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CHOLESTAT

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    Komposisi:

    Simvastatin

    Bentuk sediaan:

    10 mg dan 20 mg kaplet salut selaput

    Dos isi 3 strip x 10 kaplet salut selaput.

    Farmakologi:

    Menghambat HMG-CoA reductase, enzim yang mengkonversi perubahan 3-hydroxy-3-methyl-glutaryl-coenzyme A menjadi mevalonate. Absorpsi tidak dipengaruhi makanan. T maks (metabolit) 1-3 jam.T ½ 1,9 jam. Siklus enterohepatik, ekskresi di feses 60% dan urin 13%.

    Indikasi:

    Hiperkolesterolemia primer dan sekunder.

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    Dosis:

    - Cholestat diberikan per-oral, dosis tunggal pada malam hari.

    - Dosis awal 5-10 mg/hari.

    Kontraindikasi:

    Hipersensitif terhadap simvastatin, penderita penyakit hepar aktif atau serum transaminase yang persisten, wanita hamil & menyusui, anak-anak.

    Peringatan dan Perhatian:

    Pada terapi jangka panjang Cholestat harus dipantau secara rutin :

    - Profil lipid

    - Kadar CPK (creatine phosphokinase)

    - Kadar serum transaminase : SGOT DAN SGPT.

    Bila terjadi miopati atau kadar CPK meningkat maka hentikan Cholestat.

    Efek Samping:

    - Efek samping Cholestat umumnya ringan dan sementara.

    - Efek samping yang paling sering : Gangguan saluran cerna, nyeri pada bagian perut, konstipasi, diare, flatulensi, mual.

    - Kelainan laboratorium yang mungkin terjadi pada pemberian Cholestat: Peningkatan SGOT, SPGT, CPK serum.

     

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    CHOLESTAT

     

    Composition:

    Simvastatin 10 & 20 mg (film-coated caplet).

    Presentation:

    Box of 3 strips x 10 film coated caplets

    Pharmacology:

    In vivo, simvastatin will be hydrolyzed to active metabolite whose mechanism of action is to inhibit 3-hydroxy-3-methylglutaryl coenzym A reductase (HMG Co-A reductase) which acts as a catalyst in the conversion of HMG Co-A to mevalonic acid, the initial step of cholesterol biosynthesis.

    Indications:

    - Therapy with lipid-altering agents should be considered in individuals with significant increasing risk of ateriosclerotic vascular disease due to hypercholesterolemia. - Therapy with lipid-altering agents is a supporting therapy when diet and other non-pharmacological therapy resulting inadequate response. - Coronary heart disease. In patients with coronary heart disease and hypercholesterolemia, simvastatin is indicated for: ° Reduce the risk of total mortality by reducing coronary death. ° Reduce the risk of non-fatal myocardial infarction. ° Reduce the risk in patient going through myocard revascularitation. - Hypercholesterolemia. Lowering total cholesterol level and LDL-cholesterol in patients with primary hypercholesterolemia (type IIa and IIb).

    Contraindications:

    - Hypersensitive to simvastatin or component in this drug. - Active liver disease or unknown caused of an increased in serum transaminase. - Pregnancy and lactation.

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    Dosage:

    The common initial dose is 10 mg/day as a single dose in the evening. Patients with mild to moderate hypercholesterolemia can be treated with an initial dose of 5 mg. Dose adjustment can be made at intervals not less than 4 weeks and the maximum dose is 40 mg/day as a single dose in the evening. Lipid profile should be check minimally every 4 weeks and the dose adjustment is depend upon patient?s response to therapy.

    Warning and Precautions:

    Monitor serum transaminase level (liver function test). Safety and efficacy in children and teenager is not known.

    Adverse events:

    Abdominal pain, flatulens constipation, asthenia, headache, myopathy, rhabdomyolysis.

    Drugs Interaction:

    - When given concomitantly with immunosuppressive agent, itraconazole, gemfibrozil, niacin and erythromycin can enhance musculoskeletal disorders (rhabdomyolysis and myopathy). - Coumarin anticoagulant can prolong prothrombin time. - Antipyrine, propanolol, digoxin.

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