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| Oral hypoglycemic, Hypolipidemic, Proton Pump inhibitor, B.ComplexVitamin |
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Simvastatin
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INFORMATION FOR USE OF A MEDICAL PRACTITIONER, HOSPITAL OR LABORATORY |
| Each film coated tablet contains: Simvastatin USP……10 mg |
| Each film coated tablet contains: Simvastatin USP……20 mg |
PHARMACOLOGICAL CLASSIFICATION |
| SIM-TOR (Simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. |
| Following an oral dose of 14C-labeled simvastatin in man, 13% of the dose was excreted in urine and 60% in feces. Plasma concentrations of total radioactivity (simvastatin plus 14C-metabolites) peaked at 4 hours and declined rapidly to about 10% of peak by 12 hours postdose. Since simvastatin undergoes extensive first-pass extraction in the liver, the availability of the drug to the general circulation is low (<5%). Both simvastatin and its β-hydroxyacid metabolite are highly bound (approximately 95%) to human plasma proteins. The major active metabolites of simvastatin present in human plasma are the β-hydroxyacid of simvastatin and its 6-hydroxy, 6-hydroxymethyl, and 6-exomethylene derivatives. |
| SIM-TOR is indicated for the treatment of: |
Reductions in Risk of CHD Mortality and Cardiovascular Events |
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, Simvastatin is indicated to: |
- Reduce the risk of total mortality by reducing CHD deaths.
- Reduce the risk of non-fatal myocardial infarction and stroke.
- Reduce the need for coronary and non-coronary revascularization procedures.
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Patients with Hypercholesterolemia Requiring Modifications of Lipid Profiles |
Simvastatin is indicated to: |
- Reduce elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb).
- Treat patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia).
- Treat patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
- Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
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Make sure you have told your doctor if you: |
Are pregnant or think you may be pregnant, or are planning to become pregnant. - Are breast feeding.
- Allergic to any of its components
- Diagnosed with active liver dis
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| You must take your medicine as the doctor tells you. It is important to take SIM-TOR Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. The usual starting dose is 10 mg or 20 mg a day, given as a single dose in the evening. Your doctor may adjust your dose to a maximum of 80 mg a day, given as a single dose in the evening. |
| Take the missed dose as soon as you remember it. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your doses as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the dose that you missed. |
WHAT TO DO IF AN OVERDOSE IS TAKEN |
In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. |
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of SIM-TOR if you are taking any drug: |
· Itraconazole · Ketoconazole · Erythromycin · Clarithromycin · Telithromycin · HIV protease inhibitors · Nefazodone |
Like all medicines, SIM-TOR can cause side effects |
| Muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. |
- Hypersensitivity (allergic) reactions including:
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- swelling of the face, tongue and throat which may cause difficulty in breathing
- severe muscle pain usually in the shoulders and hips
- rash with weakness of limbs and neck muscles
- pain or inflammation of the joints
- inflammation of the blood vessels
- unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing
- shortness of breath and feeling unwell
- lupus-like disease picture (including rash, joint disorders, and effects on blood cells)
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- Inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare)
- Inflammation of the pancreas often with severe abdominal pain.
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| · Keep all medicines out of the reach of children. · Store at room temperature(20 to 25°C) |
| Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice. |
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