Rechol

RECHOL®
Tablet

 

COMPOSITION
RECHOL® 5:
Each film-coated tablet contains: Simvastatin 5 mg

RECHOL® 10
Each film-coated tablet contains: Simvastatin 10 mg

RECHOL® 20
Each flim-coated tablet contains: Simvastatin 20 mg

 

PHARMACOLOGY
Simvastatin which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which catalyzes an early and rate-limiting step in the biosynthesis of cholesterol. As a result, Simvastatin reduce low density (LDL)- and very low density (VLDL)-cholesterol, plasma triglyceride concentrations, and slightly increase high-density lipoprotein (HDL) concentrations, without the accumulation of potentially toxic sterols.

 

INDICATIONS

• Reduction of elevated total and LDL-cholesterol levels in patients with primary hypercholesterolemia, when the response to diet and other nonpharmacological measures alone has been inadequate. Simvastatin raises HDL-cholesterol and therefore lowers the LDL/HDL and total cholesterol/HDL ratios.
• Reduction of elevated cholesterol levels in patients with combined hypercholesterolemia and hypertriglyceridemia, when the hypercholesterolemia is the major abnormality.

CONTRAINDICATIONS

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

PRECAUTIONS

• Simvastatin may cause elevation of transaminase levels. When the drug was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pretreatment levels.
• It is recommended that liver function tests be performed before treatment begins and periodically thereafter in all patients.
• Simvastatin therapy should be temporarily withheld or discontinued in any patient having a risk factor predisposing to the development of renal failure secondary to rhabdomyolisis.
• The drug should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history liver disease.
• Safety and effectiveness in children and adolescents have not been established. Therefore, treatment of children or adolescents with Simvastatin is not recommend at this time.
• In any patient with homozygous form of familial hypercholesterolemia, in whom there is a complete absence of LDL receptors, therapy with Simvastatin is unlikely to result in clinical benefit.
• Simvastatin has only a moderate triglyceride lowering effect and it is not indicated where hypertriglyceridemia is the abnormally of most concern (i.e.hyperlipidemia types I, IV, and V).
• Patients should be asked to report promptly unexplained muscle pain, tenderness or weakness. Therapy with Simvastatin should be discontinued if markedly elevated CPK (creatinine phosphokinase) levels occur or if myopathy is diagnose or suspected.

ADVERSE EFFECTS
Simvastatin is generally well-tolerated; for the most part side effects have been mild and transient in nature. Adverse effects occurring with a frequency of ≥ 1% were abdominal pain, constipation, flatulence and nausea. Other side effects occurring in 0.5 - 0.9 % of patients were asthenia, acid regulation, dyspepsia, headache, insomnia, diarrhea and rash.
Other adverse effects reported are:

• Neurological : distinction of certain cranial nerves, tremor, vertigo, memory loss, peripheral neuropathy, peripheral nerve palsy, paresthesia.
• Reproductive: gynecomastia, loss of libido, erectile dysfunction.

DRUG INTERACTIONS

• Combined therapy with gemfibrozil, niacin, erythromycin or immunosuppressants should include careful monitoring for symptoms of myopathy or rhabdomyolysis.
• Concurrent use with anticoagulants (coumarin or indandione-derivative) may increase bleeding or prothrombin-time.

DOSAGE AND ADMINISTRATION
Patient should be placed on a standard cholesterol-lowering diet before receiving Simvastatin and should continue on this diet during treatment with Simvastatin.
The usual starting dose is 10 mg/day given as a single dose in the evening.
Patients with mild to moderate hypercholesterolemia can be treated with a starting dose of 5 mg of Simvastatin. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 40 mg daily given as a single dose in the evening.
Lipid determination should be preformed at intervals of no less than four weeks and dosage adjusted according to the patient's respons to therapy.
If LDL-cholesterol levels fall below 75 mg/dL (1,94 mmol/L) or total plasma cholesterol levels fall below 140 mg/dL (3,6 mmol/L) consideration should be given to reducing the dose of Simvastatin.

 

Dosage In patients with renal insufficiency
Because Simvastatin does not undergo significant renal excretion, modification of dosage should not be necessary in patients with renal insufficiency. However, caution should be exercised when Simvastatin is administered to patients with severe renal insufficiency: such patients should be started at 5 mg/day and be closely monitored.

 

PRESENTATION
RECHOL® 5
Box of 3 strips @ 10 film-coated tablets
Reg. No. DKL9521618017A1

RECHOL® 10
Box of 3 strips @ 10 film-coated tablets
Reg.No. DKL9521618017B1

RECHOL® 20
Box of 3 strips @ 10 film-coated tablets
Reg. No. DKL9721618017C1

 

ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

 

Keep in a cool (15 - 25 °C) and dry place.

 

Manufactured by:
PHAROS
Jakarta - Indonesia

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