Simhasan 10 drugs for hyperchemical hyperglycemia, preventing cardiovascular disease (2 blisters x 15 tablets)

Dosage form Box of 2 blisters x 15 tablets
Specifications Simvastatin

Ingredient

Composition information	Content
Simvastatin	10mg

Uses

indications

Simhasan 10 is indicated in the following cases:

Hyper cholesterol hypertrophy

Treatment of hypercholesterolemia or mixed blood lipid disorders, complementary to improvement therapy or other non -drug treatments (exercise, weight loss) without effective.

Hyper hypercolular hyperglycemia treatment has a family -supplemented homozygous family for improving diet and other lipid treatments (LDL filtration methods) or used in case of inefficient treatments.

Cardiovascular Prevention

Reduce the risk of disease progression and death in patients with normal or high concentration of cholesterol, which is suffering from cardiovascular disease due to symptoms or diabetes, used as a supplementary therapy for other cardiovascular protection methods and to minimize risk factors.

Pharmacokology

Simvastatin belongs to the blood lipid regulating statin group. Statin is also known as Hydroxymethylglutaryl Coenzym inhibitor (HMG - CoA) Reductase because of the competitive inhibitor with HMG - CoA Reductase is the HMG -Coa -coa -converting catalyst into Mevalonic Acid, an early precursor of cholesterol.

HMG inhibitor - CoA Reductase reduces cholesterol synthesis in the liver and reduces the concentration of cholesterol in the cell. This stimulates increased LDL -cholesterol receptors on liver cell membranes, thus increasing LDL clearance from circulation. Statin reduces total cholesterol levels, LDL - C and VLDL - C in plasma. The drug also tends to reduce the concentration of triglycerides and increase HDL - C in plasma.

Statin also has anti - atherosclerosis . Most have proved to slow down the process of progress and/or retreat atherosclerosis and/or carotid arteries. The current mechanism of action is not fully known, but this effect can be independent of the effect of regulating blood lipids.

Hematura effect

Statin lower blood pressure in hypertension and hyperglycemia. The effect of reducing blood pressure may be associated with the restoration of the endothelial disorder caused by stator, activating the endothelium nitric synthetase and reducing plasma aldosteron levels.

Anti -inflammatory effect

In people with hypercholesterolemia, with or without coronary artery disease, the statin may have anti -inflammatory activity. Statin therapy in these patients reduces CRP plasma levels (C - Reactive Protein). CRP concentration also decreases in patients with normal cholesterol with high CRP levels before treatment. Effects for CRP concentration is not correlated with changes in LDL - c. Recent studies show that reducing the CRP levels may reduce the risk of myocardial infarction recurrence or death due to coronary artery causes.

Effect for bones: Statin can increase bone density.

Pharmacokinetics

absorption

Simvastatin quickly absorbed. The absolute bioavailability of simvastatin is below 5%. The peak concentration of simvastatin in plasma is about 1-2 hours after drinking. Food does not affect the absorption process.

Distribution

Simvastatin and metabolites have an activity linking over 95% to plasma proteins. Simvastatin can be through the placenta, distributed into breast milk and through the brain barrier.

Metabolism

After drinking, simvastatin metabolizes strongly in the liver. Simvastatin metabolized by the microsom cytochrom P450 enzyme system, mainly due to isenzyme 3A4 (CYP3A4). The main metabolite of Simvastatin is present in plasma is beta hydroxy acid and 4 other active metabolites.

Elimination

Simvastatin eliminates 13% in urine and 60% through stool within 96 hours.

Before taking Simhasan 10 drugs for hyperchemical hyperglycemia, preventing cardiovascular disease (2 blisters x 15 tablets)

How to use

oral medication, single dose every day in the evening.

Dosage

adults

The usual dose is 5 - 80 mg/day, drink only once in the evening. In case of necessity, adjust the dose after at least 4 weeks to the maximum dose of 80 mg/day, drink once only in the evening. The dose of 80 mg is recommended only in patients with severe hypercholesterol, high risk of cardiovascular complications without achieving lower doses of treatment and when benefits exceeding the risks.

