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Inspection and Certifications received:

c-GMP German Federal Health Agency (2010)
c-GMP TGA (2009)
ISO 9001:2008 (2009)
c-GMP - UK MHRA (2008)
Indonesian GMP (CPOB) BPOM (Nov 2002)
Successful Audits from Alliances:

UCB - Aug 2006

GSK - Mar 2004

Santen - Jan 2004

Novartis - Nov 2003

Actavis - Sep 2003

Congratulations for PT Ferron Par Pharmaceuticals!

The CVD Continuum

Chrysant SG, World J Cardiol 2010 March 26; 2(3): 43-49

Global CVD
Mortality

http://www.who.int/cardiovascular_diseases/en/ ; http://www.world-heart-federation.org/cardiovascular-health/global-facts-map/

Ischemic Heart Disease

Mortality

Indonesia: Mortality Rate 109-151 case per 100.000

http://apps.who.int/iris/bitstream/10665/79059/1/WHO_DCO_WHD_2013.2_eng.pdf?ua=1

RISKESDAS 2013

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Thomas Mnzel et al. Circulation. 2011;123:2132-2144

Acute Coronary
Syndrome
Acute coronary syndrome (ACS) refers to a
spectrum of clinical presentations ranging from
those for ST-segment elevation myocardial
infarction (STEMI) to presentations found in non
ST-segment elevation myocardial infarction
(NSTEMI) or in unstable angina.
It is almost always associated with rupture of an
atherosclerotic plaque and partial or complete
thrombosis of the infarct-related artery.

http://emedicine.medscape.com/article/1910735-overview

Unstable Angina, NSTEMI, and STEMI differ

with regard to duration, severity, and
treatments

Overbaugh KJ. AJN t May 2009 t Vol. 109, No. 5

FAST and POWERFUL

Mechanism of Action
Nitroglycerine

Action of Nitrates on
Circulation
The major effect
is on the venous
capacitance
vessels, with
additional
coronary and
peripheral
arteriolar
vasodilatory
benefit
Opie LH & Horowitz JD. Nitrates and newer antianginals. In: Drugs for the Heart. 7 th ed. Saunders Elsevier.

Nitrates Mechanism

Effects of nitrates in
generating NO and
stimulating
guanylate cyclase to
cause a vasodilation
Opie LH & Horowitz JD. Nitrates and newer antianginals. In: Drugs for the Heart. 7 th ed. Saunders Elsevier.

FAST and POWERFUL

Clinical Efficacy

Low-dose NTG significantly reduces cardiac filling pressures

and improves microvascular perfusion in patients admitted
for acute heart failure

Nitroglycerin in acute heart

failure

Corstiaan A, et al. European Journal of Heart Failure (2009) 11, 386390

IV Nitroglycerin is highly effective in preventing adverse ischemic events (reccurent or

refractory angina) in patients with unstable angina secondary to restenosis

Perioperative
hypertension

Varon J, Malik PE. Vascular Health and Risk Management 2008:4(3) 615627

Perioperative
nitroglycerin

ISDN was successful in treating hypertension in 63% of the events, whereas NTG had an
83% success. NTG has been found to be effective in controlling hypertension

FAST and POWERFUL

Guidelines Nitroglycerin

ANGINA

2013 ESC guidelines on the management of stable coronary artery disease, European Heart Journal (2013) 34, 29493003

STEMI
2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, Circulation. 2013;127:e362-e425

2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, Circulation. 2013;127:e362-e425

HEART
FAILURE

2013 ACCF/AHA Guideline for the Management of Heart Failure, Circulation. 2013;128:e240-e327

2013 ACCF/AHA Guideline for the Management of Heart Failure, Circulation. 2013;128:e240-e327

Scottish Intercollegiate Guidelines Network (SIGN). Acute coronary syndromes. Edinburgh: SIGN; 2013. (SIGN publication no. 93).
[February 2013]. Available from URL: http://www.sign.ac.uk

FAST and POWERFUL

Product Profile

Farmakokinetik
Nitroglycerin
Distribusi luas di dalam tubuh, VD: 200 L
Konsentrasi plasma terapetik 0,1-3 ng/ml
(sd 5 ng/ml)
Nitroglycerin terikat 60% protein plasma,
metabolit 1,3-glyceryl dinitrate 60%, 1,2glyceryl dinitrate 30%
Onset 1-2 menit IV
Durasi 3-5 menit,
Waktu paruh 1-4 menit

