. The level of absorption and concentration of Atorvastatin in plasma increases proportional to the dose of Atorvastatin. After taking Atorvastatin film tablets for bioavailability equal to 95% to 99% of the solution form.

The average distribution of Atorvastatin is approximately 381 liters. The ratio of cohesion to plasma protein of Atorvastatin ≥ 98%.

Atorvastatin is converted by cytochrom P450 3A4 into hydroxylation derivatives at Ortho-and Para position and products of oxidation in beta. There are also products that experience glucuronids.

Atorvastatin and its metabolites are excreted mainly after bile after being metabolized in the liver and/or outside the liver; However, the drug does not seem to have a cycle of re -circulating the gut. The average selling time in the plasma of Atorvastatin is approximately 14 hours, but the sale time of the inhibitory activity for HMG -CAA reducing enzymes is 20-30 hours due to the contribution of active metabolites.

Before taking Statinagi medicine 20 Agimexpharm treat hypercholesterol blood cholesterol (3 blisters x 10 tablets)

How to use

Statinagi® 20 uses oral. Can take the only dose at any time of the day, at meals or hungry.

Dosage

Patients should follow the standard diet of cholesterol reduction during the process before and during Atorvastatin treatment. Dosage for each patient depending on the initial LDL-C level, treatment goals, and patient response. The initial usual dose is 10mg once a day. Dosage adjustment should be done for about 4 weeks or more. The maximum dose is 80mg once a day.

Increasing cholesterol and hyperlipidemia (mixed): Most patients are controlled at a dose of 10mg atorvastatin once a day. The treatment responds clearly within 2 weeks, and the maximum response is usually achieved within 4 weeks. This response is maintained during long -term treatment.

Hyperty hyperglycemia hyperlipidemia: Patients should be started with Atorvastatin 10mg daily. Dosage should be personalized and adjusted every 4 to 40 mg/day. After that, the dose may increase to maximum of 80 mg/day or use a combination of bile acid isolation with 40mg atorvastatin 1 time/day.

Hypered blood cholesterol hygiene: Data on this patient's object is currently limited. The dose of Atorvastatin in this patient group is 10mg to 80 mg/day. Should be used in combination with other blood lipid therapies or use when there are no other therapies.

Preventive cardiovascular disease: In initial prevention tests, the dose is 10 mg/day. A higher dose may be needed to achieve cholesterol levels (LDL-C) according to the current instructions.

renal failure: No dose adjustment.

Hepatic failure: Be cautious when using Atorvastatin in patients with liver failure. Contraindications to use Atorvastatin in patients with progressive liver disease.

Elderly: The safety and effectiveness of the drug in patients over 70 years of age recommended is similar to the general group.

Children: Hyper cholesterol. Used for children should only be done by experienced doctors in the treatment of hyperlipidemia children and patients should be re -evaluated regularly to monitor the progress.

For patients with hypercholesteroline hypertonic hypertonic heterozygous families from 10 years of age, the initial recommended dose of Atorvastatin is 10 mg/day.

The dose may be increased to 80 mg/day, depending on the response and tolerance. Dosage should be personalized depending on the recommended treatment objectives. Dosage adjustment should be done for about 4 weeks or more. Research data in adults and clinical data is limited from studies on children with hypertonic hypertonic hypertonic hypertension support to adjust the dose adjustments up to 80 mg/day.

There is very little safe and effective data in children with hypertension family blood cholesterol from 6 to 10 years old from open studies. Atorvastatin is not indicated in the treatment of patients under 10 years old. Some other drugs may be more suitable for this object.

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 using overdose? If overdose, symptomatic treatment and necessary supportive measures, liver function is required and plasma concentration monitoring.

Because Atorvastatin is strongly connected to plasma proteins, dialysis is very difficult and capable of significantly increasing the clearance of Atorvastatin.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Statinagi® 20, you may experience unwanted effects (ADR).

Common, ADR> 1/100:

Infections and parasites: rhinitis - throat.

Immune system disorders: allergic reactions.

Metabolic and nutrient disorders: Hyperglycemia.

Nervous system disorders: headache.

Respiratory disorders, chest and mediastinum: sore throat - laryngeal, nosebleeds.

Digestive disorders: constipation, flatulence, indigestion, nausea, diarrhea.

Disorder muscle tissue and connective tissue: muscle pain, joint pain, limb pain, muscle spasm, joint swelling, back pain.

Uncommon, 1/1000

Metabolic and nutrition disorders: hypoglycemia, weight gain, anorexia.

Mental disorders: nightmares, insomnia.

Nervous system disorders: dizziness, loss of sensation, drowsiness, mental disorders, dementia.

eye disorders: blurred vision.

Disorders of ears and maze: Tinnitus.

Gastrointestinal disorders: upper and lower abdominal pain, belching, pancreatitis.

Hepatitis: Hepatitis.

Skin and subcutaneous tissue disorders: urticaria, skin rash, itching, hair loss.

Disorders of musculoskeletal and connective tissue: neck pain, muscle fatigue.

Systemic and local disorders: discomfort, weakness, chest pain, peripheral edema, fatigue, blood fever.

Rare, 1/10,000 ADR

Blood and disorders of lymphatic system: platelets.

