simchol® si - PT. Ikapharmindo Putramas

®
®
SIMCHOL
SIMCHOL
10 mg
SIMVASTATIN 10 mg
10 mg
SIMVASTATIN 10 mg
TABLET SALUT SELAPUT
FILM-COATED TABLET
KOMPOSISI :
Tiap tablet salut selaput mengandung :
Simvastatin....................................................................................................................................................................10 mg
COMPOSITION :
Each film-coated tablet contains :
Simvastatin....................................................................................................................................................................10 mg
CARA KERJA OBAT :
Simvastatin merupakan obat penurun kadar kolesterol. Setelah pemberian oral, Simvastatin yang merupakan suatu lakton
inaktif dihidrolisa ke bentuk B-hidroxyacid. Dan ini merupakan suatu metabolit dasar dari penghambat 3 – hidroksi – 3 metil
glutaril-coenzim A (HMG – CoA) reduktase yang merupakan enzim yang mengkatalisa biosintesis kolesterol total plasma,
baik kadar kolesterol dari LDL (Low Density Lipoprotein) maupun VLDL (Very Low Density Lipoprotein). Dengan demikian
simvastatin efektif untuk pengobatan hiperkolesterolemia.
DRUG ACTION :
Simvastatin is a cholesterol – lowering agent. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolized
to the corresponding B-hydroxyacid form. This in an inhibitor of 3 – hydroxy – 3 methylglutaryl-coenzyme A (HMG – CoA)
reductase. This enzyme catalyzes the biosynthesis of cholesterol in plasma, LDL (Low Density Lipoprotein) as well as VLDL
(Very Low Density Lipoprotein). This is the reason for its efficacy in the treatment of hypercholesterolemia.
INDICATIONS :
– Prior to initiating therapy with simvastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes
mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, alkoholism and other drug
therapy) should excluded, and a lipid profile performed to measure total, and Triglyceride.
– Simvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol and LDL in patients with primary
hypercholesterolemia when the response to diet and other non pharmacological measures alone has been inadequate.
INDIKASI :
– Sebelum memulai terapi dengan Simvastatin, singkirkan dulu penyebab hiperkolesterolemia sekunder (seperti:
3 – hydroksi – 3 metilglutaril-coenzim A (HMG – CoA), diabetes mellitus yang tidak terkontrol, hipotiroidisme, sindroma
nefrotik, disproteinemia, penyakit kerusakan hati, alkoholisme, serta terapi dengan obat lain) dan harus dilakukan
pengukuran profil lipid total dan Trigliserida.
– Simvastatin diindikasikan sebagai penunjang pada diet untuk menurunkan kadar kolesterol total dan LDL pada penderita
hiperkolesterolemia primer, bila respon terhadap diet dan penatalaksanaan non farmakologi lain tidak memadai.
DOSAGE:
The starting dose is 10 mg once a day in the evening. Patients with light to mild hypercholesterolemia may be started at
5 mg/day as a single dose in the evening. Adjusments of dosage should be made at intervals of at 4 weeks up to a maximum
of 40 mg/day (administered in the evening). Lipid levels should be monitored periodically at intervals of not less than 4
weeks, and dosage should be individualized according to the patiens response. The patient should be placed on a standard
cholesterol-lowering diet before receiving SIMCHOL® and should be continued on this diet during treatment with the drug.
– In patients taking immunosuppressants concomitantly with (HMG – CoA) reductase inhibitors, the lowest dose of
simvastatin is recommended. When the cholesterol LDL level drops below 75 mg/dl (1.94 mmole/dl) or the total
cholesterol level in plasma falls below 140 mg/dl (3.6 mmole/L) consider the reduce the dose of Simvastatin.
– Patients renal insufficiency : Because SIMCHOL® dose not undergo significant to renal excretion, modification of dosage
should not be necessary in patients with mild to moderate renal insufficiency. However, caution should be exercised
when SIMCHOL® is administered to patients with severe renal insufficiency ; such patients should be started at 5 mg/day
by closely monitored.
– Concomitant lipid-lowering therapy : SIMCHOL® is effective alone or when used concomitantly with bile-acid sequestrants.
DOSIS :
Dosis awal 10 mg/hari sebagai dosis tunggal malam hari. Dosis awal untuk pasien dengan hiperkolesterolemia ringan
sampai sedang 5 mg/hari sebagai dosis tunggal malam hari. Penyesuaian dosis dilakukan dengan interval tidak kurang
dari 4 minggu sampai maksimal 40 mg/hari (diberikan malam hari). Pengukuran kadar lipid harus dilakukan secara periodik
dengan interval tidak kurang dari 4 minggu dan dosis disesuaikan dengan respon penderita. Pasien seharusnya menjalani
diet kolesterol sebelum menerima SIMCHOL® dan selama terapi dengan obat ini.
