Dolotin 20mg Domesco medicine supports prophylaxis of coronary artery disease, hypercholesterolemia (1 blister x 10 tablets)

Lovastatin is indicated to slow down the progression of coronary artery atherosclerosis in patients with coronary artery disease as part of the treatment strategy to reduce total cholesterol and LDL-C to the treatment goal.

Hyper cholesterol increases

Lovastatin is appointed to a diet to reduce total cholesterol and LDL-C in patients with primary blood cholesterol hypercasting (type IIA and IIB2), when not fully responded to a diet that restricts saturated fat and cholesterol and other non-drug-free measures.

Adolescent patients with hyperglycemic cholesterol of heterozygous family

Lovastatin is appointed to complement the diet to reduce total cholesterol, LDL -C and Apolipoprotein B in adolescents and girls from 10 to 17 years old have menstrual periods for at least one year, increased cholesterol of heterozygous family, if after a full test of the following diet,

Lovastatin separates HMG-CoA Reductase, a catalyst enzyme that converts HMG-COA into Meovalonate. The conversion of HMG-CoA into Mevalonate is the first step in the body's cholesterol biosynthesis.

Dynamic pharmacokinetics

Lovastatin is a lactone that is easily hydrolyzed in the body to form the corresponding p-hydroxyacid, a strong HMG-CoA Reductase inhibitor.

HMG-CoA Reductase inhibitors are the basis for quantifying b-hydroxyacid metabolites (active inhibitors) in dynamic and base hydrolysis studies later, active and potential inhibitors (all inhibitors) in plasma after drinking lovastatin.

After taking 1 dose of lovastatin associated with C14, 10 % of the dose is excreted in the urine and 83 % excreted in the feces. The second excretory line shows that the drug is absorbed equivalent to the secretion of the bile, just like any absorption drug. The plasma concentration of radioactive substances (the metabolites of lovastatin associated with C14) reaches the peak concentration after 2 hours and rapidly decreases to 10 % of the peak concentration after 24 hours. The average lobastatin absorption is about 30 % of oral dose is estimated to correspond to the comparative intravenous dose, every 4 species of testing animals.

In animal studies, after drinking, lovastatin has a high selective selection for the liver, which achieves significantly higher concentrations than non -targeted tissues. Lovastatin is largely eliminated in the liver, where the main effect of lovastatin, then excreted through bile. Due to the majority of the first elimination in the liver, Lovastatin concentration is active in the general circulation and fluctuations.

In a single -dose study on 4 patients with hypercholesterol blood, lovastatin concentration in the form of activity in the common circulation is less than 5 %.

After taking Lovastatin tablets, the change coefficient, based on the change between individuals, approximately 40 % for the area under the curve (AUC) of the total inhibitor activity in the general circulation.

Caution when using

muscle disease/muscle pepper

Lovastatin, like other HMG-Coa Reductase inhibitors, sometimes cause clear muscle diseases such as muscle pain, muscle weakness with creatin kinase (CK) taller 10 times higher than the upper limit of normal levels (ULN). Muscle disease is sometimes a form of muscle pattern attached or not accompanied by secondary acute renal failure due to myoglobin urine and harmful effects that have occurred. The risk of muscle disease increases when HMG-CAA Reductase inhibitors in plasma are high.

Risk of muscle disease/muscle pilot is related to the dose

There are several rare reports on muscle necrotic diseases (IMNM), an autoimmune muscle disease, related to the use of statin. IMNM is characterized by myastal weakness and increased plasma creatin, even when stopping using statin. The biopsy shows that necrotic muscle disease has no inflammation, this condition is improved by immunosuppressive agents.

All patients who begin to treat lovastatin or patients are increased by lovastatin, should be recommended for the risk of muscle disease and request to report as soon as there is an unexplained muscle pain, special muscle weakness when accompanied by discomfort or fever or if the symptoms and signs last after stopping Lovastatin. Lovastatin should be stopped immediately if detected or suspected of muscle disease. In most cases, the symptoms of the muscle and the increase in CK increase are resolved when stopping treatment. Periodic CK tests in patients who start treatment with lovastatin or patients are increased dose, but cannot guarantee this monitor will completely prevent muscle disease.

Many patients with muscle pattern while treating with lovastatin have had a complex history before, including renal failure as a result of diabetes. These patients need to be closely monitored. Lovastatin should be discontinued if the CPK level increases significantly or suspected or diagnosed with muscle disease. Lovastatin should be temporarily stopped temporarily for any patient who has acute or serious condition leading to the development of secondary renal failure due to muscle pattern such as blood infection, hypotension, invasive surgery, trauma, endocrine disorders, metabolism, or serious electrolytes, uncontrolled epilepsy.

