Lipanthyl hard capsules 200mg Abbott supplementing diet in triglyceride treatment (2 blisters x 15 tablets)

Dosage form Box of 2 blisters x 15 tablets
Specifications Fenofibrate

Ingredient

Composition information	Content
Fenofibrate	200mg

Uses

Indications

Drugs lipanthyl 200mg are indicated in the following cases:

increased cholesterol and hyperglyceride blood or coordination (blood lipid disorders including blood lipoprotein disorders of IIA, IB, III, IV and V) in patients who do not respond to diet diets and other non -drug treatments (for example: measures to reduce physical activity) According to high blood pressure and smoking.

Secondary blood lipoprotein treatment is also an indication if persistent blood lipoprotein abnormalities, even if the cause (for example: lipid disorders in diabetes).

Diets before taking the drug must continue.

Substances that reduce serum/cholesterol lipids and regulate triglycerides/fibrates.

fenofibrate is a derivative of fibric acid, the substance reported is the effect of changing lipid level in humans through activating peroxisome Proliferator activated receptor type A (PPark). Through the activation of ppara, fenofibrate increases hydrolysis and elimination of triglycerides -rich sub -fertilizers from plasma by activating lipoprotein lipase and reducing the production of apoprotein C - III. The activation of PPark also increases the synthesis of AI and AII apoprotein and AII.

The above starting efficiency for lipoprotein leads to reduction in LDL and VLDL containing apoprotein B and increases HDL containing AI and AII apoprotein. In addition, through the synthesis and catabolic changes of components of the VLDL, Fenofibrate increases LDL clearance and low density LDL reduction, these substances are often high in the forms of atherosclerosis lipoprotein in vascular, a common disorder in patients at risk of coronary heart disease.

There is evidence that Fenofibrate treatment may reduce cardiovascular risk but it has not shown that reducing all primary or secondary deaths of cardiovascular disease.

Treatment with medium fenofibrate 38 months shows a significant reduction in the progression of coronary artery lesions with the criteria of coronary artery quantitative shooting assessment of 40%. The deposits of cholesterol outside the vascular wall (near and yellowing) can be significantly reduced or even eliminated during the treatment process with fenofibrate.

Patients with fibrinogen hyperplasia treated with fenofibrate show significantly reduced this index, and increase the LP (A). The physical expression for inflammation such as C Reactive Protein also decreases when treated with fenofibrate. The effect of Unicosuric on fenofibrate leads to a reduction in uric acid levels by about 25%, which is an additional benefit for patients with blood lipid disorders with hyperuricemia.

Fenofibrate has been shown to have anti -platelet gathering effects in animals and in a clinical study showed a decrease in platelet collection caused by ADP, arachidonic acid and epinephrine.

pharmacokinetic

absorption

Maximum concentration in plasma (cmax) is achieved within 4 to 5 hours after drinking. The plasma concentration is stable during the continuous treatment in all individuals. Fenofibrate increases absorption when taken at meals.

Distribution

Fenofibric acid is strongly attached to plasma albumin (over 99%).

Metabolism

After taken, fenofibrate quickly hydrolyzed by esterase into metabolic active substances that are fenofibric acid. Non -detection of integer fenofibrate in plasma. Fenofibrate is not the substrate of CYP3A4. Not metabolized in the liver microsome.

Elimination

The drug is excreted mainly in urine. The drug is completely eliminated within 6 days. Fenofibrate is excreted mainly in the form of fenofibric acid and glucurono - conjugate.

For elderly patients, plasma clearance with fenofibric acid is constant. Pharmacokinetic studies after taking single doses or long -term treatment have shown that the drug is not accumulated. Fenofibric acid is not excluded when bloody.

Semi -selling time in plasma of fenofibric acid is about 20 hours.

Before taking Lipanthyl hard capsules 200mg Abbott supplementing diet in triglyceride treatment (2 blisters x 15 tablets)

How to use

capsules should be taken at meals.

Dosage

Adults

recommended dose is 200mg per day.

Children

Not yet determined the safety and effectiveness of Fenofibrate with children and teenagers under 18 years old. There is no current data. Therefore, it is not recommended to use fenofibrate with children under 18 years old.

Elderly

For elderly patients, no kidney failure, recommend the usual dosage for adults.

kidney failure

Needs to reduce the dose for patients with renal impairment. In patients with chronic renal failure in moderate level (creatinine clearance from 30 to 60ml/min) and if there is a low content available, start using 1 tablet of 100mg or 67mg micro -granular form once a day. If there is no low content, it is not recommended to use fenofibrate. In patients with chronic kidney disease (creatinine clearance

Hepatic failure

It is not recommended to use lipanthyl 200mg for patients with liver failure due to lack of data.

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?

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 lipanthyl 200mg , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive: stomach disorders , thick muscle -intestinal symptoms and stomach - abdominal pain, vomiting, nausea, diarrhea, flatulence.

Testing: Increasing transaminase, increasing bloodsteine homocysteine levels.

Uncommon, 1/1000

Neurology: headache.

Cardiovascular disease: Tailed (pulmonary veins, deep vein thrombosis).

digestive: pancreatitis .

Skin and tissue subcutaneous: Increase skin sensitivity.

Bone muscles and connective tissue: muscle disorders (for example, muscle, muscle pain, muscle inflammation, bone and bone pain and muscle weakness).

Liver: disease gallstones .

Reproduction: Sexual dysfunction.

