TominFast 40mg Extra medicine to prevent coronary artery disease (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Simvastatin

Ingredient

Composition information	Content
Simvastatin	40mg

Uses

Indications

TominFast 40 mg is indicated in the following cases:

Preventing coronary artery disease

In coronary artery disease, there is an increased cholesterol - blood, when there is no satisfactory response to the diet:

Reduce the rate of mortality and cardiovascular disease in patients with symptoms of cardiovascular disease with atherosclerosis.

Reduce the risk of stroke and ischemia.

Reduce the risk of complications in myocardial surgery (northern coronary circuit, shaping throughout the vein and piercing skin).

Prevent the progression of atherosclerosis, reducing the risk of damage and new obstruction.

Hyper cholesterol - blood, lipid -hyperplasia

In case of increased cholesterol-primary blood, to reduce total cholesterol levels, high amounts of ldl-cholesterol and high amount of triglycerides, increase HDL-cholesterol, besides compliance with diet.

Treatment of hypercholesterol - blood with family factors and heterozygous, or increased lipid - combined blood when not fully responding to the diet and with other pharmaceuticals.

Pharmacology

Group of pharmacological effects: drugs that reduce cholesterol and triglycerides.

ATC group: C10A A01.

Simvastatin active ingredient is a synthetic substance derived from the fermentation products of Aspergillus Terreus.

After drinking, simvastatin, a non-activity lactone, is hydrolyzed for beta-hydroxy acid active. This main metabolic of simvastatin inhibits HMG-COA Reductase (3-Hydroxy-3- Methylglutaryl-Coenzyme A). This enzyme catalyzes the first phase of cholesterol biosynthesis and the speed limit of the whole reaction.

In clinical studies, Simvastatin reduces total cholesterol in plasma, reduces LDL and VLDL cholesterol, slightly increases HDL cholesterol, thus reducing total/HDL cholesterol ratio and LDL/HDL ratio. Although cholesterol is the precursor of all steroid hormones, Simvastatin does not see clinically influenced by the creation of steroids.

In a multi -centered random study that lasted for 5.5 years, there was a restraint with placebo in patients with coronary artery disease (serum cholesterol concentration in the serum in the range of 5.5 - 8.0 mmol/l), Simvastatin dose of 20 - 40 mg/day reduces the risk of death of 30%, reducing the risk of death due to coronary coronary artery 42%.

Simvastatin also reduces 37% of the risk of complications in blood vessels regenerating interventions in the coronary artery. In addition, in diabetes, the drug reduces the risk of severe complications in the coronary complications.

Clinical safety data

LD50 value of simvastatin in mice is about 3.8 g/kg of weight, in mice is about 5 g/kg weight.

Maximum doses in rats and rabbits do not cause fetal defects and do not affect the ability to conceive, reproduce and on the development of birth.

Dynamic pharmacokinetics

Maximum plasma concentrations of active inhibitors occur about 1.3 - 2.4 hours after drinking. When suffering from severe kidney failure, this time is twice as long as it is.

In the liver, where the drug is mainly used, Simvastatin has a much higher concentration than other tissues.

It can be seen that the effect of the effect "first passes the liver". The drug is excreted through the bile, less than 5% of the dose of the drug is taken to the circulatory system. The drug is highly capable of attaching to plasma proteins (95%).

Before taking TominFast 40mg Extra medicine to prevent coronary artery disease (3 blisters x 10 tablets)

How to use

Take oral use.

For statin medications (including TominFast), it is advisable to start treatment with the lowest dose that the drug works. Then if necessary, the dose can be adjusted according to the needs and response of each person by increasing the dose of each batch of no less than 4 weeks apart. Besides, it is necessary to monitor the harmful reactions of the drug, especially the harmful reactions to the muscle system.

When using TominFast in combination with Amiodarone, Amlodipin, Ranolazine should not take this medication.

Do not use this drug when used in combination with Verapamil, Diltiazem, Dronedarone.

Patients must follow some conventional diets to reduce cholesterol before starting to treat TominFast and continue to follow that diet while using TominFast.

Recommendation: Do not use this drug for children under 18 years old.

Dosage

The usual dose is from 5 - 80 mg/day in the evening. If the dosage is needed, the adjustments must be 4 weeks apart. The maximum dose of the day is 80 mg (2 capsules), taken once in the evening.

Hych cholesterol-blood

For patients who need to reduce LDL-C deep reduction (over 45%), the starting dose is 10-20 mg/day. In patients, more than 45% LDL should be reduced, may start 20 - 40 mg/day orally orally in the evening. If the dosage is needed, the adjustments must be 4 weeks apart. The dosage after the adjustment is taken once in the evening.