Nervous system disorders: Peripheral neuropathy.

eye disorders: visual disorders.

Bile disorders: bile stasis.

Skin and subcutaneous tissue disorders: epigastric edema, nasal dermatitis including diverse roses, stevens-johnson syndrome and poisoned epidermal necrosis.

Disorders of musculoskeletal and connective tissue: muscle disease, muscle inflammation, muscle pattern, tendon disease, sometimes become complicated due to tissue rupture.

Very rare, ADR

Immune system disorders: Anaphylaxis.

Disorders of ears and maze: hearing loss.

Liver disorders: Hepatic failure.

Breeding system and breast disorders: Men's breast enlargement.

Unknown frequency, ADR:

Bone and bond tissue disorders: immune necrotic disease through intermediaries, muscular awards, back pain.

Testing: abnormal liver function, hyperka kinase blood. Leukemia in positive urine.

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

Statinagi® 20 drug contraindicated in the following cases:

Hypersensitivity to Atorvastatin or any ingredients of the drug.

Progressive liver disease or serum transaminase increases more than 3 times the upper limit of normal levels that cannot be explained.

During pregnancy or lactation and in women who are likely to have a baby due to not using appropriate contraception.

Be cautious when using

need to test the liver function before starting treatment and periodically later. The patient detects any signs or symptoms that liver damage needs liver function tests. Patients detecting increased transaminase levels should be monitored until the abnormalities are resolved. If transaminase increases more than 3 times the upper limit of normal level (ULN), reducing the dose or stopping atorvastatin.

Should use Atorvastatin carefully in patients who drink a lot of alcohol, beer and/or a history of liver disease.

For patients with premature hemorrhagic stroke or stroke, the risk balance and benefits of Atorvastatin 80mg are uncertain, and potentially the risk of hemorrhage stroke should be carefully considered before starting treatment.

Atorvastatin, like other HMG-COA reducing enzymes inhibitors, can rarely affect skeletal muscles and cause muscle pain, muscle inflammation, and muscle disease that can progress into muscle pilot, a life-threatening situation is characterized by creatin kinase level (CK) high (> 10 times ULN), bleeding and Myoglobin can lead to renal impairment.

Special cases of interstitial lung disease have been reported to some statins, especially long -term treatment.

Some evidence suggests that the statin increases blood sugar and in some patients at higher risk of diabetes in the future, may increase the level of blood sugar, so the appropriate diabetes care.

Patients with rare genetic problems in tolerance Galactose, Lapp Lapp Lactase or Glucose-Galactose should not use this drug.

The ability to drive and operate machinery

Atorvastatin has an impact that is not mentioning the ability to drive and operate machinery.

Pregnancy

Contraindications during pregnancy.

Breastfeeding period

Atorvastatin is contraindicated during breastfeeding.

Drug interaction

Atorvastatin is metabolized by CG CGTOCHROM P450 3A4 (CYP3A4) and substrate for protein transport, such as OatP1B1 liver absorption agent. Concentrated use of CYP3A4 inhibitors or transport proteins can lead to increased Atorvastatin levels in plasma and increase the risk of muscle disease.

Should not use strong CYP3A4 inhibitors (for example: Ciclosporin, Telithromycin, Clarithromycin, Delavirdin, Stiripentol, Ketoconazole, Voriconazole, Itraconazol, Posaconazole and HIV Protase inhibitors such as Ritonavir, Lopinavir, AtazanAr, AtazanAr, AtazanAr, Atazana Indinavir, Darunavir, etc.).

CYP3A4 induction drugs: simultaneously use Atorvastatin with cytochrom P450 3A induction substances (e.g. Efavirenz, Rifampin, World St. John's) can lead to reduced Atorvastatin levels in plasma.

Transport protein inhibitors: Transport protein inhibitors (eg ciclosporin) may increase the bioavailability of Atorvastatin.

Gemfibrozil/Fibric acid derivatives: The use of individual fibrat is sometimes related to muscle, including muscle pepper.

Ezetimib: The use of individual ezetimib is related to muscle, including muscle pattern.

Colestipol: Atorvastatin plasma concentrations and lower metabolites (Atorvastatin concentration ratio: 0.74) when concentrated with Colestipol.

Fusidic acid: The risk of muscle disease including muscle pattern may be increased when used simultaneously with fusidic acid with statin.

Colchicin: Although interactive studies between Atorvastatin and Colchicin have not been conducted, cases of muscle disease have been reported to Atorvastatin used simultaneously with Colchicin, so be cautious when appointed atorvastatin together with colchicin.

Digoxin: When using simultaneous doses of Digoxin and Atorvastatin 10 mg, plasma digoxin concentrations in the state are intended to increase slightly. Patients who are using digoxin should be monitored properly.

Oral contraceptive: simultaneous use of Atorvastatin with oral contraceptives containing norethindron and ethinyl estradiol increases the plasma concentration of norethindron and ethinyl estradiol.

warfarin: In a clinical study in patients with prolonged warfarin, simultaneous use of Atorvastatin 80 mg/day with warfarin reduces about 1.7 seconds prothrombin time in the first 4 days after taking the drug and returning to normal within 15 days after treatment with Atorvastatin.

Storage

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

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