Indications:
- Therapy with "lipid-altering agent" can be considered its use in individuals who are at increased risk of vascular atherosclerosis caused by hypercholesterolemia.
- Therapy with "lipid-altering agent" is the data supporting a strict diet, when response to diet and non-pharmacological treatment of other single inadequate.
- Coronary heart disease
In patients with coronary heart disease and hypercholesterolemia, simvastatin is indicated for:
- Reducing the risk of total mortality by reducing deaths from coronary heart disease.
- Reducing the risk of non-fatal myocardial ifark.
- Reducing the risk in patients undergoing myocardial revascularization procedures.
- Hypercholesterolemia
Lowering total and LDL cholesterol levels in patients with primary hypercholesterolemia (Type lla and LLB).
Contra Indications:
- Hypersensitivity to simvastatin or drug component.
- Active liver disease or elevated serum transaminase that persist are not clear why.
- Pregnant women and nursing mothers.
Composition:
Simvastatin 5 mg
Each film coated tablet contains:
Simvastatin 5 mg .....................................
Simvastatin 10 mg
Each film coated tablet contains:
Simvastatin 10 mg .....................................
Simvastatin 20 mg
Each film coated tablet contains:
Simvastatin 20 mg .....................................
How Drugs Work:
Simvastatin is a drug that lowers cholesterol levels (hypolipidemic) and is a synthesis of the results of fermentation of Aspergillus terreus. In vitro simvastatin will be hydrolyzed into the active metabolite.
Mechanism of action of the active metabolite of work by inhibiting 3-hydroxy-3-metilglutaril coenzyme A reductase (HMG Co-A reductase), in which this enzyme catalyzes changes in HMG Co-A into mevalonat acid which is the initial step of cholesterol synthesis.
General Recommendations:
Before starting therapy with simvastatin, secondary causes for previously excluded from hypercholesterolemia (such as uncontrolled diabetes mellitus, hypothyroidism, syndrome nifrotik, disproteinemia, obstructive liver disease, treatment with other drugs, alcoholism) and do the measurement profile of total cholesterol, HDL cholesterol and triglycerides (TG).
Posologi:
Patients must be on a diet reduced cholesterol before and during treatment with simvastatin.
- The recommended initial dose is 50-10 mg daily as a single dose at night.
- Initial dose for patients with mild to moderate hypercholesterolemia 5 mg daily. Conducted with dosing intervals of not less than 4 weeks up to a maximum of 40 mg daily as a single dose at night.
- Perform measurement of lipid levels with intervals of not less than 4 weeks and dosage adjusted to patient response.
- Patients treated with immunosuppressants with HMG Co-A reductase inhibitor, to be given the lowest dose of simvastatin is recommended.
- If the LDL cholesterol levels fell below 75 mg / dl (1.94 mmol / l) or plasma total cholesterol levels fell below 140 mg / dl (3.6 mmol / l) it is necessary to consider reducing the dose of simvastatin.
- Patients with impaired renal function: no dose adjustment is necessary, because simvastatin is excreted through the kidneys significantly. However, be careful of the insufesiensi severe kidney, the initial dose of 5 mg a day and should be monitored closely.
- Therapy with other medications: simvastatin effectively provided in the singular or in conjunction with 'bile-acid sequestrans'.
EFE Side:
- Abdominal pain, constipation, flatus, asthenia, headache, myopathy, rabdomiolisis. In certain cases occur angioneurotic edema.
- Other side effects ever reported on this class of drugs:
- Neurological: dysfunction of certain cranial nerves, tremors, dizziness, vertigo, memory loss, paresthesias, peripheral neuropathy, peripheral nerve paralysis.
- Hypersensitivity reactions: anaphylaxis, angiodema, thrombocytopenia, leukopenia, hemolytic anemia.
- Gastrointestinal: anorexia, vomiting.
- Skin: alopecia, pruritus.
- Reproductive: gynecomastia, loss of libido, erectile dysfunction.