Hyper cholesterol hypertrophy

The starting dose is usually 10 - 20 mg/day, drink only once in the evening. Patients should follow a standard diet of cholesterol and maintain during treatment with simvastatin. In patients, LDL - C (> 45%) should be reduced, starting at a dose of 20 - 40 mg/day, drinking once in the evening. Adjust the dose if necessary.

H increased cholesterol hypertension

Based on the results of a controlled clinical study, the recommended starting dose of simvastatin is 40 mg/day in the evening. In patients using simvastatin simultaneously with loomitapid, simvastatin dose must not exceed 40 mg/day.

Cardiovascular Prevention

The usual dose is 20 - 40 mg/day, only once taken in the evening in patients at higher risk of coronary artery disease ( heart failure congestive, attached or not accompanied by increased blood lipids). Should use the drug simultaneously with improving diet and exercise. Adjust the dose if necessary.

In case of combination of drugs

Do not use simvastatin dose> 10 mg/day when combined with fibrat drugs other than gemfibrozil or fenofibrat, droneedaron.

Do not use simvastatin doses> 20 mg/day when combined with Amiodaron, Amlodipin, Verapamil , Diltiazem, Ranolazin.

In case of simultaneous use with bile acid -connected groups, simvastatin should be taken before 2 hours or after 4 hours when taking the group of bile acid -connected groups.

Dosage in some special clinical subjects

Patients with renal failure

No dose adjustment in patients with medium renal failure. In patients with severe renal failure (creatinine clearance

Elderly

No dose adjustment.

Children and teenagers (10 - 17 years old)

For cases of hypercesting hypotension with heterozygous family properties, the recommended starting dose is 10 mg/day, drink only once in the evening. It is advisable to follow a standard diet that reduces cholesterol before starting to use simvastatin and maintain this diet during treatment.

The recommended dose is 10 - 40 mg/day, the maximum dose is 40 mg/day. Dosage should be concretized on each patient depending on the goals of treatment. In case of necessity, adjust the dose after at least 4 weeks.

Experience used in children before puberty is limited.

There is no research data using simvastatin in children

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?

What to do when forgetting a dose? If the time of remembering is close to the next dose time, skip the forgotten dose and continue taking the next dose as usual. Do not take double dose to compensate for the forgotten dose.

Side Effects

When using Simhasan 10 , you may experience unwanted effects (ADR).

Drug interaction studies are only done in adults.

Rare, 1/10000

Blood and lymphatic system: Anemia .

Mental disorders: Insomnia. central nervous system: headache, paresthesia, dizziness, peripheral neuropathy . digestion: constipation , abdominal pain, flatulence, indigestion, diarrhea, nausea, vomiting, pancreatitis.

Skin and subcutaneous tissue: skin, itching, hair loss .

muscle, bone and connective tissue: muscle disease (including muscle inflammation), muscle pattern attached or not accompanied by acute renal failure , muscle pain, cramps.

Hepatitis: hepatitis/jaundice.

Very rare, ADR

Central nerve: memory impairment.

liver: Hepatic failure leads to death or no death.

Not determined frequency

Central nerve: depression.

Lung and respiratory system: interstitial lung disease.

Ribbed disease, sometimes worse by tendons, immunomodoric necrosis.

Reproduction: erectile dysfunction .

Unwanted effects from research

Increased serum transaminase (Alanin Aminotransferase, Aspartat Aminotransferase, γ - Glutamyl Transpeptidase, alkaline phosphate, increased serum creatin, HBA1C, hyperglycemia, cognitive decline (such as dementia, forgetfulness, memory loss, led ...).

Other undesirable effects have been reported to statin: Sleep disorders , including nightmares; Sexual decline; Diabetes (frequency depends on the presence of risk factors such as hunger blood sugar> 5.6 mmol/liter, BMI> 30 kg/m2, high triglycerides, a history of hypertension).

Children 10 - 17 years old: Long -term impact on intellectual physical and sexual development has not been determined.

Instructions on how to handle ADR

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

Simhasan 10 contraindicated in the following cases:

Hypersensitivity to simvastatin or any ingredients of the drug.

Progressive liver disease or increased serum transaminase for unknown cause.

Pregnant or lactating women.

