SIMVAS Tablet

គុណភាពព្យាបាល
- ជាប្រភេទឱសថបញ្ចុះសារធាតុខ្លាញ់ក្នុងឈាម (Cholesterol)
- សំរាប់ព្យាបាលជម្ងឺលើសជាតិខ្លាញ់ក្នុងឈាម បណ្ដាលមកពីការឡើង LDL Cholesterol total ក្នុងឈាម។
កំរិត និង របៀបប្រើ
ប្រើទៅតាមកំរិតប្រែប្រួល Cholesterol ក្នុងឈាម
- កំរិតដំបូង : លេបម្ដងពី 5 ម.ក្រ ទៅ 10ម.ក្រ ក្នុង1ថ្ងៃ ពេលល្ងាច
- កំរិតបន្ទាប់ : លេបម្ដងពី 5 ម.ក្រ ទៅ 40ម.ក្រ ក្នុង1ថ្ងៃ ពេលល្ងាច
- កំរិតខ្ពស់ : លេបម្ដងពី 40ម.ក្រ ក្នុង1ថ្ងៃ ពេលល្ងាច
- កំរិតកាត់បន្ថយ LDL Cholesterol 20% ឬច្រើនជាងនេះ: លេបម្ដង 10ម.ក្រ ក្នុង1ថ្ងៃ។

Indication
SIMVAS (Simvastatin) is indicated as an adjunct to diet in patients with primary hypercholesterolemia (Type lla and llb) caused by elevated low density lipoprotein cholesterol concentration in patients with a significant risk of coronary artery disease, when the response to a diet restricted in saturated fat and cholesterol and other non pharmacological measures alone have been inadequate.
SIMVAS (Simvastatin) is also indicated for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (Types lla and llb).
Dosage:
The recommended starting dose is 5 to 10mg once a day in the evening. The recommended dosing range is 5 to 40mg/day as a single dose in the evening. The maximum recommended dose is 40mg/day.　Doses should be individualised according to baseline LDL-C levels, the recommended goal of therapy and the patients response.
Patients requiring reductions in LDL cholesterol of 20% or more to achieve their goal should be started on 10mg/day of Simvastatin.
A starting dose of 5mg should be considered for patients requiring smaller reductions and for the elderly adjustments of dosage should be made at intervals of 4 weeks or more. Cholesterol levels should be monitored periodically and consideration should be given or reducing the dosage if cholesterol level falls significantly below the targetted range.

ការហាមប្រើ
- អ្នកជម្ងឺងាយទទួលប្រតិកម្មជាមួយសារធាតុផ្សំណាមួយនៃឱសថនេះ
- អ្នកជម្ងឺថ្លើម ឬអ្នកជម្ងឺដែលមានកំរិត Serum transaminases នៅតែកើនឡើង
- ស្ត្រីមានផ្ទៃពោះ និងស្ត្រីបំបៅកូន ត្រូវពិគ្រោះជាមួយគ្រូពេទ្យ។

Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases.

ប្រុងប្រយ័ត្នក្នុងការប្រើរួមផ្សំជាមួយឱសថដទៃទៀតដូចជា Itraconazole, Gemfibrozil, Niacin (Nicotinic Acid), Erythromycin, Digoxin, anticoagulants។ល។

Drug interactions with immunosuppressive drugs, itraconazole, gemfibrozil, niacin (Nicotinic Acid), erythromycin, digoxin, anticoagulants, courmarin derivatives have been reported.

ស្ត្រីមានផ្ទៃពោះ និងស្ត្រីបំបៅកូន ត្រូវពិគ្រោះជាមួយគ្រូពេទ្យ។

Simvastatin should be administered to women of child bearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug. Simvastatin should be discontinued and the patient should be apprised of the potential hazard to the foetus.

ការប្រុងប្រយ័ត្ន
- ត្រូវវិភាគរក Cholesterol ក្នុងឈាមមុនប្រើឱសថនេះ ជាមួយនឹងការតមអាហារ ការហាត់ប្រាណ ការបញ្ចុះទម្ងន់ចំពោះអ្នកធាត់
- អាចបណ្ដាលអោយឡើង Serum creatine phosphokinase និង Serum transaminases ក្នុងឈាម
- អ្នកពិសារស្រា ឬធ្លាប់មានប្រវត្តិឈឺថ្លើម

General:

Before the instituting therapy with Simvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise and weight reduction in obese patients and to treat other underlying medical problems.

Simvastatin may cause elevation of serum creatine phosphokinase and serum transaminase levels. This should be considered in the differential diagnosis of chest pain in a patient on therapy with Simvastatin.

Liver Dysfunction:

Persistent increase in serum transaminases have occurred in 1% of patients who received Simvastatin in clinical trials. When drug treatment was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pretreatment levels. The increases were not associated with jaundice or other clinical signs of symptoms. There was no evidence of hypersensitivity.

It is recommended that liver function tests be performed before the initiation of treatment, at 6 and 12 weeks after initiation of therapy of elevation in dose, and periodically thereafter (e.g., semiannually). Patients who develop increased transaminase levels should be monitored with a second liver function tests until the abnormality returns to normal.

The drug should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Active liver diseases or unexplained transaminase elevations are contra-indications to the use of Simvastatin.

Simvastatin is a cholesterol lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. It is an inhibitor of 3-hydroxy 3-methyl glutaryl Coenzyme A (HMG CoA) reductase. This enzyme catalyses the conversion of HMG CoA to mevalonate which is an early and rate limiting step in the biosynthesis of Cholesterol.