- Eyes: accelerate cataracts, ophthalmoplegia.
Warning and Caution:
- During therapy with simvastatin cholesterol tests should be done periodically. In patients who have increased serum transaminase levels, special attention in the form of measurement of transaminase levels should be done, if there is a permanent increase (up to 3 times the upper limit of normal), treatment was stopped immediately.
- It is recommended that liver function tests before starting treatment, 6 and 12 weeks after the first treatment, the next is periodically (eg in semianual).
- Careful use in patients with alcoholism and / or who have a history of liver disease.
- In long-term use is recommended periodic laboratory testing every 3 months to determine further treatment.
- Simvastatin therapy should be temporarily discontinued or not continued in patients with acute and severe myopathy or in patients with risk of renal failure secondary to rabdomiolisis an increase in creatinine phosphokinase (CPK).
- Patients to immediately notify the doctor if there are no obvious muscle pain, muscles feel weak and feeble.
- Simvastatin is effective in patients with homozygous familial hipercholesterolemia.
- Simvastatin is not indicated where hypertriglyceridemia is the major abnormality (eg hyperlipidemia type I, IV and V).
- Safety and effectiveness in children and adolescents is uncertain.
Drug Interactions:
- Use in conjunction with immunosuppressants, itraconazole, gemfibrosil, niacin and erythromycin can cause an increase in skeletal muscle disorders (rabdomiolisis and myopathy).
- With anti kuogulan coumarin may prolong prothrombin time.
- Antipirin, propranolol, digoxin.
Packaging:
Simvastatin 5 mg. Box, 5 bister @ 10 tablets Saut membrane.
Simvastatin 10 mg. Box, 5 bister @ 10 tablets Saut membrane.
Simvastatin 20 mg. Box, 5 bister @ 10 tablets Saut membrane.
Storage:
Store at room temperature (25-30 degrees Celsius), protected from light.
Requires a doctor's prescription
Type: Tablet
Manufacturer: PT Dexa Medica
- Therapy with "lipid-altering agent" can be considered its use in individuals who are at increased risk of vascular atherosclerosis caused by hypercholesterolemia.
- Therapy with "lipid-altering agent" is the data supporting a strict diet, when response to diet and non-pharmacological treatment of other single inadequate.
- Coronary heart disease
In patients with coronary heart disease and hypercholesterolemia, simvastatin is indicated for:
- Reducing the risk of total mortality by reducing deaths from coronary heart disease.
- Reducing the risk of non-fatal myocardial ifark.
- Reducing the risk in patients undergoing myocardial revascularization procedures.
- Hypercholesterolemia
Lowering total and LDL cholesterol levels in patients with primary hypercholesterolemia (Type lla and LLB).
Contra Indications:
- Hypersensitivity to simvastatin or drug component.
- Active liver disease or elevated serum transaminase that persist are not clear why.
- Pregnant women and nursing mothers.
Composition:
Simvastatin 5 mg
Each film coated tablet contains:
Simvastatin 5 mg .....................................
Simvastatin 10 mg
Each film coated tablet contains:
Simvastatin 10 mg .....................................
Simvastatin 20 mg
Each film coated tablet contains:
Simvastatin 20 mg .....................................
How Drugs Work:
Simvastatin is a drug that lowers cholesterol levels (hypolipidemic) and is a synthesis of the results of fermentation of Aspergillus terreus. In vitro simvastatin will be hydrolyzed into the active metabolite.
Mechanism of action of the active metabolite of work by inhibiting 3-hydroxy-3-metilglutaril coenzyme A reductase (HMG Co-A reductase), in which this enzyme catalyzes changes in HMG Co-A into mevalonat acid which is the initial step of cholesterol synthesis.
General Recommendations:
Before starting therapy with simvastatin, secondary causes for previously excluded from hypercholesterolemia (such as uncontrolled diabetes mellitus, hypothyroidism, syndrome nifrotik, disproteinemia, obstructive liver disease, treatment with other drugs, alcoholism) and do the measurement profile of total cholesterol, HDL cholesterol and triglycerides (TG).
