Pitator 2mg Orient treats hypercholesterol in blood (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Pitavastatin

Ingredient

Composition information	Content
Pitavastatin	2mg

Uses

Indications

Pitator tablets 2mg is indicated in the following cases:

pitavastatin is used in the treatment of hypercholesteroline hypercholesteroline and mixed blood lipid disorders.

However, the drug utensil is only one of the interventions on the lipid composition of the patient's blood. There are many causes of high blood fat, especially due to lifestyle or specifically diet. Therefore, when using medications for lipid disorders, it is necessary to combine with a limited diet and cholesterol and should only be used when non -drug methods (including diet) are not enough to control blood lipids.

Pharmacokological

pitavastatin in the form of calcium salt belongs to statin drugs that lower blood cholesterol. As well as statin groups, Pitavastatin is a competitive inhibitor HMG-COA Reductase, a enzyme that has the first hydrolysis effect of the liver cholesterol biosynthesis. The result shows the rapid absorption of low density lipoprotein (LDL) from blood into the liver in LDL receptors, then reducing total cholesterol (TC) plasma. Next, the prolonged cholesterol synthesis in the liver reduces the low density lipoprotein level (VLDL).

In a random study, double blindness with moxifloxacin in healthy people, pitavastatin is not related to the range of QT or heart rate of clinical significance when using daily dose to 16mg (4 times higher dose recommended by the maximum dose).

The effect of pitavastatin on the rate of disease and death rate due to cardiovascular disease has not been determined.

pitavastatin has not been studied on blood lipid disorders type I, III and V according to Fredrickson.

pharmacokinetic pharmacokinetics

pitavastatin quickly absorbed in the digestive tract, the concentration of nails reached about 1 hour after drinking. Dynamic pharmacokinetics (CMAX and AUC) increase the proportion at the dose when the daily dose is from 1 - 24mg. Absolute bioavailability reaches about 51 % when taking the solution, taking medicine after a high -fat meal reduces CMAX by 43 % but AUC is not significantly reduced. Pharmacokinetics are almost unchanged when taking the drug in the morning and evening. In healthy people, the basic level of LDL-C when taking the dose of Pitavastatin 4mg is a bit higher than when taking the morning medicine.

High protein -linked drugs, up to 99%, mainly with albumin and α1 -acid glycoprotein.

pitavastatin metabolized by CYP2C9 and a part of CYP2C8. Main metabolites in humans are lacton, formed by a combination of Pitavastatin and Glucuronid thanks to Uridine 5′-Diphosphate (UDP) Glucuronosyltransferase (UGT1 A3 and UGT2B7). Half -life excreted on average about 12 hours, about 15% of the drug excreted through the urine, the rest is largely through the feces.

The elderly: Research shows that CMAX and Area in the elderly (> 65 years old) are 10% and 30% higher, but have not yet been clinically affected.

In people with average impaired renal function, glomerular filtration rate (30 - 59ml/minute/1.73m2) and end -stage renal failure are getting hemorrhage, pharmacokinetics (AUC and CMAX) of Pitavastatin higher than healthy volunteers.

People with impaired liver function: Pitavastatin's cmax and AUC ratio in medium liver failure (Child-Pugh B) compared to healthy healthy volunteers are 2.7 and 3.8. Meanwhile, this rate in mild liver failure (Child-Pugh a) compared to healthy people is 1.3 and 1.6. Selling time for moderate, light liver failure and healthy people are 15, 10 and 8 hours.

Before taking Pitator 2mg Orient treats hypercholesterol in blood (2 blisters x 14 tablets)

How to use

Take oral use. Pitavastatin can be taken at any time of the day without a meal (hungry/full).

Dosage

Take the drug as directed by the physician. In clinical studies, the dose of Pitavastatin is greater than 4mg once a day is related to the risk of increased muscle disease. Therefore, do not overdose 4mg Pitavastatin every day.

Adults

Take 1 - 2mg once a day. The dose can be adjusted by age and symptoms. The dose may be increased if the rate of decrease in lipoprotein-cholesterol is not sufficient. The maximum daily dose is 4mg.

After starting or when monitoring the adjustable dose of pitavastatin, lipid concentration should be determined after 4 weeks and adjust the dose depending on the response results.

Dosage for patients with renal function impairment

Starting dose for patients with medium and severe renal failure (glomerular filtration speed of 30 - 59ml/minute/1.73m2 and 15 - 29ml/minute/1.73m2) and patients with end -stage renal impairment are being clinical: Maximum dose is 2mg/time/day.

Concentrated with erythromycin: Patients with simultaneous use of erythromycin, dose not exceeding 1mg/time/day (due to drug interaction).

Concentrated with rifampin: patients use simultaneously rifampin, dose not exceeding 2mg/time/day (due to drug interaction).

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 using overdose? If overdose occurs, symptomatic monitoring and treatment.

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 Pitator Tablets 2mg, you may experience unwanted effects (ADR).

The most common adverse reactions occur today when using pitavastatin is muscle pain, back pain, osteoarthritis pain and constipation.

Common, ADR> 1/100

Mild muscle pain.

back pain, arm pain or leg.

Diarrhea, constipation.

light rash on the skin.