Simultaneously used with strong CYP3A4 inhibitors such as Itraconazol , ketoconazole, erythromycin, Clarithromycin, Telithromycin, HIV -inhibitors of HIV, Boceprevir, Telaprevir, Nefazodon, Posaconazol, Gemfrozol, GemfiBro, cyclosporin, danazol.

Patients with hypercholesteroline hypercholesterol patients with simultaneous homozygous family use Lomitapid and simvastatin with a dosage> 40 mg/day.

Precautions when using

muscle disease/muscle disease

Simvastatin and other statin medications, which can cause muscle disease, is manifested by muscle pain, muscle weakness with creatin kinase levels (CK) 10 times higher than the upper limit of normal levels. Muscle disease occasionally in the form of muscle pattern or not accompanied by acute secondary renal failure to myoglobinuria and can lead to death, although very rare. The risk of muscle disease increases according to the activity concentration of statin in plasma.

Higher risk in patients using simvastatin 80 mg when compared to some other statins than the same effect as LDL - c. Therefore, only 80 mg simvastatin should be used in patients with severe hypertonic hypertonic hypertonic and higher risk of cardiovascular complications without achieving treatment goals when using lower doses and when benefits are more than risk. In patients who are using 80 mg simvastatin that need to use another drug that causes other interactions, can be used lower doses or replaced with another statin with drug interactions - less drugs.

Consider monitoring Creatin Kinase in case of

Before treatment, Creatin Kinase test should be conducted in the following cases: impaired renal function, hypothyroidism, self -history or a history of genetic family diseases, a history of muscle disease due to the use of statin or fibrat before, the history of liver disease and/or drinking alcohol, elderly patients (> 65 years old) have special risks of medication and some patients with some patients with drugs and some patients. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with statin. If the results of Creatin Kinase> 5 times the upper limit of the normal level, do not start treatment with simvastatin.

During simvastatin 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 test Creatin Kinase for appropriate interventions.

Exzy liver test before starting treatment with simvastatin and in case of clinical indications for testing later.

The function of decreasing transport protein: The function of organic anion transport protein (OATP) decreases, increasing the level of systemic exposure to simvastatin, increasing the risk of muscle diseases and muscle pattern. The function of decreased shipping protein may occur due to inhibition by interactive drugs or in patients with genotypes of SLCO1B1 C.521T> c.

Measures to reduce the risk of muscle disease associated with simvastatin and other drugs

With strong CYP3A4 inhibitors, simultaneously using simvastatin with iTraconazol, ketoconazole , erythromycin, Clarithromycin, Telithromycin, HIV Protease inhibitors, Boceprevir, Telaprevir, Nefazodon, Posaconazol, Voricolazol Dinh. If treated with strong CYP3A4 inhibitors (increasing AUC> 5 times), simvastatin must be stopped during treatment. Be careful when combining simvastatin with less powerful CYP3A4 inhibitors (fluconazole, verapamil, diltiazem). Avoid using grapefruit juice simultaneously with simvastatin.

Contraindicated using simvastatin with gemfibrozil. Because of the increased risk of muscle disease and muscle pattern, the dosage of simvastatin should not exceed 10 mg/day in patients using simultaneously with fibrat groups, in addition to fenofibrat. Be cautious when using simvastatin with fenofibrat because each drug can cause muscle disease when used individually.

Simvastatin is not used in combination with fusidic acid. There have been reports on cases of muscle pattern (can die) in patients with drug coordination. If needed to be treated with fusidic acid, simvastatin is needed. Patients should be closely monitored if there are muscle weaknesses, muscle pain. Statin therapy may start again 7 days after the end of the dose of fusidic acid. In special cases, when using prolonged fusidic acid to treat severe infections, combination of fusidic acid with simvastatin should be considered depending on the case and the patient should be closely monitored.

Avoid using simvastatin doses> 20 mg/day with amiodaron, amlodipine, verapamil, diltiazem, ranolazin.

Simvastatin simultaneous use (especially high doses) with average CYP3A4 inhibitors (increase AUC 2-5 times) increases the risk of muscle disease. Simvastatin dose is needed, a maximum dose of 20 mg/day (for example, in combination with diltiazem).

