Savi Gemfibrozil 600 medicine for treating dyslipidemia (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Gemfibrozil

Ingredient

Composition information	Content
Gemfibrozil	600mg

Uses

Indication

Savi Gemfibrozil 600 is a drug that supports dieters and weight loss practitioners in the following cases:

Increased severe severe triglycerides with or not reducing HDL cholesterol. Lipoprotein: Lipoprotein is not high) and people with high risk of cardiovascular events that are contraindicated or in tolerance with statins.

Drugs: Fibrat lipid lowering drugs

Gemfibrozil is an anti -lipid -anti -lipid drug. Gemfibrozil reduces the level of lipoprotein rich in triglycerides such as VLDL (Very Low Density Lipoprotein: Lipoprotein is very low), slightly increasing HDL level (high density lipoprotein: high density lipoprotein) and has different effects on LDL (Low Density Lipoprotein: Lipoprotein: Effects on VLDL concentration may be mainly due to increased activity of lipoprotein lipase, especially in muscles, leading to increased triglyceride hydrolysis in VLDL and increased catabolic VLDL. Gemfibrozil reduces acid reception and inhibits VLDL in the liver. Gemfibrozil also changes the composition of VLDL by reducing the production of APOC - III in the liver, which is the active inhibitor of lipoprotein lipase and also reduces the synthesis of triglycerides in VLDL in the liver.

Along with the effect on blood lipids, Gemfibrozil also has the effect of reducing platelet aggregation, so it reduces the risk of cardiovascular disease.

The effect of gemfibrozil on lipoprotein levels depends on the increase or no increase in the initial blood lipoprotein. APOE2/APOE2 homozygous blood lipiders respond to the best response to Gemfibrozil therapy. High concentrations of triglycerides and cholesterol may decrease sharply, yellow tumors with multiple lumps and gold tumors can be completely reduced. The drug has a good effect on angina and recovery.

Gemfibrozil therapy in mild hyperlage hyperemia (for example, triglyceride

Pharmacokinetics

absorption

Gemfibrozil is absorbed quickly and much (bioavailable: 98 ± 1%) when taken before meals. Food less affecting the bioavailability of the drug. The drug reaches the top concentration of plasma within 1-2 hours.

Distribution

more than 97% Gemfibrozil is attached to plasma proteins. The drug is wide and the drug concentration in the liver, kidneys and intestines is higher than the plasma concentration. The voltage distribution in saturation state is 9 - 13 liters.

Metabolism

gemfibrozil is mainly oxidized into metabolites in the form of hydroxymethyl and carboxyl, these substances have lower activity than gemfibrozil and waste time is 20 hours. The combination of Gemfibrozil-1-O-β-Glucuronid is another important emissions of Gemfibrozil in humans.

The enzymes involved in gemfibrozil metabolism are not known. Gemfibrozil's drug interaction data and its metabolites are complicated. In vivo and in vitro studies show that Gemfibrozil inhibits CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1, UGTA3 and OATP1B1. Gemfibrozil-β-Glucuronid also inhibits CYP2C8 and OATP1B1.

Elimination

70% of oral dose is excreted in the urine, mainly in the form of a combination and the metabolites of gemfibrozil, less than 6% of the doses of oral excretion through the urine in the form of unchanged, 6% of oral dose found in the feces. The total clearance of gemfibrozil from 100 - 160 ml/min, the sale time is from 1.3 to 1.5 hours. Pharmacokinetics of linear drug with dosage.

Special subjects

Hepatic failure: There is no pharmacokinetic study of the drug in the liver failure.

Before taking Savi Gemfibrozil 600 medicine for treating dyslipidemia (6 blisters x 10 tablets)

How to use

Take oral, take medicine for 30 minutes before breakfast or dinner. Swallow of pills with water, do not chew, suck or grind. Before treatment with gemfibrozil, if the patient has problems such as hypothyroidism, diabetes, it is necessary to be best controlled as possible. In addition, it is necessary to maintain a low lipid diet during medication.

Dosage

Adults:

Dosage from 900 - 1200 mg/day.

Children: There is no complete research data, so they do not use gemfibrozil for children.

Renal failure: People with mild to moderate renal failure should be started to start the dose of 900 mg/day and must assess the kidney function before increasing the dose. Do not use gemfibrozil for people with severe kidney failure (glomerular filtration level ≤ 30 ml/min/1.73m2).

Hepatic failure: Do not use gemfibrozil for liver failure.

What to do when overdose?

Extracting Gemfibrozil overdose includes symptomatic and supportive treatment. In case of gemfibrozil overdose, the stomach must be cleaned immediately by causing vomiting or gastric lavage.

What to do when you forget 1 dose? Ignore the forgotten dose and take the next dose as usual. Do not take double the dose to compensate for the forgotten dose.

Side Effects

cases must immediately notify the doctor

Rare (can affect 1/1000 people)

Allergic reactions, which can start from sore throat, tongue, face that causes shortness of breath (angioedema). ADR The common ADR of Gemfibrozil occurs on the gastrointestinal tract but often does not lead to stopping medication.

The unwanted effect of Gemfibrozil classes the frequency that occurs as follows:

Very common, ADR ≥ 1/10

Gastrointestinal disorders: indigestion.

Nervous and mental disorders: dizziness, headache.

cardiovascular disorders: Atrial fibrillation.

Blood disorders and lymphatic systems: Bone marrow failure, severe anemia, thrombocytopenia, leukopenia, Eosin leukemia. Management. Van, muscle disease, muscle inflammation, muscle weakness, epidemic inflammation, muscle pain, joint pain, pain.

Warnings

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

Contraindicated

Savi Gemfibrozil 600 contraindications in the following cases:

Hypersensitivity to Gamfibrozil or any ingredients of the drug. Fibrat.

