Pitalip 2mg Abbott drugs for hypercholesterol blood cholesterol (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Pitavastatin

Ingredient

Composition information	Content
Pitavastatin	2mg

Uses

indications

Pitalip 2mg drugs are used to treat hypercholesterol blood.

Precautions related to indications: This medication should only be considered after a comprehensive health examination and diagnosis determined to increase blood cholesterol or hypertension of household blood.

Pharmacokology

pitavastatin is a competitive inhibitor of 3-hydroxy-3-methyl-glutaryl-coa reductase (HMG-Coa Reductase) is the main enzyme responsible for converting HMG-COA into Meovalonate.

This target reaction is an early speed limit during cholesterol biosynthesis.

By preventing this enzyme, Pitavastatin significantly reduces the plasma concentration of cholesterol lipoprotein low density (LDL-C) and total cholesterol (TC) and at lower levels than ApoLipoprotein B (APO-B) and Triglycerides (TGS) as well as increasing the height of cholesterol lipoprotein (HDLC) in patients with patients with cholesterol primary blood or mixed blood lipid disorders.

The mechanism of reducing LDL-C may be related to the decrease of the synthesis of lipoprotein very low density (VLDL) and increasing LDL-C receptors. These reactions lead to reduction in production and / or increased absorption and catabolism of LDL-C.

pitavastatin is an active molecule without activation after drinking.

Lipid lowering effect is seen within 1-2 weeks and the maximum treatment effect is achieved within 4-6 weeks.

LDL-C concentration decreases depending on the dose.

Dynamic pharmacokinetics

absorption

Birth of pitavastatin is 51%.

Pitavastatin's peak peak concentration (C Max) occurs at 1 hour after drinking. Sharing Pitavastatin and food reduces the 43%Pitavastatin absorption rate, but does not significantly reduce the absorption level of pitavastatin.

Pitavastatin concentration in plasma is higher than in the elderly (about 30% for the area under the concentration-time-time curve [AUC]).

Pitavastatin's ratio and absorption rate increased to 60% and 79% in patients with medium renal failure.

distribution

pitavastatin is absorbed into liver cells by polyppeptide transportation of organic anion (OATP) 1B1, 1B3 and 2B1.

The absorption of pitavastatin in the liver is necessary for pharmacological effects.

more than 99% pitavastatin in serum is linked to serum protein.

Data on distribution of pitavastatin into certain tissues is limited.

pitavastatin is distributed into breast milk in mice, but does not know in humans. Because serious side effects can occur in infant breastfeeding, caution with women who use this drug does not breastfeed.

metabolism and elimination

pitavastatin has the most unique metabolic characteristics compared to other statins, contributing to prolonging the time of effect and higher safety due to less drug -drug interaction.

Pitavastatin is mainly metabolized by Uridine 5'-diphosphae (UDP) Glucuronosyltransferase (e.g. UGT1A1, UGT1A3 and UGT2B7) into Pitavastatin glucoronide complexes and continue to convert into pitavastatatin lactone metabolism without operating. A small percentage of Pitavastatin is metabolized by cytochrom P450 liver enzymes (CYP), mainly 2C9 and 2C8.

The average selling time in Pitavastatin's plasma is about 12 hours. 79% or 15% of Pitavastatin oral solution are excreted corresponding to feces and urine within 7 days.

Dynamic pharmacokinetics research in liver failure: The result of a pharmacokinetics study indicates that the peak concentration in plasma or the AUC of Pitavastatin is 1.3 or 1.6 times higher in patients with mild liver impairment (type A) compared to healthy people.

In patients with average liver failure (type B child-pugh), the peak concentration in plasma or the AUC of Pitavastatin is 2.7 or 3.8 times higher than those of healthy people.

Before taking Pitalip 2mg Abbott drugs for hypercholesterol blood cholesterol (3 blisters x 10 tablets)

How to use

Pitalip 2mg tablets for oral tablets.

Dosage

The usual dose for adults is 1-2 mg of calcium pitavastatin once a day after dinner.

Dosage can be adjusted by age and symptoms of the patient.

When the LDL cholesterol level is not sufficient, it may increase the dosage to a maximum of 4 mg daily.

Precautions related to dosage and usage: In case of drug use for patients with liver disorders, the starting dose should be placed in 1 mg daily and the maximum dose must be 2 mg daily.

In case of increasing the dose of this drug, the side effects related to muscle pattern may occur, when increasing the dose to 4 mg, it should be noted some early signs of muscle pattern such as increased CK (CPK), Myoglobin urinary, muscle pain and weakness. (In clinical studies abroad, doses of 8 mg or more have been stopped due to some cases of muscle pattern and related side effects.)

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 overdose? Hemorrhage is not beneficial due to the high rate of pitavastatin protein.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

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

There are 22.2% of patients using Pitavastatin, which is reported to be reported in harmful reactions in clinical control studies and their open label extensions show that 3.9% of patients treated with pitavastatin have been stopped due to harmful reactions.

Harmful reactions are reported in this period including joint pain, headache, influenza, nasopharyngitis and allergies / hypersensitivity. The laboratory abnormalities are also informed, serum increased, aminotransferase, alkaline phosphatase, bilirubin and glucose.