Cases of rare muscle/muscle diseases related to the use of HMG - Coa Reductase inhibitors with high doses (> 1 g/day). Each drug can cause muscle disease when used individually. Doctors need to consider the benefits and risks when using combination of drugs and monitor patients closely with symptoms of muscle pain, muscle weakness, soft muscle, especially in the first month of treatment and when increasing the dose.

Patients with diabetes: There is evidence that the statin group may increase blood sugar levels in some patients. However, the benefits of reducing the risk of simvastatin's blood vessels beyond the risk of hyperglycemia, so do not stop treating with statin. Patients with risk (hungry blood sugar from 5.6 - 6.9 mmol/liter, BMI> 30 kg/m2, high triglycerides, hypertension) should be carefully monitored.

Interstitial lung disease: Some cases of interstitial lung disease have been reported due to statin use, including simvastatin, especially for long -term treatment. Some symptoms can be seen such as difficulty breathing, coughing without sputum, reducing general health (fatigue, weight loss, fever). Stop treatment with statin if a patient is suspected of interstitial lung disease.

Children: Simvastatin's safety and effectiveness is only assessed in children 10-17 years old, hyperlestoly blood cholesterol has a heterozygous family. No research when using simvastatin in children

Simhasan preparations contain lactose, should not be used in patients with rare genetic disorders in galactose intolerance, lactase deficiency or glucose - galactose absorption disorders.

The ability to drive and operate machinery

Simvastatin does not significantly affect the ability to drive, operate machinery, work on high or other cases. However, it should still be cautious because there is a report on dizziness.

Pregnancy

Contraindicated use of simvastatin in pregnant women.

Safety in pregnant women has not been established. Although there is no evidence of birth defects in infants whose mothers use simvastatin or HMG - CoA inhibitors, but treatment with simvastatin can reduce the level of meevalonate - a precursor to synthesize cholesterol in the fetus.

Atherosclerosis is a chronic process, stopping the use of drugs that reduce blood lipids during pregnancy only affects the risk of long -term with anti -cholesterol disease. Therefore, simvastatin should not be used in pregnant women, planning to get pregnant or think that they are pregnant.

The period of breastfeeding. Because many drugs can pass breast milk and cause serious unwanted effects, the mother is using simvastatin not breastfeeding.

Drug interaction

Itraconazole, ketoconazole, erythromycin, Clarithromycin, Telithromycin, HIV's Protease inhibitors, BoCeprevir, Telaprevir, Nefazodon, Posaconazol, Gemfibrozil, Cyclosporin, Danazol, Verapamil, Verapamil, Verapamil, Verapamil Amiodaron, Diltiazem: simultaneously using simvastatin with these drugs increases the risk of muscle disease and muscle disease.

Oral anticoagulant ( warfarin ): In two clinical studies on healthy volunteers and patients with cholesterol, Simvastatin at a dose of 20-40 mg/day, increasing the effect of anticoagulant drugs. Patients who are taking anticoagulant drugs should be determined before prothrombin before starting treatment with simvastatin and regularly in the early stages of treatment to ensure the change of prothrombin time is not significant.

Once stable, prothrombin time can be tested in patients with anticoagulants of Coumarin group. If the dose changes or stop treatment with simvastatin, this process should be repeated. Treatment regime with simvastatin is not related to bleeding or changes in prothrombin in patients without anticoagulants.

gemfibrozil , other fibrat blood cholesterol medications, high doses (> 1 g/day): Increased risk of muscle damage when using simvastatin simultaneously with these drugs.

Colchicin: There have been reports on cases of muscle disease and muscle pattern when using Colchicin and simvastatin in patients with impaired renal function. Patients should be closely monitored when combining drugs.

Fusidic acid: Increases the risk of muscle disease when using fusidic acid simultaneously with statin medications, including simvastatin. Treatment with simvastatin may be considered. If combined, patients need to be closely monitored.

HIV and hepatitis C (HCV): simultaneous use of simvastatin with these drugs may increase the risk of muscle damage, the most serious is muscle pattern, kidney damage leading to kidney failure and can be fatal.

Grapefruit juice: Avoid using grapefruit juice during the time of drinking simvastatin (> 1 liter/day).

Storage

In a dry place, under 30 ° C, avoid light.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.