– Pada penderita yang diobati dengan obat-obat imunosuppresan bersama dengan HMG – CoA reduktase inhibitor :
dosis Simvastatin yang dianjurkan adalah dosis terendah. Bila kadar kolesterol LDL turun dibawah 75 mg/dl (1,94
mmoL/L) atau kadar total kolesterol plasma turun dibawah 140 mg/dl (3,6 mmoL/L) maka perlu dipertimbangkan
pengurangan dosis Simvastatin.
– Pada penderita gangguan fungsi ginjal : karena SIMCHOL® tidak di ekskresikan melalui ginjal, penyesuaian dosis tidak
diperlukan pada pasien dengan kerusakan ginjal ringan sampai sedang. Meskipun demikian SIMCHOL® harus diberikan
dengan hati-hati pada pasien dengan kerusakan ginjal yang parah, pasien harus diberikan dosis awal 5 mg/hari dengan
pengawasan yang ketat.
– Tetapi bersama obat-obat penurun lemak lain: SIMCHOL® efektif apabila diberikan dalam bentuk tunggal atau bila
diberikan bersama dengan “bile acid sequestrants”.
WARNING AND PRECAUTIONS :
– Patient having a history of liver disease :
• It is recommended that liver function tests be performed before the initiation of and during Simvastatin treatment.
• Patients having a history of liver disease should be monitored for liver dysfunction symptoms during Simvastatin
therapy.
• For long – term therapy it is highly recommended that laboratory test be performed every three months to determine
the appropriate treatment.
• Patients who develop increased transaminase levels should be monitored with a second liver function evaluation
to confirm the finding and be followed thereafter with frequent liver function test.
• Should an increase of 3 X ULN or greater persist, therapy with Simvastatin should be with- drawn immediately.
– The drug should be used with caution in patient who consume substantial quantities of alcohol.
– As safety and effectiveness have not been established, treatment of children or adolescent with Simvastatin is not
recommended.
– Myopathy :
• Patients should be told to report promptly, when experiencing muscle pain, tenderness or weakness
• Simvastatin therapy should be discontinued if elevated creatinine phosphokinase is observed or myopathy is
diagnosed
• Treatment with inhibitors of HMG – CoA reductase occasionally causes myopathy. Myopathy should be taken into
account in patients with muscle pain or weakness associated with glossy elevated creatinine phosphokinase (>10
X the upper limit of normal (ULN)
Therapy with inhibitors of HMG – CoA reductase should be discontinued if the patient suffers from acute and serious
symptoms leading to myopathy, or rhabdomyolysis, with or without acute renal failure secondary to myoglobinuria,
is present.
– Simvastatin is less effective in patient with homozygous familial hypercholesterolemia.
– In patient with hypertrigliceridemia, Simvastatin only has a limited triglyceride – lowering effect and is not indicated for
the treatment of hyperlipidemia types I, IV, and V.
PERINGATAN DAN PERHATIAN :
– Pasien dengan riwayat penyakit hati :
• Dianjurkan untuk test fungsi hati sebelum dan selama pengobatan dengan Simvastatin
• Untuk pasien yang mempunyai riwayat penyakit hati, sebaiknya dilakukan pemantauan terus menerus terhadap
timbulnya gejala – gejala gangguan hati selama terapi dengan Simvastatin.
• Bila diperlukan pengobatan jangka panjang, sangat dianjurkan untuk pemeriksaan test laboratorium berkala tiap
3 bulan untuk menentukan terapi yang sesuai.
• Perhatian khusus pada penderita yang mengalami peningkatan kadar serum transaminase, pengukuran kadar
serum harus segera dan lebih sering dilakukan.
• Bila terdapat peningkatan yang nyata melebihi 3 x batas normal atas, maka pengobatan harus dihentikan.
– Hati – hati pemberian pada pecandu alkohol.
– Karena keamanan dan efektifitasnya belum terbukti, sebab itu tidak dianjurkan pemberian Simvastatin pada anak –
anak dan remaja.
– Efek pada otot :
• Pasien harus diminta segera melaporkan bila mengalami nyeri otot, lemah atau lemas.
• Pengobatan harus segera dihentikan bila terlihat gejala peningkatan kadar 'creatinine phosphokinase' atau miopati.
• Pengobatan dengan HMG – CoA reduktase inhibitor jarang menyebabkan miopati. Miopati harus dipertimbangkan
pada penderita dengan mialgia, otot lemah dan atau peningkatan kadar 'creatinine phosphokinase' (10 kali batas
normal atas). Pengobatan dengan HMG – CoA reduktase inhibitor harus ditunda/dihentikan pada penderita gejala
akut dan serius yang cenderung merupakan miopati, atau merupakan faktor predisposisi untuk perkembangan
gagal ginjal akut sekunder karena adanya rhabdomyolysis.
– Penderita dengan 'homozygous familial hypercholesterolemia' pengobatan dengan Simvastatin kurang berhasil.