Caution when using

muscle disorders (muscle disease, muscle pepper)

There have been data, muscle disease and significantly increased CPK (Creatin Phosphokinase) concentration related to Gemfibrozil. Rarely occur in the pattern.

Muscle lesions must be considered in patients with signs of spreading muscle pain and/or CPK> 5 times the permitted limit, in this case, should stop using Gemfibrozil.

HMG-CoA Reductase inhibitors (3-Hydroxy-3-Methyl-Glutaryl-Coenzyme A Reductase)

Serious muscleitis occurred with significant increase in CK (Creatin Kinase) and Myoglobin Urine when used simultaneously Gemfibrozil with HMG-CoA Reductase inhibitors. Only use this combination to control blood lipids when the benefits are far beyond the risk of muscle disease, muscle pilot and acute renal failure.

Must monitor CPK concentration when starting to use this combination for subjects at risk of muscle pattern such as: kidney failure, hypothyroidism, alcoholism, over 70 years old, genetic muscle disorders, used to be toxicity on the muscle when using fibrats or HMG-CA inhibitors.

People with gallstones

Gemfibrozil increases the secretion of cholesterol into bile, thus increasing the risk of gallstones. If gallstones are suspected, they must conduct a gallbladder test and in case of detection of stones, gemfibrozil is stopped.

monitor serum lipid

Periodically check serum lipids during the use of gemfibrozil. After 3 months of treatment without responding well to the drug, it is advisable to consider changing treatment therapy.

monitor liver function

Gemfibrozil treatment can increase ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Alkalin Phosphatase, LDH (Lactate Dehydrogenase), CK and Bilirubin. However, when stopping the drug, these indicators will return to normal. Therefore, it is necessary to monitor liver function regularly and stop taking the drug if the liver function abnormal occurs.

Monitor the number of blood cells

Periodically check the number of blood cells during the first 12 months when using Gemfibrozil. Anemia occurred, leukopenia, thrombocytopenia, eosin cells, bone marrow failure when using gemfibrozil.

Interact with other drugs (See also the interaction, cavalry of the drug)

The effect of the drug on driving and operating machinery

There has been no study of the effect of the drug on the ability to drive and operate machinery. However, the drug has an unwanted effect that causes dizziness, dizziness, reducing vision and can affect the ability to drive and operate machinery.

Use drugs for women during pregnancy and lactation

Pregnant women

There is no full research on the use of gemfibrozil for pregnant women. Animal research is unclear to conclude the effects of gemfibrozil on the fetus. Due to the risk of toxicity in unknown people, Gemfibrozil does not use during pregnancy.

breastfeeding women

It is not known whether Gemfibrozil will be distributed into human milk or not. Because Gemfibrozil has the potential to cause serious unwanted effects on breastfeeding, avoid breastfeeding.

Interactive drug

HMG-CAA Reductase inhibitors

Concentrated with Gemfibrozil may increase the risk of muscle pattern. Muscle disease and muscle pattern have or not accompanied by acute renal failure in the first 3 weeks or months after starting this combination. Periodic monitoring CK concentration does not prevent severe muscle disease or kidney damage.

anticoagulants

Be cautious when used simultaneously with Gemfibrozil. Warfarin dose should be reduced to maintain prothrombin time at the prescribed level and prevent bleeding. Need to monitor periodically and ensure prothrombin time at a stable level.

substrate of CYP2C8 (CYP: cytochrom2c8)

Gemfibrozil inhibits CYP2C8 and can increase the concentration of metabolic drugs through CYP2C8 (e.g. Dabrafenib, Loperamid, Montelukast, Paclitaxel, Pioglitazon, Rosiglitazon). Therefore, when combining gemfibrozil with major metabolic drugs through CYP2C8, the dose of these drugs must be reduced.

Repaglinid: simultaneously used with gemfibrozil increases AUC (Area under the curve) and repaglinid's CMAX. People who are using gemfibrozil are not used repaglinid and vice versa, because this combination can increase and prolong the hypoglycemia of the blood glucose of repaglinid. Contraindicated combination of these 2 drugs.

The substrate of OPTP-1B1 (Organic Anion Transporting Polypeptide-181)

gemfibrozil inhibits OPTP-1B1 and may increase the concentration of the drugs that are the substrate of oaptp-1b1 (for example, Atrasentan, Atorvastatin, Bosentan, Ezetimib, Fluvastatin, Glybid, active metabolites of Irinotecan, Rosuvastatin, Pitavastatin, Rifampin, RIFAMPIN, RIFAMPIN, RIFAMPIN, RIFAMPIN, RIFAMPIN, RIFAMPIN, RIFAMPIN Valsartan, Olmesartan). Therefore, it is necessary to reduce the dose of these drugs when combined with Gemfibrozil.

In vitro research of CYP enzyme, enzyme UGT (Uridine 5'-Diphospha Glucuronosyltransferase) and OAPTP-181

Gemfibrozil inhibits CYP2C9, CYP2C19, CYP1A2, OATP-1B1, UGT-1A1, UGT-1A3, Gemfibrozil's metabolism is Gemfibrozil 1-β-glucuronid also inhibit OATP1-B1.

Bile acid -mounted plastic

Gemfibrozil's AUC value decreased by 30% when combined with bile acid -mounted plastic (for example, 5G dose Colestipol). Therefore, these two drugs should be used for 2 hours or more.

colchicin

Increased risk of muscle driving when used in combination with gemfibrozil with Colchicin. Be cautious when using this combination in the elderly and people with impaired renal function.

Tyeum of drugs

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Storage

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

To be out of reach of children, read the user manual carefully before use.

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