Pitaterol Tablet 2mg Medical Korea reduces the total 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

Pitaterol drugs are indicated in the following cases:

Additional treatment for nutrition to reduce total cholesterol (TC), LDL -C, Apolipoprotein B (APO B), Triglycerid (TG) and increase HDL -C in patients with cholesterol - primary blood (heterozygous and non -family heterosexual) and lipid disorders - mixed blood. Learning

pitavastatin calcium is a drug in the HMG-Coa Reductase inhibitor group. The drug inhibits cholesterol in the liver by inhibiting an enzyme to create cholesterol, HMG-CoA Reductase. The drug reduces general cholesterol level as well as cholesterol LDL in the blood (LDL cholesterol is considered a "bad" cholesterol that plays the main role in coronary artery disease). Reducing LDL cholesterol levels slowed down the progression of coronary artery disease.

pharmacokinetic

absorption

Plasma peak concentration reaches about 1 hour after taking the drug. Both peak concentration (CMAX) and the area under the curve (AUC) increased proportional to the single dose of 1 - 24 mg Pitavastatin per day. Absolute bioavailability is 51%.

Pitavastatin oral with high fat food (50% fat content) reduces the absorption of drugs by about 43% through CMAX assessment but does not affect the level of AC's absorption.

Pitavastatin concentration in plasma is not different when drinking in the morning or afternoon. An assessment on a healthy volunteer when taking a dose of 4 mg Pitavastatin, the percentage of LDL-Cholesterol changes compared to the original when drinking evening is 2 times greater than taking the drug in the morning. Pitavastatin is absorbed in the small intestine and absorbed very little in the colon.

Distribution

Pitavastatin binds to more than 99%plasma proteins, mainly attached to albumin and Alpha-1 Glyco protein acid protein, and an integral distribution of about 148L.

Metabolism

weak metabolic drugs through the liver by CYP 2C9 and partially by CYP 2C8. Over the process of glucuronidization thanks to the 5-diiphosphate glucuronosyl transferase enzymes (UGT1A3 and UGT2B7), the main metabolite is Pitavastatin Lacton formed.

Elimination

After drinking, pitavastatin and metabolites are mainly discharged in feces (79%) and partially through urine (15%). The sale time of the drug is 12 hours.

Before taking Pitaterol Tablet 2mg Medical Korea reduces the total cholesterol (3 blisters x 10 tablets)

How to use

Pitaterol drugs are taken orally.

Dosage

Adults

Dosage: 1- 4 mg/time/day. The recommended starting dose is 2 mg and the maximum dose is 4 mg. Dosage should be used depending on the individual based on the patient's treatment and response purposes.

After the initial dose, it is necessary to analyze blood lipid concentration after 4 weeks of treatment to adjust the dose accordingly.

Other objects

Patients with medium and severe renal impairment (glomerular filtration corresponding to 30 - 59 ml/min/1.73m2 and 15 - 29 ml/min/1.73m2 without dialysis) and end -stage kidney disease

It is recommended that the starting dose is 1 mg/day/day and the maximum dose is 2 mg/time/day.

Patients taking drugs with erythromycin

Do not overdose 1 mg/time/day.

Patients taking drugs with rifampi

Do not overdose 2 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 is required to treat symptoms and take supportive measures. The dialysis appraisal does not significantly increase the purification of pitavastatin due to the very high pitavastatin protein.

What to do when forgetting 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 pitaterol, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Systemic: Hypersensitivity (including rash, itching, urticaria). Enlightenment, paranoia, agitation and nightmares.

Uncommon, 1/1000

The digestive system: abdominal pain, indigestion, nausea, weakness, hepatitis, jaundice, death and no death of liver failure. Cognitive decline (memory loss, forgetfulness, memory impairment, memory disorders).

Respiratory system: interstitial lung disease.

Reproductive system: erectile dysfunction and muscle spasm.

Instructions on how to handle ADR

Changes in serum liver enzyme concentration usually out in the first months of pitavastatin treatment.

Patients with high serum transaminase concentration must monitor the second liver function test to confirm the results and monitor treatment until the abnormalities return to normal.

If the serum transaminase or ALT (GTP or GPT) concentration levels are persistent than 3 times the upper limit of normal, it is necessary to stop treating with statin. The patient should stop the statin immediately reporting any manifestation such as: muscle pain for unknown reasons, sensitivity and muscle weakness, especially if accompanied by discomfort or fever. Statin therapy must be stopped if the CPK concentration increases significantly, 10 times higher than the upper limit of normal and if diagnosed or suspected is muscle disease.