Indikasi NTG
Gagal jantung yang tidak responsif karena
infark miokard akut
Angina tidak stabil yang sulit disembuhkan
dengan beta blocker dan nitrat sublingual
Pembedahan
Mengontrol hipertensi dengan cepat selama
pembedahan jantung
Menurunkan tekanan darah dan menjaga
hipotensi yang terkontrol selama prosedur
pembedahan
Mengontrol iskemia miokard selama dan
setelah pembedahan

Dosis
Indikasi

Dosis Awal

Dosis selanjutnya

Pembedahan

25 g/menit
(untuk
mengontrol
hipertensi )

Kenaikan dosis 25
g/menit setiap 5 menit
hingga tekanan darah
stabil

Pengobatan
iskemia
miokard
perioperatif

15-20 g/menit Kenaikan dosis 10-15

g/menit hingga efek
yang diharapkan tercapai

Gagal jantung 20-25 g/menit Dapat dikurangi menjadi

kongestif yang
10 g/menit atau
tidak
ditingkatkan bertahap 20responsif
25 g/menit tiap 15-30
menit sampai efek yang
diharapkan tercapai
Angina tidak

10 g/menit

Kenaikan dosis 10

Cara Pemberian

NTG harus diencerkan sebelum pemberian IV, Campuran

pelarut yang sesuai: 5% dextrose atau 0,9 % sodium
chloride injection (NaCl)
Campuran disiapkan dengan cara mengganti volume
nitroglycerin dengan volume yang sama dari larutan
pembawa (misal: 10 mg/50 cc )
NTG: isotonis dan kompatibel dengan larutan infus yang
umumnya digunakan. Tidak ada inkompatibilitas
Kompatibel dengan botol infus gelas, polyethylene, pompa
syringe, syringe plastik atau gelas
Nitroglycerine tidak kompatibel dengan bahan PVC (dapat
terjadi kehilangan zat aktif dalam jumlah banyak <40%) &
polyurethan
Hemodinamik dipantau selama pemberian

Konsentrasi
100 g/ml, 5x10 ml ampul
NTG IV dalam 500 ml

Laju infus
Mikrotetes/menit
ml/jam

Tetes/menit

10

20

12

30

18

40

24

50

30

10

60

36

12

70

42

14

80

48

16

90

54

18

100

60

20

110

66

22

120

72

24

130

78

26

140

84

28

150

90

30

Dosis (g/menit)

Peringatan dan
Perhatian
Monitoring ketat denyut nadi dan tekanan
darah
Pasien menderita hipotiroid, penyakit
ginjal dan hati yang berat, hipotermia dan
malnutrisi
Pasien dengan tekanan desakan kapiler
paru normal atau rendah dapat menjadi
sensitif khususnya terhadap efek hipotensi
Masa kehamilan dan menyusui
Kemanan dan efikasi pada anak belum
diketahui

Efek Samping
Sistem saraf: sakit kepala, pusing
Saluran cerna: mual, muntah dan nyeri
abdomen
Jantung: hipotensi, takikardia, palpitasi,
bradikardia paradoksial
Lain-lain: diaforesis, ketakutan, kekelahan,
rasa tidak nyaman, retrosternal, kejang
otot

Interaksi Obat
Obat penurun tekanan darah seperti: beta
blocker, antagonis kalsium, vasodilator
Alkohol meningkatkan efek nitroglycerin
Efek hipontensif disebabkan oleh obatobat sbb: sidenafil, tadalafil, vardenafil,
neuroleptik dan antidepresan trisiklik

Overdosis
OD ringan: hipotensi dan takikardia
Jika tekanan sistolik turun dibawah 90
mmHg dan denyut jantung meningkat
10% dari nilai awalnya infus sebaiknya
dihentikan
Jika hipotensi menetap atau pada kasus
yang berat, diatasi dengan mengangkat
kaki dan atau memberikan obat yang
meningkatkan tekanan darah atau
menghentikan infus

OD Berat: pemberian methoxamine

Summary
FAST ACTING : Fast onset in 1
minutes
POWERFUL : Strong vasodilator
Recommended by Guidelines
Cost effective

Hypertensive emergency
Large elevations in SBP or DBP (>180
mmHg or >120 mmHg, respectively)
associated with impending or
progressive OD, such as major
neurological changes, hypertensive
encephalopathy, cerebral infarction,
intracranial haemorrhage, acute LV failure,
acute pulmonary oedema, aortic dissection,
renal failure, or eclampsia.

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NICAFER
Composition:
Each ampoule (10 ml) contains
nicardipine HCl
1 mg/ml
Indications:
Emergency treatment of acute
hypertensive crises during
surgery
Hypertensive emergencies
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