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Vascor
SIMVASTATIN 20mg/40mg

PRODUCT DESCRIPTION
Vascor Tablet 20: An oval, scored and marked "UP 20" orange film coated tablet.
Vascor Tablet 40: An oval, scored and marked "UP 40" pink film coated tablet.

COMPOSITION
Vascor Tablet 20: Each tablet contains 20 mg of Simvastatin.

Vascor Tablet 40: Each tablet contains 40 mg of Simvastatin.

PHARMACOLOGY
Simvastatin is absorbed from the GI tract and is hydrolysed to its active metabolite, Beta-hydroxyacid form. Simvastatin undergoes extensive first pass metabolism in the liver. Both drug and the active metabolite are about 95% protein bound. It is mainly excreted in the faeces via bile as metabolites. About 10 to 15% is recovered in the urine, mainly in inactive form. The half life of the active metabolite is 1.9 hours.

INDICATIONS
Simvastatin is used for primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia in patients who have not responded to diet and appropriate measures; to reduce the incidence of clinical coronary events end slow progression of coronary atherosclerosis in patients with coronary heart disease.

MECHANISMS OF ACTION
Simvastatin belongs to the lipid regulating drug class commonly known as statins. Its pharmacological class is 3hydroxy-3-methylglutaryl coenzyme A (HMG Co-A) reductase inhibitor. Simvastatin competitively inhibits the HMG Co-A reductase, the enzyme involved in cholesterol synthesis. Simvastatin reduces total cholesterol, low density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides. It also increases high density lipoprotein (HDL) cholesterol. They are considered to exert beneficial effects by stimulating an increase in LDL receptors on hepatocyte membranes thereby increasing the clearance of LDL from the circulation.

SIDE EFFECTS
Myositis is a rare but significant clinical adverse effect. Other common side-effects include headache, altered liver-function tests and GI disturbances such as vomiting and nausea. Rare side effects include rash, alopecia, anaemia, dizziness, depression, paraesthesia, peripheral neuropathy, hepatitis, jaundice, pancreatitis, hypersensitivity syndrome (angioedema). Counselling: Advise patients to report any unexplained muscle pain, tenderness and weakness promptly.

PRECAUTIONS
Simvastatin should be used with caution in those with a history of liver disease or those with high intake of alcohol. The manufacturer advises liver function test be carried out before and within 1-3 months of starting treatment and thereafter at intervals of 6 months for 1 year, unless indicated sooner by signs and symptoms of hepatotoxicity. Treatment should be discontinued if serum transaminase concentration rises to, and persist at, 3 times the upper limit of reference range. Patients should be advised to report any muscle pain.

Use in pregnancy and nursing mothers: Refer contraindications.

Use in paediatric: It is not recommended as the safety and effectiveness study has not yet been established.

Use in elderly: The efficacy assessment by the reduction in total-C and LDL-C, appeared to be the same in the whole population and the group of elderly who were given simvastatin in controlled clinical studies. Moreover, the frequency of laboratory or clinical adverse investigations shown no apparent increase.

Laboratory findings: Occasionally, serum transaminases have been reported to increase persistently. Alkaline phosphate and g-glutemyl trenspeptidese have been reported to be raised. Mild and transient abnormalities in liver function test. Increased serum CK levels, derived from skeletal muscle have been reported.

CONTRAINDICATIONS
Porphyria, pregnancy, breast-feeding and active liver disease. (Female patients taking Simvastatin should be counselled to have adequate contraception during and at least 1 month after discontinuing treatment). Hypersensitivity to any component of this preparation.

DRUG INTERACTIONS
Increased risk of myopathy with clarithromycin, erythromycin, nefadazone, itraconazole, ketoconazole, and possibly other imidazoles and triazoles, cyclosporin, other statins, fibrate and nicotinic acid. Simvastatin enhances effect of warfarin and nicoumalone.

DOSAGE AND ADMINISTRATION
Hyperlipidaemia: 10 mg daily at night adjusted at intervals of not less than 4 weeks; usual range is 10 to 40 mg daily at night.

Coronary heart disease: Initially 20 mg daily at night.

Renal Insufficiency: If moderate, modification is unnecessary. If severe with creatinine clearance < 30 mL/min, it is advised to carefully monitor especially with dosage > 10 mg a day.

Dose Adjustment: If necessary, should be adjusted to a maximum of 40 mg per day and made at intervals of et least 4 weeks.

SYMPTOMS AND TREATMENT OF OVERDOSAGE
There are few reports on patients with maximum dose of 450 mg, none had typical symptoms and all recovered. Should adopt general measures.

PHARMACEUTICAL INFORMATION

Storage conditions

Store in a dry place below 30C. Protect from light.
Keep medicines out of reach of children.

Shelf Life
Please refer to outer package

Pack sizes/package
Blister packs of 30's, 90's, 100's and 120's.

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