Cholestat

Simvastatin……………………………………………………………………… 20 mg

- Therapy with “lipid-altering agents” may be considered in individu with the risk of vascular atherosclerosis due to hypercholesterolemia.
- Therapy with “lipid-altering agents” is an adjunct therapy to well-controlled diet, used only if responses to diet and non-pharmacological therapy are not sufficient.
- Coronary heart disease
    For patient with coronary heart disease and hypercholesterolemia, simvastatin is indicated to :
        • Reduce the risk of total mortality caused by coronary diseases.
        • Reduce the risk of non-fatal myocardial infarction
        • Reduce the risk of revascularisation myocardial procedure.
- Hypercholesterolemia
Reduce total cholesterol and LDL in patients with primary hypercholesterolemia (type IIa and IIb).

General recommendation:
Before starting therapy with simvastatin, eliminate secondary cause of hypercholesterolemia (such as uncontrolled diabetes mellitus, hypotiroid, nephrotic syndrome, dysproteinemia, obstructive liver disease, treatment with other drugs, alcoholism) and control profile of total cholesterol, LDL and triglycerides (TG).
 

- Hypersensitive to simvastatin or component of the drug
- Active liver disease or unknown, persistent increase of serum transaminase
- Pregnant woman and nursing mother
 

- During therapy with simvastatin, cholesterol level must be monitored periodically. For patients with increasing level of transaminase serum, monitoring transaminase level must be done and if the increasing level is persistent (3 times upper normal level), therapy must be discontinued.
- Examine liver function before starting therapy, 6 and 12 weeks after the first dosage, and periodically afterwards (e.g. semiannual).
- Use carefully in patient with alcoholism and/or with history of liver dysfunction.
- For long-term use, it is suggested to do the blood test every 3 months before the next therapy.
- Therapy with simvastatin must be stopped temporary or discontinued in patients with acute severe myopaty and in patient with the risk of secondary renal failure due to rhabdomyolisis or increase of Creatinine Phosphokinase (CPK).
- Patient must tell the doctor immediately if unknown muscle pain and weakness occur.
- Simvastatin is not effective in patients with “homozygous familial hypercholesterolemia”
- Simvastatin is not recommended for patient with hypertriglyseridemia (type I, IV, V hyperlipidaemia).
- Safety and effectiviness in children and adolescent are unknown.
 

- Abdominal pain, constipation, flatulence, asthenia, headache, myopathy, rhabdomyolisis. In certain case, angioneurotic oedema may occur.
- Side effects that were reported, including :
    • Neurology: cranial nerve dysfunction, tremor, dizziness, vertigo, loss of memory, paresthesia, peripheral neuropathy, peripheral nerve paralysis.
    • Hypersensitivity reaction: anaphylaxis, angioedema, trombocytopenia, leucopenia, hemolytic anemia.
    • Gastrointestinal: anorexia, vomiting.
    • Skin: alopecia, pruritus
    • Reproduction: gynecomastia, loss of libido, erection dysfunction
    • Eye: accelerate cataract, ophtalmoplegia
 

Patient must reduce cholesterol intake, prior to and during therapy with simvastatin.
- Initial dose recommendation is 5-10 mg daily as a single dose at night. Initial dose for patient with mild to moderate hypercholesterolemia is 5 mg daily. Dose adjustment must be done not less than 4 weeks, until maximum dose 40 mg daily as single dose at night. Blood lipid measurement must be done not less than 4 weeks interval and dose may be adjusted according to patient’s response.
- Using the lowest recommended dose of simvastatin for patient with concomitant use of imunosupressan and HMG Co-A reductase inhibitor therapy.
- If LDL level decreases below 75 mg/dl (1,94 mmol/l) or total cholesterol decreases below 140 mg/dl (3,6 mmol/l), considered to reduce the dose of simvastatin.
- Patient with renal dysfunction: no dose adjusment is required, since simvastatin is not mainly excreted by renal. Eventhough, use carefully in patient with severe renal insufficiency with initial dose 5 mg daily and must be well-controlled.
- Therapy with other drugs: Simvastatin is effective as single drug or in concomintant use with “bile-acid sequestrans”.