Uncommon, 1/1000

Muscle pain, sensitivity, or unknown weakness.

mixed, there are memory problems.

Fever, abnormal fatigue, and dark urine.

Increasing thirst, increasing urination, hunger, dry mouth, breath with fruit smell, drowsiness, dry skin, blurred vision, weight loss.

Nausea, pain in the upper abdomen, itching, anorexia, dark urine, clay, jaundice.

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

Pitator tablets 2mg contraindicated in the following cases:

Sensitive to any ingredients of the drug. Hypersensitivity reactions include rash, itching, urticaria have notified to pitavastatin.

Progressive liver disease, including persistent hypercondrition, unexplained liver.

Pregnant women or may be pregnant during medication.

Lactating women.

Cyclosporin simultaneous use.

Precautions for use

There have been notice of some cases of muscle disease and muscle pattern caused by HMG-CoA Reductase inhibitors (including pitavastatin) accompanied by an increase in metomatographic and secondary renal failure. These risks can occur at any level, but increase at the dose.

Be cautious for patients with muscle disease, such as the elderly (> 65 years old), renal failure, thyroid defects have not cured. The risk of disease can be increased when using fibrat drugs or niacin materials that change lipid, so be careful when using pitavastatin for these objects.

Be cautious when used simultaneously with some medications that can interact such as erythromycin, rifampicin, colchicin, niacin, fibrats (see drug interactions).

A few rare cases are immune-mediated necrotizing myopathy-Imnm), a type of autoimmune muscle disease, related to statin. Immunity through muscle necrosis is characterized by the weakness of the near muscles (Proximal Muscle) and increasing the persistent creatin kinase (CK), even after stopping statin treatment. Pitavastatin should be stopped when CK increased significantly, when suspected or diagnosed with muscle disease.

Should stop treating with Pitavastatin temporarily when the patient is in acute condition, suffering from some more severe diseases, which can cause muscle disease or secondary kidney failure leading to muscle elimination (such as blood infections, hypotension, dehydration, surgery, severe trauma, hormonal, or electrolyte disorders, or uncontrolled convulsions), need not instructed the patient if the cause of the patient is unable If accompanied by fever or discomfort.

Liver enzyme abnormalities

Cases of increased liver transaminase (AST, ALT) have been reported when using HMG-CAA Reductase inhibitors (including pitavastatin). Most schools only increase temporary, or will decrease when the drug is stopped. Liver enzyme should be checked at treatment, 12 weeks, and every 6 months. Continuous monitoring should be monitored if the patient increases the liver transaminase until the signs are out of signs, and pay attention to the patient about the symptoms related to liver disease such as fatigue, anorexia, discomfort in the upper right of the abdomen, dark urine or jaundice, if ALT or AST increases continuously to three times compared to the upper limit of normal levels, should stop treating with pitavastatin or decrease.

There have been reports in some rare cases of liver failure leading to death or not due to statin (including pitavastatin). Pitavastatin should be discontinued if serious liver damage with clinical symptoms and hyperkema blood or jaundice observed during treatment with pitavastatin. Do not use pitavastatin if there is no other cause of liver disease.

As with other HMG-Coa Reductase inhibitors, caution and warning should be used when using pitavastatin for alcoholic patients. Contraindicated to use pitavastatin for people with progressive liver disease (including unexplained schools).

Increased hemoglobin glycosylation (Hbalc) or increased blood glucose when hungry has notified in patients treated with HMG-CoA Reductase inhibitors (Statin substances, including pitavastatin).

Recovery perceptions

There has been a rare announcement of cognitive impairment (such as dementia, or forgetting, memory impairment, confusion) related to the use of statin. These reactions are usually not serious and recover when stopping statin, the time of symptoms appears very different (1 day - a few years) and all symptoms (on average 3 weeks).

Use children's drugs: Safety and effectiveness of pitavastatin in children has not been determined.

Patients with renal failure: reduce the dose of pitavastatin.

Patients with liver failure: Contraindicated in patients with liver disease.

The ability to drive and operate machinery

Be careful when used for driving objects and operating machinery.

Pregnancy

Contraindicated in women who have or suspect pregnancy because of the teratogenic effect of pitavastatin.

Breastfeeding period

pitavastatin has excreted breast milk. Should stop the drug or stop breastfeeding, taking into account the importance of the drug for the mother.

Drug interaction

cyclosporine: cyclosporine increases pitavastatin levels in the blood. Contraindicated use of these two drugs.

erythromycin: erythromycin significantly increases the concentration of pitavastatin in the blood. If using these two drugs simultaneously, the dose of pitavastatin must not exceed 1mg, once a day.

rifampin: significantly increases the concentration of pitavastatin in the blood. If using these two drugs simultaneously, the dose of pitavastatin must not exceed 2mg, once a day.

gemfibrozil and other fibrates: Due to increased risk of muscle disease/muscle pattern, should avoid simultaneous use of gemfibrozil with pitavastatin/other fibrates.

Niacin: The risk of muscle disease - bone may increase when used in combination with pitavastatin with niacin, should consider reducing the dose of pitavastatin.

Warfarin: Patients who are using warfarin should be monitored prothrombin time and test Inr when used in combination with pitavastatin.

Storage

In a dry place, avoid light, temperature below 30 ° C.

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.