Experience after being marketed, side effects of 2% or more have been determined.

Harmful reactions include 3.9% back pain, 3.1% muscle pain, 3.6% constipation and 2.6% of diarrhea observed during the use of pitavastatin after being approved.

Regardless of the cause and effect assessment, the harmful reactions are reported including the following: abdominal discomfort, abdominal pain, indigestion, nausea, weakness, fatigue, discomfort, hepatitis, jaundice, death and non -death, dizziness, loss, insomnia, depression, interstitial lungs, erectile dysfunction and muscle spasms. The following are serious reactions in terms of clinical.

Mechanical pepper (unknown ratio):

Medical terms to refer to the decomposition of muscle fibers that lead to release of muscle fibers into the bloodstream.

Signs and symptoms are considered painful, soft, weak and muscle swelling.

Besides muscle pain, the other main symptom of muscle pattern is dark urine, red or colored color due to myoglobinuria and can observe the serum increased CK.

Serious complications of pattern pepper, developing renal failure and may be related to high incidence and death, so pitavastatin treatment should be stopped in any patient with these symptoms.

The main symptom is muscle weakness due to functional disorders of muscle fibers, sometimes it can grow.

Pitavastatin treatment should also be stopped in any patient with muscle pain spread, muscle tension, cramps, stiffness, spasm or a noticeable serum increase.

There may be significant increase in liver transaminase (AST and ALT).

Check the liver enzyme test before starting treatment and regularly.

can sometimes detect low platelets.

Therefore, it is necessary to closely monitor blood tests.

If any abnormalities are determined, pitavastatin should be stopped and appropriate treatment.

Warnings

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

Contraindicated

Pitalip 2mg contraindications in the following cases:

Hypersensitivity to pitavastatin or any component in the formula.

active liver disease, including increased aminotransferase levels (transaminase) in serum unexplained serum.

Women are or may be pregnant and nursing women. Simultaneous use with cyclosporin.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

If you have muscle, back or body muscle pain, stop taking medicine and consult a physician.

Liver function tests should be done before taking the drug and 6 and 12 weeks after taking the drug. For patients who often use drugs, should check liver function every 6 months or as recommended by a doctor.

If the transaminase level is three times larger than the limit on normal, stop taking the drug and consult a doctor.

Be cautious when used with digoxin, warfarin because the concentration of these drugs in the blood may be high and become dangerous.

The risk of muscle disease or muscle pattern will increase when taking the drug with the following drugs. For example: Azole antifungal drugs such as ketoconazole, iTraconazole; Macrolide such as erythromycin, clarithromycin; HIV Protease inhibitors such as Indinavir, Ritonavir, Nelfinavir, Saquinavir; Verapamil; Diltiazem; Gemfibrozil; Nicotinic acid; xyclosporine; Amiodaron.

The risk of muscle pattern will increase under the following conditions such as high doses, elderly people; Patients with liver and kidney failure; Alcoholism; Hypertroid patient.

Be cautious when used with colchicin, especially in the elderly or patients with liver, kidney failure because of the risk of muscle disease or muscle pattern.

The use of drugs can increase blood sugar.

The ability to drive and operate machinery

People who often drive or operate machinery should use Pitalip 2mg?

Doctors may depend on the specific case that recommends or not recommend that patients take the drug when driving and operating machinery.

Women during pregnancy and nursing mothers

Women during pregnancy should use Paralip 2mg?

pitavastatin is contraindicated in women who are or may be pregnant.

There is no adequate and controlled research on pitavastatin in pregnant women, although, congenital abnormalities and / or bone deformities occur in animals. Should breastfeeding women take Pitalip 2mg?

It is not known whether Pitavastatin will be excreted in breast milk, however, it has proven that a small amount of other drugs in this group goes into breast milk.

Mouse studies have shown that Pitavastatin is excreted into breast milk. Because another drug in this group goes into breast milk and HMG-Coa Reductase inhibitors that can cause serious harmful reactions in breastfed babies, contraindicated pitavastatin during breastfeeding.

Drug interaction

drug interactions may affect the activity of the drug or cause side effects. Should notify the doctor or pharmacist a list of drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

pitavastatin is gently metabolized by CYP 2C9 and is lower than CYP 2C8.

cyclosporine:

Absolutely contraindications to the same time. This leads to the risk of serious harmful reactions such as muscle disease or muscle pattern.

Fine derivatives (fenofibrate, gemfibrozil, etc.):

pitavastatin should avoid simultaneously with these drugs, especially patients with kidney problems.

can observe an increase in the risk of skeletal muscle effects (for example, muscle or muscle pilot) and abnormalities in the laboratory (increased CK, Myoglobin in the blood and urine, or worsen kidney function).

niacin:

may increase the risk of skeletal muscles.

simultaneously use pitavastatin and niacin, should consider reducing the dose of pitavastatin.

erythromycin:

shared, causing pharmacokinetic interaction, increasing C max 3.6 times and AUC increased by 4.6 times of Pitavastatin.

If used simultaneously, the dosage of pitavastatin must not exceed 1 mg x 1 time/day.

rifampin:

Rifampin significantly increases the contact with pitavastatin.

In patients taking rifampin, do not exceed the dose of Pitavastatin 2 mg 1 time/day.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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