The only dose of 80 mg/day (2 capsules/day) only in the evening is proposed in patients with severe hypercholesterol blood ganglers and higher risk of cardiovascular complications but failed to achieve lower dose treatment goals; And when the benefits are expected to be greater than the potential risks.

Hypersensitivity to homozygous family type

The starting dose of 40 mg/day single in the evening.

Prevention of cardiovascular complications

Normal dose 40 mg/day, single dose in the evening in patients with high risk of coronary artery disease. Drug treatment can be started simultaneously with diet and exercise.

Coordination treatment

Simvastatin is effective when used alone or in combination with bile acid medications. Simvastatin should be used for more than 2 hours or after more than 4 hours compared to the time of using bile acid.

Patients with immunosuppressive treatment (cyclosporine, fibrate, niacin) recommend not to use this drug.

Renal function

Vi Simvastatin is not much discharged through the kidneys, so it is generally not necessary to reduce the dose when the patient has medium renal failure.

In patients with severe renal failure (creatinine clearance below 30 ml/minute), careful consideration when taking this medication.

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? No patients have specific symptoms, and all patients recover without sequelae. In case of overdose, general therapy must be applied and monitor liver function.

What to do when forgetting a 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

Adults

rarely

Blood disorders and lymphatic system: Anemia Hair. 0.02%).

Very rare

Mental disorders: Insomnia.

depression.

interstitial pneumonia. Lupus -like vessels and syndrome, muscle pain caused by rheumatism, muscleitis, vasculitis, thrombocytopenia, eosin leukemia, ESR increase, arthritis and joint pain, urticaria, light sensitivity, fever, redness, shortness of breath and discomfort.

Rare: increased serum transaminase (alanine aminotransferase, aspartate aminotransferase, glutamyl transpeptidase), increased alkaline phosphatase; Increased serum ck concentration.

Increased serum glucose levels when fasting and increasing HBA1C has been reported to statins, including simvastatin.

There have been a number of reports after bringing the drug to the market with unexpected effects of cognitive impairment (for example: dementia, forgetting memory loss, confused) related to the use of statin, including simvastatin. The reports are generally not serious, and can recover when the statin stops.

The following unwanted effects have been reported to some statins:

Sleep disorders, including nightmares.

Sexual dysfunction. I

In a 48 -week study related to children and teenagers from 10 to 17 years old with heterozygic blood cholesterol disease (n = 175), the safety and tolerance of the group treated with simvastatin is generally similar to the placebo group. Long -term influence on physical, intellectual and sexual maturity is not well known because there is no enough data.

Warnings

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

Contraindicated

TominFast 40 mg is contraindicated for the following cases:

Hypersensitivity to simvastatin or any excipients. Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin; Protease inhibitors of HIV, Boceprevir, Telaprevir, Nefazodone, Posaconazol, Gemfibrozil, Cyclosporin, Danazol.

Be cautious when using

influence the muscle

Simvastatin and other HMG-COA Reductase inhibitors sometimes cause muscle diseases, manifested through muscle pain or muscle weakness whether or not accompanied by an increase in creatine phosphokinase (CPK) (10 times more than the upper limit of normal value). Rarely occur muscle pattern, whether or not with secondary acute renal failure after myoglobin-di.

Mechanical disease due to interaction between drugs

There is an increase in the rate and severity of muscle disease when using HMG-Coa Reductase inhibitors at the same time with pharmaceuticals that can cause muscle disease alone, such as gemfibrozil and other fibrate drugs, and niacin (nicotinic acid) at lipid reduction dose (> 1 g/day), colchicine.

Simvastatin and other drugs inhibit the HMG-COA Reductase enzyme are metabolized by the cytochrom P450 system. Some drugs at the dose of treatment can significantly increase the plasma concentration of HMG-CA Reductase inhibitors and thus increase the risk of muscle disease. These drugs include cyclosporin, otraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors.

Reduce the risk of muscle disease

General measures:

Patients who start using simvastatin must be reminded of the risk of muscle disease and must quickly report when muscles have pain, pain, or weakness without explaining the cause. A higher CPK increase in a patient with unexplained symptoms in the muscle proves to have muscle disease. Simvastatin must be discontinued if there is or suspected muscle disease. In most cases, muscle symptoms and increased CPK will end up when quickly stopping the drug.

In patients with the previous kidney failure, often the consequence of prolonged diabetes must be cautious when increasing the dose. Simvastatin must be discontinued a few days before having a large surgery selected and when there is a serious and acute medical or surgical disease.

Measures to reduce the risk of muscle disease due to pharmacological interactions:

When combined treatment has a simvastatin or any medication, it is necessary to consider benefits.

Must carefully monitor the signs and symptoms of muscle pain, even pain or muscle weakness, especially in the first months of treatment and during the increased dose of the drugs.

