Insigrel,

dr. Yoska Yasahardja

Medical Scientific Dept
PT Kalbe Farma

Excellence and Alignment

EPIDEMIOLOGI
Di Indonesia Sindrom Koroner Akut (SKA)
merupakan penyebab utama dari seluruh
kematian, yakni sebesar 26,4%.
Satu diantara empat orang yang meninggal
di Indonesia adalah akibat PJK.

1. Pharmaceutical care untuk pasien penyakit jantung koroner: Fokus sindrom

koroner akut. Direktorat Bina Farmasi Komunitas dan Klinik. DITJEN Bina
Kefarmasian dan Alat Kesehatan. Departemen Kesehatan. 2006
2. Majid A. Penyakit jantung koroner: Patofisiologi, pencegahan dan
pengobatan terkini. Pidato pengukuhan jabatan guru besar tetap Universitas
Sumatra Utara. 2007

Overview of ACS
Acute Coronary
Syndromes*
1.57 Million Hospital Admissions - ACS
UA/NSTEMI

STEMI

1.24 million

0.33 million

Admissions per year

Admissions per year

*Primary and secondary diagnoses. About 0.57 million NSTEMI and 0.67 million UA.
Heart Disease and Stroke Statistics 2007 Update. Circulation 2007; 115:69171.

Zat aktif dan sediaan:

Clopidogrel

75 mg

Kemasan:
Dus @ 3 strip
1 strip @ 10 tablet
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Farmakodinamik Insigrel

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INDIKASI INSIGREL

Kejadian aterotrombosis yang menyertai:

Serangan IM: pemakaian beberapa hari - < 35 hari
Serangan stroke iskemik: 7 hari - < 6 bulan)
Penyakit pembuluh darah perifer
SKA dengan elevasi segmen non-ST (angina angina
unstable atau infark miokard Non Insigrel wave) yang
dikombinasikan dengan Aspirin
Clopidogrel juga sudah di approved oleh FDA
untuk:
AMI dengan Elevasi segmen ST yang tidak bisa
menjalani proses angioplasti arteri koroner

Excellence and Alignment

Excellence and Alignment

Excellence and Alignment

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UJI BE Insigrel

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The Comparative BioeInsigreluivalence Study of A Generic (Insigrel 75 mg

Tablet from PT. Kalbe Farma Tbk) and the Proprietary (Plavix from SanofiAventis) 2 x 75 mg Clopidogrel Tablet in Healthy Human Subjects. BfR
(Bundesinstitut fur Risikobewertungen) certified GLP
Investigator:
Principle investigator: Dr. Toong Chow LEE
Research Physician : Dr. Wan Lin TAN
Info Kinetics Sdn/ Bhd - Gleneagles Clinical Research Centre.
3rd Floor Gleneagles Medical Centre - 1 Jalan Pangkor
10050 Pulau Pinang Malaysia Tel: +604-2285760 & Fax: +604-2285715
Disain:
Open, two-way cross-over study (2 treatments, 2 periods & 2
seInsigreluences).
Subyek 24 sukarelawan sehat
Obat masing-masing 2x 75 mg
Pemeriksaan darah pada sebelum minum obat dan jam ke: 0.33,
0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, dan 24.
Data on file PT. Kalbe Farma Tbk..

Excellence in Execution

The Comparative BioeInsigreluivalence Study of A Generic (Insigrel 75 mg

Tablet from PT. Kalbe Farma Tbk) and the Proprietary (Plavix from SanofiAventis) 2 x 75 mg Clopidogrel Tablet in Healthy Human Subjects.
Hasil Data Farmakokinetik:
Pharmacokinetic
Parameters

Test (Insigrel 75 mg)

Dose (2 x 75 mg)
(n=20)
(mean SD)

Reference (Plavix )
Dose (2 x 75 mg)
(n=20)
(mean SD)

AUC0-t (h.ng/mL)

3.36 2.43

3.42 2.37

AUC0-~ (h.ng/mL)

3.58 2.58

3.66 2.54

Cmax (ng/mL)

1.64 1.25

1.73 1.23

Tmax (h)

1.03 0.49

1.08 0.49

T1/2 (h)

2.80 2.40

3.07 1.73

Data on file PT. Kalbe Farma Tbk..

Excellence in Execution

The Comparative BioeInsigreluivalence Study of A Generic (Insigrel 75 mg

Tablet from PT. Kalbe Farma Tbk) and the Proprietary (Plavix from SanofiAventis) 2 x 75 mg Clopidogrel Tablet in Healthy Human Subjects.
Hasil Data Farmakokinetik:

Data on file PT. Kalbe Farma Tbk..

Excellence in Execution

Excellence and Alignment