Posologi:
Patients must be on a diet reduced cholesterol before and during treatment with simvastatin.
- The recommended initial dose is 50-10 mg daily as a single dose at night.
- Initial dose for patients with mild to moderate hypercholesterolemia 5 mg daily. Conducted with dosing intervals of not less than 4 weeks up to a maximum of 40 mg daily as a single dose at night.
- Perform measurement of lipid levels with intervals of not less than 4 weeks and dosage adjusted to patient response.
- Patients treated with immunosuppressants with HMG Co-A reductase inhibitor, to be given the lowest dose of simvastatin is recommended.
- If the LDL cholesterol levels fell below 75 mg / dl (1.94 mmol / l) or plasma total cholesterol levels fell below 140 mg / dl (3.6 mmol / l) it is necessary to consider reducing the dose of simvastatin.
- Patients with impaired renal function: no dose adjustment is necessary, because simvastatin is excreted through the kidneys significantly. However, be careful of the insufesiensi severe kidney, the initial dose of 5 mg a day and should be monitored closely.
- Therapy with other medications: simvastatin effectively provided in the singular or in conjunction with 'bile-acid sequestrans'.
EFE Side:
- Abdominal pain, constipation, flatus, asthenia, headache, myopathy, rabdomiolisis. In certain cases occur angioneurotic edema.
- Other side effects ever reported on this class of drugs:
- Neurological: dysfunction of certain cranial nerves, tremors, dizziness, vertigo, memory loss, paresthesias, peripheral neuropathy, peripheral nerve paralysis.
- Hypersensitivity reactions: anaphylaxis, angiodema, thrombocytopenia, leukopenia, hemolytic anemia.
- Gastrointestinal: anorexia, vomiting.
- Skin: alopecia, pruritus.
- Reproductive: gynecomastia, loss of libido, erectile dysfunction.
- Eyes: accelerate cataracts, ophthalmoplegia.
Warning and Caution:
- During therapy with simvastatin cholesterol tests should be done periodically. In patients who have increased serum transaminase levels, special attention in the form of measurement of transaminase levels should be done, if there is a permanent increase (up to 3 times the upper limit of normal), treatment was stopped immediately.
- It is recommended that liver function tests before starting treatment, 6 and 12 weeks after the first treatment, the next is periodically (eg in semianual).
- Careful use in patients with alcoholism and / or who have a history of liver disease.
- In long-term use is recommended periodic laboratory testing every 3 months to determine further treatment.
- Simvastatin therapy should be temporarily discontinued or not continued in patients with acute and severe myopathy or in patients with risk of renal failure secondary to rabdomiolisis an increase in creatinine phosphokinase (CPK).
- Patients to immediately notify the doctor if there are no obvious muscle pain, muscles feel weak and feeble.
- Simvastatin is effective in patients with homozygous familial hipercholesterolemia.
- Simvastatin is not indicated where hypertriglyceridemia is the major abnormality (eg hyperlipidemia type I, IV and V).
- Safety and effectiveness in children and adolescents is uncertain.
Drug Interactions:
- Use in conjunction with immunosuppressants, itraconazole, gemfibrosil, niacin and erythromycin can cause an increase in skeletal muscle disorders (rabdomiolisis and myopathy).
- With anti kuogulan coumarin may prolong prothrombin time.
- Antipirin, propranolol, digoxin.
Packaging:
Simvastatin 5 mg. Box, 5 bister @ 10 tablets Saut membrane.
Simvastatin 10 mg. Box, 5 bister @ 10 tablets Saut membrane.
Simvastatin 20 mg. Box, 5 bister @ 10 tablets Saut membrane.
Storage:
Store at room temperature (25-30 degrees Celsius), protected from light.
Requires a doctor's prescription
Type: Tablet
Manufacturer: PT Dexa Medica
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