Testing: increased blood creatinine.

Rare, 1/10,000

Systemic: allergies.

Blood and lymphatic system: Reducing blood and lymphatic haemoglobin, reducing the number of leukemia.

Hepatitis: hepatitis.

Instructions on how to handle ADR

When experiencing side effects of Lipanthyl 200mg, 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

Lipanthyl 200mg contraindicated drug in the following cases:

Hepatic failure (including cholecystic cirrhosis and unusual liver function is unexplained).

gallbladder disease.

Serious chronic kidney disease.

Children.

Breastfeeding period.

Acute or chronic pancreatitis except in the case of acute pancreatitis due to severe hyperglyceride.

History of allergies to light or toxicity to light when treated with fibrate or ketoprofen.

Hypersensitivity to pharmaceutical substances or any excipients.

Precautions when used

Lipanthyl 200mg drugs do not replace the diet. Need regular medication. Must regularly check blood recipe.

Secondary hyperlipidemia: The cause of secondary hyperlipidemia such as uncontrolled type 2 diabetes, hypothyroidism, nephrotic syndrome, blood protein disorders, obstructive liver disease, are taking medicinal therapy, alcoholism, these conditions should consider thorough treatment before treatment with fenofibrate. For patients with hyperlipidemia that is using estrogen or contraceptive therapies containing estrogen, it should be clearly defined whether hyperlipidemia is primary or secondary (maybe the increased lipid index is due to the drinking of the ocelaton).

Liver function: Like other lipid reducing drugs, increased transaminase concentration has been recorded in some patients. In most cases, this increase is transient, small and asymptomatic. Recommended tracking of transaminase concentration periodically every 3 months in the first 12 months of treatment and periodic treatment.

Be cautious with patients with increased transaminase levels and should stop treatment if AST (SGOT) and ALT (SGPT) concentration increases more than 3 times the upper limit of normal levels. When symptoms show that hepatitis occurs (such as jaundice, itching) and this diagnosis is confirmed by the test, it is advisable to stop using fenofibrate.

Pancreatitis has been recorded in patients using fenofibrate. This shows that failure in patients with serious hyperglyceride blood, this is a direct effect of the drug or the secondary phenomenon caused by biliary tract or mud causes bile duct obstruction.

Mechanical toxicity, including cases of rare muscle, have or not with kidney failure, have been reported when using fenofibrate and other lipids. The incidence of these disorders increases with low blood albumin cases and has a history of kidney failure.

Patients with potential elements of muscle disease or muscle pattern include: over 70 years old, personal history or family with genetic disorders in muscle, kidney failure, hypothyroidism and alcoholism, these can increase the risk of muscle progression. For these patients, careful consideration between benefits and risks when using fenofibrate.

Should suspect muscle toxicity in patients with spreading muscle pain, muscle inflammation, muscle spasms and muscle weakness or increasing CPK significantly (the concentration exceeds 5 times the normal level). In this case, it should be discontinued with fenofibrate.

The risk of muscle toxicity may increase if coordinated with another fibrate or a HMG inhibitor - COA Reductase, especially cases that have been muscle disease. Therefore, fenofibrate combination with HMG - CoA Reductase inhibitors or another fibrate should only be applied to patients with severe mixed blood lipid disorders and high cardiovascular risk without muscle history and need to closely monitor muscle toxic potential.

It is advisable to stop treating in cases where Creatinie index increases> 50% ULN (the upper limit of normal levels). Recommendations measurement of creatinie concentration in the first 3 months from the beginning of treatment and periodically later.

Due to lactose -containing drugs, patients with rare genetic problems are galactose intolerance, Lapp Lactase deficiency or glucose - galactose should not be used.

The ability to drive and operate machinery

has no effect.

Pregnancy

There is no adequate data on the use of fenofibrate in pregnant women. Fenofibrate should only be used after evaluating benefits/ risk.

Breastfeeding period

Contraindications.

Medicinal interaction

Anticoagulant oral drugs: Fenofibrate increases oral anticoagulant effect and can increase the risk of bleeding. It is recommended that the anticoagulant dose is reduced by about a third when it starts treatment and then gradually adjusts if it is necessary to follow the Inr monitoring (international standardization rate). Therefore, this combination is not recommended

ciclosporin: Some cases of severe renal function impaired have been reported when used simultaneously fenofibrate and ciclosporin. Therefore, closely monitor the kidney function of these patients and stop treatment with fenofibrat in case of serious changing test parameters.

HMG inhibitors - CoA Reductase and other fibrats: The risk of serious muscle poisoning increases if fenofibrate is used simultaneously with HMG - COA Reductase or other fibrat inhibitors. Such coordination therapy should be used carefully and the patient is closely monitored on signs of muscle poisoning.

In vitro studies use human liver microsome shows that fenofibrate and fenofibric acid are not the same inhibitor Cytochrome (CYP) P450 CYP3A4, CYP2D6, CYP2E1 or CYP1A2. They are weak inhibitors CYP2C19 and CYP2A6, and CYP2C9 inhibitors from mild to medium at the treatment concentration.

Patients with simultaneous use of fenofibrate and metabolic drugs CYP2C19, CYP2A6, and especially CYP2C9 have a narrow treatment index should be carefully monitored and if necessary, recommend the dose adjustment of these drugs.

Storage

Store lipanthyl 200mg in the original packaging, to avoid moisture. Storage below 30 ° C.

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