– Pada penderita hypertrigliseridemia, Simvastatin hanya berkhasiat menurunkan trigliserid terbatas dan tidak diindikasikan
untuk hiperlipidemia tipe I, IV, V.
ADVERSE EFFECTS :
– Gastrointestinal disorders (constipation, flatulence), headache, respiratory tract infection.
– Other effect that have been reported : nausea, diarrhea, dyspepsia, rhabdomyolysis, hepatitis, angioneurotic oedema.
– Skin : alopecia
– Neurological : dysfunction of cranial nervers, tremor, vertigo, memory loss, paresthesia, periphheral neuropathy,
peripheral nerve palsy.
– Gastrointestinal : pancreatitis, anorexia, vomiting, nausea, diarrhea, dyspepsia.
– Reproductive : gynecomastia, loss of libido, erectile dysfuction.
– Eye : ophthalmoplegia, progression of cataracts.
– Hypersensitivity reactions.
– Laboratory tests : rare cases of real and persistent elevated serum transaminase; mild and transient abnormalities in
liver function test result, increase in creatinine phosphokinase musculoskeletal levels.
EFEK SAMPING :
– Gangguan gastrointestinal (konstipasi, flatulen), sakit kepala, gangguan/infeksi saluran napas, ruam.
– Efek samping lain yang pernah dilaporkan : nausea, diare, dispepsia, rhabdomyolysis, hepatitis, angioneuritic oedema
terisolasi.
– Pada kulit : alopecia
– Neurologic : disfungsi saraf kranial, tremor, vertigo, hilang memori, parestesia, neuropati perifer, 'pheripheral nerve
palsy'.
– Gastrointestinal : pankreatitis, anoreksia, vomiting, nausea, diare, dispepsia.
– Organ reproduksi : ginekomastia, libido berkurang, disfungsi erektil.
– Pada mata : ophthalmoplegia, progresifitas katarak.
– Reaksi hipersensitifitas.
– Hasil test laboratorium : jarang dilaporkan peningkatan kadar serum transaminase nyata dan persisten; abnormalitas
test fungsi hati sedang dan sementara; peningkatan kadar 'creatinine phosphokinase' pada otot rangka.
CONTRAINDICATIONS :
– Patients hypersensitive to this drug.
– Patients with active liver disease.
– Pregnant women and nursing mothers.
KONTRAINDIKASI :
– Penderita yang hipersensitif terhadap obat ini.
– Penderita dengan penyakit hati akut.
– Wanita hamil dan menyusui.
DRUG INTERACTIONS :
Coumarin derivatives
Simvastatin potentiates the anticoagulant effect of warfarin. In patients taking coumarin anticoagulant prothrombin time
should be determined before starting simvastatin.
Fibric acid derivatives and nicotinic acid
Concomitant administration of Simvastatin with fibric acid / nicotinic acid potentiates the cholesterol lowering effect.
“Caution should be exercised when using the drug concomitantly with immunosuppresive agents and niacin”
INTERAKSI OBAT :
Derivat kumarin
Pemberian simvastatin mempertinggi efek antikoagulan dari warfarin. Untuk penderita yang menggunakan anti koagulan
(kumarin) seharusnya protrombin dideterminasi lebih dahulu untuk memulai terapi dengan simvastatin.
Derivat asam fibrat dan asam nikotinat
Pemberian simvastatin bersamaan dengan asam fibrat/asam nikotinat akan menaikkan efek reduksi / penurunan kolesterol.
“Hati – hati penggunaan bersamaan dengan obat – obat immunosuppresive atau niacin”.
KEMASAN :
Dus isi 3 strip @ 10 tablet
PRESENTATIONS :
Boxes of 3 strips containing 10 tablets each.
Store in a dry place below 30°C
Reg. No.: DKL 9909314117 B1
No. Reg.: DKL 9909314117 B1
ON MEDICAL PRESCRIPTION ONLY
Simpan di tempat kering pada suhu di bawah 30°C
HARUS DENGAN RESEP DOKTER
Diproduksi oleh :
Manufactured by :
PT. IKAPHARMINDO PUTRAMAS
PT. IKAPHARMINDO PUTRAMAS
PHARMACEUTICAL LABORATORIES
JAKARTA - INDONESIA
PHARMACEUTICAL LABORATORIES
JAKARTA - INDONESIA
Sign Approval
INSERT SIMCHOL
Date
Volume
Size (mm)
Revised
050613
140 x 350
2
PACK. DEV
R&D
QC
Marketing/Bus. Dev
COLOR
TC. 122
TC. 141
TC.165
Black
CREATIVE Dept.
PT. IKAPHARMINDO PUTRAMAS Pharmaceutical Laboratories Jl. Pulogadung Raya No. 29, Kawasan Industri Pulogadung, Jakarta 13920
t: +62 21 4614 766 / 46 000 86, f: +62 21 468 24501 - 02, www.ikapharmindo.com