Increased risk of muscle disease/muscle disease when using simultaneously with lovastatin with the following drugs

Strong CYP3A4 inhibitors

Like other HMG-Coa Reductase inhibitors, Lovastatin is the substrate of Cytochrome P450 3A4 (CYP3A4). These metabolic inhibitors can increase lobastatin levels in plasma and increase the risk of muscle disease. These drugs include iTraconazole, Ketoconazole, Posaconazole, Voriconazole, Macrolid antibiotics such as Erythromycin and Clarithromycin, Telithromycin, HIV Protase inhibitors, Boceprevir, Telaprevir, anti -depression drugs such as Nefazodon or other products containing cobicones. Contraindications to combine these drugs with lovastatin. If the short -term treatment with strong CYP3A4 inhibitors is inevitable, it is advisable to postpone treatment with lovastatin during treatment with those drugs.

gemfibrozil

Should avoid combining lovastatin with gemfibrozil.

Other lipids (fibrats or niacin ≥1 g/day)

Be cautious when using fibrats or doses that reduce the lipid of niacin (≥1 g/day) with lovastatin, as these drugs can cause muscle disease when used alone. The benefits of lipid changes when combining lovastatin with fibrat or niacin should be carefully considered with the risks from these combinations.

cyclosporin

Should avoid lovastatin with cyclosporin.

Danazol, Diltiazem, Dronedaron or Verapamil with high doses of lovastatin

Do not use more than 20 mg/day in patients being treated with Danazol, Diltiazem, Droneedaron or Verapamil drugs. The benefits of using lovastatin in patients are using Danazol, Diltiazem, Dronedaron or Verapamil should be carefully considered with the risks from these combinations.

amiodaron

Do not use lovastatin at a dose of 40 mg/day in patients who are using amiodaron, so avoid combining lovastatin at a dose higher than 40 mg/day simultaneously with amiodaron unless there is clinical benefits greater than increased risk of muscle disease. The risk of muscle and muscle disease increases when using amiodaron simultaneously with high doses of drugs in the HMG-CA Reductase inhibitors.

colchicin

Cases of muscle disease, including muscle pepper, have been reported when using Lovastatin at the same time with colchicin and should be cautious when prescribing lovastatin with colchicin.

ranolazin

The risk of muscle disease, including muscle pattern, can be increased when used simultaneously with ranolazin. The adjustment of lovastatin dose can be considered during the treatment process simultaneously with ranolazin.

Liver dysfunction

Continuous increase (more than 3 times the upper limit of normal levels) of plasma transaminase occurs at 1.9 % of adult patients are used at least 1 year in lobastatin in early clinical trials. When using non -continuous drugs or stop taking the drug in these patients, the transaminase level usually decreases slowly before treatment. This increase usually appears from 3 to 12 months after starting with lovastatin treatment and is not related to jaundice or other symptoms or other clinical signs.

Recommended testing of liver enzymes before starting treatment and when signs or symptoms of liver damage occur. All patients treated with lovastatin need advice to promptly report symptoms that can indicate liver damage, including fatigue, anorexia, upper right abdomen, dark urine or jaundice. Should re -check according to clinical indications for later testing requirements.

There are several rare reports on critical and non -critical liver failure in patients using statin, including lovastatin. If the liver damage is serious with clinical symptoms and/or high blood bilirubin or jaundice appears during Lovastatin treatment, immediately stops the treatment process. If there is no other cause, do not reuse lovastatin.

This drug should be used carefully in patients with alcohol and/or a history of liver disease. Contraindicated lovastatin in case of active liver disease or transaminase increase is not explained.

Average hyperplasia (less than 3 times less than normal limits) have been reported after treatment with lovastatin. These changes appeared early after starting treatment with lovastatin, usually temporary, without any symptoms and no need to stop the treatment.

Lovastatin may increase the creatin phosphokinase. This should be considered in the diagnosis of chest pain in patients being treated with lovastatin.

Hyper cholesterol has a family homozygous family: Lovastatin is less effective in patients with hyperchemical hyperglycemia with rare homozygous family, possibly because these patients do not have functional LDL receptors. Lovastatin can increase serum transaminase (see unwanted effects) in these patients.

