Uses of Simze Plus

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1. Uses of the drug Simze Plus

1.1 Indications Simze Plus is indicated for use in the following cases:
Treatment to improve levels of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol, support for nutrition in patients with primary hypercholesterolemia caused by an increase in low-molecular-weight lipoprotein (LDL) cholesterol. In patients at risk for coronary artery disease who do not respond to diet, lower levels of low-density lipoprotein (LDL) cholesterol in patients with both hypercholesterolemia and hypertriglyceridemia. 1.2 How to use - Dosage How to use:
Simze Plus can be taken with or without food and concurrently with statin drugs.
Dosage:
Usual dose: 1 tablet per day, in the evening.
It is recommended to start treatment with the lowest effective dose, then, if necessary, to adjust the dose according to individual needs and response by increasing the dose at intervals of not less than 4 weeks and Adverse drug reactions must be monitored, especially adverse reactions to the muscular system.
Note: The above dosage is for reference only. The specific dose depends on the condition and the progression of the disease. To get the right dose, you need to consult your doctor or healthcare professional.
1.3 Overdose, missed dose and management Overdose:
If an overdose occurs, seek symptomatic and supportive treatment as necessary. Because the drug is strongly bound to plasma proteins, hemodialysis is not expected to significantly increase clearance of simvastatin.
Missed dose:
Add dose as soon as you remember. However, if the interval between the next dose is too short, skip the missed dose and resume the dosing schedule. Do not take a double dose to make up for a missed dose.

2. Notes when using the drug Simze Plus

Before using the drug you need to carefully read the instructions for use and refer to the information below.
Contraindications
Simze Plus is contraindicated in the following cases:
Do not use simvastatin in combination with an HMG - CoA reductase inhibitor in patients with active liver disease or persistent elevation of serum transaminase levels of unknown cause. core. Simvastatin should not be used in combination with strong CYP3A4 inhibitors such as: Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, posaconazole, gemfibrozil, cyclosporin, danazol. The patient is hypersensitive to any component of the drug. Pregnant women, lactating women. Precautions/Precautions for use
Before initiating statin therapy, causes of hypercholesterolemia must be ruled out (eg, poorly controlled diabetes, hypothyroidism, nephrotic syndrome, disorders). protein in the blood, obstructive liver disease, taking some other drugs, alcoholism) and need to measure total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.
Must conduct lipid measurement periodically at intervals of not less than 4 weeks and adjust the dose according to the patient's response to the drug. The goal of treatment is to lower LDL cholesterol so LDL cholesterol levels must be used to initiate treatment and assess response to treatment. Only when LDL cholesterol cannot be tested should total cholesterol be used to monitor treatment.
In clinical trials, a small number of adult patients taking statins experienced marked increases in serum transaminases (>3 times the limit of normal). When the drug is discontinued in these patients, transaminase levels usually fall slowly back to pre-treatment levels. Some of these patients had abnormal liver function test results prior to statin therapy and/or consumed excessive amounts of alcohol.
Therefore, liver enzyme tests should be performed prior to initiating treatment with simvastatin and in cases where clinical indications require testing thereafter. The drug should be used with caution in patients who drink heavily and/or have a history of liver disease.
Consider creatine kinase (CK) monitoring in the following cases:
Before treatment, a CK test should be performed in the following cases: Renal impairment, hypothyroidism, personal or family history hereditary myopathy, history of myopathy due to previous simvastatin or fibrate use, history of liver disease and/or heavy alcohol consumption, elderly patients (>70 years of age) with risk factors for rhabdomyolysis , the possibility of drug interactions and some special patient populations. In these cases, the benefits/risks should be weighed and the patient monitored clinically during treatment with simvastatin. If CK test results are > 5 times the upper limit of normal, treatment with simvastatin should not be initiated. During treatment with simvastatin, patients should be informed of muscle manifestations such as myalgia, muscle stiffness, and weakness. When these symptoms are present, the patient should have a CK test for appropriate interventions. Statin therapy should be discontinued or discontinued in any patient presenting with acute and severe myopathy or predisposing factors for the development of acute renal failure due to rhabdomyolysis, eg, severe acute infection, hypotension. pressure, surgery and major trauma, metabolic, endocrine, electrolyte abnormalities, or uncontrolled seizures.
Simvastatin should only be given to women of childbearing age when they are definitely not pregnant and only in cases of very high blood cholesterol that has not responded to other medications.
Ability to drive and use machines
Not affected.
Pregnancy
Simvastatin reduces the synthesis of cholesterol and possibly many other biologically active substances derived from cholesterol, so the drug can cause harm to the fetus if administered to a pregnant woman. Therefore, simvastatin is contraindicated during pregnancy.
Lactation
Simvastatin is distributed into milk. Because of the potential for serious adverse effects in the nursing infant, simvastatin is contraindicated in nursing mothers.

3. Side effects of the drug Simze Plus

When using Simze Plus, you may experience unwanted effects (ADRs). Common, ADR > 1/100
Digestive system: Diarrhea, abdominal pain, constipation, flatulence. Musculoskeletal system: Back pain, joint pain. Systemic: Cognitive impairment (eg, memory loss, confusion), hyperglycemia, increased HbA1c. Uncommon, 1/1000 < ADR < 1/100
Digestive system: Nausea, pancreatitis, hepatitis. Musculoskeletal system: Myopathy or rhabdomyolysis. Rare, 1/10000 < ADR < 1/1000
Systemic: Hypersensitivity reactions, including angioedema and skin rash, have occurred rarely. Guidelines for the management of ADR
Changes in serum liver enzyme levels usually occur during the first months of treatment with simvastatin . Patients with elevated serum aminotransferase levels should have a second liver function test to confirm the results and monitor treatment until abnormalities return to normal. If AST or ALT (GOT or GPT) serum aminotransferase (transaminase) levels persist above 3 times the upper limit of normal, treatment with simvastatin should be discontinued. Any brain manifestations such as unexplained muscle pain, tenderness, and weakness should be reported immediately, especially if accompanied by malaise or fever. Simvastatin should be discontinued if CPK levels are markedly elevated, above 10 times the upper limit of normal, and if myopathy is diagnosed or suspected.

4. Drug interactions

Increased risk of muscle damage when Simvastatin is used concomitantly with the following drugs: Gemfibrozil, other fibrate-lowering agents, high-dose niacin (> 1 g/day), Colchicine.
Concomitant use of the lipid-lowering drug simvastatin with drugs to treat HIV and hepatitis C virus (HCV) may increase the risk of muscle damage, most seriously rhabdomyolysis, kidney failure leading to failure kidneys and can be fatal.
Avoid using large amounts of grapefruit juice (>1 liter/day).
Do not use more than 10 mg simvastatin/day when used in combination with: Verapamil, diltiazem, dronedarone (the combination of these drugs with simvastatin 20 mg content is contraindicated).
Do not use more than 20mg simvastatin/day when used in combination with: Amiodarone, amlodipine, ranolazine.

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