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

Pitaterol drugs contraindicated in the following cases:

Patients with a history of hypersensitivity to the ingredients of the drug. The hypersensitivity reaction may include rashes, itching and urticaria.

Patients with liver diseases may include increased liver transaminase concentration.

pregnant women or pregnancy.

Precautions when using

The drug is only used when prescribed by a doctor.

Before and during treatment with pitavastatin, it is recommended to combine blood cholesterol control by measures such as diet, weight loss, exercise and treatment of diseases that may be the cause of lipid growth. Periodic lipid quantification, and adjust the dose according to the patient's response to the drug.

The goal of treatment is to reduce LDL cholesterol so it is necessary to use LDL cholesterol levels to start treatment and evaluate treatment. Only when the LDL cholesterol is not tested, will the total cholesterol use to monitor treatment.

In clinical trials, a small number of patients who take statins see a significant increase in serum transaminase (> 3 normal limits).

When stopping the drug in these patients, the transaminase concentration often lowered to the level before treatment. Some of these patients before the tri with statin had abnormal liver function test results and/or drink a lot of alcohol. Therefore, it is necessary to conduct liver enzyme tests before starting treatment with pitavastatia and in the case of clinical indications that test requirements.

Consider monitoring Creatin Kinase (CK) in the case:

Before treatment, CK tests should be conducted in the following cases: impaired renal function, hypothyroidism, self -history or family history of genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, the history of liver disease and/or drinking a lot of alcohol, elderly patients (> 70 years old) have special risks of medication and drug -related patients. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with statin. If the results of CK test> 5 times the upper limit of normal levels, do not start treatment with statin.

During satin treatment, patients need to notify when there are muscle manifestations such as muscle pain, muscle stiffness, muscle weakness ... When there are these manifestations, patients need to do CK tests to take appropriate interventions. Statin therapy must be suspended or stop in any disease that manifests that acute and severe muscle disease or has risk factors prone to acute renal impairment due to muscle pattern, such as severe bacterial infections, hypotension, surgery and large injuries, abnormalities in metabolism, endocrine, electrolytes or uncontrolled convulsions.

The ability to drive and operate machinery

The drug can cause side effects on the nerves (headache, dizziness), muscle impact (muscle aches), so be careful when driving and operating machinery.

Pregnancy

Contraindications.

Breastfeeding period

Animal studies have shown that Pitavastatin can be excreted into breast milk. HMG-CAA Reductase inhibitors have the potential to cause serious harmful reactions for breastfed babies, so contraindicated use of pitavastatin for pregnant or lactating women.

Drug interaction

cyclosporin: cyclosporin significantly increases the side effects of pitavastatin. Contraindicated use of cydosporin with pitavastatin.

erythromycin: erythromycin significantly increases the side effects of pitavastatin. In patients with erythromycin, do not use Pitavastatin overdose 1 mg/day/day.

Rifampin: Rifampin significantly increases the side effects of pitavastatin. In patients using rifampin, do not use Pitavastatin overdose 2 mg/time/day.

Gemfibrozil: Gemfibrozil increases the side effects of muscle disease/muscle pattern of Pitavastatin. Avoid simultaneous use of pitavastatin with gemfibrozil. Other fibrat blood cholesterol medications: simultaneously use HMG-Coa Reductase inhibitors with other fibrat blood cholesterol medications that may increase the risk of muscle damage. Therefore, be careful when coordinating pitavastatin and these drugs.

Niacin: Side effects on musculoskeletal can increase when using pravastatin in combination with high doses (> 1 g/day), in this case, Pitavastatin dose is reduced.

warfarin: Pitavastatin interacted negligible with R- and S-Warfarin. The drug affects much for prothrombin (PT) time and international standardization ratio (INR) on patients treated with chronic warfarin. However, patients who are using warfarin should be monitored PT and INR in the first stage of treatment with pitavastatin.

HIV's protease inhibitors and hepatitis C: Although the exact mechanism of the interaction is not clear, the simultaneous use of protease inhibitors may increase the effect of pitavastatin, increasing the risk of muscle damage, the most serious is the muscle, kidney damage leads to renal failure and may be fatal. Therefore, pitavastatin should therefore be used for HIV patients who are taking protease inhibitors. Recommendation: When using simultaneously Pitavastatin with protease inhibitors such as Atazanavir, Atazanavir and Ritonavir, Darunavir and Ritonavi, Lopinavir and Ritonavir, unlimited dose of Pitavastatin.

Storage

Store in closed packaging, avoid light, temperature below 30 ° C.

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