The drug contains lactose excipients, patients with galactose tolerance problems, patients with lapp lactase enzyme deficit or glucose-galactose abutment should not be used.

Use drugs for women during pregnancy and lactation

Pregnancy

Safety on pregnant women has not been set. Has recorded rare clinical reports on birth defects after exposure to HMG-CoA Reductase inhibitors from the fetus.

However, in an analysis on more than 200 cases of pregnancy exposed to lovastatin or HMG-CoA Reductase inhibitors in the first 3 months of pregnancy, the rate of birth defects can be compared to the rate in the common population.

These cases of pregnancy are enough to eliminate tripled or more in birth defects on the foundation ratio. Treatment with lovastatin in pregnant women can reduce the level of meevalonate, the precursor of cholesterol in the fetal biosynthesis.

Atherosclerosis is a chronic process and stopping the drug that reduces blood lipid during pregnancy often has little impact on the risk of long -term associated with primary cholesterol hypercasting. For these reasons, Lovastatin should not be used for pregnant or pregnant women.

Breastfeeding period

It is unknown whether Lovastatin is excreted in human milk or not. Because the small amount of a drug in this group is excreted through milk and the risk of unwanted reactions is important in newborns, during the time of using Lovastatin should not breastfeed.

The effect of the drug on the ability to drive, operate machinery

The drug can cause unwanted effects such as dizziness, dizziness, abnormalities, mental disorders, anxiety, insomnia, depression. Be careful when used for people who are driving and operating machinery.

Interactive drug

CYP3A4 pills

Lovastatin is metabolized by CYP3A4 but does not have the activity of CYP3A4 inhibitors so it may not affect the plasma concentration of other drugs metabolized through CYP3A4. Strong CYP3A4 inhibitors (such as Itraconazol, Ketoconazole, Posaconazol, Voriconazole, Clarithromycin, Telithromycin, HIV Protease inhibitors, BoCeprevir, Telaprevir, Nefazodon, Erythromycin and drugs containing cobicistat) Lovastatin's elimination.

Blood lipid medications can cause muscle disease when used alone

The risk of muscle disease is also increased by blood lipid medications such as gemfibrozil, other fibrats, niacin (nicotinic acid) (≥1 g/day), these drugs are not strong CYP3A4 inhibitors, but can cause muscle disease when used alone.

Other drug interactions

Avoid simultaneous use and limit of lovastatin dosage when used simultaneously with some drugs that can increase the risk of muscle damage, the most serious is muscle pattern, kidney damage leading to kidney failure and can be fatal:

cyclosporin

Increased risk of muscle and muscle disease when used simultaneously with cyclosporin. Contraindications when coordinating.

Danazol, diltiazem, droneedaron or verapamil

The risk of muscle disease/muscle disease increases when using simultaneously with Danazol, diltiazem, droneedaron or special verapamil with high doses of lovastatin.

amiodaron

The risk of muscle disease/muscle pattern increases when Amiodaron is used simultaneously with HMG-CoA Reductase inhibitors.

Coumarin anticoagulant

In a small clinical trial, Lovastatin is used for patients treated with warfarin, no effect on prothrombin time. However, another HMG-CoA Reductase inhibitor has been found to increase less than two seconds of prothrombin time in healthy volunteers using low doses of warfarin. In addition, bleeding and/or increasing prothrombin time has been reported in a few patients using anticoagulant drugs simultaneously with lovastatin. It is recommended that patients taking anticoagulants, determining prothrombin time before starting lovastatin and regularly during the first treatment to ensure that there is no significant change in prothrombin time. When prothrombin time is stable, prothrombin can be monitored at the commonly recommended for patients with anticoagulant drugs. If the dose changes Lovastatin, the same process is repeated. Treatment with lovastatin is not related to bleeding or with changes during prothrombin in patients without anticoagulants.

colchicin

Cases of muscle disease include muscle pepper, which have been reported when using lovastatin with colchicin. + Ranolazin: The risk of muscle disease including muscle pattern may increase when used simultaneously with ranolazin.

Endocrine function

Increased HBA1C and thrilling blood sugar has been reported with HMG-CoA Reductase inhibitors including lovastatin.

Be cautious if a HMG-Coa Reductase or other drug inhibitors are used to reduce cholesterol levels in patients who are also taking other drugs (such as spironolacton, cimetidine) that can reduce the concentration or activity of endogenous steroid hormones.

Tyeum of drugs

Do not have studies on oral medications, do not mix this drug with other drugs.