Do not combine simvastatin with fibrate or nicotinic acid.

Simvastatin combination with other fibrate drugs or nicotinic acids must be monitored very carefully.

If it is required to use these drugs with simvastatin, clinical experience shows that the risk of muscle disease will be less than niacin compared to fibrates.

Avoid using large amounts of grapefruit juice (grapefruite juice) (> 1 liter day).

Unbelievable with cyclosporine, fibrate or nicotinic acids

Contraindicated to use simvastatin at the same time with iTraconazole, ketoconazole, erythromycin, Clarithromycin, HIV protease inhibitors. If there is no other way that must be used for a short day Itraconazole, Ketoconazole, erythromycin, Clarithromycin, Simvastatin can stop short -term because there is no bad consequences when long -term treatment to reduce cholesterol is stopped for a short time.

Recommended the liver enzyme test before starting statin treatment and in the case of clinical indications for testing later.

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 diseases, a history of muscle disease due to the use of statin or fibrat before, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) have muscle risk factors, possibly abundant drugs and some compliance with drug interactive human beings and some abundance of drugs and some cases of drug interaction and some complaints and drugs. special.

In these cases, risk benefits should be considered and monitor patients clinically when treated with statin. If CK tests> 5 times the upper limit of normal levels, do not start statin treatment.

During statin 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 CK to take appropriate interventions

influence on vision

In clinical studies, the harmful effects of simvastatin do not see long -term use.

Children under 18 years old

Do not use simvastatin because there is no clinical evidence of the safety and effectiveness of the drug.

Elderly

The effect of simvastatin in patients over 65 years old is similar to other adult patients and the ratio of side effects will not increase.

Consider when using TominFast with patients with risk factors leading to muscle damage. The statin is at risk of harmful reactions to muscle systems such as muscle atrophy, muscle inflammation, especially for patients with risk factors such as patients over 65 years old, patients with untreated thyroid diseases, patients with kidney disease. Need to closely monitor the harmful reactions during drug use.

Excipients

In each film bag contains 245.80 mg of lactose (40 mg tablets). Patients with rare genetic diseases in tolerance of galactose, deficiency of lactase enzymes or Glucose - Galactose are not used this drug.

The ability to drive and operate machinery

In the recommended dose, Simvastatin has no effect or negligible effect on driving and operating machinery.

Pregnancy

Contraindicated use of simvastatin during pregnancy.

can only use drugs for women in the childbirth age when there are appropriate contraception.

If a patient is pregnant while using simvastatin, it is necessary to stop treatment and notify the patient the side effects that may be caused by the drug on the fetus.

There are several reports on birth defects when exposed to the uterus with HMG-CoA Reductase inhibitors. In these cases, the rate of birth defects, natural miscarriage and pregnancy or death is not higher than the common ratio.

The period of breastfeeding

There is no data on simvastatin excretion and the derivatives of the drug in breast milk, so the simvastatin should not be used during breastfeeding.

If using the drug is inevitable, you must stop breastfeeding.

Drug interaction

Pharmacological interactions

Interacts with blood lipid medications, which can cause muscle disease when used alone.

Increase the risk of muscle damage when using statin simultaneously with the following drugs:

gemfibrozil.

Other fibrat blood cholesterol medications.

High doses (> 1 g/day). colchicine.

Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leading to kidney failure and may be fatal.

Dynamic interactions

gemfibrozil and other fibrate drugs, niacin (nicotinic acid) at the dose reduces lipid in plasma (1 g/day): When these drugs are used simultaneously with simvastatin, there is a risk of muscle disease and must avoid it at the same time.

ciclosporin, ketoconazole, otraconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone may increase the risk of muscle disease due to increased plasma concentrations when treated with simvastatin.

Coumarin derivatives: Simvastatin moderate moderate effects on anticoagulants, which increases prothrombin time, called International Normalensive Ratio (INR). In patients treated with cooumarin derivatives, prothrombin must be measured before starting Simvastatin treatment and frequent when starting treatment to ensure that prothrombin time has not changed much. If there is a change of simvastatin dose, it is necessary to repeat the above processes.

digoxin: using simvastatin and digoxin at the same time will slightly increase the concentration of digoxin in plasma.

Amiodaron: There is an increased risk of muscle disease and muscle pattern when using simultaneously amiodarone with high -dose simvastatin. In a clinical trial, 6% of patients with muscle disease use simvastatin 80 mg and amiodarone. Using TominFast along with CYP3A4 inhibitors may increase the concentration of simvastatin in plasma, leading to an increased risk of muscle and muscle disease. Therefore, should not be used simultaneously with amiodarone.

Storage

Store in a cool dry place, avoid light, temperature below 30⁰C.

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